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1. Corrigendum to "Enhanced Antitumor Effects of an Engineered Measles Virus Edmonston Strain Expressing the Wild-type N, P, L Genes on Human Renal Cell Carcinoma". Mol Ther; 2010 Jun;18(6):1248

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Corrigendum to "Enhanced Antitumor Effects of an Engineered Measles Virus Edmonston Strain Expressing the Wild-type N, P, L Genes on Human Renal Cell Carcinoma".

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  • (PMID = 28178499.001).
  • [ISSN] 1525-0024
  • [Journal-full-title] Molecular therapy : the journal of the American Society of Gene Therapy
  • [ISO-abbreviation] Mol. Ther.
  • [Language] eng
  • [Publication-type] Published Erratum
  • [Publication-country] United States
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2. Chaudry Q, Raza SH, Young AN, Wang MD: Automated Renal Cell Carcinoma Subtype Classification Using Morphological, Textural and Wavelets Based Features. J Signal Process Syst; 2009 Apr;55(1):15-23

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Automated Renal Cell Carcinoma Subtype Classification Using Morphological, Textural and Wavelets Based Features.
  • : We present a new image quantification and classification method for improved pathological diagnosis of human renal cell carcinoma.
  • The methodologies used for feature extraction include image morphological analysis, wavelet analysis and texture analysis, which are combined to develop a robust classification system based on a simple Bayesian classifier.
  • The misclassified images are significantly different from the rest of images in their class and therefore cannot be attributed to weakness in the classification system.

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  • (PMID = 28133502.001).
  • [ISSN] 1939-8018
  • [Journal-full-title] Journal of signal processing systems
  • [ISO-abbreviation] J Signal Process Syst
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / U54 CA119338
  • [Publication-type] Journal Article
  • [Publication-country] United States
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3. Fernández Rivera C, Alonso Hernández Á, Mosquera Reboredo J, Rodríguez Gómez I: Association of bladder adenocarcinoma and BK virus infection in a pancreatico-renal transplant recipient. NDT Plus; 2010 Jun;3(3):300-302
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Association of bladder adenocarcinoma and BK virus infection in a pancreatico-renal transplant recipient.
  • Viral infection has been related to post-transplantation tumour development, particularly Epstein-Barr virus, human papillomavirus, hepatitis B and C viruses, and herpes virus 8.
  • Recently, BK virus (BKV) has emerged as an important cause of tumour formation in solid organ transplant recipients.
  • BKV oncogenic potential relates to the ability to inactivate the functions of tumour suppression proteins p53 and pRB family, and induction of chromosomal aberrations.
  • We report a case of urinary bladder adenocarcinoma in a pancreatico-renal transplant recipient which was diagnosed 2 years after BKV infection.
  • Immunohistochemical staining for SV-40 was positive in neoplastic cells but negative in non-neoplastic cells.

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  • [Cites] Pediatr Transplant. 2008 Aug;12(5):600-5 [18652620.001]
  • [Cites] Oncogene. 2006 May 4;25(19):2727-35 [16547506.001]
  • [Cites] Transplantation. 2008 Apr 15;85(7 Suppl):S42-8 [18401263.001]
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  • (PMID = 28657060.001).
  • [ISSN] 1753-0784
  • [Journal-full-title] NDT plus
  • [ISO-abbreviation] NDT Plus
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] England
  • [Keywords] NOTNLM ; BK virus / kidney transplantation / renal transplantation / urinary bladder neoplasms
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4. Hara W, Tran P, Li G, Su Z, Puataweepong P, Adler JR, Soltys SG, Chang SD, Gibbs IC: Cyberknife for Brain Metastases of Malignant Melanoma and Renal Cell Carcinoma. Neurosurgery; 2009 Feb 01;64(suppl_2):A26-A32

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cyberknife for Brain Metastases of Malignant Melanoma and Renal Cell Carcinoma.

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  • (PMID = 28173174.001).
  • [ISSN] 1524-4040
  • [Journal-full-title] Neurosurgery
  • [ISO-abbreviation] Neurosurgery
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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5. Kwok Y, Patchell RA: Commentary (Kwok/Patchell): Radiation Therapy in the Management of Brain Metastases From Renal Cell Carcinoma. Oncology (Williston Park); 2006 May 01;20(6)

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Commentary (Kwok/Patchell): Radiation Therapy in the Management of Brain Metastases From Renal Cell Carcinoma.

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  • (PMID = 28326511.001).
  • [ISSN] 0890-9091
  • [Journal-full-title] Oncology (Williston Park, N.Y.)
  • [ISO-abbreviation] Oncology (Williston Park, N.Y.)
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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6. Metastatic renal cell carcinoma presenting as a circumscribed orbital mass. Eur J Ophthalmol; 2008 May-Jun;18(3):483

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Metastatic renal cell carcinoma presenting as a circumscribed orbital mass.
  • PURPOSE: To report a case of renal cell carcinoma presenting as a well-circumscribed orbital tumor.
  • Imaging showed a well circumscribed tumor in the region of the medial rectus muscle.
  • Excision biopsy revealed a diagnosis of metastatic renal cell carcinoma that was confirmed on abdominal imaging.
  • CONCLUSIONS: Renal cell carcinoma can rarely present as a well-circumscribed orbital mass and should be included in the differential diagnosis of such lesions.

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  • (PMID = 28221622.001).
  • [ISSN] 1724-6016
  • [Journal-full-title] European journal of ophthalmology
  • [ISO-abbreviation] Eur J Ophthalmol
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Italy
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7. Chaudry Q, Raza SH, Sharma Y, Young AN, Wang MD: Improving Renal Cell Carcinoma Classification by Automatic Region of Interest Selection. Proc IEEE Int Symp Bioinformatics Bioeng; 2008 Oct;2008

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Improving Renal Cell Carcinoma Classification by Automatic Region of Interest Selection.
  • In this paper, we present an improved automated system for classification of pathological image data of renal cell carcinoma.
  • The task of analyzing tissue biopsies, generally performed manually by expert pathologists, is extremely challenging due to the variability in the tissue morphology, the preparation of tissue specimen, and the image acquisition process.
  • In continuation of our previous work, which proposed a knowledge-based automated system, we observe that real life clinical biopsy images which contain necrotic regions and glands significantly degrade the classification process.

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  • (PMID = 28393153.001).
  • [Journal-full-title] Proceedings. IEEE International Symposium on Bioinformatics and Bioengineering
  • [ISO-abbreviation] Proc IEEE Int Symp Bioinformatics Bioeng
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / U54 CA119338
  • [Publication-type] Journal Article
  • [Publication-country] United States
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8. Ying-Long S, Yue-Min X, Hong X, Xiao-Lin X: Papillary renal cell carcinoma in the horseshoe kidney. South Med J; 2010 Dec;103(12):1272-4
MedlinePlus Health Information. consumer health - Kidney Cancer.

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Papillary renal cell carcinoma in the horseshoe kidney.
  • Papillary renal cell carcinoma in the horseshoe kidney is uncommon.
  • We report a case of papillary renal cell carcinoma in the horseshoe kidney and discuss its incidence, diagnosis, and treatment.
  • [MeSH-major] Carcinoma, Renal Cell / complications. Kidney / abnormalities. Kidney Neoplasms / complications


9. Pascual Samaniego M, González Núñez MA, Bravo Fernández I, Ruiz Serrano M, Ramos Martín JA, García González A: [Synchronous metastases of the spermatic cord from papillary renal cell carcinoma]. Actas Urol Esp; 2007 Apr;31(4):404-10
MedlinePlus Health Information. consumer health - Kidney Cancer.

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Synchronous metastases of the spermatic cord from papillary renal cell carcinoma].
  • [Transliterated title] Carcinoma renal papilar con metástasis sincr6nica en el cordón espermático.
  • Papillary renal cell carcinoma has been related with higher survival rate and lower metastatic cancer mortality rate than clear renal cell carcinoma.
  • We present an aggressive case related to unusual features for this histological type, like a tumor size higher than ten cm, great perirrenal fat and suprarenal gland infiltration, tumoral thrombosis of the infrahepatic cava vein, retroperitoneal adenopatic tumoral infiltration, high nuclear grade and synchronous solitary distant organ metastases of the right spermatic cord, finding three previous cases in the literature with this last feature.
  • Prognostic implication of the papillary renal cell carcinoma type is unclear in cases like this, so probably we need better molecular and cytogenetic studies to get a correct classification of this histological type.
  • [MeSH-major] Carcinoma, Renal Cell / secondary. Genital Neoplasms, Male / secondary. Kidney Neoplasms / pathology. Spermatic Cord

  • Genetic Alliance. consumer health - Papillary renal cell carcinoma.
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  • (PMID = 17633928.001).
  • [ISSN] 0210-4806
  • [Journal-full-title] Actas urologicas españolas
  • [ISO-abbreviation] Actas Urol Esp
  • [Language] spa
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Spain
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10. Lim JC, Wojcik EM: Fine-needle aspiration cytology of papillary renal cell carcinoma: the association with concomitant secondary malignancies. Diagn Cytopathol; 2006 Dec;34(12):797-800
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Fine-needle aspiration cytology of papillary renal cell carcinoma: the association with concomitant secondary malignancies.
  • Papillary renal cell carcinoma is a rare type of renal malignancy.
  • Cytogenetic findings characteristic for this tumor have been described as well as mutations of the proto-oncogene c-met.
  • Secondary malignancies occurring together with papillary renal cell carcinomas are rare, and are often of genitourinary tract origin.
  • We describe two cases of papillary renal cell carcinoma occurring in association with two other visceral malignancies, gastrointestinal stromal tumor and colon adenocarcinoma.Two cases of papillary renal cell carcinoma diagnosed by fine-needle aspiration (FNA), occurring in association with gastrointestinal malignancies were reviewed.
  • Both aspirates showed cytologic features characteristic for papillary renal cell carcinoma, namely papillary structures, foamy histiocytes, intracytoplasmic hemosiderin, and nuclear grooves.
  • Subsequent histology and immunohistochemical stains supported the cytologic diagnosis.
  • The histologic diagnosis of gastrointestinal stromal tumor and colon adenocarcinoma were confirmed.
  • Papillary renal cell carcinoma is a type of renal carcinoma that can be often accurately diagnosed by FNA.
  • The possible role of the protooncogene c-met in the development of these tumors was explored.
  • [MeSH-major] Adenocarcinoma / pathology. Carcinoma, Renal Cell / pathology. Colonic Neoplasms / pathology. Gastrointestinal Stromal Tumors / pathology. Kidney Neoplasms / pathology. Neoplasms, Multiple Primary


11. Billemont B, Hornecker M, Ropert S, Blanchet B, Jais J, Blanchard P, Meric J, Alexandre J, Tod M, Goldwasser F: Correlation of sorafenib plasma concentrations and clinical toxicity: A prospective population pharmacodynamic and pharmacokinetic study. J Clin Oncol; 2009 May 20;27(15_suppl):e14585

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e14585 Background: Sorafenib is an angiogenesis inhibitor recently approved for the treatment of metastatic renal cell carcinoma and hepatocarcinoma.
  • Toxicity events were graded according to National Cancer Institute Common Toxicity Criteria 3.0.
  • RESULTS: Pts (23 males), ECOG 0-1 (27 pts), median age 62.8 years (range 37-78), with metastatic hepato-carcinoma (11), melanoma (6), thyroid cancer (8), renal cell carcinoma (7), received a median treatment duration of 94 days (range : 7-330).

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  • (PMID = 27963746.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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12. Hug B, Boni J, Leister C, Burns J, Sonnichsen D: A single-dose, placebo- and moxifloxacin-controlled 3-period study of the effects of temsirolimus on cardiac repolarization in healthy subjects. J Clin Oncol; 2009 May 20;27(15_suppl):2551

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 2551 Background: Temsirolimus (CCI-779) is a novel selective inhibitor of the mammalian target of rapamycin (mTOR) approved by the US FDA for the treatment of patients with advanced renal cell carcinoma.
  • This study was designed to assess the effect of a single dose of 25 mg IV temsirolimus on the corrected QT interval (QTc) in healthy subjects.
  • At 11 of 12 secondary time points, the upper bound for the temsirolimus QTc 90% CIs for the time-matched change from baseline difference from placebo was less than 10 msec without evidence of QTc trends or relationship to temsirolimus or sirolimus whole blood concentrations.
  • Mean concentrations were comparable to those observed in patients with renal cell carcinoma following administration of 25 mg IV temsirolimus.
  • The findings are consistent with the lack of QTc interval prolongation observed in studies of cancer patients.

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  • (PMID = 27961877.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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13. Kamai T, Tomosugi N, Abe H, Yoshida K: Protein profiling of tumor tissues by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry to discriminate between localized and metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16098

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Protein profiling of tumor tissues by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry to discriminate between localized and metastatic renal cell carcinoma.
  • : e16098 Background: We previously reported that mRNA of interferon-alpha receptor type 2 (IFNAR2) was upregulated in metastatic and IFN-a resistant renal cell carcinoma (RCC) in comparison to localized RCC or metastatic tumors with good response to IFN-a (BMC Cancer, 2007).
  • Protein profiling using human tumor tissues may give insight into cellular pathways leading to carcinogenesis and metastasis in RCC.
  • METHODS: We examined mRNAs expression for IFNAR2 in paired tumor and non-tumor samples from the surgical specimens of Japanese patients with RCC using a real-time reverse transcription polymerase chain reaction.
  • Then we selected representative five IFNAR2 upregulated clear cell carcinomas cases with metastatic tumor, five IFNAR2 upregulated metastatic sarcomatoid carcinomas, and five normal expression clear cell carcinomas with localized tumor.
  • We investigated protein profiling in the tumor tissues of above three groups using surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-TOF MS) coupled with IMAC-Cu chips.
  • The heat map analysis based on the clustering distinguished completely metastatic tumors with IFNAR2 upregulated groups from localized tumors with IFNAR2 normal expression group.
  • Furthermore, the heat map discriminated metastatic sarcomatoid carcinomas from metastatic clear cell carcinomas with a sensitivity of 100% and a specificity of 80%.
  • CONCLUSIONS: SELDI-TOF MS profiling of tumor tissues can be applied to differentiate patients with three types of RCCs.
  • Our findings may reflect different molecular mechanism between localized and metastatic carcinomas, and the different response to immunotherapy with IFN-α.

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  • (PMID = 27963090.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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14. Ritch C, Lee DJ, Desai M, McKiernan JM: Role of obesity and race in predicting recurrence rates and survival in renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16052

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Role of obesity and race in predicting recurrence rates and survival in renal cell carcinoma.
  • However, the relationship between obesity, race, and renal cell carcinoma (RCC) is highly debated.
  • We sought to explore the relationship between BMI and race, and determine the predictors for survival and recurrence after nephrectomy (Nx) for RCC.
  • METHODS: A retrospective analysis of the Columbia Urologic Oncology Database found that 1118 consecutive patients underwent partial or radical Nx for RCC between 1988 and 2008.
  • The two year cancer-specific survival was 89.6%, 92.7%, and 96.1% for normal weight, overweight, and obese patients, respectively (p=0.036).
  • A multivariate Cox regression found that male sex, BMI, size of tumor removed, tumor stage, and margin were independent predictors of RFS.
  • Overweight and obese patients were more likely to survive from RCC without recurrence than normal weight patients (p=0.04).
  • CONCLUSIONS: BMI is an independent predictor of RFS in patients undergoing partial or radical Nx for RCC.

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  • (PMID = 27963003.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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15. Chung EK, Posadas EM, Kasza K, Karrison T, Manchen E, Michalak L, Hahn OM, Stadler WM: A phase II trial of gemcitabine(G), capecitabine (C), and bevacizumab (B) in patients (pts) with metastatic renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):e16072

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II trial of gemcitabine(G), capecitabine (C), and bevacizumab (B) in patients (pts) with metastatic renal cell carcinoma (RCC).
  • : e16072 Background: RCC is resistant to most traditional DNA and DNA repair targeted chemotherapy; although modest response rates to nucleotide analog based therapy, including GC, have been reported.
  • Bevacizumab has activity in RCC.
  • We thus performed a single center phase II trial of GCB in pts with metastatic RCC.
  • METHODS: Eligibility included clear cell or unclassified histologies, performance status 0-1, measurable disease, normal organ function and no prior treatment with VEGF binding agents or pyramidine analogs.
  • Following significant hematotoxicity in the first 7 of 8 pts, chemotherapy was modified to G 1,000 mg/m2 (days 1, 8), C 1,000 mg po bid (days 1-14) and B 15 mg/kg (day 1) on a 21 day cycle with disease re-evaluation every 3 cycles.

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  • (PMID = 27963038.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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16. Gruenwald V, Fenner M, Varvenne M, Reuter C, Ganser A, Ivanyi P: Association of therapy with sunitinib and treatment-related hyperparathyroidism in renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16023

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Association of therapy with sunitinib and treatment-related hyperparathyroidism in renal cell carcinoma.
  • Here, we report on abnormalities of the mineral metabolism in patients with renal cell carcinoma (RCC) treated with MTKI.
  • METHODS: We identified a total of 61 patients with metastatic RCC and evaluable markers of bone metabolism, which were either treated at our institution (N=53) or followed (N=8) during March 2005 and December 2008.
  • Patients received either sunitinib (4 weeks on/2 weeks off schedule) or sorafenib (continuous dosing) for metastatic disease.

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  • (PMID = 27962981.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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17. Hong T, Ryan DP, Blaszkowsky LS, Mamon HJ, Mino-Kenudson M, Adams J, Yeap B, Winrich B, DeLaney TF, Fernandez-Del Castillo C: Phase I study of preoperative (pre-op) short course chemoradiation (CRT) with proton beam therapy (PBT) and capecitabine (cape) for resectable pancreatic ductal adenocarcinoma (PDAC) of the head. J Clin Oncol; 2009 May 20;27(15_suppl):e15536

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase I study of preoperative (pre-op) short course chemoradiation (CRT) with proton beam therapy (PBT) and capecitabine (cape) for resectable pancreatic ductal adenocarcinoma (PDAC) of the head.
  • We explore the feasibility of a one-week course of pre-op CRT with PBT and cape followed by pancreaticoduodenectomy (PD).
  • Eligibility included no CT involvement of SMA or celiac artery; adequate renal, hepatic and hematopoetic function; and ECOG PS 0/1.
  • Reasons for no resections were: metastatic disease-3 and unresectable tumor- 1.
  • Mean resected tumor diameter was 2.9 cm (2.2-4.3).
  • Average percentage of fibrosis in tumor mass was 74%.

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  • (PMID = 27962312.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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18. Perez-Gracia J, Prior C, Guillen-Grima F, Gonzalez A, Panizo A, Segura V, Grande-Pulido E, Gurpide A, Melero I, Calvo A: Identification of baseline predictive markers of sunitinib activity using a human cytokine antibody array in patients with metastatic renal cell carcinoma (MRCC). J Clin Oncol; 2009 May 20;27(15_suppl):5113

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Identification of baseline predictive markers of sunitinib activity using a human cytokine antibody array in patients with metastatic renal cell carcinoma (MRCC).
  • USA) which evaluates 174 cytokines related to angiogenesis and tumor proliferation pathways and has been validated in clinical studies.
  • Following array data normalization, the most relevant cytokines based on statistical significance and on biological plausibility, were assessed with ELISA in the whole group of patients and the results were correlated with clinical benefit (response or disease stabilization) or progression.
  • TNF-α and MMP-9 baseline levels were significantly increased in non-responders and they were significantly associated with progression-free and overall survival respectively.

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  • (PMID = 27964392.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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19. Pelz HF, Krekeler G, Bergmann L, Roigas J, Steiner T, Loeschmann PA, Kosch M: Evaluation of safety, tolerability, and activity: A registry for temsirolimus-treated patients with advanced or metastatic renal cell carcinoma (aRCC) in the usual health care setting. J Clin Oncol; 2009 May 20;27(15_suppl):e16127

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Evaluation of safety, tolerability, and activity: A registry for temsirolimus-treated patients with advanced or metastatic renal cell carcinoma (aRCC) in the usual health care setting.
  • Up to the December 15, 2008, 124 centers have recruited 130 patients.

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  • (PMID = 27963375.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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20. Harrison MR, Pili R, Logan T, Wilding G, Eickhoff J, Sidor C, Staab M, Arnott J, Liu G: Phase II study of 2-methoxyestradiol NanoCrystal dispersion (2ME2) alone and in combination with sunitinib (SU) in patients with metastatic renal cell carcinoma (mRCC) progressing on SU. J Clin Oncol; 2009 May 20;27(15_suppl):e16116

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of 2-methoxyestradiol NanoCrystal dispersion (2ME2) alone and in combination with sunitinib (SU) in patients with metastatic renal cell carcinoma (mRCC) progressing on SU.
  • : e16116 Background: Panzem NCD (2ME2) is a non-estrogenic derivative of estradiol with antiproliferative and antiangiogenic activity that downregulates HIF-1α.
  • METHODS: Pts with clear cell mRCC who had previously received or were currently receiving SU with disease progression were eligible.
  • Simon optimal 2-stage design was used with plans to enroll 21 pts/arm, and if activity was seen to continue enrollment for a total of 41 pts/arm.
  • Reasons for treatment discontinuation include: disease progression (7), pt/doctor discretion (3), AE (3), and noncompliance (1).
  • CONCLUSIONS: 2ME2 appears to have some single-agent activity, with an MR in a pt removed from study due to AE and a metabolic PR (ΔSUVmax -84%) in a pt with SD by RECIST.

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  • (PMID = 27963313.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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21. Rini BI, Halabi S, Rosenberg J, Stadler WM, Vaena DA, Atkins JN, Picus J, Czaykowski P, Dutcher J, Small EJ: Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: Results of overall survival for CALGB 90206. J Clin Oncol; 2009 May 20;27(15_suppl):LBA5019

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: Results of overall survival for CALGB 90206.

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  • (PMID = 27961198.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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22. Plimack ER, Wong Y, Von Mehren M, Malizzia L, Roethke SK, Li T, Litwin S, Hudes GR, Haas NB: A phase I study of temsirolimus (TEM) and bryostatin (BRYO) in patients with metastatic renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):5111

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase I study of temsirolimus (TEM) and bryostatin (BRYO) in patients with metastatic renal cell carcinoma (RCC).
  • : 5111 Background: TEM, an inhibitor of mTOR complex 1 (TORC1), is approved for the treatment of metastatic RCC.
  • BRYO inhibits protein kinase C, a downstream effector of mTOR complex 2 (TORC2).
  • We observed additive effects of TEM and BRYO against RCC in vitro.
  • Eighteen pts had RCC: clear cell (12), papillary (3), clear cell with sarcomatoid/spindle features (2), unclassified (1), Among RCC pts, 3 had no prior therapy.
  • Five non-RCC pts (4 sarcoma, 1 paraganglioma) received up to 3 cycles of treatment.
  • One additional non-RCC pt (prior radiation) experienced DLT (Gr 3 neutropenia) at TEM 37.5 mg.
  • Among RCC pts, there were no 1<sup>st</sup> cycle DLT's.
  • One RCC pt withdrew prior to receiving treatment.
  • Of the 17 remaining RCC pts, 3 had PRs and 9 had SD.
  • One treatment naïve pt (TEM 15 mg) continues with PR for 2+ years after discontinuing treatment.
  • One pt (had progressed on sunitinib) continues in a PR at 14+ months.
  • PR was seen in both clear cell and papillary histologies.
  • Two pts, both with PR, remain on treatment, having received 18 and 8 cycles.
  • CONCLUSIONS: The TEM/Bryo combination is feasible for multiple cycles on a weekly schedule at full doses of each agent with durable PR and SD in RCC refractory to other therapies.

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  • (PMID = 27964394.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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23. Battaglia M, Gernone A: Long-term use of sorafenib (SOR) in metastatic renal cell carcinoma (mRCC) previously treated with systemic therapy. J Clin Oncol; 2009 May 20;27(15_suppl):e16123

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term use of sorafenib (SOR) in metastatic renal cell carcinoma (mRCC) previously treated with systemic therapy.
  • : e16123 Background: The recent development of new targeted agents for the treatment of advanced RCC has definitely changed the approach and the outcome of this disease.
  • RESULTS: To date, 20 pts are evaluable for response: of them, 13 (59%) achieved a partial response (PR) after 3 mos. of therapy whose median duration was 13 mos. (range, 7-18), while 7 (31%) remained with stable disease (SD) with a median length of 14 mos. (range, 5-17).
  • Among those who progressed (2 pts), the median time to disease progression was 7 mos.
  • However, notwithstanding the rather small sample size of pts., the overall clinical benefit rate (PR+SD) turned out particularly high (> 90%): chiefly, the evidence of a long lasting disease control both for patients achieving partial response and for those with stable disease makes SOR a very useful treatment for patients with mRCC.

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  • (PMID = 27963393.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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24. van der Veldt A, Meijerink MR, van den Eertwegh AJ, Haanen JB, Boven E: Choi response criteria for prediction of clinical outcome in patients with metastatic renal cell cancer treated with sunitinib. J Clin Oncol; 2009 May 20;27(15_suppl):5044

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Choi response criteria for prediction of clinical outcome in patients with metastatic renal cell cancer treated with sunitinib.
  • : 5044 Background: Sunitinib (SU) has been approved for the treatment of metastatic renal cell cancer (mRCC).
  • Since SU can induce extensive necrosis, RECIST may be inappropriate for tumor response evaluation.
  • According to Choi criteria partial response (PR) was defined as ≥10% decrease in size or ≥15% decrease in density, while progressive disease (PD) was defined as ≥10% increase in size without meeting PR criteria by density.
  • RESULTS: For RECIST and Choi criteria, respectively, 230 and 156 tumor lesions were eligible.
  • At first evaluation, according to RECIST 7 pts had PR, 39 stable disease (SD), and 10 PD, while according to Choi criteria 33 pts had PR, 8 SD and 15 PD.
  • The median tumor density decreased significantly (Wilcoxon Signed Ranks test, p ≤ 0.001).
  • At first evaluation in patients with PR, Choi criteria had a significantly better predictive value for PFS and OS (p < 0.001 and p < 0.001, respectively) than RECIST (p = 0.384 and p = 0.392, respectively).
  • For clinical benefit (PR+SD), the predictive value of RECIST and Choi criteria for PFS and OS were comparable (both p < 0.001).

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  • (PMID = 27962953.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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25. Schipperus M, Cornfeld M, Rijnbeek B, Berns B, Rossi J: CNTO328 (Anti-IL-6 mAb) treatment and hemoglobin (Hb) levels in renal cell cancer. J Clin Oncol; 2009 May 20;27(15_suppl):e20648

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] CNTO328 (Anti-IL-6 mAb) treatment and hemoglobin (Hb) levels in renal cell cancer.
  • Hepcidin is an important factor in the pathogenesis of 'anemia of chronic disease'.
  • CNTO328 treatment has previously been shown to produce profound Hb increases in Castleman's disease, a disorder caused by deregulated IL-6 production.
  • We subsequently conducted this retrospective review to assess whether CNTO328 treatment is associated with an increase in Hb level in renal cell cancer patients (pts).
  • METHODS: All laboratory results for pts with metastatic renal cell carcinoma in this open label phase 2 study were reviewed.
  • Pts were treated with CNTO328 (6 mg/kg) IV infusions Q2 weeks and were evaluated for tumor response and markers of pharmacodynamic effect.
  • Of 18 pts evaluable for tumor response, 11 (61%) had SD and 7 (39%) had PD.
  • Hb responses were early (by day 8) and independent of tumor response.
  • CONCLUSIONS: Though pts were not anemic at baseline, our results suggest that CNTO328 leads to sustained increase in Hb levels, not correlated with tumor response.
  • This increase in Hb is presumably due to the reduction of hepcidin via IL-6 blockade and targeting the hepcidin pathway may lead to new therapies for anemia of cancer.

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  • (PMID = 27961655.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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26. Schwandt A, Garcia JA, Elson P, Wyckhouse J, Finke JH, Ireland J, Triozzi P, Zhou M, Dreicer R, Rini BI: A translational phase II trial of celecoxib plus interferon-alpha (IFN-α2b) in metastatic renal cell carcinoma (RCC) patients (pts) with 3+ COX-2 tumor immunostaining. J Clin Oncol; 2009 May 20;27(15_suppl):5116

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A translational phase II trial of celecoxib plus interferon-alpha (IFN-α2b) in metastatic renal cell carcinoma (RCC) patients (pts) with 3+ COX-2 tumor immunostaining.
  • : 5116 Background: Cyclooxygenase-2 (COX-2) has been correlated with RCC stage and grade, and overexpression can lead to dysregulation of dendritic cells (DC) and CD4+/CD25+/FOXP3+ regulatory T cells (Treg).
  • A previous trial of celecoxib in combination with IFNα2b in RCC (Rini et al, Cancer.
  • 2006) demonstrated an association between more intense COX-2 RCC tumor staining and clinical response.
  • METHODS: Pts with cytokine-naïve mRCC with at least 10% maximal COX-2 tumor staining received IFNα2b MU five times/week plus celecoxib 400 mg BID continuously.
  • Baseline tumor tissue was stained for COX-2, CD4+ and CD8+ T cells, Treg and DC (s100 and CD208).
  • Peripheral blood prostaglandin E2 (PGE2), DC and Treg number/function and intracellular T cell cytokine production were measured at baseline, at the end of cycles 2 and 4 and at end of treatment.
  • Immune parameters were analyzed using non-parametric methods.
  • The ORR was 21% and 69% of pts experienced tumor shrinkage.
  • Baseline 3+ COX-2 staining was associated with elevated peripheral blood PGE2 levels (p = 0.02), reduced DC IL-12 expression (p = 0.04) and reduction in IFN gamma-producing CD3+CD4+ T-cells (p = 0.04) compared to a control group of RCC pts with <10% 3+ COX-2 staining (n = 21).
  • No significant changes in immunomodulatory cells were observed with therapy.
  • COX-2 RCC tumor expression promotes an immunosuppressive phenotype.

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  • (PMID = 27964389.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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27. Heymach J, Jonasch E, Wang X, Du DZ, Yan S, Xu L, Herynk MH, McKee KS, Tran HT, Tannir NM, Zurita AJ: A cytokine and angiogenic factor (CAF) plasma signature for selection of sorafenib (SR) therapy in patients (pts) with metastatic renal cell carcinoma (mRCC). J Clin Oncol; 2009 May 20;27(15_suppl):5114

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A cytokine and angiogenic factor (CAF) plasma signature for selection of sorafenib (SR) therapy in patients (pts) with metastatic renal cell carcinoma (mRCC).
  • : 5114 Background: SR, an oral inhibitor of Raf kinase, RET-receptor (R), VEGFR-1, 2, and 3, PDGFR-β, FLT-3, and c-KIT tyrosine kinases, has been shown to prolong progression-free survival (PFS) in mRCC after cytokine failure.
  • Plasma was collected from 69 pts at baseline (BL; SR 34, SR+IFN 35), 59 on day (D) 28, and 57 pts on D56.
  • The primary objective of this analysis was to establish a CAF signature based on a set of individual markers at BL with a significant and differential impact on the association between treatment arm and PFS.
  • RESULTS: Among 52 CAFs available at BL, higher than median EGF concentrations associated with poor outcome independently of treatment arm, whereas low IL-2 had the opposite effect (p = 0.003 for both).
  • Only OPN showed a significant treatment by factor interaction at BL (p < 0.01), suggesting that OPN has a differential effect on PFS in the two arms.
  • A 6-marker CAF signature at BL containing OPN, sCA9, VEGF, sVEGFR-2, ColIV, and TRAIL demonstrated predictive value on PFS.

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  • (PMID = 27964391.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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28. Srinivasan R, Linehan WM, Vaishampayan U, Logan T, Shankar SM, Sherman LJ, Liu Y, Choueiri TK: A phase II study of two dosing regimens of GSK 1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in patients (pts) with papillary renal carcinoma (PRC). J Clin Oncol; 2009 May 20;27(15_suppl):5103

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II study of two dosing regimens of GSK 1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in patients (pts) with papillary renal carcinoma (PRC).
  • Two of 4 PRC pts treated with intermittent dosing of GSK089 on a Phase I study sustained partial responses (PR) for 1 and > 3 years respectively.
  • In cohort 1, of the 35 evaluable pts, 4 pts (2 HPRC and 2 SPRC) had confirmed PRs and 27 had stable disease (SD) as best response with 6 ≥12mo, 3 ≥ 9mo and 3 ≥ 6mo.
  • Four of 5 HPRC pts (1 not evaluated) had shrinkage (15-53%) in all measurable tumors.
  • Twenty-three SPRC pts had shrinkage (2-58%) in the sum of measurable tumors.
  • CONCLUSIONS: GSK089 is well tolerated and demonstrates anti-tumor activity in pts with PRC with both 5-on/9-off and daily dosing.

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  • (PMID = 27964374.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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29. McGhie J, Mackenzie MJ, Winquist E, Ernst S, Sax L, O'Brien P: Cardiovascular events (CVEs) associated with tyrosine kinase inhibitor (TKI) therapy in patients with metastatic renal cell carcinoma (mRCC) at a regional cancer center. J Clin Oncol; 2009 May 20;27(15_suppl):e16040

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cardiovascular events (CVEs) associated with tyrosine kinase inhibitor (TKI) therapy in patients with metastatic renal cell carcinoma (mRCC) at a regional cancer center.
  • Data was retrospectively extracted including age, sex, diagnosis, histology, past cardiac history, cardiac risk factors, number and type of TKI regimens, and CVEs.
  • Average age was 61 years (range, 23-78), 72% were male and 80% were clear cell in origin.

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  • (PMID = 27963022.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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30. Sher AF, Chu D, Wu S: Risk of bleeding in cancer patients treated with the angiogenesis inhibitor bevacizumab: A meta-analysis. J Clin Oncol; 2009 May 20;27(15_suppl):9584

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Risk of bleeding in cancer patients treated with the angiogenesis inhibitor bevacizumab: A meta-analysis.
  • : 9584 Background: Bleeding is a serious adverse event associated with bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor (VEGF) used extensively in the treatment of cancer.
  • This study was conducted to determine the overall risk of bleeding associated with bevacizumab in cancer patients by a meta-analysis of randomized controlled trials (RCT).
  • RESULTS: A total of 13048 patients with a variety of solid tumors from 20 RCTs were included for analysis.
  • The risk of bleeding with bevacizumab may vary with tumor type, with higher risk seen in patients with colorectal cancer (RR=6.6, 95% CI: 3.6-12.2) and renal cell cancer (RR=3.7, 95% CI: 2.6-5.5).
  • Bevacizumab is associated with different patterns of bleeding, with epistaxis being the most common.
  • CONCLUSIONS: There is a significant increase in the risk of bleeding in cancer patients receiving bevacizumab.
  • The risk may vary with the dose of bevacizumab and tumor type.

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  • (PMID = 27963709.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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31. Booth CM, Li G, Mackillop WJ: The impact of socioeconomic status (SES) on stage of cancer at time of diagnosis: A population-based study in Ontario, Canada. J Clin Oncol; 2009 May 20;27(15_suppl):6505

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The impact of socioeconomic status (SES) on stage of cancer at time of diagnosis: A population-based study in Ontario, Canada.
  • : 6505 Background: Lower SES is known to be associated with worsened cancer survival.
  • Here we evaluate the impact of SES on stage of cancer at diagnosis in Ontario which has universal health insurance.
  • METHODS: All incident cases of breast, colon, rectal, non-small cell lung, cervical and larynx cancer diagnosed in Ontario 2003-2005 were identified using the Ontario Cancer Registry.
  • Stage information is only captured routinely for patients seen at Ontario's 8 Regional Cancer Centers (RCCs).
  • Using a best stage grouping approach, cases were assigned stage based on pathologic TNM if available and clinical TNM otherwise.
  • Using postal code at time of diagnosis cases were assigned to quintiles (Q); Q1 represents the communities where the poorest 20% of the Ontario population resided.
  • A Cox model was used to evaluate overall survival, SES, stage, and age.
  • RESULTS: Stage at diagnosis was available for 19,239/23,254 (83%) of cases seen at RCCs.
  • Among cases with breast cancer, those in Q1 were less likely to have stage I disease (43 vs 47%, p = 0.004) and more likely to have stage IV disease (5 vs 4%, 0.008) than Q2-5.
  • With lung cancer, cases in Q1 were more likely to have stage I disease compared to Q2-5 (16 vs 13%, p = 0.015).
  • Distribution of stage I and stage IV disease did not differ by SES across other individual diseases.
  • However, for all 6 cancers combined, cases in Q1 were less likely than Q2-5 to have stage I disease (27 vs 30%, p = 0.001) and more likely to have stage IV disease (21 vs 18%, p < 0.0001).
  • We found significant gradients in 3-year overall survival across Q1-Q5 for breast (5% absolute difference in survival, p < 0.001), colon (4%, p = 0.049), and cervical (18%, p = 0.031) cancers.
  • Adjustment for stage and age only slightly diminished these survival gradients.
  • CONCLUSIONS: Despite universal health care, SES remains associated with survival among patients with cancer in Ontario.
  • These data suggest that the difference in outcome is only partially explained by differences in stage at diagnosis.

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  • (PMID = 27964005.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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32. Secter M, MacKenzie MJ, O'Brien P, Whiston F: Skeletal related events in patients with metastatic renal cell carcinoma: A retrospective review. J Clin Oncol; 2009 May 20;27(15_suppl):e16118

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Skeletal related events in patients with metastatic renal cell carcinoma: A retrospective review.
  • : e16118 Background: Approximately one third of patients with renal cell carcinoma (RCC) will develop bone metastases during the course of their disease.
  • Previous studies suggest that the rate of skeletal related events (SREs) in patients with metastatic renal cell carcinoma is high, and that bisphosphonate therapy can lower the rate of SREs.
  • We conducted a retrospective review of patients with metastatic renal cell carcinoma and bone metastases seen at our academic cancer centre.
  • METHODS: After approval by the Research Ethics Board, a retrospective review of all patients seen at the London Regional Cancer Centre with a diagnosis of RCC between January 2006 and December 2008 was performed.
  • RESULTS: 196 patients with metastatic RCC were identified.
  • Common sites of metastases were vertebra (66%), pelvis (50%), and femur (42%).
  • CONCLUSIONS: Despite significant recent improvements in the overall care of RCC, and expansion of the number of therapeutic options, bone metastases and consequent SREs continue to cause significant morbidity.
  • Our rate of SREs is actually higher than that documented in the placebo arm of a randomized trial of a bisphosphonate in RCC from the pre-tyrosine kinase era.

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  • (PMID = 27963309.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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33. Grozav AG, Willard B, Kinter M, Vaziri SA, Bukowski RM, Rini BI, Ganapathi MK, Ganapathi R: Target identification by phosphoproteomics: RIN1 modulation of sorafenib-induced cytotoxicity in renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e14543

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Target identification by phosphoproteomics: RIN1 modulation of sorafenib-induced cytotoxicity in renal cell carcinoma.
  • : e14543 Background: Sorafenib (SFB) is a multi-tyrosine kinase inhibitor clinically useful in treatment of metastatic renal cancer.
  • METHODS: In this study we used targeted phosphoproteomics to identify tyrosine phosphorylated proteins that are differentially affected in control and SFB-treated human CAKI-1 renal cell carcinoma cells.
  • RESULTS: Among identified proteins, signal transducer and activator of transcription 1 (STAT1) and Ras and Rab interactor 1 (RIN1) were found to be hypophosphorylated in SFB-treated compared to untreated CAKI-1 cells based on quantitative MS analysis, by peptide counts and native peptide reference method.
  • A ∼4-fold decrease in expression and phosphorylation of STAT1 was observed in cells treated with 10 μM SFB for 48h.
  • Similar effects on decreased phosphorylation of STAT1 and RIN1 were also observed in 786-O renal cell carcinoma treated with SFB.
  • Hypophosphorylation of RIN1 at tyrosine 36 was observed in CAKI-1 cells treated with 5 μM sunitinib but not with imatinib (≤ 10 μM).
  • Treatment of CAKI-1 cells with RIN1 targeted, but not control si-RNA led to down-regulation of RIN1 expression and attenuation of antiproliferative effects of SFB.
  • Notably, ∼2-fold higher expression of RIN1 protein (total and phosphorylated) was observed in CAKI-1 cells selected for resistance following continuous exposure to 7.5 μM SFB.
  • However, unlike parent CAKI-1 cells, prolonged exposure of these SFB-resistant CAKI-1 cells to 7.5 μM SFB did not completely abrogate phosphorylation of RIN1 at tyrosine 36.
  • CONCLUSIONS: These results demonstrate that RIN1, a Ras effector protein with multiple biochemical functions, is a target for the anti-tumor effects of SFB in kidney cancer cells.

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  • (PMID = 27963618.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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34. Naito S, Eto M, Shinohara N, Tomita Y, Fujisawa M, Namiki M, Nishikido M, Usami M, Tsukamoto T, Akaza H: A phase II study of S-1 for the treatment of cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5100

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II study of S-1 for the treatment of cytokine-refractory metastatic renal cell carcinoma.
  • The purpose of this study was to evaluate the efficacy and safety of S-1 in cytokine-refractory metastatic renal cell carcinoma (mRCC), and to examine the relation between response and mRNA expression levels of 5-FU-related enzymes.
  • METHODS: Eligible patients had a histologically confirmed diagnosis of clear cell or papillary type of RCC, measurable lesions, treatment histories with cytokines, an ECOG performance status of 0 or 1 (2 was allowed in patients with bone metastasis), an age of at least 20 years, prior nephrectomy, and adequate organ functions.
  • The most common grade 3-4 adverse events assessed according to the CTCAE v.3.0 included anemia (6.7%), neutropenia (8.9%), anorexia (8.9%), hyperglycemia (6.7%), stomatitis (4.4%), diarrhea (4.4%), and fatigue (4.4%).
  • Measurement of the mRNA level of 5-FU-related enzyme in tumors before treatment may facilitate prediction of the response to S-1.

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  • (PMID = 27964380.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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35. Barbastefano J, Garcia JA, Elson P, Wood LS, Lane BS, Dreicer R, Campbell S, Rini BI: Association of percentage of tumor burden removed with debulking nephrectomy and progression-free survival (PFS) in metastatic renal cell carcinoma (mRCC) patients (Pts) treated with VEGF-targeted therapy. J Clin Oncol; 2009 May 20;27(15_suppl):5095

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Association of percentage of tumor burden removed with debulking nephrectomy and progression-free survival (PFS) in metastatic renal cell carcinoma (mRCC) patients (Pts) treated with VEGF-targeted therapy.
  • The objective of this study was to determine if fractional percentage of tumor volume (FPTV) removed with debulking nephrectomy is associated with PFS on subsequent VEGF-targeted therapy.
  • FPTV was determined by the diameter of the primary tumor divided by the total tumor burden (per RECIST criteria) by investigator re-review of imaging studies.
  • PFS was defined from the start date of systemic therapy to disease progression per RECIST criteria.
  • RESULTS: Seventy-five Pts were identified; 76% male, median age 60 years (range, 34-84), 95% clear cell histology and 69% ECOG PS 0.
  • The median diameter of the primary tumor was 9.3 cm (range, 3.3-21 cm).
  • In univariable analysis, the FPTV removed was associated with prolonged PFS (p < 0.001), as were low nuclear grade (p = 0.009), longer interval from diagnosis to treatment (p = 0.05), normal hemoglobin (p = 0.02), number of metastatic sites (p = 0.05), and lack of lung (p = 0.05) and brain (p = 0.05) metastasis.
  • In multivariable analysis, the FPTV removed, as well as the interval from diagnosis to treatment (p = 0.03), were found to be independent predictors of PFS (< 0.001).
  • CONCLUSIONS: Improved PFS on targeted systemic therapy is significantly associated with a greater percentage of tumor burden removed at debulking nephrectomy.

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  • (PMID = 27964293.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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36. Cella D, Michaelson MD, Cappelleri JC, Bushmakin AG, Charbonneau C, Kim ST, Li JZ, Motzer RJ: Quality of life (QOL) with sunitinib versus interferon-alfa (IFN-α) as first-line therapy in patients with metastatic renal cell carcinoma (mRCC): Final results. J Clin Oncol; 2009 May 20;27(15_suppl):6529

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Quality of life (QOL) with sunitinib versus interferon-alfa (IFN-α) as first-line therapy in patients with metastatic renal cell carcinoma (mRCC): Final results.
  • QOL was measured by the Functional Assessment of Cancer Therapy-General (FACT-G), which has 4 subscales, the FACT-Kidney Symptom Index-15 item (FKSI-15), which includes a Disease-Related Symptoms (FKSI-DRS) subscale, and the EQ-5D questionnaire's utility index (EQ-5D Index) and visual analog scale (EQ-VAS).

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  • (PMID = 27964035.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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37. Escudier BJ, Bellmunt J, Negrier S, Melichar B, Bracarda S, Ravaud A, Golding S, Jethwa S, AVOREN Investigators: Final results of the phase III, randomized, double-blind AVOREN trial of first-line bevacizumab (BEV) + interferon-α2a (IFN) in metastatic renal cell carcinoma (mRCC). J Clin Oncol; 2009 May 20;27(15_suppl):5020

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Final results of the phase III, randomized, double-blind AVOREN trial of first-line bevacizumab (BEV) + interferon-α2a (IFN) in metastatic renal cell carcinoma (mRCC).
  • METHODS: Eligible pts had predominantly clear-cell mRCC, prior nephrectomy, no prior systemic therapy for metastatic disease, KPS ≥70%, no CNS metastases and adequate organ function.
  • Pts were randomised to IFN (9MIU tiw) + BEV (10 mg/kg q2w) or placebo until disease progression.
  • An independent radiological review confirmed previous investigator assessments, showing PFS of 10.4 vs 5.5 months (HR 0.57) and a response rate of 31% vs 12% in the two arms, verifying the robustness of the investigator analysis.

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  • (PMID = 27962907.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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38. Angevin E, Lopez JA, Pande A, Moldovan C, Shi M, Soria JC, Wang X, Harzstark A, Saro J, Escudier B: TKI258 (dovitinib lactate) in metastatic renal cell carcinoma (mRCC) patients refractory to approved targeted therapies: A phase I/II dose finding and biomarker study. J Clin Oncol; 2009 May 20;27(15_suppl):3563

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] TKI258 (dovitinib lactate) in metastatic renal cell carcinoma (mRCC) patients refractory to approved targeted therapies: A phase I/II dose finding and biomarker study.
  • : 3563 Background: TKI258 is a potent receptor tyrosine kinase inhibitor (TKI) that selectively targets VEGFR, PDGFR, FGFR, CSF1R, c-KIT, RET, TrKA, and FLT3.
  • Preliminary evidence of efficacy is observed with one minor response (-17% at C4), 4 stable disease and 1 dramatic shrinkage/necrosis of some target lesions (lymph node & suprarenal mass).

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  • (PMID = 27961690.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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39. Bhatia S, Heath E, Puzanov I, Miller W Jr, Curti B, Gordon M, Ernstoff M, Hausman D, Hunder N, Thompson J: Phase II study of recombinant IL-21 (rIL-21) plus sorafenib as second- or third-line therapy for metastatic renal cell cancer (mRCC): Final results. J Clin Oncol; 2009 May 20;27(15_suppl):3023

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of recombinant IL-21 (rIL-21) plus sorafenib as second- or third-line therapy for metastatic renal cell cancer (mRCC): Final results.
  • There is an unmet need for novel therapies after failure of vascular endothelial growth factor (VEGF)-directed agents. rIL-21, a cytokine that enhances CD8+ T-cell and NK cell activity, has single-agent antitumor activity (J Clin Oncol. 2008;26:2034).
  • Based on promising results of a phase I study of rIL-21 plus sorafenib, we initiated a phase II study to explore the safety and efficacy of this combination as second- or third-line treatment for mRCC.
  • Twelve patients remain on study; 13 withdrew for progressive disease (PD), 6 for toxicity, and 2 for other reasons.
  • IRR has been performed for the first 23 patients who completed at least 1 full TC, with 6 confirmed PR (26%), 1 unconfirmed PR (4%), 14 SD (61%), and 2 PD (9%).

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  • (PMID = 27962069.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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40. Choueiri TK, Regan M, Oh W, Clement J, Amato A, McDermott D, Cho D, Atkins M, Signoretti S: Prognostic and predictive values of carbonic anhydrase IX (CAIX) and pathologic features in patients with metastatic clear cell renal cell carcinoma receiving targeted therapy. J Clin Oncol; 2009 May 20;27(15_suppl):e16067

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Prognostic and predictive values of carbonic anhydrase IX (CAIX) and pathologic features in patients with metastatic clear cell renal cell carcinoma receiving targeted therapy.
  • : e16067 Background: Tumor Carbonic Anhydrase IX (CAIX) expression and histologic features can predict outcome in patients with metastatic renal cell carcinoma (mRCC) treated with immunotherapy.
  • METHODS: We identified 118 patients with mRCC initiating first- line VEGF-targeted therapy including 94 with clinical data, clear cell histology and available tissue.
  • Tumors were evaluated for specific histologic features and for CAIX expression by immunohistochemistry using the MN75 antibody.
  • The relationship between these pathology findings and tumor shrinkage and other treatment outcomes was assessed.
  • RESULTS: Higher tumor clear cell component was independently associated with greater tumor shrinkage (p=0.02), response (p=0.02) and treatment duration (p=0.02).
  • Patients with high vs. low tumor CAIX expression had mean tumor shrinkages of -12% vs. -5%, respectively (p=.38).
  • There was heterogeneity in tumor responsiveness to sunitinib or sorafenib according to CAIX status (p=0.055 for interaction): mean shrinkage was -17% vs. -25% (mean difference +8%, 95% CI -14% to +31%) for sunitinib-treated patients with high vs. low tumor CAIX expression compared to -13% vs. +9% (mean difference -22%, 95% CI -42% to -1%) for sorafenib-treated patients.
  • CONCLUSIONS: Patients with higher clear cell component in their tumors are likely to experience superior clinical benefit from VEGF-targeted therapy.
  • Although CAIX expression was not found to be of prognostic value in patients with clear cell mRCC treated with VEGF-targeted therapy, it may be a predictive biomarker for response to sorafenib treatment.

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  • (PMID = 27963063.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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41. Goldberg J, Demetri GD, Choy E, Rosen L, Pappo A, Dubois S, Geller J, Chai F, Ferrari D, Wagner AJ: Preliminary results from a phase II study of ARQ 197 in patients with microphthalmia transcription factor family (MiT)-associated tumors. J Clin Oncol; 2009 May 20;27(15_suppl):10502

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preliminary results from a phase II study of ARQ 197 in patients with microphthalmia transcription factor family (MiT)-associated tumors.
  • : 10502 Background: ARQ 197 is a selective, non-ATP competitive inhibitor of c-Met, a receptor tyrosine kinase implicated in tumor cell migration, invasion, and proliferation.
  • The drug has demonstrated a favorable safety profile and preliminary anti-cancer activity in three phase 1 studies.
  • MiT tumors include clear cell sarcoma (CCS), alveolar soft part sarcoma (ASPS), and translocation-associated renal cell carcinoma (TLA RCC) and are linked biologically by a shared activated transcriptional mechanism which directly upregulates c-Met.
  • Tumors with this type of chromosomal abnormality are generally resistant to all approved therapies and, in the absence of complete surgical resection, prove invariably fatal.
  • METHODS: This is a multi-center, single arm, two-stage phase 2 trial in patients (pts) 13 years of age or older with MiT tumors.
  • If either a complete response (CR) or a partial response (PR) were to be observed in the 23 pts in stage 1, the study would be advanced to stage 2 where 16 additional patients will be enrolled.
  • Tumor responses are measured in 8-week intervals per RECIST criteria.
  • RESULTS: To date, 28 pts (19 females, 9 males; median age = 21; 7 CCS, 17 ASPS, 4 RCC) have been treated.
  • One pt with CCS demonstrated a confirmed PR, 15 pts (10 ASPS, 2 CCS, 3 RCC) demonstrated stable disease (SD) for durations up to 29+ weeks, and 4 pts progressed.
  • An overall response rate of 5% and a disease control rate (CR+PR+SD) of 80% were demonstrated among 20 pts who were evaluable for efficacy.
  • The most common drug-related adverse events (AEs) have been fatigue (35.7%), nausea (35.7%), vomiting (21.4%), decreased hemoglobin (10.7%).
  • CONCLUSIONS: To date, ARQ 197 has demonstrated an extremely favorable safety profile and preliminary evidence of anti-cancer activity in these young pts.
  • The criterion for advancing the study from stage 1 to stage 2 has been met.
  • Stage 2 enrollment is ongoing.

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  • (PMID = 27963690.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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42. Merchan JR, Pitot HC, Qin R, Liu G, Fitch TR, Picus J, Maples WJ, Erlichman C: Phase I/II trial of CCI 779 and bevacizumab in advanced renal cell carcinoma (RCC): Safety and activity in RTKI refractory RCC patients. J Clin Oncol; 2009 May 20;27(15_suppl):5039

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase I/II trial of CCI 779 and bevacizumab in advanced renal cell carcinoma (RCC): Safety and activity in RTKI refractory RCC patients.
  • : 5039 Background: Combined mTOR and VEGF blockade is a potentially promising and rational strategy for the treatment of advanced RCC.
  • We previously reported the phase I safety and efficacy results of CCI 779 (C) +bevacizumab (B) n RTKI naïve stage IV RCC patients (pts) (J Clin Oncol.
  • We now report the interim results of the phase 2 study of C+B in RTKI refractory RCC patients.
  • METHODS: Design: Open label, phase I/II study of C+B in advanced RCC pts.
  • Patients with measurable stage IV RCC with a component of clear/conventional cell type, performance status 0-2 and good organ function were eligible.
  • Most common (>5%) Gr 3-4 AEs (N = 29) included fatigue (6), hypercholesterolemia (2), hypertriglyceridemia (2), anorexia (2), rash (2), and anemia (2).
  • Responses were: PR/SD/PD = 4 (16%)/18 (72%)/3 (12%).
  • Clinical benefit rates (PR/SD) in RTKI refractory RCC patients (88%) are encouraging.
  • Correlative studies on available plasma, serum and tumor samples for angiogenic and molecular biomarkers are underway.

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  • (PMID = 27962933.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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43. Mateus C, Massard C, Tomasic G, Wechsler J, Boige V, Le Cesne A, Soria JC, Escudier B, Robert C: Cutaneous genital complications of antiangiogenic agents. J Clin Oncol; 2009 May 20;27(15_suppl):e14568

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • They were treated with sorafenib (3 pts), sunitinib (5 pts), and a new pan-HER and VEGFR inhibitor (BMS 514, EVRI) (1 pt) for renal cell cancer (4 pts), hepatocellular carcinoma (2 pts), lung cancer (1 pt) and sarcoma (1 pt).
  • CONCLUSIONS: Polymorphous genital inflammatory rash is a new skin side effect that can be associated with any cancer therapies targeting VEGFR in men and in women.

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  • (PMID = 27963696.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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44. Azad NS, Henning R, Yu M, Davidson B, Figg WD, Calvo K, Venkatasen A, Annunziata C, Meltzer P, Kohn E: Translational proof of mechanism (PoM) for sorafenib with bevacizumab: Endpoint analysis and clinical activity. J Clin Oncol; 2009 May 20;27(15_suppl):3574

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 3574 Background: We hypothesized that molecular targeting of tumor and its microenvironment with rational combination therapy would yield improved outcome.
  • Bevacizumab (B) is a monocolonal antibody to vascular endothelial growth factor (VEGFF) and sorafenib (S) is a small molecule inhibitor of the VEGF receptor-2 and RAF-kinase.We have previously reported that S 200mg bid with B 5mg/kg q2wk resulted in partial responses and prolonged disease stabilization (ovarian cancers, renal cell cancer, leiomyosarcoma).
  • Serial tumor biopsies were obtained for translational proof of mechanism analysis.
  • RESULTS: 18 sets of 3 biopsies were obtained, assessed for morphologic response (MR; decrease to <60% viable tumor seen), and processed for TLA and IHC.
  • 11 pts had morphologic response including all 4 PR and 6/12 SD pts.
  • CONCLUSIONS: These exploratory results demonstrate proof of mechanism in the tumor and its microenvironment for the combination of S and B.
  • Phase II studies in multiple tumor types are ongoing.

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  • (PMID = 27961719.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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45. Tunn U, Stenzl A, Kindler M, Strauss A, Miller K, Ruebel A, Albrecht M, Gruenwald V: The effect of zoledronic acid on bone metastasis in patients suffering from renal cell cancer (RCC): A German prospective single-arm clinical trial. J Clin Oncol; 2009 May 20;27(15_suppl):5107

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The effect of zoledronic acid on bone metastasis in patients suffering from renal cell cancer (RCC): A German prospective single-arm clinical trial.
  • : 5107 Background: The incidence of RCC increased over the last decades and about 30% of patients will develop bone metastasis.
  • These pts. face considerable skeletal morbidity e.g. bone pain, pathologic fractures, spinal cord compression or tumor induced hypercalcemia (TIH).
  • A prospective trial was initiated in RCC metastatic to bone evaluating the SRE (skeletal related event) rate under therapy with zoledronic acid (ZA).
  • METHODS: Patients with RCC must have had ≥1 bone metastasis and ≤2 prior applications of a bisphosphonate.
  • Bone lesions response was observed in 3 pts. (2 CR, 1 PR) out of 33 pts. currently available.

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  • (PMID = 27964367.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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46. Norum J, Nieder C, Kondo M: Sunitinib, sorafenib, temsirolimus, or bevacizumab in the treatment of metastatic renal cell carcinoma (RCC): A review of health economic evaluations. J Clin Oncol; 2009 May 20;27(15_suppl):e17539

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Sunitinib, sorafenib, temsirolimus, or bevacizumab in the treatment of metastatic renal cell carcinoma (RCC): A review of health economic evaluations.
  • : e17539 Background: Renal cell carcinoma (RCC) is the most prevalent kidney cancer and the 5-year overall survival figure in metastatic disease (mRCC) is about 10%.
  • The PubMed, ASCO abstracts, Google, and the Igaku Chuo Zasshi databases were searched in November 2008 with key terms: kidney, renal, cancer, cost, sunitinib, sorafenib, temsirolimus, and bevacizumab.
  • As long as cross-over to the experimental arm is allowed (based on improvement in progression free survival) overall survival data are difficult to interpret and the cost difference between the treatment and the control arm minimised.

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  • (PMID = 27963791.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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47. Albouy B, Billemont B, Massard C, Gross-Goupil M, Rixe O, Escudier B: Pancreatic metastasis from renal cell carcinoma: Presentation, recurrence, survival, and response to antiangiogenic therapy. J Clin Oncol; 2009 May 20;27(15_suppl):e16137

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Pancreatic metastasis from renal cell carcinoma: Presentation, recurrence, survival, and response to antiangiogenic therapy.
  • : e16137 Background: Pancreas represents an uncommon site of metastasis in renal cell carcinoma (RCC).
  • We examined the outcome in a series of RCC patients (pts) with pancreatic metastases, treated by either surgery or antiangiogenic therapy.
  • METHODS: We reviewed the charts of RCC pts treated for pancreatic metastases, between 2001 and 2008, in Institut Gustave Roussy and Pitié-Salpetrière Hospital.
  • Data base was reviewed to determine presentation, clinical symptoms, pancreatic metastases treatment, use of systemic therapy, disease-free survival (DFS) or progression-free survival (PFS) and overall survival (OS) after treatment.
  • RESULTS: A total of 40 pts with pancreatic metastases from RCC have been analyzed.
  • Best response was partial response in 30% of pts and stable disease in 50% of pts.
  • CONCLUSIONS: Patients with RCC pancreatic metastases seem to have a longer survival than the usual metastatic RCC pts.
  • Surgical resection must be discussed in pauci-metastatic disease, as it can be associated with prolonged survival.

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  • (PMID = 27963352.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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48. Flaig TW, Costa L, Breaker K, Schultz M, Crighton F, Kim FJ, Drabkin HA: Erlotinib with sirolimus for advanced renal cell carcinoma: Preliminary efficacy results. J Clin Oncol; 2009 May 20;27(15_suppl):e16037

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Erlotinib with sirolimus for advanced renal cell carcinoma: Preliminary efficacy results.
  • : e16037 Background: The mammalian target of rapamycin (mTOR) is an important therapeutic target in the treatment of renal cell carcinoma (RCC).
  • Temsirolimus, an analog of rapamycin, prolongs survival when used to treat high-risk RCC patients and is approved for the treatment of advanced RCC.
  • Pre-clinical data indicate that the combined inhibition of the epidermal growth factor receptor (EGFR) and mTOR results in enhanced anti-cancer activity, especially in cell lines with wt-VHL.
  • METHODS: All patients on this study had metastatic or unresectable renal cell carcinoma with progression despite sunitinib and/or sorafenib.
  • No confirmed complete or partial responses were observed, but meaningful stable disease (SD) (e.g., > 6 months) was noted in a small group of patients.
  • The most common adverse events were rash and diarrhea with the majority of these observed as a grade 1 event.
  • Grade 3 and 4 toxicities included rash, mucositis, neurological motor weakness, dehydration, worsening cardiac function, non-ST elevation MI, and anemia.
  • CONCLUSIONS: The combination of erlotinib and sirolimus produces a median PFS of 12 weeks in a significantly pretreated RCC population, which is not dissimilar to recent results with other mTOR inhibitors in this setting.
  • The toxicity profile of this combination is consistent with the expectations of this pre-treated patient population with advanced RCC.

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  • (PMID = 27962945.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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49. Thayer S, Cooke J, Kaura S: A retrospective database analysis to assess the impact of zoledronic acid (ZOL) on skeletal-related events (SREs) in solid tumor cancer and multiple myeloma (MM) patients (pts). J Clin Oncol; 2009 May 20;27(15_suppl):9518

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A retrospective database analysis to assess the impact of zoledronic acid (ZOL) on skeletal-related events (SREs) in solid tumor cancer and multiple myeloma (MM) patients (pts).
  • : 9518 Background: For cancer pts with malignant bone lesions (BM), SREs including pathologic fracture, spinal cord compression, hypercalcemia of malignancy, and radiotherapy and/or surgery to bone are associated with significant morbidity and mortality and reduced quality of life.
  • ZOL is an IV bisphosphonate (BP) proven to reduce and delay incidence of SREs in several tumor types.
  • Pts older than 18 years with solid tumors (breast, prostate, lung, bladder, or renal cell cancers) or MM and BM diagnosed between Jan 2001 and Dec 2006 were included.
  • CONCLUSIONS: This study showed that in cancer pts with BM, persistence with ZOL resulted in reduced risk of developing first and subsequent SREs.

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  • (PMID = 27964490.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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50. Wulfing C, Herrmann E, Trojan L, Schrader A, Becker F, Stähler M, Haferkamp A, Legal W, Brenner W, Hartmann A, German Papillary Renal Cancer Study Group: Independent validation of the 2002 UICC TNM staging system for papillary renal cell carcinoma in a multicenter cohort. J Clin Oncol; 2009 May 20;27(15_suppl):5092

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Independent validation of the 2002 UICC TNM staging system for papillary renal cell carcinoma in a multicenter cohort.
  • : 5092 Background: Papillary renal cell carcinoma (pRCC) is the second most malignant histologic subtype in nephrectomy specimens.
  • To date, the most recognized staging system to stratify renal cancer patients is the 2002 UICC TNM classification system.
  • The Kaplan-Meier method was used to derive the cumulative cancer-specific survival.
  • RESULTS: 498 (74.1%) patients had organ-confined tumor stages (≤pT2).
  • Synchronous distant metastases in the entire group occurred in 58 (8.7%) patients and 69 (11.2%) others developed metastatic disease during follow-up.
  • Cancer-specific survival (CSS) was significantly related to TNM stage and histologic grading in univariate as well as in multivariate analysis (all p < 0.0001).
  • 5-year CSS in pT1b tumors (90.0%) was significantly shorter compared to pT1a tumors (98.3%) (p = 0.017).
  • Patients with ≥pT3 were at high risk for metastases (50.6%), while metastatic disease associated with ≤pT2 tumors occurred in 7.8% (p < 0.0001).
  • Once metastatic disease was present, prognosis was poor (5-year CSS: 7.2%).
  • Age was associated with a worse prognosis in the subgroup of ≥pT3 tumors in univariate (p = 0.026), but not in multivariate analysis.
  • CONCLUSIONS: The 2002 UICC TNM staging system is applicable for pRCC.
  • Clinical and radiologic follow-ups should be offered in frequent intervals to patients with venous thrombus and/or locally advanced disease.
  • The role of age remains unclear, but should not be underestimated at risk stratification after tumor resection.

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  • (PMID = 27964296.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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51. Hruby G, Van Batavia J, Wosnitzer M, Benson M, Desai M, McKiernan J, Newhouse J: Association of estimated glomerular filtration rate (eGFR) with odds of a renal lesion. J Clin Oncol; 2009 May 20;27(15_suppl):e16025

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Association of estimated glomerular filtration rate (eGFR) with odds of a renal lesion.
  • : e16025 Background: Patients with ESRD on long term hemodialysis are known to be at an increased risk for renal cell carcinoma.
  • We postulate that some component of chronic renal failure not corrected by dialysis might be the tumor-inducing factor.
  • We sought to determine if chronic renal insufficiency is a risk factor for developing renal cell carcinoma.
  • METHODS: A case- control study was used to determine a relationship between renal carcinoma and glomerular filtration rate (MDRD) (eGFR) and using patients with prostate cancer as controls.
  • 1,298 patients from the Columbia University Urologic Oncology Database were identified with either prostate or kidney cancer who had sufficient information to predict eGFR. eGFR calculations were performed for both groups. eGFR was divided into two groups based upon the cut-off value of ≥90. eGFR was also categorized according to the MDRD definitions of chronic kidney disease (CKD), CKD1-4 (values≥90, 60≤values<90, 30≤values<60, and values<30, respectively).
  • Logistic regression techniques were used to quantify the association between pre-operative glomerular filtration rate and the presence of renal or prostate cancer.
  • RESULTS: The mean age of the prostate (n=713) and kidney (n=585) group was 59.9 and 61 years, respectively (p=0.041).
  • The first model found eGFR <90 was significantly associated with the presence of a renal carcinoma when controlling for age and race (OR=1.93, CI=1.49-2.49).
  • The second model investigated the eGFR-CKD categories while controlling for age and race and was able to predict the presence of renal cancer (p < 0.001).
  • Patients with an eGFR value of 60≤X<90 had an OR of 1.47 (CI= 1.13-1.92) for renal cancer when compared to patients with normal eGFR levels.
  • CONCLUSIONS: Diminished renal function showed a significant association with the presence of renal cancer.
  • Chronic renal insufficiency may be a risk factor for the development of renal carcinoma.

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  • (PMID = 27962983.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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52. Liu Z, Burke J, Zheng J, Johnson J: Survival and association with time to treatment change in patients with metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16160

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Survival and association with time to treatment change in patients with metastatic renal cell carcinoma.
  • : e16160 Background: Metastatic renal cell carcinoma (MRCC) is associated with high mortality rates.
  • METHODS: Administrative claims data from a large, US managed care plan were used to identify commercially insured and Medicare patients with newly diagnosed MRCC from 01/01/03-12/31/07 and continuous enrollment for 12 months prior to and at least 90 days after MRCC diagnosis.

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  • (PMID = 27963434.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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53. Tsimafeyeu V I, Madzhuga A, Demidov L: Hypercoagulability as a prognostic factor for survival in patients with metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16134

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Hypercoagulability as a prognostic factor for survival in patients with metastatic renal cell carcinoma.
  • : e16134 Background: In experimental systems, interference with coagulation can affect tumor biology.
  • We suggested that abnormal coagulation could be a negative predictor for response to immunotherapy and survival among patients with metastatic renal cell carcinoma (MRCC).
  • In addition, two groups of MRCC patients with (n = 28) or without (n = 28) hypercoagulability were compared in a case-control study.
  • Short survival and low response rate also were significantly associated with hypercoagulability in a case-control study.
  • Median cancer-specific survival was 8.2 months and 14.6 months, respectively (p = 0.0011).
  • Disease control rate (overall response + stable disease) was significantly higher in patients with normal coagulation: 71.4 versus 42.9% (p = 0.003).

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  • (PMID = 27963368.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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54. Burke JP, Liu Z, Zheng J, Johnson J: Incidence, annualized cost, and utilization burden in patients with metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e17529

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Incidence, annualized cost, and utilization burden in patients with metastatic renal cell carcinoma.
  • : e17529 Background: Data on burden of metastatic renal cell carcinoma (MRCC) is scarce.
  • METHODS: Administrative claims data from a large, US managed care plan were used to identify commercially insured and Medicare enrollees with newly diagnosed MRCC during 01/01/03-12/31/07 and continuous enrollment 12 months prior to and at least 90 days after MRCC diagnosis.
  • Mean (median) annual medical costs per patient increased by year of diagnosis from $70,797 ($33,031) in 2003 to $92,521 ($48,117) in 2007.

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  • (PMID = 27963253.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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55. Jonasch E, Tsavachdidou D, Wood CG, Matin SF, Corn PG, Tamboli P, Wang X, Tannir N: Phase II presurgical study of bevacizumab plus erlotinib in untreated patients with metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5004

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II presurgical study of bevacizumab plus erlotinib in untreated patients with metastatic renal cell carcinoma.
  • : 5004 Background: The safety and efficacy of presurgical bevacizumab in patients with metastatic renal cell carcinoma (mRCC) is not known.
  • METHODS: Patients with newly diagnosed clear cell mRCC whose primary tumor was considered resectable were enrolled.
  • If patients demonstrated progressive disease and had a declining performance status after eight weeks, nephrectomy was deferred.
  • Postoperatively, patients continued on study drug(s) if disease stabilization or regression had occurred.
  • By the Memorial Sloan-Kettering Cancer Center criteria, 82% of patients had intermediate-risk, and 18% had poor-risk features.

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  • (PMID = 27962894.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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56. Gupta S, Parsa V, Heilbrun L, Smith D, Dickow B, Heath E, Vaishampayan U: Safety and efficacy analysis of sunitinib (S), bevacizumab (B), and M-Tor inhibitors in metastatic renal cell cancer (mRCC) patients (pts) with renal insufficiency (RI). J Clin Oncol; 2009 May 20;27(15_suppl):5108

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Safety and efficacy analysis of sunitinib (S), bevacizumab (B), and M-Tor inhibitors in metastatic renal cell cancer (mRCC) patients (pts) with renal insufficiency (RI).
  • There are limited data on the clinical toxicity profile and efficacy of these agents in pts with RI.
  • METHODS: The primary objective was to assess the safety and efficacy of S, B, T and E in pts with RI.
  • Pts with a calculated creatinine clearance (CrCl) of ≤ 60ml/min [chronic kidney disease stage 3 or higher per K/DOQI guidelines by the National Kidney Foundation] were deemed to have RI.
  • Data on safety and efficacy of the therapy were collected and analyzed with respect to renal function.
  • RESULTS: 19 of 51 (37%) pts had RI.
  • Pts with RI had a higher median rise in blood pressure (BP) with S and B than pts with normal renal function.
  • Patients with RI had an increased incidence of rash and higher dose interruption rates with m-TOR inhibitors.
  • No major differences in toxicities including cardiac, thyroid, renal, lipid profile abnormalities or hyperglycemia were observed.
  • CONCLUSIONS: More than a third of pts with mRCC receiving targeted therapy have RI, hence highlighting the importance of evaluating tolerability of therapies in pts with RI.

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  • (PMID = 27964365.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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57. Vermaat J, van der Tweel I, Mehra N, Sleijfer S, Engwegen JY, Korse CM, Schellens JH, Haanen JB, Beijnen JH, Voest EE: Use of serum proteins identified by proteomics to predict prognosis in patients with metastatic renal cell cancer (mRCC) and comparison to the currently used MSKCC survival model. J Clin Oncol; 2009 May 20;27(15_suppl):11078

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Use of serum proteins identified by proteomics to predict prognosis in patients with metastatic renal cell cancer (mRCC) and comparison to the currently used MSKCC survival model.
  • : 11078 Background: In mRCC the Memorial Sloan-Kettering Cancer Center (MSKCC) risk model (Motzer et al.,JCO2002) is widely used for clinical trial design and patient management.
  • METHODS: Sera from 125 mRCC patients, mostly interferon-treated, collected between 2001-2006 in three Dutch Cancer Centers, were screened by SELDI-TOF mass spectrometry (MS).

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  • (PMID = 27963200.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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58. Falchook GS, Wheler JJ, Tannir NM, Naing A, Jackson E, Hong D, Lawhorn KN, Ng C, Amin H, Kurzrock R: Hypoxia-inducible factor-1α (HIF-1α) modulation in combination with anti-angiogenic therapy. J Clin Oncol; 2009 May 20;27(15_suppl):3555

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Pharmacodynamic assessment included plasma VEGF, VEGFR2, 20S proteasome inhibition, DCE-MRI, and tumor expression of HIF-1α, VEGF, VEGFR2, and polymorphisms of VEGF and VEGFR2.
  • Two partial responses were observed in patients with renal cell carcinoma (RCC) (Total patients with RCC = 6).
  • Minor responses or stable disease lasting ≥4 months was achieved in 8 patients, including RCC (1), breast (1), leiomyosarcoma (1), nasopharyngeal (2), hepatocellular (1), neuroendocrine (1), lacrimal gland adenocystic carcinoma (1).
  • The most common drug-related toxicities observed included hypertension (36%), fatigue (34%), thrombocytopenia (29%), and myalgia (19%).

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  • (PMID = 27961363.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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59. Srinivas S, Harshman L, Hauke RJ: Sorafenib monotherapy in patients with treatment-naïve metastatic renal cell cancer: preliminary results of a phase II intra-patient dose-escalation study. J Clin Oncol; 2009 May 20;27(15_suppl):e14564

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Sorafenib monotherapy in patients with treatment-naïve metastatic renal cell cancer: preliminary results of a phase II intra-patient dose-escalation study.
  • : e14564 Background: In a phase I dose finding study, the maximum tolerated dose of sorafenib was determined to be 400 mg bid.
  • METHODS: Patients with treatment-naïve metastatic renal cell with clear cell histology were enrolled at Stanford University and the University of Nebraska Medical Center.
  • One patient achieved a partial response and seven experienced disease stabilization.

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  • (PMID = 27963689.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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60. Floercken A, Takvorian A, Singh A, Hopfenmüller W, Pezzutto A, Dörken B, Westermann J: Modulation of regulatory T cells and myeloid-derived suppressor cells by sorafenib and sunitinib in renal cell carcinoma patients. J Clin Oncol; 2009 May 20;27(15_suppl):e16002

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Modulation of regulatory T cells and myeloid-derived suppressor cells by sorafenib and sunitinib in renal cell carcinoma patients.
  • : e16002 Background: Induction of regulatory T (Treg) and myeloid-derived suppressor cells (MDSC) is a major mechanism for the escape of tumors from immunological control.
  • Increased levels of Treg cells have been described in renal cell cancer (RCC) patients and seem to correlate with an adverse outcome.
  • Furthermore, reduction of Treg has been reported for RCC patients under sunitinib therapy.
  • The aim of our study was to analyse the influence of sorafenib and sunitinib on the frequency of Treg and MDSC in patients with metastatic RCC (mRCC).
  • However, there was a significant increase of CD3+CD4+CD25+FOXp3+Treg (13,5% vs. 36,3% of gated cells, p= 0.02) and the ratio FOXp3+/FOXp3- CD3+CD4+ T cells (0,16% vs. 0,56% of gated cells, p= 0.02) in the group of sorafenib-treated patients compared to sunitinib-treated patients during the 1st month of therapy and thereafter.
  • A negative influence of sorafenib on primary immune responses has been described and has mainly been attributed to functional impairment of dendritic cells (DC).
  • Whether altered DC function under sorafenib is responsible for the induction of Treg in RCC patients will have to be addressed in future studies.
  • In immunoresponsive tumors such as RCC, immunological effects of kinase inhibitors are particularly relevant for the design of combination trials with immunotherapeutic agents.

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  • (PMID = 27962943.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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61. Delea TE, Khuu A, Kay A, Zheng J, Baladi JF: Association between treatment effects on disease progression (DP) endpoints and overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC). J Clin Oncol; 2009 May 20;27(15_suppl):5105

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Association between treatment effects on disease progression (DP) endpoints and overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC).
  • While the association between DP endpoints and OS has been established in other cancers, it has not been rigorously examined in patients with mRCC.

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  • (PMID = 27964370.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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62. Baselga J, Gianni L, Gradishar WJ, Hudis C, Perez EA, Piccart-Gebhart M, Schwartzberg LS, Sledge G, Fleming TR: Phase IIb double-blind, randomized, placebo-controlled trials for the efficacy and safety of sorafenib in patients (pts) with metastatic or locally advanced breast cancer (BC): Review of the Trials to Investigate the Effects of Sorafenib in BC (TIES) program. J Clin Oncol; 2009 May 20;27(15_suppl):e12000

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase IIb double-blind, randomized, placebo-controlled trials for the efficacy and safety of sorafenib in patients (pts) with metastatic or locally advanced breast cancer (BC): Review of the Trials to Investigate the Effects of Sorafenib in BC (TIES) program.
  • : e12000 Sorafenib is a potent multikinase inhibitor approved by the FDA and EMEA for the treatment of advanced renal cell carcinoma and hepatocellular carcinoma.
  • All studies will combine sorafenib with first- and/or second-line chemotherapy and/or hormonal therapy in pts with HER2-negative metastatic or locally advanced BC, enroll 220 pts, stratify pts by visceral vs nonvisceral disease, allow pts with evaluable and measurable disease, and include pts with treated brain metastases.

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  • (PMID = 27964262.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / P30 CA008748
  • [Publication-type] Journal Article
  • [Publication-country] United States
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63. Bregni M, Bernardi M, Servida P, Pescarollo A, Crocchiolo R, Treppiedi E, Corradini P, Ciceri F, Peccatori J: Long-term follow-up of metastatic renal cancer patients undergoing reduced-intensity allografting. J Clin Oncol; 2009 May 20;27(15_suppl):7037

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term follow-up of metastatic renal cancer patients undergoing reduced-intensity allografting.
  • : 7037 Background: Stem cell transplantation from a HLA-compatible sibling donor is an adoptive immunotherapy for cytokine-refractory, metastatic clear-cell renal cell cancer (RCC).
  • METHODS: Twenty-five RCC patients (Table) received a reduced-intensity allograft from an HLA-identical sibling donor after a thiotepa, fludarabine, and cyclophosphamide conditioning regimen, and a cyclosporine-based GVHD prophylaxis.
  • Allogeneic peripheral blood hematopoietic cells were collected by apheresis after filgrastim treatment of the donor.
  • RESULTS: Best response to allograft was evaluable in 24 patients: 1 complete remission, 4 partial remissions, 12 minor response or stable disease, 7 progressive disease.
  • Cause of death was infection in four cases, GVHD in one case, and acute renal failure in one case.
  • Fourteen patients died for progressive disease at median 415 (36-958) days from transplant.
  • At a median observation time of 65 months, 5 patients are alive, one in CR, one in PR, and three with stable disease.
  • At multivariate analysis, CRP value before transplant, number of CD34+ infused cells and disease status at +90 significantly correlated with survival.
  • CONCLUSIONS: Transplantation is able to induce long-term disease control in a fraction (20%) of relapsed RCC patients.

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  • (PMID = 27961411.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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64. Sumiyoshi Y, Hashine K, Niwakawa M, Yamaguchi R, Fujii H, Hamamoto Y, Fukino K: Phase I trial of sorafenib in combination with interferon-alpha in Japanese patients with unresectable or metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16107

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase I trial of sorafenib in combination with interferon-alpha in Japanese patients with unresectable or metastatic renal cell carcinoma.
  • : e16107 Background: Sorafenib (SOR) is a multi-kinase inhibitor, targeting Raf kinase and the receptor tyrosine kinases VEGFR-2 and PDGFR-β.
  • Interferon-α (IFN) is most commonly used for metastatic renal cell carcinoma (RCC) in Japan.
  • In this phase I study, we investigated the safety profile, pharmacokinetics (PK), and tumor response of SOR/(recombinant)IFN combination in Japanese patients (pts) with RCC.
  • METHODS: After 2 weeks of IFN-alone treatment, a total of 18 pts (6 in each cohort) with unresectable/metastatic RCC received 28-day cycles of continuous SOR 200 (Cohort 1 [C1]) or (Cohorts 2 and 3 [C2 and C3]) 400 mg bid combined with intramuscular IFN 6 (C1 and C2) or 9 (C3) MIU three times a week (tiw).
  • Objectives were safety/tolerability and recommended dose of SOR/IFN as primary, and tumor response and PK as secondary.
  • Common drug-related grade 3/4 adverse events (AEs) included fatigue (50%), lipase increased (44%) and neutropenia (39%), all of which were reversible and manageable.
  • It seemed attributable to DIC accompanied by RCC.
  • Five PR (1 in C1 and 4 in C3) and 11 SD (4 in C1, 5 in C2, and 2 in C3) were achieved as the best response.
  • CONCLUSIONS: SOR/IFN combination has promise for clinical benefit in RCC, and its recommended dose was continuous SOR 400 mg bid and IFN 6 MIU tiw.

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  • (PMID = 27963330.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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65. Ravaud A, Oudard S, Gravis-Mescam G, Sevin E, Zanetta S, Théodore C, de Fromont M, Mahier-Aït Oukhatar C, Chêne G, Escudier B: First-line sunitinib in type I and II papillary renal cell carcinoma (PRCC): SUPAP, a phase II study of the French Genito-Urinary Group (GETUG) and the Group of Early Phase trials (GEP). J Clin Oncol; 2009 May 20;27(15_suppl):5146

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] First-line sunitinib in type I and II papillary renal cell carcinoma (PRCC): SUPAP, a phase II study of the French Genito-Urinary Group (GETUG) and the Group of Early Phase trials (GEP).
  • : 5146 Background: Sunitinib (Su) has been approved in metastatic clear cell carcinoma due to high objective response rates (ORR) and a prolonged progression-free survival (PFS).
  • Type I and II papillary RCC pts have a poor prognosis, with limited effective agents.
  • METHODS: SUPAP is a single-arm prospective study using a 2-stage design including 21 patients (pts) to achieve a 20% ORR and if ≥ 2 pts have an OR, 20 additional pts will be included.
  • Main eligibility criteria included type I or II PRCC confirmed by central pathological review, PS 0-1, measurable disease, first line of treatment.
  • Using the MSKCC scoring system : 5, 14 and 4 pts were in the favorable, intermediate or poor risk group, 4 undetermined.
  • In type II PRCC, 1/23 pts had a partial response (PR), 13/23 pts had a stable disease (SD) with 4 pts with a SD ≥ 12 weeks, 5/23 pts were progressive, 3/23 pts were too early for evaluation and 1/23 was not evaluable.
  • In type I PRCC, none had a partial response (PR), 3/5 pts had stable disease (SD) and 2/5 pts were too early for evaluation.
  • Toxicity of sunitinib was similar as reported in pivotal phase III with Su in metastatic RCC.
  • 12 pts required a dose reduction at any time mainly for non-hematologic toxicities.
  • CONCLUSIONS: Although some activity has been observed, response rate was lower than in clear cell tumors.

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  • (PMID = 27964444.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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66. Larbaoui B: Preoperative concomitant chemoradiotherapy with capecitabine in locally advanced rectal carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e15134

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preoperative concomitant chemoradiotherapy with capecitabine in locally advanced rectal carcinoma.
  • : e15134 Background: Preoperative concomitant chemoradiotherapy has shown to improve local control and sphincter preservation with decreased acute toxicity compared with postoperative treatment in locally advanced rectal carcinoma.
  • The primary endpoint of this phase II trial was pathologic tumor response.
  • METHODS: Inclusion criteria: rectal adenocarcinoma <12 cms from anal verge, clinical stage T3-4, adequate renal, hematological and liver function.
  • Clinical stage (determined by CT or RMI): T3: 70% and T4: 30%.
  • Tumor location (from anal verge): < 6 cm in 8pts, >6 cm in 7pts.
  • Tumor down staging was observed in 9pts (60%), including 5pts with complete pathological response (33.3%).
  • CONCLUSIONS: Preliminary results show that preoperative concomitant chemoradiotherapy with Capecitabine is an effective regimen with an acceptable safety profile for locally advanced rectal cancer, leading to a high probability of tumor downstaging.

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  • (PMID = 27960909.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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67. de Martino M, Klatte T, Seligson DB, LaRochelle J, Shuch B, Caliliw RR, Li Z, Kabbinavar FF, Pantuck AJ, Belldegrun AS: Use of CA9 gene single nucleotide polymorphisms to predict prognosis and treatment response of metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5003

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Use of CA9 gene single nucleotide polymorphisms to predict prognosis and treatment response of metastatic renal cell carcinoma.
  • : 5003 Background: Carbonic anhydrase 9 gene (CA9) is located in a prognostically relevant chromosomal area on chromosome 9p and is encoding for one of the most significant protein markers in metastatic renal cell carcinoma (MRCC), CAIX.
  • In contrast to CAIX protein, however, no efforts have been made to date to study CA9 gene in metastatic RCC.
  • METHODS: Genomic DNA was extracted from frozen tumor samples of 54 patients with clear cell MRCC.
  • Patients with the C allele variant of rs12553173 had improved median survival (27.3 vs. 13.6 months, p = 0.0431) and a greater likelihood of response to IL-2 (57% vs. 22%, p = 0.081) Likewise, high CAIX expression was associated with longer median survival (25.5 vs. 8.5 months, p < 0.0001) and a greater IL-2 response rate (37% vs. 8%, p = 0.070).
  • The C allele variant of rs12553173 is associated with improved overall survival and a greater likelihood of response to IL-2.

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  • (PMID = 27962895.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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68. Gyergyay F, Nagyványi K, Bodrogi I: Decreased toxicity schedule of suitinib in renal cell cancer: 2 weeks on/1 week off. J Clin Oncol; 2009 May 20;27(15_suppl):e16113

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Decreased toxicity schedule of suitinib in renal cell cancer: 2 weeks on/1 week off.
  • : e16113 Background: Sunitinib (SU) is an oral multitargeted tyrosine kinase inhibitor of VEGFRs, PDGFRs, KIT, FLT3, CSF-1R and RET approved for treatment of metastatic renal cell cancer (mRCC).
  • METHODS: Pts with mRCC, measurable disease, ECOG PS 0-2 received SU 50 mg po daily 4 weeks on/2 weeks off.
  • Objective response occurred: PR (13) 42%; CR (2) 5%; SD (9) 25%.

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  • (PMID = 27963329.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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69. Arnault JP, Mateus C, Wechsler J, Spatz A, Tomasic G, Sibaud V, Aractingi S, Grange JD, Escudier B, Robert C: Paradoxical cutaneous squamous cell proliferations in patients treated with sorafenib. J Clin Oncol; 2009 May 20;27(15_suppl):9564

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Paradoxical cutaneous squamous cell proliferations in patients treated with sorafenib.
  • We report 12 patients presenting with solitary or multiple cutaneous squamous cell proliferations occurring in the months following initiation of sorafenib and we discuss the significance of this unexpected association.
  • RESULTS: Twelve patients treated by sorafenib for renal cell cancer or hepatocellular carcinoma presented one or several skin tumours with a typical keratoacanthoma (KA) appearance 3 to 9 months after the onset of sorafenib therapy.
  • Histologic examination of 22 lesions found classical non aggressive KAs in 16 cases and more aggressive squamous cell carcinoma-like lesions with deep dermis invasion and cellular atypias in 5 patients.
  • CONCLUSIONS: Sorafenib treatment can be associated with cutaneous squamous cell proliferation resembling KAs.
  • Although our observations suggest that these skin neoplasms have a low aggressive potential, these reports address the questions of the paradoxical proliferating effect of a drug that usually has an anti-proliferating effect.
  • They also reactivate the unresolved controversy about the relationship between KA and authentic squamous cell carcinoma.
  • Surgical excision is the treatment of choice in order to rule out authentic squamous cell carcinoma.

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  • (PMID = 27963671.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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70. Rizack T, Mega A, Berz D: Is squamous cell histology an adverse prognosticator for survival of malignancies of the upper urinary tract? J Clin Oncol; 2009 May 20;27(15_suppl):6617

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Is squamous cell histology an adverse prognosticator for survival of malignancies of the upper urinary tract?
  • : 6617 Background: Carcinomas of the renal pelvis and ureter are rare diseases, accounting for only about 1% of all urogenital malignancies.
  • Previous reports suggest that squamous cell histology is associated with inferior survival.
  • METHODS: We analyzed the Surveillance, Epidemiology and End Results database for cancer specific survival rates in patients with renal pelvis and ureteral malignancies who were diagnosed between 1973 and 2003 in the SEER catchment geographic areas.
  • The primary exposure of interest was the underlying histology, squamous cell versus transitional cell differentiation.
  • We performed descriptive statistics, non parametric survival analysis, and cox proportional hazard analysis.
  • RESULTS: We identified 13,213 eligible patients, 7,716 renal pelvis and 5,497 ureteral carcinomas.
  • Among this cohort, 179 patients had squamous cell carcinoma (SCC), 12,395 had transitional cell carcinoma (TCC), including 121 papillary, and 619 had other histologies.
  • The cox analysis revealed a HR 0.42 (95% CI 0.36-0.47) for TCC when compared to SCC and corrected for decade of diagnosis, age, gender, prior treatment, and race.
  • The difference between the two groups was entirely attributable to survival differences in patients with loco-regional disease.
  • CONCLUSIONS: SCCs of the upper urinary tract present at a higher clinical stage and appear to represent more aggressive disease when compared to other histologies.
  • However, when appropriately staged according to lymph node status, the survival of TCC and SCC of the upper urinary tract is identical when compared stage by stage.

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  • (PMID = 27961775.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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71. Lettieri JT, Dubowy R, Xia C, Rotolo C, Zinny MA: Bioavailability of sorafenib tablets administered as a liquid suspension. J Clin Oncol; 2009 May 20;27(15_suppl):e14549

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e14549 Background: Sorafenib is a multikinase inhibitor currently approved by the FDA for the treatment of advanced renal-cell carcinoma (RCC) and unresectable hepatocellular carcinoma (HCC), and by the EMEA for the treatment of HCC and advanced RCC.
  • Utilizing a randomized, crossover design, subjects received either two 200-mg intact tablets (IT) with 8 ounces water, or two 200-mg tablets disintegrated over 10 minutes in 2 ounces of water (ST), with an additional 6 ounces of water swallowed as a rinse of the dosing vessel.

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  • (PMID = 27963627.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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72. Wiederkehr D, Casciano R, Stern L, Zheng J, Baladi J: Therapeutic care in metastatic renal cell carcinoma during the follow-up phase of the RECORD-1 phase III trial. J Clin Oncol; 2009 May 20;27(15_suppl):e17531

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Therapeutic care in metastatic renal cell carcinoma during the follow-up phase of the RECORD-1 phase III trial.
  • : e17531 Background: Following drug discontinuation for progression or adverse event in a clinical trial for relapsed or stage IV kidney cancer, supportive care including surgery, palliative radiotherapy, or bisphosphonates continue to be recommended by National Comprehensive Cancer Network (NCCN).
  • METHODS: World Health Organization Anatomical Therapeutic Chemical codes or therapeutic names, captured from the follow-up phase in a phase III clinical trial (RECORD-1) of patients with metastatic renal cell carcinoma (mRCC) patients, were used to describe antineoplastic therapies following discontinuation of study drug.
  • While the placebo control with supportive care in a double-blind phase is acceptable to evaluate the efficacy and safety of a therapy for regulatory approval purposes, decision makers must also consider how these data may inform comparisons with the usual alternatives available to and used by physicians and patients in the non-trial setting.

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  • (PMID = 27963810.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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73. Bloch J, Mouawad R, Spano J, Vigniot S, Magné N, Khayat D: Long-term follow-up of endogenous erythropoietin, VEGF levels and red blood count in patients receiving different antiangiogenic treatment. J Clin Oncol; 2009 May 20;27(15_suppl):e14648

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term follow-up of endogenous erythropoietin, VEGF levels and red blood count in patients receiving different antiangiogenic treatment.
  • : e14648 Background: Anemia, commonly defined as a hemoglobin level of <12 g/dL, occurs in over 30% of cancer patients at any time point and its incidence increases with treatment.
  • The concept of antiangiogenic treatment for solid tumors has recently emerged and we wondered why patients under such kind of treatment did not experience anemia requiring transfusion or the use of erythropoietin.
  • The goal of this study is to follow-up endogenous serum EPO, VEGF concentrations, hemoglobin (Hb) and hematocrit (Ht) levels in various metastatic cancers patients receiving different anti-angiogenic treatment and to try to establish the possible relation between these parameters.
  • PATIENTS AND METHODS: 30 patients (20 men and 10 women) with different cancer type (20 RCC and 10 thyroids) with a median age of 56 year were included in this study.

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  • (PMID = 27964238.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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74. Heath EI, Blumenschein GR Jr, Cohen RB, LoRusso PM, LoConte N, Kim ST, Chao R, Wilding G: Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: Updated phase I study results. J Clin Oncol; 2009 May 20;27(15_suppl):e14509

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: Updated phase I study results.
  • : e14509 Background: Sunitinib (SU) is an oral, multitargeted tyrosine kinase inhibitor of VEGFRs, PDGFRs, KIT, FLT3, and RET, approved for the treatment of advanced RCC and imatinib-resistant/intolerant GIST.
  • METHODS: Successive pt cohorts with advanced solid tumors (STs) received oral SU at 25, 37.5, or 50 mg for 2 wks during 3-wk cycles (Schedule 2/1) or for continuous 3 wk cycles (CDD schedule) with P (175-200 mg/m<sup>2</sup>) plus C (AUC=6 mg·min/mL) on day 1 of each of 4 cycles.
  • Response was evaluated for pts with measurable disease.
  • Tumor types included NSCLC (n=10), SCLC, esophageal, and pancreatic (n=4 of each), and other (n=21).

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  • (PMID = 27963544.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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75. Clisant S, Adenis A, Dansin E, Desauw C, Degardin M, Mortier L, Fournier C, Penel N: Oral metronomic chemotherapy using cyclophosphamide in metastatic patients (pts) after standard treatment: Results of a randomized phase II trial. J Clin Oncol; 2009 May 20;27(15_suppl):e13519

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Oral metronomic chemotherapy using cyclophosphamide in metastatic patients (pts) after standard treatment: Results of a randomized phase II trial.
  • We hypothesized that each treatment offer disease control without significant severe toxicity.
  • METHODS: This multi-center-randomized study was aimed to assess the efficacy and tolerance of both treatments.
  • Primary endpoint was stable disease rate at 2 months: 2mSD (RECIST).
  • Main eligibility criteria were as follows: non-breast cancer, pts with progressive disease refractory to standard therapies or without established standard care, ECOG=0-1, neither hypercalcemia nor hypoalbuminemia.
  • The second stage was allowed because at least 2mSD were seen among 12 first pts.
  • Most common primaries were: colorectal cancer (30 pts), soft tissue sarcoma (17), lung cancer (13), head & neck (8) and unknown primaries (4).
  • Three long-lasting SD (6 months +) are currently being observed in 3 pts receiving OMC (2 sarcomas and 1 RCC).
  • CONCLUSIONS: OMC and MA offer SD in patients with advanced, refractory and progressive tumors, without any significant toxicity.
  • The non-progression rate with OMC (15%) is in a same range of efficacy that was recently reported with new targeted therapy or anti-angiogenic agents administered in such pts.

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  • (PMID = 27961314.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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76. Klatte T, Remzi M, Said JW, Haitel A, Kabbinavar FF, Waldert M, de Martino M, Marberger M, Belldegrun AS, Pantuck AJ: A nomogram predicting disease-specific survival after nephrectomy for papillary renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5091

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A nomogram predicting disease-specific survival after nephrectomy for papillary renal cell carcinoma.
  • : 5091 Background: Whereas multiple nomograms have been developed to assess outcomes of patients with clear cell renal cell carcinoma, a model to assess prognosis of papillary renal cell carcinoma (PRCC) has not yet been developed.
  • After data collection and slide review of a large cohort of patients, the aim of this study was to develop and to internally validate a nomogram for prediction of disease-specific survival for PRCC.
  • METHODS: Out of 2,687 patients who underwent surgery for a renal tumor between 1989 and 2008 at two institutions, 258 (10%) were found to have PRCC.
  • H&E slides were reviewed by one uro-pathologist at each institution for papillary sub-type, tumor grade, microvascular invasion, sarcomatoid features, collecting system invasion and presence and extent of tumor necrosis.
  • A nomogram was constructed as a graphical representation of significant variables of disease-specific survival in multivariate Cox proportional hazards regression analysis.
  • In univariate analysis, incidental detection, T, N, M stage, grade, microvascular invasion, collecting system invasion, papillary sub-type, sarcomatoid features, and necrosis were all associated with prognosis.
  • Multivariate Cox proportional hazards analysis, however, identified incidental detection, T stage, M stage, microvascular invasion, and necrosis, but not papillary sub-type as independent prognostic factors of disease-specific survival.
  • These variables formed the basis of the nomogram that predicted 5-year disease-specific survival probability.
  • CONCLUSIONS: A highly accurate tool utilizing basic clinical and pathological information for predicting disease-specific survival was developed specifically for PRCC.

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  • (PMID = 27964297.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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77. Beaumont J, Cella D, Hutson T, Bracarda S, Grünwald V, Thompson J, Ravaud A, Urbanowitz G, Hollaender N, Motzer R: Patient-reported outcomes in a randomized trial of everolimus with metastatic renal cell carcinoma patients. J Clin Oncol; 2009 May 20;27(15_suppl):e17516

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Patient-reported outcomes in a randomized trial of everolimus with metastatic renal cell carcinoma patients.
  • : e17516 Background: Patient-reported outcomes (PRO), including health-related quality of life (HRQL), were assessed in a Phase III trial of everolimus in metastatic renal cell carcinoma (mRCC) patients.
  • Patients completed the FACT-Kidney Symptom Index- Disease Related Symptoms (FKSI-DRS) and EORTC-QLQ C30 at baseline and monthly during treatment.
  • Secondary analyses considered tumor progressions that occurred prior to deterioration or censoring date as FKSI deterioration events and compared time to PRO deterioration by tumor progression.
  • Secondary analyses showed median time to deterioration in FKSI-DRS was approximately doubled for the everolimus arm compared to placebo, and patients who progressed experienced a more rapid deterioration in FKSI-DRS and QL scores.
  • CONCLUSIONS: Compared to placebo everolimus delayed progression of disease-related symptoms and KPS.
  • Secondary analyses suggest a delay in deterioration in kidney cancer related symptoms via tumor control.

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  • (PMID = 27963270.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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78. LoRusso P, Markman B, Tabernero J, Shazer R, Nguyen L, Heath E, Patnaik A, Papadopoulos K: A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced solid tumors. J Clin Oncol; 2009 May 20;27(15_suppl):3502

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced solid tumors.
  • XL765 has shown dose-dependent target modulation and tumor growth inhibition or shrinkage in multiple human xenografts.
  • Tumor response is assessed by RECIST every 8 weeks.
  • Non-specific neurological complaints (1) and rash (1) were the DLTs that occurred at 100 mg qd.
  • The most common (> 10% of pts) related adverse events were elevated liver enzymes, nausea and diarrhea.
  • Robust pharmacodynamic modulation of PI3K pathway signaling in PBMCs, hair follicles, skin, and tumors was evident following administration of XL765.
  • Five pts had durable stable disease (> 3 months): appendiceal cancer (15 mg bid) 8 cycles; RCC (15 mg bid) 4 cycles; NSCLC (30 mg bid) 4 cycles; mesothelioma (60 mg bid) 10 cycles; CRC (100 mg qd) 6 cycles.

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  • (PMID = 27961282.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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79. Higgins B, Packman K, Zhang Y, Char H, Simcox M, Kolinsky K: In vivo activity of R1530 (R) alone and in combination with bevacizumab (B) and peginterferon alfa-2a (P) in a renal cell carcinoma (RCC) xenograft model. J Clin Oncol; 2009 May 20;27(15_suppl):e14629

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] In vivo activity of R1530 (R) alone and in combination with bevacizumab (B) and peginterferon alfa-2a (P) in a renal cell carcinoma (RCC) xenograft model.
  • Its inhibitory profile includes several kinases that play critical roles in cancer cell growth and division as well as tumor angiogenesis.
  • These properties translate into a potent cytotoxicity in a wide range of cancer cell lines in vitro and tumor growth inhibition in human tumor xenografts.
  • Preclinical studies were conducted to evaluate the effects of R alone and in combination with B and P in the Caki-1 RCC xenograft model.
  • A final study compared 1/2 OD R to OD R triplets to attempt to increase tumor growth inhibition (TGI) and increase life span (ILS).
  • Therefore, either agent can be alternatively dose reduced without a loss of tumor response or detriment to survival in this preclinical model of RCC.

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  • (PMID = 27964219.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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80. Hutson TE, Bellmunt J, Porta C, Staehler M, Szczylik C, Nadel A, Anderson S, Bukowski RM, Eisen T, Escudier B: Long-term safety of sorafenib (SOR) for the treatment (tx) of advanced clear-cell renal-cell carcinoma (RCC): Data analysis from patients (pts) treated for over 1 year in the phase III TARGET study. J Clin Oncol; 2009 May 20;27(15_suppl):e16057

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term safety of sorafenib (SOR) for the treatment (tx) of advanced clear-cell renal-cell carcinoma (RCC): Data analysis from patients (pts) treated for over 1 year in the phase III TARGET study.
  • : e16057 Background: Results of the phase III multicenter TARGET study, a randomized, double-blind, placebo (PBO)- controlled study of tx with SOR in pts with clear-cell RCC in whom 1 prior systemic therapy had failed, indicated that SOR is effective (PFS 5.5 vs 2.8 mo, HR=0.44, P<0.000001, and 39% increase in survival for SOR vs PBO, HR=0.71, P=0.015) and safe in pts with advanced RCC (Escudier et al.
  • METHODS: Pts (N=903) with advanced metastatic clear-cell RCC that had progressed after 1 systemic tx, ECOG PS 0-2, and low- or intermediate-risk MSKCC score were randomized 1:1 to SOR 400 mg BID or PBO.
  • Pts with preexisting cardiac disease or hypertension tolerated long-term tx with SOR; no dose reduction was required.
  • Long-term tx of pts with advanced RCC with SOR is medically manageable, with a predictable AE profile.

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  • (PMID = 27963000.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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81. Molina AM, Tickoo SK, Ishill N, Trinos MJ, Schwartz LH, Russo P, Feldman DR, Patil S, Motzer RJ: Treatment outcome and survival for patients (pts) with sarcomatoid-variant metastatic renal cell carcinoma (RCC): Memorial Sloan-Kettering Cancer Center (MSKCC) experience. J Clin Oncol; 2009 May 20;27(15_suppl):e16017

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Treatment outcome and survival for patients (pts) with sarcomatoid-variant metastatic renal cell carcinoma (RCC): Memorial Sloan-Kettering Cancer Center (MSKCC) experience.
  • : e16017 Background: Sarcomatoid-variant represents a spindle cell phenotype of RCC that can be present in any subtype, usually showing aggressive biological behavior.
  • MSKCC experience was studied to provide data on outcome and survival to systemic therapy for metastatic, sarcomatoid-variant RCC.
  • METHODS: Clinical features, treatment outcome and survival were reviewed in 63 pts with sarcomatoid-variant metastatic RCC from a database of 650 pts treated at MSKCC with systemic therapy (cytokines, anti-angiogenesis targeted therapy and chemotherapy).
  • The percentage of sarcomatoid component in the tumors was assessed.
  • RESULTS: Histology subtypes with sarcomatoid-variant among the 63 pts included 46 clear cell, 5 papillary, 5 chromophobe, 1 collecting duct, and 6 unclassified.
  • Differences in PFS were observed based on therapy (sunitinib vs. all other) and histology (clear cell vs. non-clear cell).
  • The median PFS for sunitinib therapy was 4.4 months (95% CI 2.2-6.7) versus 2 months (95% CI 1.7-2.7) for all other therapies (p = 0.02); and 3 months (95% CI 2.3-4.5) for clear cell versus 1.6 months (95% CI 1.0-2.1) for non-clear cell histology (p = 0.007).
  • CONCLUSIONS: Metastatic sarcomatoid-variant RCC is associated with a poor prognosis.
  • Studies to assess outcome, characterize tumor biology, and develop novel treatment strategies are warranted.

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  • (PMID = 27962911.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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82. Djellali L, Larbaoui B, Boukerche A, Ghazi S, Chaiba I, Meziane N, Yekrou D, Youcef DF: Preoperative concomitant chemoradiotherapy with oxaliplatin and 5-fluorouracil in locally advanced rectal carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e15108

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preoperative concomitant chemoradiotherapy with oxaliplatin and 5-fluorouracil in locally advanced rectal carcinoma.
  • : e15108 Background: Preoperative concomitant chemoradiotherapy has shown to improve local control and sphincter preservation with decreased acute toxicity compared with postoperative treatment in locally advanced rectal carcinoma.
  • The primary endpoint of this phase II trial was pathologic tumor response.
  • Secondary endpoint was sphincter preservation and toxicity Methods: Inclusion criteria: rectal adenocarcinoma <12 cms from anal verge, clinical stage T3-4, adequate renal, hematological and liver function.
  • Clinical stage (determined by CT or RMI): T3: 66.6% and T4: 33.3%.
  • Tumor location (from anal verge): < 6 cm in 10pts, >6 cm in 5pts.
  • Tumor down-staging was observed in 10pts (66.6%), including 5pts with complete pathological response (33.3%).
  • Main adverse effects (NCI-CTC): diarrhea G3-4: 14.2%, sensitive peripheral neurotoxicity G1: 26.6%, nausea/vomiting G3-4: 11%, Anemia G3-4: 7.1%, neutropenia G3-4: 14.2% Conclusions: Preliminary results show that preoperative concomitant chemoradiotherapy with oxaliplatin and 5FU-folinic acid is an effective regimen with an acceptable safety profile for locally advanced rectal cancer, leading to a high probability of tumor downstaging.

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  • (PMID = 27964340.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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83. Kamoi K, Kawauchi A, Miki T, Aron M, Remer E, Haber G, Berger A, Crouzet S, Ricardo B, Gill I: Laparoscopic renal cryoablation: Risk factor analysis to predict oncologic outcomes with minimum 5-year follow-up. J Clin Oncol; 2009 May 20;27(15_suppl):5094

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Laparoscopic renal cryoablation: Risk factor analysis to predict oncologic outcomes with minimum 5-year follow-up.
  • : 5094 Background: We analysed risk factors to predict oncologic outcomes at 5-11 year after laparoscopic renal cryoablation (LRC).
  • METHODS: Between 09/1997 and 010/2008, we performed renal cryoablation in 340 patients.
  • Mean tumor size was 2.3 cm (0.9-5.0 cm).
  • Overall, there were 7 cancer deaths.
  • In the 69 patients with biopsy-proven renal cell cancer (median follow-up 81 mos; range 60-132 mos), 5-year overall, disease-specific, and disease- free survival was 75%, 92%, and 82%, respectively, while 10-year overall, disease-specific, and disease-free survival was 46%, 83%, and 79%, respectively.
  • On multivariate analysis, previous radical nephrectomy for RCC was the only significant predictor for both recurrence- free survival and cancer-specific survival (p = 0.023 and 0.030, respectively).
  • Relative risk of patients who has a history of radical nephrectomy for RCC treatment was 4.1 (95% CIs, 1.2 to 13.4), and 5.4 (95% CIs, 1.2 to 27.7) for disease-free survival and disease-specific survival, respectively.
  • CONCLUSIONS: Laparoscopic renal cryoablation is effective oncologic treatment for renal mass in select patients.
  • Disease-specific survival of 92% at 5-years and 83% at 10-years is possible.
  • Preceding radical nephrectomy for RCC treatment was the only independent predicting factor for both disease-free and disease-specific survival.

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  • (PMID = 27964294.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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84. Zigeuner R, Hutterer G, Chromecki T, Rehak P, Pummer K: Macroscopic versus microscopic vascular tumour invasion in patients with clear cell renal cell carcinoma: Does it make a difference? J Clin Oncol; 2009 May 20;27(15_suppl):5093

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Macroscopic versus microscopic vascular tumour invasion in patients with clear cell renal cell carcinoma: Does it make a difference?
  • : 5093 Background: We evaluated the prognostic impact of macroscopic vs. microscopic vascular invasion on metastasis-free survival in a large European single centre series of patients with RCC over a period of 23 years.
  • METHODS: The pathology reports of 2333 consecutive patients operated between 01/1984 and 12/2006 were re-evaluated with regard to histological subtype, pT categories (TNM 2002), tumor grade, lymph node status, tumor size, presence of necrosis, and vascular invasion (defined as either absent, microscopic, or macroscopic).
  • Only patients with unilateral clear cell (CC)-RCC and no distant metastases at operation were included.
  • RESULTS: Out of 1797 CC-RCC-patients fulfilling the selection criteria, 1754 (97.6%) with complete data including follow-up were evaluated.
  • Microscopic and macroscopic invasion was noted in 99 (5.6%) and 278 (15.8%) tumours, respectively.
  • Multivariate analysis proved pT-categories, grade, node status, size, necrosis and overall vascular invasion (p < 0.0001; RR = 2.09, 95%CI = 1.46-2.98) as independent predictors of metastatic disease.
  • Microscopic invasion was an independent predictor of metastatic disease, whereas macroscopic invasion which is directly related to categories pT3b/c was not.
  • Vascular invasion should be considered in prognostic models for patients with RCC.

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  • (PMID = 27964295.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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85. Hong M, Jeung H, Chung H, Ahn J, Roh J, Noh S, Rha S: Predictive factors associated with clinical outcome and safety in Korean patients with metastatic renal cell carcinoma treated with sunitinib. J Clin Oncol; 2009 May 20;27(15_suppl):e16111

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Predictive factors associated with clinical outcome and safety in Korean patients with metastatic renal cell carcinoma treated with sunitinib.
  • : e16111 Background: Sunitinib has become a standard treatment for metastatic renal cell carcinoma (RCC).
  • METHODS: In total, 81 histologically proven metastatic RCC patients who were treated with sunitinib were reviewed between Jan 2006 and Dec 2008.
  • Tumor response was evaluated according to the RECIST criteria, and safety was assessed by NCI-CTC (version 3.0).
  • Primary endpoint was progression-free survival (PFS) and secondary endpoints included overall survival (OS), overall response rate (ORR), disease control rate (DCR), and toxicities.
  • Clear cell type was predominant (85%).
  • The most common grade 3/4 adverse events of sunitinib was thrombocytopenia (32%).

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  • (PMID = 27963327.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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86. Elrafei TN, Hazza M, Tindel N: Use of percutaneous kyphoplasty to treat painful vertebral compression fractures (VCF) in solid tumors. J Clin Oncol; 2009 May 20;27(15_suppl):e20568

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Use of percutaneous kyphoplasty to treat painful vertebral compression fractures (VCF) in solid tumors.
  • : e20568 Background: Vertebral compression fractures are a major source of morbidity in metastatic carcinoma.
  • Kyphoplasty involves inflation of a balloon for painful kyphotic deformity restoring the vertebral body to its original height and creating a cavity for percutaneous injection of polymethylmethacrylate (PMMA).
  • Although it is FDA approved for cancer-associated VCF most of the data is in the myeloma population.
  • RESULTS: Review of 447 consecutive orthopedic spine cases identified 40 kyphoplasty patients, 30 of which met the inclusion criteria - 21 with benign compression fractures secondary to osteoporosis/trauma and 9 with malignant disease (3 breast CA, 2 lung, 1 cervix, 1 RCC, 2 myeloma).
  • Median age was in the cancer group was 55 (37-81) vs. 68(41-93) in benign group.
  • One patient had prior radiation in the cancer group.
  • The average preoperative visual analog pain score was 7 (range 3-9) and postoperative pain score was 2.0 (0-9) in the cancer group.
  • CONCLUSIONS: Kyphoplasty provided marked pain relief in patients with VCF secondary to solid tumors and myeloma.
  • The results are comparable to non-cancer population in safety and efficacy, and are feasible in selected cancer patients with pain due to pathologic compression fractures.

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  • (PMID = 27961129.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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87. Jeppesen AN, Jensen HK, Donskov F, Marcussen N, von der Maase H: Serum-sodium as an independent prognostic factor in metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5102

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Serum-sodium as an independent prognostic factor in metastatic renal cell carcinoma.
  • : 5102 Background: Recently, low serum sodium has been associated with poor disease-free and overall survival in localized renal cell carcinoma (RCC) (Vasudev, Clin Can Res. 2008).
  • The present study investigated the prognostic impact of serum-sodium values below normal in patients with metastatic RCC (mRCC).
  • CONCLUSIONS: Low serum-sodium is a new, validated, independent prognostic factor in patients with metastatic RCC.

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  • (PMID = 27964376.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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88. Garrido-Laguna I, Rudek M, Tan A, Uson M, Iacobuzio-Donahue C, Angenendt M, Jimeno A, Laheru D, Barret M, Hidalgo M: Preclinical identification of biomarkers of response to mTOR inhibitors and subsequent application in a phase II trial of sirolimus in pancreatic cancer patients refractory to gemcitabine. J Clin Oncol; 2009 May 20;27(15_suppl):4612

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preclinical identification of biomarkers of response to mTOR inhibitors and subsequent application in a phase II trial of sirolimus in pancreatic cancer patients refractory to gemcitabine.
  • : 4612 Background: Treatment for advanced pancreatic cancer refractory to gemcitabine has not been defined.
  • We conducted an efficacy study in pancreatic cancer xenografts to identify biomarkers of response to mTOR inhibition and attempted to translate the results by conducting a phase II trial of sirolimus in this patient population.
  • Tumors were profiled with array CGH and gene expression arrays at baseline.
  • RESULTS: In the preclinical study, mTOR sensitive tumors showed upregulation of genes involved in the renal cell cancer pathway.
  • Baseline tumor p-S6K was not predictive for survival.
  • The most common grade 3 adverse event was hyperglycemia in 10% of the patients.
  • 7 (23%) patients achieved stable disease.
  • Efficacy data is limited by the selection of a heavily pretreated and poor prognosis population (DFS≤47 days).

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  • (PMID = 27964189.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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89. Dial E, Duh M, Fournier A, Antras L, Rodermund D, Neary MP, Oh WK: Cost implications of intravenous bevacizumab treatment in patients with renal cell carcinoma (RCC): A retrospective claims database analysis. J Clin Oncol; 2009 May 20;27(15_suppl):5112

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cost implications of intravenous bevacizumab treatment in patients with renal cell carcinoma (RCC): A retrospective claims database analysis.
  • : 5112 Background: Angiogenesis inhibitor (AI) therapies are promising novel treatments for patients with RCC.
  • The incremental costs associated with IV vs. oral administration of selected AI therapies (oral sunitinib or sorafenib, or IV bevacizumab off-label) for the treatment of RCC were evaluated.
  • METHODS: Patients with ≥ 2 RCC claims (ICD-9 189.0, 198.0) were identified from a large US commercial health insurance claims database from 1/02 to 12/07.
  • Cost comparisons between the IV AI group and each separate oral AI group were performed using multivariate Tobit regressions for each category separately, adjusting for age, gender, region, health plan, time from first RCC claim and first metastasis claim to treatment initiation.
  • CONCLUSIONS: Patients with RCC treated with bevacizumab incur an incremental $58,826 to $60,546 total medical cost per patient per year compared to those treated with sunitinib or sorafenib.

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  • (PMID = 27964393.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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90. Kroog GS, Feldman DR, Kondagunta GV, Ginsberg MS, Fischer PM, Trinos MJ, Patil S, Ishill NM, Motzer RJ: Phase I trial of RAD001 (everolimus) plus sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5037

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase I trial of RAD001 (everolimus) plus sunitinib in patients with metastatic renal cell carcinoma.
  • : 5037^ Background: RAD001 (everolimus) and sunitinib (SUTENT) both have activity in metastatic renal cell carcinoma (mRCC).
  • RESULTS: Of 20 pts (median age 62; 13 clear cell (cc) and 7 non-cc RCC) enrolled, 19 are evaluable for DLT including 3 in cohort 1 (2.5 mg RAD001 daily/ 37.
  • 3/5 pts with confirmed partial responses have non-cc RCC (2 chromophobe; 1 papillary).
  • 5 mg sunitinib is recommended for phase II and shows responses in non-cc RCC.
  • (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research.
  • NIH-sponsored trials are exempt from the Policy restrictions.

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  • (PMID = 27962935.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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91. Procopio G, Verzoni E, Bracarda S, Ricci S, Sacco C, Ridolfi L, Porta C, Miceli R, Zilembo N, Bajetta E, ITMO Study Group: A randomized, open label, prospective study comparing the association between sorafenib (So) and interleukin-2 (IL-2) versus So alone in advanced untreated renal cell cancer (RCC): Rosorc Trial. J Clin Oncol; 2009 May 20;27(15_suppl):5099

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A randomized, open label, prospective study comparing the association between sorafenib (So) and interleukin-2 (IL-2) versus So alone in advanced untreated renal cell cancer (RCC): Rosorc Trial.
  • : 5099 Background: So is an orally active multikinase inhibitor with a well documented activity in advanced RCC.
  • METHODS: In this multicenter, randomized, open label, phase II study, 128 previously untreated metastatic RCC patients (pts) were randomized to receive 400 mg of So, orally given twice daily continuously, in combination with IL-2, 4.5 MIU administered subcutaneously, five times a week for six consecutive weeks any eight weeks (arm A), or So alone (arm B) at the same dose.
  • Therapy continued until progression of disease or unacceptable toxicity.
  • Eligible pts had histological diagnosis of RCC, ECOG 0-2, no brain metastases, measurable disease and any Motzer's score.
  • Response rates (all partial responses, PR) were 23 % and 10 % in arm A and B respectively.
  • Overall disease control rates (PR + stable disease SD) were 81 % versus 74 %.
  • Tumour shrinkage was reported in 52 % and 34 % of arm A and B therapies respectively.
  • The most common adverse events (AEs) were asthenia, hand foot syndrome, hypertension, fever, diarrhoea and mucositis.
  • CONCLUSIONS: The safety and efficacy data suggest that the association So + IL-2 is safe and feasible and, compared to So alone, improves tumour shrinkage, disease control rate and PFS.

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  • (PMID = 27964308.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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92. Amato R, Hernandez-McClain J, Harrop R, Cen P, Doshi G: Vaccination of renal cell cancer (RCC) patients with modified vaccinia Ankara (MVA) delivering tumor antigen 5T4 administered alone or with interleukin 2 (IL-2) or interferon-alpha (IFN). J Clin Oncol; 2009 May 20;27(15_suppl):3026

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Vaccination of renal cell cancer (RCC) patients with modified vaccinia Ankara (MVA) delivering tumor antigen 5T4 administered alone or with interleukin 2 (IL-2) or interferon-alpha (IFN).
  • : 3026 Background: The attenuated vaccinia virus (MVA) has been engineered to deliver the tumor antigen 5T4 (TroVax).
  • More than 90% of RCCs overexpress the 5T4 antigen.
  • METHODS: Eligibility: Pathologic diagnosis of clear cell or papillary RCC, progressive measurable metastases, any prior therapy, adequate physiological parameters, Karnofsky performance status ≥ 80%, and no active CNS involvement.
  • Clinical responses were assessed by measuring changes in tumor burden via computed tomography or magnetic resonance imaging scan.
  • 20 pts demonstrated disease stabilization for ≥ 3 months.

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  • (PMID = 27962068.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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93. Benedict A, Figlin RA, Charbonneau C, Kreif N, Hariharan S, Négrier S: Economic evaluation of sunitinib versus other new targeted therapies as first-line treatment of metastatic renal cell carcinoma (mRCC) in the United States. J Clin Oncol; 2009 May 20;27(15_suppl):e17556

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Economic evaluation of sunitinib versus other new targeted therapies as first-line treatment of metastatic renal cell carcinoma (mRCC) in the United States.
  • : e17556 Background: RCC, the most prevalent kidney cancer, is a relatively rare malignancy that carries a poor prognosis.
  • Costs of drugs, routine follow-up, treatment-related adverse events, disease progression, and best supportive care of terminally-ill patients were included in the model.

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  • (PMID = 27963850.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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94. Mancuso AP, Donato De Paola E, Catalano A, Calabrò F, Messina C, Zivi A, Cerbone L, Vigna L, Caristo R, Sternberg CN: Phase II dose escalation study of sorafenib in patients with metastatic renal cell carcinoma (mRCC) who have had prior treatment with VEGFR-TKI antiangiogenic treatment. J Clin Oncol; 2009 May 20;27(15_suppl):e16027

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II dose escalation study of sorafenib in patients with metastatic renal cell carcinoma (mRCC) who have had prior treatment with VEGFR-TKI antiangiogenic treatment.
  • : e16027 Background: Sorafenib is an orally active multikinase inhibitor (Raf kinase, VEGFR 1, 2, 3 and PDGFR inhibitor) for the treatment of advanced RCC.
  • Pts with no progressive disease (evaluated at 12 weeks) continued to receive Sorafenib at the standard dose, while progressive pts received an increasing dose (600 mg BID) with early disease restaging after 4 weeks.
  • RESULTS: 18 pts were entered; baseline characteristics: PS 0-1: 94%; median age 62 years (41-82); nephrectomy: 100%; surgery for metastatic disease: 28%, clear-cell 78%, papillary-cell 16%, sarcomatoid 6%.
  • Overall, 72% of pts had disease control without significant correlations between response to prior therapy and hypertension.
  • The most common toxicity (NCIC 3.0, all pts) was grade (g) ≥ 1 diarrhea in 10 pts, g2-3 hand-foot syndrome in 7 pts and g-3 mucositis in 1 pt.
  • Other hematological and non-hematological toxicities were g1 with a frequency < 15%.

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  • (PMID = 27962966.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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95. Wosnitzer M, Lee DJ, Hirsch AJ, McKiernan JM: Predictors of renal function in nephron sparing surgery for renal cell carcinoma in solitary kidneys. J Clin Oncol; 2009 May 20;27(15_suppl):e16045

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Predictors of renal function in nephron sparing surgery for renal cell carcinoma in solitary kidneys.
  • : e16045 Background: Partial nephrectomy (PN) is an effective option for the treatment of renal cell carcinoma (RCC) in patients who need to preserve renal function.
  • However, the oncologic safety and functional outcome after PN in solitary kidneys have not been fully examined.
  • We assessed the outcomes after PN, and evaluated predictors of post-operative renal function.
  • METHODS: A retrospective analysis of the Columbia Urologic Oncology database found 1327 patients were treated for RCC from 1988 - 2008, of whom 38 consecutive patients underwent PN on a solitary kidney.
  • Glomerular filtration rate (GFR) was estimated with the Modification of Diet in Renal Disease (MDRD) equation.
  • Severe chronic kidney disease (CKD) and renal failure were defined as GFR of 15-30 cc/min/1.73m2 and GFR<15, respectively.
  • RESULTS: The study group included 30 men and 8 women with unilateral RCC.
  • The mean estimated blood loss was 465cc, the mean tumor diameter was 3.9cm, and 6 (17%) of the patients had a positive surgical margin.
  • 9 patients (30%) had recurrence of RCC at a mean of 23 months postoperatively.
  • Recurrence occurred in the kidneys of 4 patients, lung in 3 patients, bone in 3 patients, and the ipsilateral adrenal gland in one patient.
  • Preoperative GFR (HR=1.01, p<0.01) and the volume of kidney removed (HR=0.93, p=0.01) were associated with severe CKD and renal failure on a univariate Cox regression analysis, but were not independent predictors after adjusting for age, race, tumor stage and grade.
  • Preoperative GFR, volume removed, age, tumor stage or grade were not independent predictors of RCC recurrence.
  • CONCLUSIONS: PN in solitary kidneys pose difficult challenges for surgical and clinical management.
  • Nephron sparing surgery for the treatment of RCC is feasible with acceptable morbidity and renal function outcome.
  • The volume of renal parenchyma removed and the preoperative GFR are associated with renal function loss several months after surgery, and may be useful in predicting long-term renal function.

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  • (PMID = 27963019.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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96. LaRochelle JC, Dastane A, Rao N, Klatte T, Shuch B, Kabbinavar F, Said J, Belldegrun A, Pantuck A: Use of chromosome 9p status to identify a subset of high-risk localized renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5090

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Use of chromosome 9p status to identify a subset of high-risk localized renal cell carcinoma.
  • : 5090 Background: We investigated whether deletion of chromosome 9p in clear cell renal cell carcinoma (ccRCC) predicts worse disease-specific (DSS) and recurrence-free survival (RFS), and if it is associated with worse prognosis in tumors < 4 cm.
  • Tumor grade, stage, size, 9p status, nodal involvement, and the presence of metastasis were recorded.
  • Disease-specific and recurrence-free survival were determined, and independence was assessed using Cox proportional hazards models.
  • RESULTS: 9p deletions were detected in 14% of tumors.
  • 54% of 9p-deleted tumors were high grade (G3-4) vs. 38% without 9p deletions, and 60% of 9p-deleted tumors were T3-4 vs 38% without 9p deletions (p < 0.01).
  • In localized disease, median RFS for those with 9p deletions was 53 months and was not reached in those without 9p deletions (p<0.01).
  • In 188 patients presenting with localized RCC < 4 cm, loss of 9p occurred in 3/7 (42.9%) of patients with post-nephrectomy recurrence vs. 13/168 (7.2%) of patients without disease recurrence (p = 0.001).
  • DSS for patients with 9p deletion in tumors < 4 cm was significantly worse than DSS in those without 9p deletions (HR 6.18; p = 0.02), and an independent effect on RFS was seen for 9p deletions in localized RCC (HR 2.3, p < 0.01).
  • 9p status was not a significant predictor in metastatic RCC.
  • CONCLUSIONS: Deletion of chromosome 9p in ccRCC occurs in 14% of patients and is associated with higher grade and T stage, presence of nodal and distant disease, worse prognosis, and in patients with small NOMO tumors, 9p deletions but not tumor size was independently associated with RFS.

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  • (PMID = 27964298.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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97. Oudard S, Eisen T, Szczylik C, Siebels M, Negrier S, Chevreau C, Cihon F, Bukowski RM, Escudier B: Efficacy and safety of sorafenib in patients with advanced clear-cell renal cell carcinoma (RCC) with diabetes: Results from the phase III TARGET study. J Clin Oncol; 2009 May 20;27(15_suppl):e16099

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Efficacy and safety of sorafenib in patients with advanced clear-cell renal cell carcinoma (RCC) with diabetes: Results from the phase III TARGET study.
  • : e16099 Background: Results of the phase III TARGET trial, a randomized, double-blind, placebo-controlled study of sorafenib (SOR) treatment in pts with clear-cell RCC in whom 1 prior systemic therapy had failed, indicated that SOR is effective and safe for pts with advanced RCC, leading to the approval of SOR for the treatment of advanced RCC.
  • METHODS: Pts (N=903) with advanced clear-cell RCC, ECOG PS 0-2, and low- or intermediate-risk MSKCC score were randomized 1:1 to SOR 400 mg BID or placebo (PBO).
  • Trends in improved PFS were observed for SOR regardless of baseline diabetes status; however, the small diabetic subset limits interpretation of a SOR OS benefit in this subpopulation.

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  • (PMID = 27963086.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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98. Heng DY, Xie W, Regan MM, Cheng T, North S, Knox JJ, Kollmannsberger C, McDermott D, Rini BI, Choueiri TK: Prognostic factors for overall survival (OS) in patients with metastatic renal cell carcinoma (RCC) treated with vascular endothelial growth factor (VEGF)-targeted agents: Results from a large multicenter study. J Clin Oncol; 2009 May 20;27(15_suppl):5041

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Prognostic factors for overall survival (OS) in patients with metastatic renal cell carcinoma (RCC) treated with vascular endothelial growth factor (VEGF)-targeted agents: Results from a large multicenter study.
  • : 5041 Background: Prognostic factors (PF) for OS have yet to be fully defined for patients with metastatic RCC in the era of VEGF-targeted therapy.
  • METHODS: Baseline characteristics and outcomes on anti-VEGF-naïve metastatic RCC patients were collected from three US and four Canadian centers.
  • Four of the five PFs previously identified by MSKCC were independent predictors of short survival, including hemoglobin below the lower limit of normal (LLN) (p < 0.0001), corrected calcium above the upper limit of normal (ULN) (p = 0.0006), Karnofsky performance status <80% (p < 0.0001) and time from initial diagnosis to initiation of therapy ULN (pULN (p = 0.012) were independent adverse PFs.
  • This model produced a c-index of 0.74 and the bootstrap procedure confirmed good internal validity.

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  • (PMID = 27962941.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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99. Bhargava P, Esteves B, Nosov DA, Lipatov ON, Lyulko AA, Anischenko AA, Chacko RT, Lee P, Al-Adhami M, Ryan J: Updated activity and safety results of a phase II randomized discontinuation trial (RDT) of AV-951, a potent and selective VEGFR1, 2, and 3 kinase inhibitor, in patients with renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):5032

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Updated activity and safety results of a phase II randomized discontinuation trial (RDT) of AV-951, a potent and selective VEGFR1, 2, and 3 kinase inhibitor, in patients with renal cell carcinoma (RCC).
  • In a phase II RDT of AV-951 (1.5 mg/day; 3 wks on, 1 wk off) in RCC, preliminary ORR at wk 16 was 28% (ASCO GU.
  • METHODS: Pts with locally advanced or metastatic RCC (any histology) and no prior VEGF-targeted therapy received AV-951 for 16 wks, after which further treatment was assigned based on response.
  • Pts with ≥ 25% tumor shrinkage continued treatment with AV-951, while pts with < 25% change from baseline were randomly assigned to receive AV-951 or placebo for 12 wks (double-blinded).
  • 53% pts were treatement naïve, 72% had undergone nephrectomy and 83% had RCC with clear cell component.
  • With a median duration of treatment of 5 mo (range 0-12 mo), the investigator assessed ORR (CR+PR) is 27.2% (30% in clear cell RCC), SD 60.5% and Disease Control Rate (CR/PR + SD) 88%.
  • The most common treatment-related AEs (all grades) were hypertension (HTN, 42%) and dysphonia (16%).
  • CONCLUSIONS: Interim results of this phase II study demonstrate that AV-951 is active in RCC.
  • The AE profile of AV-951 is consistent with that of a selective VEGFR inhibitor, with minimal off-target toxicities.

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  • (PMID = 27962939.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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100. Drabkin HA, Sharma G, Costa LJ, Korch C, Gemmill RM: Synergistic growth inhibition of RCC and NSCLC cell lines by sorafenib plus vorinostat and induction of angiogenic genes by ER stress. J Clin Oncol; 2009 May 20;27(15_suppl):e16114

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Synergistic growth inhibition of RCC and NSCLC cell lines by sorafenib plus vorinostat and induction of angiogenic genes by ER stress.
  • : e16114 Sorafenib, vorinostat and the combination were examined in 34 RCC and NSCLC cell lines.
  • At baseline, bFGF, VEGF and IL-8 were highly expressed in RCCs, whereas Gro-α, VEGF, and IL-8 predominated in NSCLCs.
  • Importantly, sorafenib at 8 μM, but not lower doses, induced ER stress in these cell lines and thapsigargin or tunicamycin treatment recapitulated many, but not all, of the observed angiogenic gene responses to sorafenib.
  • In summary, sorafenib plus vorinostat potently inhibits the in vitro growth of RCC and NSCLC cell lines.

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  • (PMID = 27963311.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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