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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]

[Cites] NDT Plus. 2009 Jun;2(3):246-9 [25984002.001]

[Cites] Oncogene. 2003 Aug 11;22(33):5192-200 [12910256.001]

[Cites] Virus Res. 1989 Apr;12(4):315-30 [2543158.001]

[Cites] J Am Soc Nephrol. 2004 Jun;15(6):1582-8 [15153569.001]

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[Cites] Transplantation. 2005 May 27;79(10):1277-86 [15912088.001]

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[Cites] Transplantation. 2002 Jun 27;73(12):1933-6 [12131691.001]

(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

   

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Commentary (Pollock): Radiation Therapy in the Management of Brain Metastases From Renal Cell Carcinoma.

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(PMID = 28326510.001).

[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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[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

   

[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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[Cites] Hum Pathol. 1996 Nov;27(11):1115-6 [8912817.001]

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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

   

[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

   

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Recurrence of renal cell carcinoma in a renal allograft after partial transplant nephrectomy: a case report.

Treatment options for renal cell carcinoma (RCC) in a renal allograft include radical nephrectomy or nephron-sparing surgery (NSS).

We report the case of local recurrence of an RCC in kidney allograft.

Five years after previously undergoing NSS, a recurrent lesion was diagnosed in the upper pole of the kidney graft in a 74-year-old patient during routine duplex ultrasonography.

Considering the poor function of the kidney allograft with the need for dialysis, a removal of the graft was performed without peri- and postoperative adverse events.

The final pathology revealed recurrence of a clear-cell adenocarcinoma of the kidney allograft (pT1a, G1).

In conclusion, patients after NSS for small renal masses in kidney allograft should remain under careful observation in order to detect early local recurrence.

[MeSH-major] Carcinoma, Renal Cell / surgery. Kidney Neoplasms / surgery. Kidney Transplantation. Neoplasm Recurrence, Local / surgery. Nephrectomy / methods. Postoperative Complications / surgery

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[Copyright] Copyright (c) 2009 S. Karger AG, Basel.

(PMID = 19752625.001).

[ISSN] 1423-0399

[Journal-full-title] Urologia internationalis

[ISO-abbreviation] Urol. Int.

[Language] eng

[Publication-type] Case Reports; Journal Article

[Publication-country] Switzerland

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Differential expression of ABCF2 protein among different histologic types of epithelial ovarian cancer and in clear cell adenocarcinomas of different organs.

Previously, we reported that ABCF2 protein expression is higher in clear cell than serous histotype of ovarian adenocarcinomas and that its expression correlates with chemoresponse in patients with clear cell ovarian cancer.

In this study, we examined ABCF2 protein expression in mucinous, endometrioid, and poorly differentiated type of ovarian adenocarcinomas.

In addition, ABCF2 expression was evaluated in clear cell adenocarcinomas derived from different organs.

A total of 335 epithelial ovarian cancers, 23 clear cell adenocarcinomas of uterine corpus, and 34 clear cell adenocarcinomas of kidney were included in this study.

The results showed that cytoplasmic ABCF2 expression was significantly higher in clear cell-type ovarian cancer specimens compared with other types (P < .0001).

There was a close relationship between nuclear ABCF2 expression levels and age of patients with clear cell ovarian cancer.

Multivariate logistic regression model also demonstrated that cytoplasmic ABCF2 expression was associated with clear cell histology (odds ratio, 5.557; 95% confidence interval, 2.694-11.462; P < .0001).

In addition, both clear cell adenocarcinomas of the ovary and the uterine corpus showed significantly higher levels of ABCF2 expression, compared with those of the clear cell adenocarcinoma of the kidney (P < .0001).

These data suggest that ABCF2 protein may be a candidate marker for clear cell adenocarcinomas of the ovary and the uterine corpus and may be important for the pathogenesis of these diseases.

[MeSH-major] ATP-Binding Cassette Transporters / biosynthesis. Adenocarcinoma, Clear Cell / pathology. Ovarian Neoplasms / pathology

[MeSH-minor] Adult. Aged. Aged, 80 and over. Diagnosis, Differential. Epithelial Cells / chemistry. Epithelial Cells / pathology. Female. Humans. Immunohistochemistry. Logistic Models. Middle Aged. Multivariate Analysis. Odds Ratio

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(PMID = 16996567.001).

[ISSN] 0046-8177

[Journal-full-title] Human pathology

[ISO-abbreviation] Hum. Pathol.

[Language] eng

[Grant] United States / NCI NIH HHS / CA / P50CA165009; United States / NCI NIH HHS / CA / R33CA103595

[Publication-type] Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't

[Publication-country] United States

[Chemical-registry-number] 0 / ABCF2 protein, human

   

[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

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(PMID = 21037511.001).

[ISSN] 1541-8243

[Journal-full-title] Southern medical journal

[ISO-abbreviation] South. Med. J.

[Language] eng

[Publication-type] Case Reports; Journal Article

[Publication-country] United States

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

: e16110 Background: Sunitinib, an inhibitor of multiple tyrosine kinases, is FDA approved for metastatic renal cell cancer (mRCC).

We sought to identify 1) baseline patient (pt) characteristics that predispose for DM, 2) the most common AEs requiring DM in a non-protocol setting, and 3) the impact of dose limiting AEs on treatment continuation.

METHODS: Single-center, retrospective chart review.

Pts ≥ 18 years of age with mRCC of clear-cell histology on sunitinib therapy with active follow-up at MDACC were eligible.

By univariate analysis, increased age (p=0.04; OR 1.04, 1.002-1.081 CI) and elevated BUN (p=0.03; OR 1.06, 1.006 -1.108 CI) were directly associated with increased incidence of dose-limiting AEs.

In a multivariate analysis, only BUN remained significant.

DM were often attributed to multiple AEs (55%), with fatigue, mucositis, hand-foot syndrome and nausea being the most common.

CONCLUSIONS: Elevated baseline BUN is associated with an increased rate of DM in patients with RCC receiving sunitinib.

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(PMID = 27963325.001).

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] A randomized, double-blind phase III study of pazopanib in treatment-naive and cytokine-pretreated patients with advanced renal cell carcinoma (RCC).

: 5021^ Background: Pazopanib, an oral multikinase angiogenesis inhibitor, has shown clinical efficacy in patients (pts) with advanced RCC.

In this study (VEG105192), the efficacy and safety of pazopanib was compared with placebo in advanced RCC.

METHODS: Pts (N = 400 planned) with clear cell advanced RCC and measurable disease with no prior treatment or 1 prior cytokine-based treatment, were stratified and randomized (2:1) to pazopanib 800 mg QD or placebo.

Pts received continuous treatment until disease progression (PD), death or unacceptable toxicity.

Most common AEs in pazopanib-treated pts were diarrhea (52%; 4% Gr 3/4), hypertension (40%; 4% Gr 3/4), hair color change (38%; <1% Gr 3/4), nausea (26%; <1% Gr 3/4), anorexia (22%; 2% Gr 3/4), and vomiting (21%; 2% Gr 3/4).

The most common laboratory abnormality was ALT elevation (53%; 10% Gr 3; 2% Gr 4).

NIH-sponsored trials are exempt from the Policy restrictions.

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(PMID = 27962920.001).

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Phase II study of sorafenib combined with gemcitabine and 5-fluorouracil in patients with metastatic renal cell carcinoma: Preliminary results.

: e16093 Background: The tyrosine kinase inhibitors sorafenib and sunitinib have been approved for use in patients with advanced RCC and have supplanted immunotherapy as first-line therapy.

Nevertheless, complete responses have been observed only rarely with these agents and only 10% of patients experience PR.

In order to improve the objective response rate and the durability of those responses in patients, we conducted a single-institution, single-arm phase II trial of gemcitabine and 5-fluorouracil (5-FU) combined with sorafenib in patients with RCC.

METHODS: Eligibility criteria included advanced, histologically confirmed RCC; age >18 years; ECOG PS ≤ 2, adequate bone marrow, renal and hepatic function; measurable/evaluable lesions.

The rate of objective response and disease control (including stable disease, complete responses and partial responses) were 38% (95% CI, 18-62%) and 86% (95% CI, 64-97%), respectively.

CONCLUSIONS: The combination of sorafenib with gemcitabine and 5-FU shows promising activity for patients with metastatic RCC.

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(PMID = 27963083.001).

[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

   

[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

   

[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

   

[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

   

[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^st 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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

: 3018 Background: Programmed death-1 (PD-1), an inhibitory receptor expressed on activated T cells, may suppress antitumor immunity.

METHODS: Patients (pts) with treatment refractory metastatic non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), colon cancer (CC), melanoma (MEL), or prostate cancer (CRPC), and no history of autoimmune disease received a single infusion of MDX-1106 at 10 mg/kg.

Disease status was evaluated at week (wk) 8 by RECIST criteria.

Pts with stable disease or lesional responses could receive additional MDX-1106 at wks 12 and 16.

Those with PR/CR were observed without retreatment.

RESULTS: 21 pts (5 CC, 2 NSCLC, 8 MEL, 5 HRPC, 1 RCC) were treated from 10/07 to present, and 6 were retreated.

One pt with RCC had a PR after 3 doses, lasting 5+ months (mo).

Biopsy of a regressing MEL lymph node metastasis showed a moderately increased and selective CD8+ T cell infiltrate post treatment.

Interestingly, in contrast to PK results, flow cytometric analysis demonstrated sustained occupancy of 60-80% PD-1 molecules on T cells for at least 3 mo following a single dose.

Analyses of circulating lymphocyte subsets and tumor B7-H1 expression are in progress.

CONCLUSIONS: Intermittent dosing of MDX-1106 at 10 mg/kg demonstrated clinical activity against RCC and MEL without serious toxicity.

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(PMID = 27962055.001).

[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

   

[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

   

[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

   

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Population pharmacokinetic modeling for intravenous temsirolimus and sirolimus metabolite in subjects with various solid tumors.

: 2522 Background: Temsirolimus (TEMSR) is an mTOR inhibitor approved for treatment of patients with advanced renal cell carcinoma, and under development for relapsed/refractory mantle cell lymphoma (MCL).

Modeling for TEMSR employed a 4-compartment model with saturable distribution to red cells and peripheral tissue, and modeling for SIR utilized a linear 2- compartment model with factor for dose.

Covariates included demographic factors, clinical labs, and disease condition.

In a typical patient (56-year-old male weighing 76.5 kg), disease affected TEMSR clearance (62.4 L/h in MCL, 92.1 L/h in breast cancer vs. 112 L/h for other subjects).

CONCLUSIONS: No significant differential effects were observed for age, gender, race, or hepatic and renal laboratory measures.

Covariates of disease, while significant, have only modest effects on the exposure profile.

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(PMID = 27961845.001).

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Population pharmacokinetic (PK) analysis of ABT-869 in solid tumors and acute myelogenous leukemia (AML) patients.

: 3567 Background: ABT-869 is an orally bioavailable, potent and specific inhibitor of all vascular endothelial growth factor and platelet derived growth factor family receptor tyrosine kinases.

The objectives of this analysis were to understand the population pharmacokinetics of ABT-869 and explore the effect of several demographic/disease state covariates influencing ABT-869 disposition.

METHODS: A population PK analysis of 181 patients (pts) enrolled in two phase 1 (multiple types of solid tumors and AML) and three phase 2 monotherapy studies (non-small cell lung cancer, hepatocellular carcinoma [HCC] and renal cell carcinoma) was conducted.

Available plasma concentrations obtained after intensive and sparse pre-dose PK sampling were analyzed by population PK using the non linear mixed effects modeling (NONMEM) approach.

Potential covariates including body weight, body surface area (BSA), age, sex, creatinine clearance (CrCL) and disease state (HCC vs. non-HCC pts) were tested.

Race and impaired renal function does not appear to alter PK.

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(PMID = 27961681.001).

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Mass balance, pharmacokinetics, and metabolism of [¹⁴C] brivanib (BMS-582664), prodrug of BMS-540215, in subjects with advanced or metastatic solid tumors.

: 3566 Background: Brivanib alaninate (BMS-582664, B) is an oral prodrug of BMS-540215, a dual tyrosine kinase inhibitor of VEGFR and FGFR signaling pathways which are important for angiogenesis and tumor growth.

METHODS: A two-part, open-label, single-dose study was conducted in subjects with advanced or metastatic solid tumors.

Subjects continued in this study until disease progression or unacceptable toxicity.

RESULTS: 4 subjects (2 NSCLC, 1 ovarian, 1 renal cell carcinoma) were treated with B in both parts A & B.

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(PMID = 27961680.001).

[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

   

[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

   

[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

   

[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

   

[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.

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

   

[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

   

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] CT response assessment combining reduction in size and arterial enhancement correlates with time to progression in metastatic renal cancer patients treated with TKIs.

: e16062 Background: Targeted therapy is now the standard of care in advanced Renal Carcinoma (RCC).

Response assessment by RECIST criteria is insensitive as treated tumours often have only a modest change in size despite the induction of significant necrosis and does not correlate with time to progression (TTP).

The Choi criteria (10% size reduction or 15% contrast enhancement reduction) are routinely used in the assessment of GIST tumours treated with targeted agents.

We report the use of combined size and density assessment in RCC metastases treated with either sunitinib or cediranib.

METHODS: CT scans from 32 patients with metastatic RCC treated with either sunitinib (18) or cediranib (14) were assessed.

Scans from 10 patients were not evaluable as non-contrast enhanced scans were performed due to impaired renal function.

Scans from 20 evaluable patients at baseline and 12 weeks on treatment were assessed using RECIST, Choi, and modified criteria in which both a 10% decrease in size and 15% decrease in enhancement in the arterial phase were required to define a response (PR).

Response assessment was performed using each of the three methods and correlated with time to disease progression (itself RECIST defined).

RESULTS: There was no difference in TTP between RECIST defined PR (346.8 days) and SD (328.5 days) (P=0.965).

TTP in Choi defined PR (358.4 days) and SD (189.6 days) groups showed improved but non-significant separation of TTP duration (P=0.266).

TTP in PR (421.5 days) and SD (200.3 days) groups defined by a combined assessment of reduction in size and enhancement showed greatly improved separation (P=0.064).

CONCLUSIONS: A combined reduction in both size and arterial phase enhancement of RCC metastases treated with TKIs correlates with time to progression.

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(PMID = 27963066.001).

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Influence of food on the pharmacokinetics (PK) of panobinostat (LBH589), an orally active histone deacetylase inhibitor, in patients with advanced cancer.

: 2550 Background: The effect of food on the bioavailability and PK of panobinostat (PAN) are of considerable importance in allowing appropriate dosing of chronic oral cancer therapy.

METHODS: Patients (pts) with advanced cancer received 20 mg PAN twice a week of a 21-day cycle and were randomized to receive 1 of 6 treatment sequences where PAN PK was evaluated weekly under fasting, high fat and normal breakfast.

PK parameters were estimated by using non-compartmental analysis.

Although tumor response was not the main objective, a pt with recurrent RCC, following sunitinib and sorafenib treatment, has achieved a PR after ∼6 cycles of PAN and is continued on study.

CONCLUSIONS: Since the overall extent of absorption and variability was not changed due to food, PAN administration with or without food is unlikely to significantly impact systemic PAN exposure in cancer patients.

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(PMID = 27961876.001).

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

: e19517 Background: The multikinase inhibitor sorafenib targets several serine/threonine and receptor tyrosine kinases by blocking RAF kinase, a critical component of the RAF/MEK/ERK signaling pathway regulated by the Ras oncogene, which is mutated both in primary patient samples and in human MM lines (35-50%).

As the frequency of these mutations increases with advancing disease and increasing drug resistance, inhibition of the RAF/MEK/ERK signaling pathway, as well the angiogenic VEGFR-2/PDGFR beta cascade by sorafenib may be a useful new approach for the treatment of MM.

This dose was based on the label for metastatic renal cell carcinoma.

Three patients experienced Grade 4 toxicity consisting of thrombocytopenia, anemia and renal failure.

3 patients had stable disease (2.4-15.9 months) and the remainder progressed.

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(PMID = 27960944.001).

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[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).

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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] High-grade proteinuria associated with bevacizumab in patients with renal cell cancer and non-renal cell cancer.

It is a widely used angiogenesis inhibitor in the treatment of renal cell cancer (RCC) and other solid tumors.

This study was conducted to determine the risk of developing proteinuria among RCC and non-RCC patients receiving bevacizumab.

The risk of high-grade proteinuria may also depend on tumor type; the incidence of high-grade proteinuria was 10.0% (95% CI: 4.3-22.4%) with a RR 48.7 (95% CI: 9.7-244.3) among 703 RCC patients compared with an incidence of 1.7% (95% CI: 0.09-3.2%) and RR of 5.2 (95% CI: 3.3-8.4) among 5,999 non-RCC patients.

The risk may vary with bevacizumab dose and tumor type.

RCC patients may have higher risk than non-RCC patients.

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(PMID = 27963106.001).

[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

   

[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

   

[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

   

[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

   

[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.

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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

   

[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

   

[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

   

[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

   

[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

   

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Prospective cardiotoxicity screening during tyrosine kinase inhibitor therapy for renal cell carcinoma: An institutional experience.

In light of prior studies at our institution documenting a high rate of symptomatic heart failure in patients with renal cell carcinoma undergoing treatment with sunitinib, we instituted a prospective screening protocol to characterize the incidence and natural history of TKI-associated cardiotoxicity.

METHODS: From March-December 2008, patients receiving TKI therapy for renal cell carcinoma received cardiac biomarker screening (NT- BNP and Troponin I at baseline and after week 4 of each cycle) and transthoracic echocardiography (baseline, 1 month, 3 months, and every 3 months thereafter).

TKI treatment appeared to 'unmask' previously subclinical cardiac injury, including prior silent myocardial infarction (one patient), left ventricular hypertrophy (four patients), and valvular disease (three patients).

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(PMID = 27962944.001).

[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

   

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Gastrin-releasing peptide receptors in the tumor vascular bed of various human cancers: high incidence in urinary tract cancers.

: e14575 Background: Tumoral Gastrin-releasing peptide (GRP) receptors are potential targets for diagnosis and therapy using radiolabeled or cytotoxic GRP analogs.

GRP-receptor overexpression has been detected in cancer cells and, more recently, also in the vascular bed of selected tumors.

More information on vascular GRP-receptors in cancer is required to asses their potential for vascular targeting applications.

METHODS: Frequent human cancers from the breast (n=134), lung (n=57), prostate (n=50), kidney (n=32), colon (n=46), urinary tract (n=26) and biliary tract (n=23) were analyzed using in vitro GRP-receptor autoradiography on tissue sections with the ¹²⁵I-[Tyr⁴]-bombesin radioligand and/or the universal radioligand ¹²⁵I-[D-Tyr⁶, ß-Ala¹¹, Phe¹³, Nle¹⁴]-bombesin(6-14).

GRP-receptor expressing tumoral vessels were evaluated in each tumor group for prevalence, quantity (vascular score) and GRP-receptor density.

RESULTS: Prevalence of vascular GRP-receptors is variable, ranging from 13% (prostate cancer) to 92% (urinary tract cancer).

Different tumor-types within a given site may have divergent prevalence of vascular GRP-receptors (e.g. lung: small cell cancer: 0%; adenocarcinoma: 59%; squamous carcinoma: 83%).

Also the vascular score varies widely, with highest score in urinary tract cancer (1.69), moderate scores in lung (0.91), colon (0.88), kidney (0.84) and biliary tract (0.69) cancers and low scores in breast (0.39) and prostate (0.14) cancers.

Normal non- neoplastic control tissues from these organs lack vascular GRP-receptors.

CONCLUSIONS: Tumoral vessels in all evaluated sites overexpress GRP-receptors, suggesting a major biological function of GRP-receptors in the tumor vascular bed.

Vascular GRP-receptor expression varies between the tumor-types indicating tumor-specific mechanisms in their regulation.

Urinary tract cancers express vascular GRP-receptors so abundantly, that they are promising candidates for vascular targeting applications.

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(PMID = 27963648.001).

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Immune self-tuning in renal cell carcinoma patients.

: e22069 Background: Renal cell carcinoma (RCC) cells can inhibit protective antitumor immunity by secretion of immunosuppressive factors leading to the induction of regulatory T cells.

The objective of this study was to investigate the prognostic impact of mRNA expression levels of IL10, TGFβ and forkhead box transcription factor (FoxP3) mRNA in peripheral blood mononuclear cells (PBMCs) of metastatic RCC patients before receiving treatment with sorafenib.

Disease evaluation was performed every 8 weeks following RECIST criteria.

RESULTS: In contrast to FoxP3, mRNA expression levels of IL10 and TGFβ were significantly higher in the 46 RCC patients compared to healthy volunteers: Median expression levels [ratio marker /housekeeping gene PBGD] were 5.56E-05 vs 2.05E-04 (P=0.034) for IL10 and 7.38E-02 vs 3.04E- 01 (P=0.023) for TGFβ.

CONCLUSIONS: RCC caused an immune-suppressive phenotype in PBMC characterized by increased mRNA expression levels of IL10 and TGFβ.

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(PMID = 27963212.001).

[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

   

[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

   

[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

   

[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

   

[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

   

[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.

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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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Survival update from a multicenter, randomized, phase III trial of vitespen versus observation as adjuvant therapy for renal cell carcinoma in patients at high risk of recurrence.

: 3009 Background: Vitespen (formerly HSPPC-96) is a novel, autologous, heat shock protein (gp96)-peptide complex vaccine.

The survival registry is investigating long-term efficacy of vitespen in renal cell carcinoma (RCC) patients at high risk for recurrence postnephrectomy.

Patients randomized in C-100-12 (1:1, vitespen vs. observation) had AJCC stage I (T1b), II (≥5 cm; Fuhrman grade 3/4), stage III, or stage IV (M0) RCC, ≥25% clear cells, ECOG performance score 0/1 and ≥7 g viable tumor tissue for vaccine production.

Descriptively, updated OS data show a favorable trend in the vitespen arm vs. observation in all analysis sets, especially among patients with earlier-stage disease (stage I/II high grade; n = 118) or at intermediate risk for recurrence (stage I/II high grade, III T1, T2, T3a, low grade; n = 184 ), with 13/125 (10.4%) vs. 21/115 (18.3%), and 18/184 (9.8%) vs. 33/178 (18.5%) deaths reported in the vitespen and observation arms, respectively.

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(PMID = 27962044.001).

[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

   

[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

   

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Expression and circulating levels of lymphangiogenic parameters in renal cell cancer: Implication for antiangiogenic treatments.

In renal cell cancer (RCC) lymphatic tumor spread exist but data focusing on lymphangiogenesis are rare.

Since the VEGF-C/VEGF-D/VEGFR-2, R-3 axis appears to be the signaling pathway for tumor-induced lymphangiogenesis and an attractive target for therapeutic intervention; we analyzed the expression and the presence of the soluble forms in 30 RCC patients and results were correlated with clinicopathological parameters.

METHODS: Tumor and sera from 30 RCC patients (20 clear cell (ccRCC)&10 papillary (pRCC) were included in this study.

The expressions of VEGFR-2,R-3 &VEGF-C,-D expressions on tumor were evaluated by immunohistochemestry.

Using ELISA assays, sVEGFR-2, R-3 &sVEGF-C,-D were measured in sera of RCC patients in comparison to 20 healthy controls.

RESULTS: In overall patients, a high expression of VEGF-C,-D and their receptors were observed in more than 55%of the patients as compared to the negative control.

Only median sVEGF- R3 level was significantly higher (p=0.005) in RCC patients as compared to healthy donors.

CONCLUSIONS: we showed that in RCC the lymphangiogenic factors are expressed or present as soluble form, a different expression pattern in ccRCC and pRCC existe.

Therefore, further studies are necessary to determine if lymphangiogenesis can play a role as a prognostic tool or a target for therapeutic intervention in renal cell carcinoma.

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(PMID = 27963428.001).

[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

   

[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.

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

   

[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

   

[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

   

[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

   

[Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.

[Title] Medical costs of sorafenib compared with sunitinib in treatment of patients <65 years with renal cell carcinoma: A retrospective claims database analysis.

: e17536 Background: Sorafenib (SR) and sunitinib (SU) are FDA approved (12/05 and 1/06, respectively) tyrosine kinase inhibitors for patients (pts) with advanced renal cell carcinoma (RCC).

Inclusion criteria were ≥2 RCC claims (ICD-9 189.0, 198.0), continuous health care coverage, >180 days of coverage before RCC diagnosis.

SR and SU pts were identified based on oral therapy after initial RCC-related claim (intent-to-treat).

Univariate and multivariate Tobit analyses were conducted; control factors included age, sex, region, plan type, comorbidity, prior Tx/procedures, and time since RCC Dx.

RESULTS: Of 10,462 RCC pts identified, 144 and 220 received initial therapy with SR and SU, respectively.

In the 180 days before RCC diagnosis, total direct medical costs, baseline demographics, and comorbidities were similar between groups.

CONCLUSIONS: Retrospective analysis of this US claims database for RCC pts <65 treated first with SR showed statistically significant lower total medical costs (particularly inpatient costs) than for pts treated first with SU.

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(PMID = 27963796.001).

[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

   

[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