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[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] 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] Phenotype Analysis of Tumour-infiltrating Lymphocytes and Lymphocytes in Peripheral Blood in Patients with Renal Carcinoma.

INTRODUCTION: When checking tumour growth, a number of observations indicate that the immune system plays a significant role in patients with renal cell carcinoma (RCC).

Infiltration by lymphocytes (tumour infiltrating lymphocytes, TILs) is more prevalent in RCC than any other tumours.

T lymphocytes are the dominant population of TIL cells.

Views concerning the role of T lymphocytic subpopulations, B lymphocytes and NK cells in an anti-tumour response are not established.

AIM: The aim is to determine the phenotype and activation of T and B lymphocytic subpopulations and NK cells and to compare their representation in tumour stroma and peripheral blood lymphocytes (PBL) in patients with RCC.

MATERIAL AND METHODS: Samples of peripheral blood taken from the cubital and renal veins and tumour stroma cells were obtained from 44 patients in the course of their surgeries carried out due to primary RCC.

TILs were isolated from mechanically disintegrated tumour tissue.

The number of CD3+/CD8+ T lymphocytes was significantly higher in TILs, 42.6 % (p+ T lymphocytes were the majority population in peripheral blood, 41.35 % (p +/69+ T lymphocytes was significantly higher in TILs, 32.9 %, compared to PBL (p+/CD25+, CD8+/57+ and CD4+/RA+ (naive CD4+ T lymphocytes) were higher in PBL (p-/16+56+) NK cells and CD3+/DR+ T cells in TILs and PBL were not significant.

CONCLUSION: The above-mentioned results prove that the characteristics and intensity of anti-tumour responses are different in compared compartments (tumour/PBL).

The knowledge of the phenotype and functions of effector cells, which are responsible for anti-tumour response, are the basic precondition for understanding the anti-tumour immune response and the cause of its failure.

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(PMID = 28795946.001).

[ISSN] 1211-4286

[Journal-full-title] Acta medica (Hradec Kralove)

[ISO-abbreviation] Acta Medica (Hradec Kralove)

[Language] eng

[Publication-type] Journal Article

[Publication-country] Czech Republic

[Keywords] NOTNLM ; CD4⁺ / CD8⁺ / Flow cytometry / Renal cell carcinoma / Tumour-infiltrating lymphocytes

   

[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] 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] 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] Corrigendum to "Enhanced Antitumor Effects of an Engineered Measles Virus Edmonston Strain Expressing the Wild-type N, P, L Genes on Human Renal Cell Carcinoma".

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(PMID = 28178499.001).

[ISSN] 1525-0024

[Journal-full-title] Molecular therapy : the journal of the American Society of Gene Therapy

[ISO-abbreviation] Mol. Ther.

[Language] eng

[Publication-type] Published Erratum

[Publication-country] United States

   

[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.

[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] Association of therapy with sunitinib and treatment-related hyperparathyroidism in renal cell carcinoma.

Here, we report on abnormalities of the mineral metabolism in patients with renal cell carcinoma (RCC) treated with MTKI.

METHODS: We identified a total of 61 patients with metastatic RCC and evaluable markers of bone metabolism, which were either treated at our institution (N=53) or followed (N=8) during March 2005 and December 2008.

Patients received either sunitinib (4 weeks on/2 weeks off schedule) or sorafenib (continuous dosing) for metastatic disease.

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(PMID = 27962981.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

[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] 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] 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] 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] 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] 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] 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] Phase II study of everolimus (E) with imatinib (IM) in patients with previously-treated renal carcinoma (RCC).

: e16075 Background: Inhibitors of mTOR improve progression-free survival (PFS) in advanced RCC.

We hypothesized that co-administration of the mTOR inhibitor E with an upstream receptor tyrosine kinase inhibitor could augment activity in advanced RCC.

We chose to study IM due to its inhibition of PDGFR, a relevant target for RCC with potential activity at both the tumor cell and the pericyte.

METHODS: Eligible patients had metastatic or unresectable clear cell renal carcinoma, at least one prior systemic therapy, no prior mTOR inhibitor therapy, performance status 0-2, and measurable disease.

A two-stage design was employed to test for a 3-month PFS of ≥ 70% vs. ≤ 50%.

Best response was stable disease (67%) and progressive disease (33%).

Most common grade 3+ events were: fatigue (16%), pleural effusion (16%), edema (11%), and renal failure (11%).

The study was closed after the first stage as the 3-month PFS did not meet continuation criteria.

CONCLUSIONS: The combination of E 2.5 mg with IM 600 mg in previously-treated patients with advanced RCC did not meet the study-defined level of activity to warrant further investigation.

The natural history assumptions for this pretreated RCC population may have been overly optimistic.

Further development of this regimen for RCC is not recommended.

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(PMID = 27963048.001).

[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] An open-label extension study to evaluate safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC).

: 5110 Background: The efficacy and safety of pazopanib (paz), a multikinase angiogenesis inhibitor, was evaluated in a randomized, double-blind placebo-controlled phase III study (VEG105192), in treatment-naïve and cytokine-pretreated patients (pts) with advanced RCC.

Pts with progressive disease (PD) on placebo had the option to receive paz 800 mg QD via an extension study (VEG107769).

RR was described along with 95% confidence intervals (CIs).

PFS was summarized descriptively using Kaplan-Meier estimates for the median, quartiles and PFS rates at 6, 12, and 18 mo along with approximate 95% CIs.

The most common AEs were hypertension (46%; 4% Gr 3/4), hair color changes (39%; 0% Gr 3/4), diarrhea (38%; 1% Gr 3/4), anorexia (24%; 1% Gr 3/4), and nausea (24%; 0% Gr 3/4).

The most common Gr 3 chemistry laboratory abnormalities were hyponatremia (7%) and elevated ALT (7%) and AST (6%); no Gr 4.

CONCLUSIONS: Patients with advanced RCC who developed PD on placebo in a phase III study subsequently achieved clinical benefit from paz treatment in this extension study.

These findings support the continued evaluation of paz in advanced RCC.

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(PMID = 27964395.001).

[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] ECOG 8802: Phase II trial of doxorubicin (Dox) and gemcitabine (Gem) in metastatic renal cell carcinoma (RCC) with sarcomatoid features.

: 5038 Background: Patients (pts) with RCC containing sarcomatoid features have poor prognoses.Cytokine therapy is ineffective, and experience with mTor inhibitors or multi-targeted tyrosine kinase inhibitors is early.

We evaluated Dox/Gem in these pts with locally advanced or metastatic disease to confirm previous activity of this regimen in a single institution trial.

METHODS: Pts received Dox 50mg/m² IV push and Gem 1500mg/m² IV over 30 minutes every 2 weeks (with G-CSF 5 mcg/kg/d days 2 or 3 to 10 or pegfilgrastim 6 mg day 2) until disease progression or unacceptable toxicity.

A 2-stage design was used; >4 responses were needed for efficacy.

RESULTS: From February 2004 to April 2007, 39 pts with RCC of sarcomatoid (47%) or mixed histology (53%) containing sarcomatoid features were accrued by ECOG (n = 35), NCCTG (n = 2), and CALGB (n = 2).

Pts were mostly male (81%), with cT3/T4 (68%), node negative (61%), M1 (58%) disease at diagnosis and ECOG PS 0-1.

1 complete and 5 partial responses (PR) were observed (16%, 90% CI 7.1-28.8%).

A 7th patient had an unconfirmed PR and an eighth patient had > 50 percent decrease in tumor burden after an initial progression.

9 patients had stable disease.

CONCLUSIONS: Dox/Gem met efficacy criteria in RCC with sarcomatoid features.

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(PMID = 27962934.001).

[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] Phase II trial of ABT-869 in advanced renal cell cancer (RCC) after sunitinib failure: Efficacy and safety results.

: 5036 Background: ABT-869 is a novel, orally active and potent inhibitor of all VEGF and PDGF receptor tyrosine kinases.

Results from a phase I study suggested antitumor activity in advanced solid tumors including RCC.

METHODS: We conducted an open-label, multicenter phase II trial of oral ABT-869 in advanced RCC.

Eligibility criteria included progressive disease (PD) within 100 days of enrollment after at least 2 cycles of sunitinib, prior nephrectomy, and adequate organ function.

RESULTS: 53 patients (pts, median age, 61 y [range, 40-80]; clear-cell histology [41 pts]; median number of prior therapies, 2 [range, 1-4]) were enrolled from 8/07 to 10/08.

The most common adverse events (AEs) were diarrhea (78%), fatigue (67%), hypertension (53%), nausea (51%) and vomiting (39%).

CONCLUSIONS: ABT-869 has activity in RCC after sunitinib failure.

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(PMID = 27962936.001).

[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] Pancreatic metastasis from renal cell carcinoma: Presentation, recurrence, survival, and response to antiangiogenic therapy.

: e16137 Background: Pancreas represents an uncommon site of metastasis in renal cell carcinoma (RCC).

We examined the outcome in a series of RCC patients (pts) with pancreatic metastases, treated by either surgery or antiangiogenic therapy.

METHODS: We reviewed the charts of RCC pts treated for pancreatic metastases, between 2001 and 2008, in Institut Gustave Roussy and Pitié-Salpetrière Hospital.

Data base was reviewed to determine presentation, clinical symptoms, pancreatic metastases treatment, use of systemic therapy, disease-free survival (DFS) or progression-free survival (PFS) and overall survival (OS) after treatment.

RESULTS: A total of 40 pts with pancreatic metastases from RCC have been analyzed.

Best response was partial response in 30% of pts and stable disease in 50% of pts.

CONCLUSIONS: Patients with RCC pancreatic metastases seem to have a longer survival than the usual metastatic RCC pts.

Surgical resection must be discussed in pauci-metastatic disease, as it can be associated with prolonged survival.

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(PMID = 27963352.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

[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] Prognostic factors of clear renal cell carcinoma in pT1a cases.

: e16064 Background: The proportion of clear cell renal cell carcinoma (CRCC) cases diagnosed at pT1a is known to be increasing significantly.

For each case, the following pathological parameters were analyzed: patient age, tumor location (upper, middle, low), Furhman grade, presence of capsule, presence of lympho-vascular invasion, growth pattern (expansive or infiltrating), presence of scar, presence of hemorrhage, and presence of necrosis.

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(PMID = 27963068.001).

[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-effectiveness analysis of first-line treatment for metastatic renal cell carcinoma (mRCC) in Colombia (ONCOLGroup study).

: e16150 Background: Renal cell carcinoma has increased its incidence by 126% since 1950.

A local study developed a complete economic evaluation of sunitinib versus IFN in first-line treatment of mRCC in Colombia, finding that sunitinib was more cost-useful and cost-effective.

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(PMID = 27963418.001).

[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] Protein profiling of tumor tissues by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry to discriminate between localized and metastatic renal cell carcinoma.

: e16098 Background: We previously reported that mRNA of interferon-alpha receptor type 2 (IFNAR2) was upregulated in metastatic and IFN-a resistant renal cell carcinoma (RCC) in comparison to localized RCC or metastatic tumors with good response to IFN-a (BMC Cancer, 2007).

Protein profiling using human tumor tissues may give insight into cellular pathways leading to carcinogenesis and metastasis in RCC.

METHODS: We examined mRNAs expression for IFNAR2 in paired tumor and non-tumor samples from the surgical specimens of Japanese patients with RCC using a real-time reverse transcription polymerase chain reaction.

Then we selected representative five IFNAR2 upregulated clear cell carcinomas cases with metastatic tumor, five IFNAR2 upregulated metastatic sarcomatoid carcinomas, and five normal expression clear cell carcinomas with localized tumor.

We investigated protein profiling in the tumor tissues of above three groups using surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-TOF MS) coupled with IMAC-Cu chips.

The heat map analysis based on the clustering distinguished completely metastatic tumors with IFNAR2 upregulated groups from localized tumors with IFNAR2 normal expression group.

Furthermore, the heat map discriminated metastatic sarcomatoid carcinomas from metastatic clear cell carcinomas with a sensitivity of 100% and a specificity of 80%.

CONCLUSIONS: SELDI-TOF MS profiling of tumor tissues can be applied to differentiate patients with three types of RCCs.

Our findings may reflect different molecular mechanism between localized and metastatic carcinomas, and the different response to immunotherapy with IFN-α.

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(PMID = 27963090.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

[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] 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] 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] Laparoscopic renal cryoablation: Risk factor analysis to predict oncologic outcomes with minimum 5-year follow-up.

: 5094 Background: We analysed risk factors to predict oncologic outcomes at 5-11 year after laparoscopic renal cryoablation (LRC).

METHODS: Between 09/1997 and 010/2008, we performed renal cryoablation in 340 patients.

Mean tumor size was 2.3 cm (0.9-5.0 cm).

Overall, there were 7 cancer deaths.

In the 69 patients with biopsy-proven renal cell cancer (median follow-up 81 mos; range 60-132 mos), 5-year overall, disease-specific, and disease- free survival was 75%, 92%, and 82%, respectively, while 10-year overall, disease-specific, and disease-free survival was 46%, 83%, and 79%, respectively.

On multivariate analysis, previous radical nephrectomy for RCC was the only significant predictor for both recurrence- free survival and cancer-specific survival (p = 0.023 and 0.030, respectively).

Relative risk of patients who has a history of radical nephrectomy for RCC treatment was 4.1 (95% CIs, 1.2 to 13.4), and 5.4 (95% CIs, 1.2 to 27.7) for disease-free survival and disease-specific survival, respectively.

CONCLUSIONS: Laparoscopic renal cryoablation is effective oncologic treatment for renal mass in select patients.

Disease-specific survival of 92% at 5-years and 83% at 10-years is possible.

Preceding radical nephrectomy for RCC treatment was the only independent predicting factor for both disease-free and disease-specific survival.

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(PMID = 27964294.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

[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] 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] Efficacy and safety of sorafenib in patients with advanced clear-cell renal cell carcinoma (RCC) with diabetes: Results from the phase III TARGET study.

: e16099 Background: Results of the phase III TARGET trial, a randomized, double-blind, placebo-controlled study of sorafenib (SOR) treatment in pts with clear-cell RCC in whom 1 prior systemic therapy had failed, indicated that SOR is effective and safe for pts with advanced RCC, leading to the approval of SOR for the treatment of advanced RCC.

METHODS: Pts (N=903) with advanced clear-cell RCC, ECOG PS 0-2, and low- or intermediate-risk MSKCC score were randomized 1:1 to SOR 400 mg BID or placebo (PBO).

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(PMID = 27963086.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

[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] 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.

[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] 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] Preclinical identification of biomarkers of response to mTOR inhibitors and subsequent application in a phase II trial of sirolimus in pancreatic cancer patients refractory to gemcitabine.

: 4612 Background: Treatment for advanced pancreatic cancer refractory to gemcitabine has not been defined.

We conducted an efficacy study in pancreatic cancer xenografts to identify biomarkers of response to mTOR inhibition and attempted to translate the results by conducting a phase II trial of sirolimus in this patient population.

Tumors were profiled with array CGH and gene expression arrays at baseline.

RESULTS: In the preclinical study, mTOR sensitive tumors showed upregulation of genes involved in the renal cell cancer pathway.

Baseline tumor p-S6K was not predictive for survival.

The most common grade 3 adverse event was hyperglycemia in 10% of the patients.

7 (23%) patients achieved stable disease.

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(PMID = 27964189.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

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

[Title] A phase II trial of perifosine in patients with advanced renal cell carcinoma (RCC) who have failed tyrosine kinase inhibitors (TKI).

: 5101 Background: The recently demonstrated activity of inhibitors of TORC1 in RCC has raised the possibility that even greater effects may be achieved by targeting upstream of this pathway.

Perifosine is a synthetic alkylphospholipid which inhibits Akt activity and also has cell-dependent effects upon the MAP-kinase pathway.

Prior single-agent trials showed disease stabilization/regression in patients (pts) with advanced RCC; however, few pts were previously treated with a TKI.

Therefore, we conducted a multi-center phase II trial to determine the safety and efficacy of perifosine in pts with advanced RCC refractory to VEGFR TKI.

Secondary objectives included overall response rate (> PR), and safety, Eligibility: ECOG PS 0-1, pts with metastatic RCC who have RECIST defined progression on either sunitinib or sorafenib.

Median age 67 (range 47-78) and 16 were male; 90% of pts had predominantly clear cell histology.

CONCLUSIONS: Perifosine has promising activity in pts with RCC who have failed prior TKI therapy.

Additional studies are under consideration to evaluate perifosine for clinical benefit in pts with previously treated RCC.

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(PMID = 27964377.001).

[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] Correlation of N-telopeptide of type I collagen (NTX) with survival and fractures in patients (pts) with bone metastases from renal cell carcinoma (RCC).

: e16016 Background: The osteolysis marker NTX has shown prognostic significance in pts with bone metastases from a broad range of solid tumors, but its potential in pts with RCC has not been investigated.

METHODS: This was an exploratory correlative analysis of NTX levels and outcomes in the RCC subset of pts treated with zoledronic acid (ZOL) in a 21-month phase III trial (Rosen et al.

Endpoints included overall survival (OS), disease progression in bone, and pathologic fractures.

RESULTS: Among 55 ZOL-treated RCC pts, 29 had baseline NTX data (median = 60 nmol/mmol CR).

CONCLUSIONS: In pts with RCC receiving ZOL, serial NTX assessments may provide important prognostic insight.

Although based on a small sample size, correlations between recent NTX levels and outcomes in RCC pts are more profound than those previously reported in pts with other solid tumors (Brown et al.

J Natl Cancer Inst. 2005).

Elevated NTX could alert physicians to the need to more closely monitor bone lesions and intervene to prevent fractures in RCC pts.

This may be especially important in the context of new systemic therapies that are improving the outlook in the advanced RCC setting.

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(PMID = 27962910.001).

[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] Is squamous cell histology an adverse prognosticator for survival of malignancies of the upper urinary tract?

: 6617 Background: Carcinomas of the renal pelvis and ureter are rare diseases, accounting for only about 1% of all urogenital malignancies.

Previous reports suggest that squamous cell histology is associated with inferior survival.

METHODS: We analyzed the Surveillance, Epidemiology and End Results database for cancer specific survival rates in patients with renal pelvis and ureteral malignancies who were diagnosed between 1973 and 2003 in the SEER catchment geographic areas.

The primary exposure of interest was the underlying histology, squamous cell versus transitional cell differentiation.

We performed descriptive statistics, non parametric survival analysis, and cox proportional hazard analysis.

RESULTS: We identified 13,213 eligible patients, 7,716 renal pelvis and 5,497 ureteral carcinomas.

Among this cohort, 179 patients had squamous cell carcinoma (SCC), 12,395 had transitional cell carcinoma (TCC), including 121 papillary, and 619 had other histologies.

The cox analysis revealed a HR 0.42 (95% CI 0.36-0.47) for TCC when compared to SCC and corrected for decade of diagnosis, age, gender, prior treatment, and race.

The difference between the two groups was entirely attributable to survival differences in patients with loco-regional disease.

CONCLUSIONS: SCCs of the upper urinary tract present at a higher clinical stage and appear to represent more aggressive disease when compared to other histologies.

However, when appropriately staged according to lymph node status, the survival of TCC and SCC of the upper urinary tract is identical when compared stage by stage.

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(PMID = 27961775.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

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

[Title] Histopathology in surgically treated renal cell carcinoma: Is there a survival difference when stratified by stage?

: 5089 Background: The impact of renal cell carcinoma histopathology (RCC) on survival has been conflicting and limited to retrospective institutional studies.

Therefore, we sought to determine the role of RCC histopathology on stage-specific survival rates in a population-based cohort.

METHODS: We utilized the National Cancer Institute's Surveillance, Epidemiology, and End Results database and identified 21,258 patients who underwent partial or radical nephrectomy for RCC between 1996 and 2004.

Patients were stratified based on histopathologic diagnosis (clear cell, papillary, chromophobe, sarcomatoid, and collecting duct) and pathologic stage.

We performed Cox-proportional hazard modeling and Kaplan-Meier survival analyses to determine overall- and cancer-specific survival.

RESULTS: Using univariate analysis, histopathology significantly impacted overall- and cancer-specific survival (p< 0.001).

Specifically, patients with papillary and chromophobe variants had lower stage disease at the time of surgery and had improved survival compared to clear cell subtypes, (HR: 0.50; 95% CI, 0.42-0.60 and HR: 0.31; 95% CI, 0.22-0.44, respectively).

When controlled for stage, improved outcomes for chromophobe and papillary histologies persisted, although it did not achieve statistical significance at all stages.

On the other hand, patients with sarcomatoid disease were more likely to present with high stage disease and invariably had worse survival compared to clear cell carcinoma (HR: 8.74; 95%, CI 7.70-9.91).

When controlled for stage, this difference achieved statistical significance across all stages (p< 0.001).

CONCLUSIONS: Histopathologic subtype in patients with RCC does predict overall- and cancer-specific survival.

Patients with sarcomatoid RCC, even those presenting with low-stage disease, have poor survival.

These findings may give further value to recent data suggesting the increased utility of percutaneous renal biopsy and its potential impact on management.

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(PMID = 27964288.001).

[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] The effect of zoledronic acid on bone metastasis in patients suffering from renal cell cancer (RCC): A German prospective single-arm clinical trial.

: 5107 Background: The incidence of RCC increased over the last decades and about 30% of patients will develop bone metastasis.

These pts. face considerable skeletal morbidity e.g. bone pain, pathologic fractures, spinal cord compression or tumor induced hypercalcemia (TIH).

A prospective trial was initiated in RCC metastatic to bone evaluating the SRE (skeletal related event) rate under therapy with zoledronic acid (ZA).

METHODS: Patients with RCC must have had ≥1 bone metastasis and ≤2 prior applications of a bisphosphonate.

Bone lesions response was observed in 3 pts. (2 CR, 1 PR) out of 33 pts. currently available.

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(PMID = 27964367.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

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

[Title] Phase I trial of RAD001 (everolimus) plus sunitinib in patients with metastatic renal cell carcinoma.

: 5037^ Background: RAD001 (everolimus) and sunitinib (SUTENT) both have activity in metastatic renal cell carcinoma (mRCC).

RESULTS: Of 20 pts (median age 62; 13 clear cell (cc) and 7 non-cc RCC) enrolled, 19 are evaluable for DLT including 3 in cohort 1 (2.5 mg RAD001 daily/ 37.

3/5 pts with confirmed partial responses have non-cc RCC (2 chromophobe; 1 papillary).

5 mg sunitinib is recommended for phase II and shows responses in non-cc RCC.

NIH-sponsored trials are exempt from the Policy restrictions.

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(PMID = 27962935.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

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

[Title] Synergistic growth inhibition of RCC and NSCLC cell lines by sorafenib plus vorinostat and induction of angiogenic genes by ER stress.

: e16114 Sorafenib, vorinostat and the combination were examined in 34 RCC and NSCLC cell lines.

At baseline, bFGF, VEGF and IL-8 were highly expressed in RCCs, whereas Gro-α, VEGF, and IL-8 predominated in NSCLCs.

Importantly, sorafenib at 8 μM, but not lower doses, induced ER stress in these cell lines and thapsigargin or tunicamycin treatment recapitulated many, but not all, of the observed angiogenic gene responses to sorafenib.

In summary, sorafenib plus vorinostat potently inhibits the in vitro growth of RCC and NSCLC cell lines.

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(PMID = 27963311.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

[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] Antitumor activity of patient-derived renal cell carcinoma cells fused with allogeneic dendritic cells: In vitro results and clinical responses.

: 3056 Background: Renal cell carcinoma (RCC) has been shown to be highly susceptible to immune-based treatment strategies.

METHODS: In the present study, patient-derived tumor cells were fused with allogeneic dendritic cells (DC) to elicit antitumor activity against RCC.

DC from HLA-A2+ healthy donors were fused with primary RCC cells from 10 patients.

Phenotype of fusion cells was characterized by flow cytometer and confocal microscopy.

In vitro, T-cell proliferation, IFN-γ secretion, and cytotocic T lymphocytes (CTL) activity elicited by allogeneic DC/RCC fusion cells were assessed.

Clinically, 10 patients were vaccinated with allogeneic DC/RCC fusion vaccine.

RESULTS: After fusion, the created hybrids expressed both tumor-associated antigen and DC-derived molecules and could stimulate the proliferation and IFN-γ secretion of T-cells as well as elicit strong CTL activity against RCC cells in vitro.

In vivo, neither serious adverse effects nor signs of autoimmune disease were observed after vaccination therapy.

Six patients showed stable disease with stabilization of previously progressive disease (follow-up 1.5 year).

CONCLUSIONS: The data suggest that allogeneic DC/RCC fusion vaccine is safe and can elicit immunological responses in patients with RCC.

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(PMID = 27961996.001).

[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 chromosome 9p status to identify a subset of high-risk localized renal cell carcinoma.

: 5090 Background: We investigated whether deletion of chromosome 9p in clear cell renal cell carcinoma (ccRCC) predicts worse disease-specific (DSS) and recurrence-free survival (RFS), and if it is associated with worse prognosis in tumors < 4 cm.

Tumor grade, stage, size, 9p status, nodal involvement, and the presence of metastasis were recorded.

Disease-specific and recurrence-free survival were determined, and independence was assessed using Cox proportional hazards models.

RESULTS: 9p deletions were detected in 14% of tumors.

54% of 9p-deleted tumors were high grade (G3-4) vs. 38% without 9p deletions, and 60% of 9p-deleted tumors were T3-4 vs 38% without 9p deletions (p < 0.01).

In localized disease, median RFS for those with 9p deletions was 53 months and was not reached in those without 9p deletions (p<0.01).

In 188 patients presenting with localized RCC < 4 cm, loss of 9p occurred in 3/7 (42.9%) of patients with post-nephrectomy recurrence vs. 13/168 (7.2%) of patients without disease recurrence (p = 0.001).

DSS for patients with 9p deletion in tumors < 4 cm was significantly worse than DSS in those without 9p deletions (HR 6.18; p = 0.02), and an independent effect on RFS was seen for 9p deletions in localized RCC (HR 2.3, p < 0.01).

9p status was not a significant predictor in metastatic RCC.

CONCLUSIONS: Deletion of chromosome 9p in ccRCC occurs in 14% of patients and is associated with higher grade and T stage, presence of nodal and distant disease, worse prognosis, and in patients with small NOMO tumors, 9p deletions but not tumor size was independently associated with RFS.

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(PMID = 27964298.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

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

[Title] A phase I study of AS1409, a novel antibody-cytokine fusion protein, in patients with malignant melanoma (MM) or renal cell carcinoma (RCC).

ED-B-fibronectin is expressed in tumor vasculature.

IL-12 stimulates T and NK cell activity.

Responses to IL12 occur in MM and RCC, but with high systemic toxicity.

AS1409 is designed to target IL-12 to tumor vasculature.

METHODS: Patients with MM or RCC were treated in a dose-escalating trial of weekly i.v.

Patients without unacceptable toxicity or disease progression could continue therapy.

RESULTS: 13 patients (9 males; median age 53 years; 11 MM, 2 RCC) were treated (7 at 15mcg/kg, 6 at 25mcg/kg).

A partial response was seen in a patient with MM metastatic to lymph nodes treated at 15mcg/kg, and a best response of stable disease was seen in 4 patients.

Biomarker activation and objective radiological evidence of anticancer activity was observed at this dose.

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(PMID = 27962070.001).

[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] Efficacy and thyroidal effects of sunitinib in Japanese patients with metastatic renal cell carcinoma: Hypothyroidism and thyroid atrophy as potential biomarkers for sunitinib?

: e16097 Background: Although hypothyroidism is a well-known adverse effect of sunitinib in western patients (pts) with metastatic renal cell carcinoma (MRCC), the effects on thyroid gland of sunitinib in Japanese pts still remain unclear.

We therefore evaluated thyroid dysfunction and thyroid atrophy in Japanese RCC pts who received sunitinib.

CT volumetry of the thyroid gland was performed utilizing the data obtained for tumor assessment in a phase II trial.

Tumor response was evaluated based on the RECIST criteria.

CONCLUSIONS: In addition to high anti-tumor efficacy, hypothyroidism and thyroid atrophy were commonly observed in Japanese MRCC pts who received sunitinib.

Although further study should be required, these abnormal findings in thyroid gland following treatment with sunitinib may be potential biomarkers for tumor response to sunitinib.

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(PMID = 27963089.001).

[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] Dosing patterns in patients with renal cell carcinoma treated with sorafenib or sunitinib: A retrospective claims database analysis.

: 5097 Background: Tyrosine kinase inhibitors (TKIs; sorafenib [SR], sunitinib [SU]) are FDA approved for the treatment of advanced renal cell carcinoma (RCC).

We analyzed the dose reduction patterns in pts with RCC treated with SR, approved Dec 05, or SU, approved Jan 06.

Inclusion criteria were ≥2 claims for RCC (ICD9 189.0 or 198.0), continuous healthcare coverage, >180 days of coverage before RCC diagnosis, no claim for SR or SU prior to RCC diagnosis, initial standard daily RCC dose per package insert recommendation (800 mg for SR or 50 mg for SU), and ≥2 consecutive dispensings.

No significant differences in baseline demographics existed between the groups except for a higher incidence of stroke (7.9% vs 3.6%, p = 0.037) and other cancer site (93.7% vs 87.8%, p = 0.036) in the SR group.

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(PMID = 27964291.001).

[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 gefitinib and pegylated interferon alfa 2b (PEG-IFN) in previously-treated renal cell carcinoma (RCC).

: e16115 Background: Modulation of the epidermal growth factor receptor (EGFR) pathway is relevant to IFN activity in RCC.

Cell lines sensitive to IFN's antiproliferative effects downregulate EGFR, while IFN treatment of resistant cells precludes such an effect. (Eisenkraft et al, Cancer Res.

To explore this hypothesis, we conducted a trial of the EGFR tyrosine kinase inhibitor gefitinib plus PEG-IFN in RCC patients (pts).

METHODS: Unresectable or metastatic RCC pts (no limit on prior therapies; performance status 0-2, and adequate end-organ function) were eligible.

A 6-month progression free survival (PFS) rate of 50% was considered promising (vs. 30%) in a two-stage design incorporating the Green-Dahlberg rule.

We accrued 21 patients in the first-stage of accrual.

Accrual slowed with increased use of small molecule kinase inhibitors, bevacizumab, and temsirolimus for RCC.

Response duration: CR (35+ months) and PR (3, 5, 5, 38+ months).

Most common treatment-related toxicities were leucopenia, thrombocytopenia, rash, nausea, diarrhea, and hyperglycemia.

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(PMID = 27963312.001).

[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 and long term prognosis of papillary renal cell carcinoma.

: e16020 Background: Papillary renal cell carcinoma (pRCC) represents the largest subgroup of non clear-cell kidney cancer.

In this study we assessed tumour characteristics and long-term prognosis of patients with pRCC in comparison with conventional clear-cell cancer (ccRCC).

METHODS: We evaluated 744 patients who had undergone renal surgery for RCC between 1990 and 2005.

RESULTS: Both groups pRCC and ccRCC were alike concerning age, body mass index, and the incidence of regional lymph node or distant metastasis at diagnosis.

Even though patients with pRCC presented more often with smaller (p = 0.039) and low grade tumours (p = 0.006), there was no statistically significant difference in tumour recurrence or tumour related death.

Moreover, looking at the whole cohort Kaplan-Meier curves revealed no differences regarding tumour specific survival between pRCC and ccRCC (p = 0.94; 5-year survival 78% vs. 77%).

However, we observed a trend towards an improved outcome for organ confined (pT1-2) cancer, but a significantly inferior prognosis for locally advanced stage (pT3-4) and/or metastatic papillary tumours at the time of renal surgery.

However, applying multivariate analysis including age, sex, and tumour grade, histology could neither be retained as a significant independent prognostic marker in the metastatic setting (p = 0.068, cox regression analysis) nor in a subgroup analysis focussing on patients with advanced cancer (pT3-4 and/or N+/M+; p = 0.064, cox regression analysis).

As we could not confirm a favourable clinical course for pRCC in general, standardized aftercare programmes and - if necessary - systemic treatment, especially in the era of novel targeted drugs, are also needed for this common RCC subtype.

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(PMID = 27962984.001).

[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] Economic evaluation of sunitinib versus other new targeted therapies as first-line treatment of metastatic renal cell carcinoma (mRCC) in the United States.

: e17556 Background: RCC, the most prevalent kidney cancer, is a relatively rare malignancy that carries a poor prognosis.

Costs of drugs, routine follow-up, treatment-related adverse events, disease progression, and best supportive care of terminally-ill patients were included in the model.

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(PMID = 27963850.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

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

[Title] Phase II dose escalation study of sorafenib in patients with metastatic renal cell carcinoma (mRCC) who have had prior treatment with VEGFR-TKI antiangiogenic treatment.

: e16027 Background: Sorafenib is an orally active multikinase inhibitor (Raf kinase, VEGFR 1, 2, 3 and PDGFR inhibitor) for the treatment of advanced RCC.

Pts with no progressive disease (evaluated at 12 weeks) continued to receive Sorafenib at the standard dose, while progressive pts received an increasing dose (600 mg BID) with early disease restaging after 4 weeks.

RESULTS: 18 pts were entered; baseline characteristics: PS 0-1: 94%; median age 62 years (41-82); nephrectomy: 100%; surgery for metastatic disease: 28%, clear-cell 78%, papillary-cell 16%, sarcomatoid 6%.

Overall, 72% of pts had disease control without significant correlations between response to prior therapy and hypertension.

The most common toxicity (NCIC 3.0, all pts) was grade (g) ≥ 1 diarrhea in 10 pts, g2-3 hand-foot syndrome in 7 pts and g-3 mucositis in 1 pt.

Other hematological and non-hematological toxicities were g1 with a frequency < 15%.

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(PMID = 27962966.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

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

: e14549 Background: Sorafenib is a multikinase inhibitor currently approved by the FDA for the treatment of advanced renal-cell carcinoma (RCC) and unresectable hepatocellular carcinoma (HCC), and by the EMEA for the treatment of HCC and advanced RCC.

Utilizing a randomized, crossover design, subjects received either two 200-mg intact tablets (IT) with 8 ounces water, or two 200-mg tablets disintegrated over 10 minutes in 2 ounces of water (ST), with an additional 6 ounces of water swallowed as a rinse of the dosing vessel.

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(PMID = 27963627.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

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

[Title] Cardiovascular toxicity follwing sunitinib therapy in metastatic renal cell cancer: A multicenter analysis.

We reviewed cardiac adverse events in patients with metastatic renal cell carcinoma (RCC) who underwent treatment with this agent.

METHODS: The medical records of 175 patients with metastatic RCC treated with sunitinib at eight Italian Institutions were retrospectively reviewed.

Among these 17 patients, 12 (70.6%) also experienced left-ventricular systolic (LVEF) dysfunction; in all, 33 of the 175 patients (18.9%) developed some degree of cardiac abnormality, of which 12 were of classified as grade 3 LVEF dysfunction and/or congestive heart failure (CHF) (6.9%).

A significant univariate association for predictors of CHF were history of hypertension (p=0.008), history of coronary heart disease (p=0.0005) and prior treatment with an angiotensin converting enzyme inhibitor (ACE) (p= 0.04).

Multivariate analysis suggested that a history of coronary artery disease (OR 18, 95% CI, 4-160 p 0.005) and hypertension (OR 3, 95% CI, 1.5-80 p 0.04) were the only significant independent predictors of CHF.

CONCLUSIONS: Patients undergoing sunitinib, especially those with a previous history of hypertension and coronary heart disease, are at increased risk for cardiovascular events and should be monitored for exacerbations of their hypertension and for evidence of LVEF dysfunction during treatment.

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(PMID = 27963002.001).

[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 perifosine in metastatic renal cell carcinoma (RCC) progressing after prior therapy (Rx) with a VEGF receptor inhibitor.

In a prior trial, 15 RCC patients (pts) were enrolled in a randomized dose finding study, 9 were evaluable for response and 3 (33%) had a partial response (PR).

Median age 64 (range 46-80) and 36 were male; Median prior Rx was 2 (range 1 - 5); Clear cell = 37, non clear cell = 6, data n/a = 3.

Most common toxicity was grade 1 & 2 nausea (56%), arthralgia (47%), vomiting (36%), fatigue (33%) and cognitive changes (28%).

CONCLUSIONS: Perifosine, similar to mTOR inhibitors, appears to have clinical benefit in mRCC as reflected by the PR rate and a 15 wk median overall PFS.

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(PMID = 27962937.001).

[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 sorafenib and RAD001 for metastatic clear cell renal cell carcinoma.

: 5104 Background: Both RAD001 and sorafenib have activity against advanced clear cell renal cell carcinoma (ccRCC).

Independently-reviewed best objective responses in 13 evaluable pts include 3 confirmed partial responses (10, 17+, and 23+ months), 6 stable disease (2+, 4+, 4.5, 6+, 13, and 23+ months), and 4 progressive disease.

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(PMID = 27964372.001).

[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] Failure of initial VEGF-targeted therapy in metastatic renal cell carcinoma (mRCC): What next?

: 5098 Background: The characterization and efficacy of second-line targeted therapy in patients with metastatic RCC who failed first-line VEGF-targeted therapy in a population-based setting is of clinical relevance but remains to be assessed.

METHODS: Provincial registries and clinical databases from seven cancer centers (3 in US and 4 in Canada) identified patients with mRCC who received first-line anti-VEGF targeted therapy between 2005-2007.

Of these, 218 patients (34%) received second-line targeted therapy: the median age was 62 yrs (range, 41-87), median KPS was 90%, 90% had prior nephrectomy, 3.8% had non-clear cell histology, 5.8% had brain metastases and 79% had > 1 metastatic site.

Patient characteristics were similar aside from more non-clear cell histology in patients receiving second-line mTOR-inhibiting agents (14% vs 3% p = 0.045).

However, patient selection may account for this finding and overall survival was not significantly different.

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(PMID = 27964309.001).

[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] 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] Cost-effectiveness of zoledronic acid in the prevention of skeletal-related events in patients with bone metastases from renal cell carcinoma: Comparison between France, Germany, and the United Kingdom.

: 5106 Background: Zoledronic acid (ZOL) significantly reduces the risk of new skeletal-related events (SREs) in patients (pts) with bone metastases from RCC.

This study assessed and compared the cost-effectiveness of ZOL in pts with RCC from French, German, and United Kingdom (UK) societal perspectives.

METHODS: This analysis was based on a retrospective analysis of RCC pts with bone metastases who were enrolled in a 9-mo trial of ZOL or placebo (PBO) plus concomitant antineoplastic therapy.

SRE costs were estimated using diagnosis-related group tariff information and published literature.

CONCLUSIONS: Treatment with ZOL reduces SREs, improves QOL, and lowers health-related costs compared with PBO in French, German, and UK pts with bone metastases from RCC.

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(PMID = 27964368.001).

[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 percutaneous kyphoplasty to treat painful vertebral compression fractures (VCF) in solid tumors.

: e20568 Background: Vertebral compression fractures are a major source of morbidity in metastatic carcinoma.

Although it is FDA approved for cancer-associated VCF most of the data is in the myeloma population.

RESULTS: Review of 447 consecutive orthopedic spine cases identified 40 kyphoplasty patients, 30 of which met the inclusion criteria - 21 with benign compression fractures secondary to osteoporosis/trauma and 9 with malignant disease (3 breast CA, 2 lung, 1 cervix, 1 RCC, 2 myeloma).

Median age was in the cancer group was 55 (37-81) vs. 68(41-93) in benign group.

One patient had prior radiation in the cancer group.

The average preoperative visual analog pain score was 7 (range 3-9) and postoperative pain score was 2.0 (0-9) in the cancer group.

CONCLUSIONS: Kyphoplasty provided marked pain relief in patients with VCF secondary to solid tumors and myeloma.

The results are comparable to non-cancer population in safety and efficacy, and are feasible in selected cancer patients with pain due to pathologic compression fractures.

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(PMID = 27961129.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

[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] 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 follow-up of endogenous erythropoietin, VEGF levels and red blood count in patients receiving different antiangiogenic treatment.

: e14648 Background: Anemia, commonly defined as a hemoglobin level of <12 g/dL, occurs in over 30% of cancer patients at any time point and its incidence increases with treatment.

The concept of antiangiogenic treatment for solid tumors has recently emerged and we wondered why patients under such kind of treatment did not experience anemia requiring transfusion or the use of erythropoietin.

The goal of this study is to follow-up endogenous serum EPO, VEGF concentrations, hemoglobin (Hb) and hematocrit (Ht) levels in various metastatic cancers patients receiving different anti-angiogenic treatment and to try to establish the possible relation between these parameters.

PATIENTS AND METHODS: 30 patients (20 men and 10 women) with different cancer type (20 RCC and 10 thyroids) with a median age of 56 year were included in this study.

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(PMID = 27964238.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

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

[Title] Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: Updated phase I study results.

: e14509 Background: Sunitinib (SU) is an oral, multitargeted tyrosine kinase inhibitor of VEGFRs, PDGFRs, KIT, FLT3, and RET, approved for the treatment of advanced RCC and imatinib-resistant/intolerant GIST.

METHODS: Successive pt cohorts with advanced solid tumors (STs) received oral SU at 25, 37.5, or 50 mg for 2 wks during 3-wk cycles (Schedule 2/1) or for continuous 3 wk cycles (CDD schedule) with P (175-200 mg/m²) plus C (AUC=6 mg·min/mL) on day 1 of each of 4 cycles.

Response was evaluated for pts with measurable disease.

Tumor types included NSCLC (n=10), SCLC, esophageal, and pancreatic (n=4 of each), and other (n=21).

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(PMID = 27963544.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

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

We hypothesized that each treatment offer disease control without significant severe toxicity.

METHODS: This multi-center-randomized study was aimed to assess the efficacy and tolerance of both treatments.

Primary endpoint was stable disease rate at 2 months: 2mSD (RECIST).

Main eligibility criteria were as follows: non-breast cancer, pts with progressive disease refractory to standard therapies or without established standard care, ECOG=0-1, neither hypercalcemia nor hypoalbuminemia.

The second stage was allowed because at least 2mSD were seen among 12 first pts.

Most common primaries were: colorectal cancer (30 pts), soft tissue sarcoma (17), lung cancer (13), head & neck (8) and unknown primaries (4).

Three long-lasting SD (6 months +) are currently being observed in 3 pts receiving OMC (2 sarcomas and 1 RCC).

CONCLUSIONS: OMC and MA offer SD in patients with advanced, refractory and progressive tumors, without any significant toxicity.

The non-progression rate with OMC (15%) is in a same range of efficacy that was recently reported with new targeted therapy or anti-angiogenic agents administered in such pts.

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(PMID = 27961314.001).

[ISSN] 1527-7755

[Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology

[ISO-abbreviation] J. Clin. Oncol.

[Language] eng

[Publication-type] Journal Article

[Publication-country] United States

   

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

[Title] A phase I study of everolimus plus sorafenib in patients with metastatic renal cell carcinoma (mRCC).

: e16056 Background: Everolimus, a mTOR inhibitor and Sorafenib, a Raf kinase inhibitor had shown their efficacy in RCC, as single agents.

METHODS: Patients predominantly had clear cell RCC, and progressive measurable diseases on prior treatments including immunotherapy, TKI and/or Everolimus.

Patients were evaluated weekly for toxicities and every 8 weeks for radiological response, including at least both PET/CT and CT scans at baseline and 1^st staging.

The most common side effect was grade 1/2 hand-foot syndrome (4/15, 27%).

47% (7/15) of the patients had stable disease.

CONCLUSIONS: The MTD of combining daily Everolimus 10mg and twice daily sorafenib 400mg are safe and effective for progressive metastatic RCC.

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(PMID = 27962999.001).

[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] Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma (mRCC) with severe renal impairment or on haemodialysis.

Due to the inclusion criteria of clinical trials, no studies of sunitinib have enrolled patients with severe renal impairment or those undergoing haemodialysis, and thus further investigation of the effect of sunitinib in this population is required.

Medical records were searched to identify only those patients with a creatinine clearance (CL_cr) of <30ml/min or who had end stage renal disease (ESRD) requiring haemodialysis.

PR or SD was observed as best response in 17 (81%) patients.

The most common treatment-related adverse events (AEs) included fatigue, diarrhoea, hand foot skin reaction (HFSR), nausea and vomiting and rash.

CONCLUSIONS: These data suggest that patients treated with sunitinib who have severe renal impairment, or ESRD on haemodialysis, have a PFS that is comparable to patients with normal renal function.

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(PMID = 27964363.001).

[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 factors for overall survival with sunitinib as first-line therapy in patients with metastatic renal cell carcinoma (mRCC).

RESULTS: In multivariate analysis of sunitinib patients, factors associated with longer OS include: interval from diagnosis to treatment ≥1 yr, ECOG PS of 0, lower corrected calcium, absence of bone metastases, lower lactic dehydrogenase (LDH), and higher hemoglobin (Hgb) ( table ).

For the IFN-α treatment arm, male gender, absence of bone or lymph node metastases, lower LDH, higher Hgb, lower corrected calcium, higher neutrophil count, and interval from diagnosis to treatment ≥1 yr were associated with longer OS.

Further studies are warranted to independently validate these findings as well as to identify tumor-specific prognostic factors.

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(PMID = 27962940.001).

[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