Clinical prognostic factors associated with outcome in patients with metastatic clear-cell renal cell cancer treated with everolimus.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 443-443
Author(s):  
Robert J. Amato ◽  
Amber Flaherty ◽  
Somyata Saxena ◽  
Mika Stepankiw
Keyword(s):  
Prognostic Factors ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Clear Cell ◽  
Left Kidney ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
Factors Associated ◽  
Kidney Involvement ◽  
Clear Cell Rcc

443 Background: Everolimus, an oral mammalian target of rapamycin (mTOR) inhibitor, has demonstrated efficacy affects tumor growth by blocking growth factor stimulation, arresting cell cycle progression, and inhibiting angiogenesis. mTOR inhibitors and agents with primarily antiangiogenic activity have been shown to have efficacy in renal cell cancer (RCC). This study expanded the original everolimus study of 41 patients with metastatic clear cell renal cell cancer to 66 patients to examine outcome and clinical prognostic factors associated with outcome Methods: Patients had confirmed predominantly clear cell RCC. Everolimus was given at a dose of 10 mg daily orally without interruption (28-day cycle), with dose modifications for toxicity (graded according to National Cancer Institute Common Toxicity Criteria, version 3.0). Patients were evaluated every 2 cycles (8 weeks) using Response Evaluation Criteria in Solid Tumors (RECIST). Results: Of 66 evaluable and treated patients, 73% were male, and 45% were >60. Forty-five percent had right kidney involvement, 49% left kidney involvement, and 6% had dual kidney involvement. Eighty-six percent had prior systemic therapy, and 76% of patients had at least two metastatic sites including lung (72%), liver (26%), bone (48%), lymph nodes (50%), adrenal (21%), and other (39%). Twenty-four (36%) of patients had a progression-free survival (PFS) of ≥12 months, and 40 patients (61%) had an overall survival (OS) ≥12 months. Factors most likely to have an influence on OS benefit was high LDH, alkaline phosphatase, and calcium; low hemoglobin; and prior treatment with tyrokinase inhibitors. Conclusions: Everolimus was found to have clinical benefit in patients with clear cell RCC. Clinical prognostic factors may help determine patients most likely to receive benefit from everolimus. Information regarding curves and correlation between prognostic factors and OS and PFS will be presented.

Toxicities of axitinib, sunitinib and temsirolimus: implications for progression-free and overall survival in metastatic renal cell cancer

2020 ◽  
Author(s):  
Annemarie Uhlig ◽  
Johannes Uhlig ◽  
Lutz Trojan ◽  
Michael Woike ◽  
Marianne Leitsmann ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cancer Patients ◽  
Skin Reaction ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
Cox Models ◽  
Metastatic Renal Cell Cancer ◽  
Hand Foot Skin Reaction

The aim of this study was to evaluate the association between axitinib, sunitinib and temsirolimus toxicities and patient survival in metastatic renal cell cancer patients. Overall survival (OS) and progression-free survival (PFS) of metastatic renal cell cancer patients from the prospective multicenter STAR-TOR study were assessed using multivariable Cox models. A total of 1195 patients were included (n = 149 axitinib; n = 546 sunitinib; n = 500 temsirolimus). The following toxicities significantly predicted outcomes: hand–foot skin reaction (hazard ratio [HR] = 0.29) for PFS with axitinib; stomatitis (HR = 0.62) and pneumonitis (HR = 0.23) for PFS with temsirolimus; stomatitis (HR = 0.52) and thrombocytopenia (HR = 0.6) for OS with temsirolimus; fatigue (HR = 0.71) for PFS with sunitinib; hand–foot skin reaction (HR = 0.56) and fatigue (HR = 0.58) for OS with sunitinib. In conclusion, in metastatic renal cell cancer, axitinib, sunitinib and temsirolimus demonstrate specific toxicities that are protective OS/PFS predictors.

An Italian, multicenter, real-world, retrospective study of first-line pazopanib in unselected metastatic renal-cell carcinoma patients: the ‘Pamerit’ study

2020 ◽  
Author(s):  
Alessandra Mosca ◽  
Ugo De Giorgi ◽  
Giuseppe Procopio ◽  
Umberto Basso ◽  
Giacomo Cartenì ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Renal Cell Cancer ◽  
Real World ◽  
Renal Cell ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival ◽  
Metastatic Renal Cell Cancer ◽  
Metastatic Rcc

Abstract Objective Despite the current immunotherapy era, VEGFR inhibitors maintain effectiveness in metastatic renal cell cancer. Real-world data concerning pazopanib are limited. The aim of this study is to add information about efficacy and safety of pazopanib as first-line treatment in metastatic renal cell cancer patients not enrolled into clinical trials. Methods Retrospective analysis (the PAMERIT study) of first-line pazopanib in real-world metastatic renal cell cancer patients among 39 Centers in Italy. Outcomes were progression-free survival, overall survival, objective response rate and treatment-related adverse events. Kaplan–Meier curves, log-rank test and multivariable Cox’s models were used and adjusted for age, histology, previous renal surgery, International Metastatic RCC Database Consortium score and pazopanib initial dose. Results Among 474 patients, 87.3% had clear cell metastatic renal cell cancer histology. Most of them (84.6%) had upfront renal surgery. Median progression-free survival and overall survival were 15.8 and 34.4 months, respectively, significantly correlating with International Metastatic RCC Database Consortium’s good prognosis (P < 0.001), ECOG PS 0 (P < 0.001), age (<75 years, P = 0.005), surgery (P < 0.001) and response to pazopanib (P < 0.001). After 3 months of pazopanib, overall disease control rate have been observed in 76.6% patients. Among International Metastatic RCC Database Consortium’s favorable group patients, 57/121 (47%) showed complete/partial response. No unexpected AEs emerged. Conclusions In this real-world study, metastatic renal cell cancer patients treated with first-line pazopanib reached greater progression-free survival and overall survival than in pivotal studies and had high response rates when belonging to International Metastatic RCC Database Consortium’s favorable group, without new toxicities. Pazopanib has been confirmed a valid first-line option for International Metastatic RCC Database Consortium’s good prognosis metastatic renal cell cancer patients who cannot be submitted to immunotherapy.

C07 Polymorphisms of RAGE and glyoxalase I genes in patients with clear cell renal cell cancer

2013 ◽  
Vol 12 (4) ◽  
pp. e1115, C07
Author(s):  
M. Chocholatý ◽  
K. Havlová ◽  
M. Schmidt ◽  
M. Kalousová ◽  
M. Jáchymová ◽  
...  
Keyword(s):  
Renal Cell Cancer ◽  
Renal Cell ◽  
Clear Cell ◽  
Cell Cancer ◽  
Glyoxalase I

NAXIVA: A phase II neoadjuvant study of axitinib for reducing extent of venous tumor thrombus in clear cell renal cell cancer (RCC) with venous invasion.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 275-275
Author(s):  
Grant D. Stewart ◽  
Sarah J. Welsh ◽  
Stephan Ursprung ◽  
Ferdia Gallagher ◽  
Iosif Mendichovszky ◽  
...  
Keyword(s):  
Renal Cell Cancer ◽  
Surgical Approach ◽  
Renal Cell ◽  
Tumor Thrombus ◽  
Response Rate ◽  
Clear Cell ◽  
Cell Cancer ◽  
Surgical Morbidity ◽  
Venous Tumor Thrombus ◽  
Extent Of Surgery

275 Background: Venous tumor thrombus (VTT) extension occurs in 4-15% cases of renal cell cancer (RCC). The Mayo classification distinguishes 4 levels of VTT extension between the renal vein and supradiaphragmatic inferior vena cava (IVC). Although surgery is performed with curative intent, mortality is high (5-15%) with complications increasing with the level of the VTT. 5-year survival rates are poor; ~40-65% in non-metastatic RCC. It is hypothesised that neoadjuvant targeted therapy could downstage the VTT reducing the extent of surgery, leading to reduced surgical morbidity and mortality, and increased survival. However, level I or II evidence is lacking. NAXIVA provides the first level II evidence in this patient group, assessing the response of VTT to axitinib. Extensive translational sampling will provide in depth interrogation of VTT (using genomics, proteomics, immunophenotyping and metabolomics) to examine the role of the tumor microenvironment of VTT and response to axitinib. Methods: NAXIVA was a single arm, single agent, multi-center phase 2 feasibility study of axitinib in patients with both metastatic and non-metastatic clear cell RCC prior to nephrectomy and thrombectomy. A Simon two stage minimax design was adopted and the trial designed for adequate power to distinguish a <5% from a >25% improvement in the Mayo VTT level. 21 patients were recruited over a 24 month period between 15/Dec/2017 and 06/Jan/2020 at 5 sites across the UK. Patients were treated with 8 weeks of axitinib (starting dose 5mg bd, increasing to 10mg bd as tolerated) prior to planned surgery. The primary endpoint was the percentage of evaluable patients with an improvement in VTT according to the Mayo classification (assessed using MRI abdomen scans at screening and week 9, prior to surgery. Secondary endpoints were percentage change in surgical approach, percentage change in VTT height, response rate (by RECIST) and evaluation of surgical morbidity assessed by Clavien-Dindo classification. Results: The percentage of evaluable patients with an improvement in VTT according to the Mayo classification was 26.58% [80% CI: 15.76%, 39.74%] (6 of 21 evaluable patients). 35.29% (6 of 17 patients who progressed to surgery) had a change in surgical approach to a less invasive option. There was a median percentage reduction in VTT height of 21.49% (SD=27.60%). The response rate (by RECIST) in the evaluable population was 61.90% SD, 14.29% PR, 9.52% PD. In terms of surgical morbidity 11.76% (2 of 17 patients who progressed to surgery) experienced a Clavien-Dindo 3 or greater complication (0 CD3, 1 CD4, 1 CD5). Conclusions: NAXIVA provides unique prospective data on the feasibility of neoadjuvant axitinib administration to down stage IVC VTT and reduce the extent of surgery. Work is ongoing to establish predictors of response. Clinical trial information: NCT03494816 .

scholarly journals A Four-Gene Promoter Methylation Marker Panel Consisting of GREM1, NEURL, LAD1, and NEFH Predicts Survival of Clear Cell Renal Cell Cancer Patients

2016 ◽  
Vol 23 (8) ◽  
pp. 2006-2018 ◽  
Author(s):  
Iris J.H. van Vlodrop ◽  
Sophie C. Joosten ◽  
Tim De Meyer ◽  
Kim M. Smits ◽  
Leander Van Neste ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Renal Cell Cancer ◽  
Promoter Methylation ◽  
Renal Cell ◽  
Clear Cell ◽  
Cell Cancer ◽  
Gene Promoter ◽  
Marker Panel ◽  
Methylation Marker

scholarly journals Phase Ii Study of Individualized Sunitinib As First-Line Therapy for Metastatic Clear Cell Renal Cell Cancer (Mrcc)

2014 ◽  
Vol 25 ◽  
pp. iv292 ◽  
Author(s):  
G.A. Bjarnason ◽  
B. Naveen ◽  
E. Winquist ◽  
C.K. Kollmannsberger ◽  
C. Canil ◽  
...  
Keyword(s):  
Phase Ii ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Clear Cell ◽  
Phase Ii Study ◽  
Cell Cancer ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

Prognostic factors and survival in Japanese patients with brain metastasis from renal cell cancer

2019 ◽  
Vol 24 (10) ◽  
pp. 1231-1237
Author(s):  
Nobushige Takeshita ◽  
Masafumi Otsuka ◽  
Tomohiko Kamasako ◽  
Takatoshi Somoto ◽  
Toshihiro Uemura ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Brain Metastasis ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Cell Cancer ◽  
Japanese Patients
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