Second-line therapy for refractory renal-cell carcinoma

2012 ◽  
Vol 83 (1) ◽  
pp. 112-122 ◽  
Author(s):  
Fable Zustovich ◽  
Giuseppe Lombardi ◽  
Ornella Nicoletto ◽  
Davide Pastorelli
2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 430-430 ◽  
Author(s):  
Daniel Yick Chin Heng ◽  
Connor Wells ◽  
Frede Donskov ◽  
Brian I. Rini ◽  
Jae-Lyun Lee ◽  
...  

430 Background: Third-line targeted therapy efficacy in metastatic renal cell carcinoma (mRCC) is not well characterized and many funding bodies do not provide reimbursement for it. Methods: The International mRCC Database Consortium (IMDC) consists of consecutive patient series from 25 cancer centers. It was queried for specific sequences of targeted therapy and third-line therapy. Kaplan Meier estimates were used for survival. Cox proportional hazards models were used to adjust hazard ratios for confounders. Patients that stopped second-line therapy were divided into two groups: those that went onto third-line therapy and those did not. Results: 4,050 patients were treated with first-line targeted therapy, of which 2,011 (49.6%) had second-line therapy and 879 (21.7%) had third-line targeted therapy. The most common third-line therapies were everolimus 25%, sorafenib 14%, sunitinib 13%, temsirolimus 11%, pazopanib 10%, and axitinib 6%. IMDC prognostic groups at third-line therapy initiation were 6% favorable risk, 67% intermediate risk, and 27% poor risk. Overall response rate for third-line therapy was 10.5% and 50.9% had stable disease in those patients that were evaluable. Median PFS was 5.1 months (95% CI, 4.5-5.7) and median OS from third-line therapy initiation was 12.0 months (95% CI, 10.7-12.9). Patients stopping second-line therapy that move on to third-line therapy vs. those that do not receive third line therapy have a median OS from stopping second-line therapy of 13.1 vs. 2.3 mons (p<0.0001). When adjusted for second-line IMDC prognostic criteria and KPS at second-line treatment cessation, patients who do receive third-line therapy have a HR of death of 0.41 (95% CI, 0.32-0.52; p<0.0001) compared to those that do not receive third-line therapy. This may be in part due to patient selection. To further limit bias, when excluding patients that live less than 3 months after second-line therapy cessation, the adjusted HR was similar. Conclusions: Third-line targeted therapy has demonstrated activity and is prevalent in use. Further studies are required to determine appropriate sequencing.


2014 ◽  
Author(s):  
Sebastian Hölters ◽  
Lothar Bergmann ◽  
Viktor Grünwald ◽  
Ulrich Keilholz ◽  
Carsten Ohlmann ◽  
...  

2017 ◽  
Vol 15 (6) ◽  
pp. e1081-e1088 ◽  
Author(s):  
Annalisa Guida ◽  
Laurence Albiges ◽  
Lisa Derosa ◽  
Yohann Loriot ◽  
Christophe Massard ◽  
...  

2016 ◽  
Vol 14 (6) ◽  
pp. e595-e607 ◽  
Author(s):  
Stéphane Oudard ◽  
Florence Joly ◽  
Lionnel Geoffrois ◽  
Brigitte Laguerre ◽  
Nadine Houede ◽  
...  

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e030522
Author(s):  
Yukari Bando ◽  
Nobuyuki Hinata ◽  
Takashi Omori ◽  
Masato Fujisawa

IntroductionNivolumab has been proven to prolong overall survival as a second-line therapy for patients with advanced renal cell carcinoma (RCC) in a phase III clinical trial. However, versatile biomarkers have not been established to predict the efficacy of nivolumab against target disease.Methods and analysisAfter registration, screening test and serum-soluble programmed cell death 1-ligand 1 (sPD-L1) measurement will be performed by using the ELISA; patients will be grouped into high sPD-L1 or low sPD-L1 groups. Nivolumab (240 mg every 2 weeks by intravenous drip infusion) will be administered to each participant. For this prospective study, statistical power calculation indicated that 48 participants with metastatic or unresectable RCC are needed to assess the efficacy of this method. The participants must be at the age of at least 20 years at the time of informed consent and require second-line therapy after failure of first-line therapy or discontinuation due to adverse effects. All data will be collected in our institution. The primary endpoint is progression-free survival, and secondary endpoints are overall survival and objective response rate. In this protocol, we will examine sPD-L1 as a promising predictive marker.Ethics and disseminationThis protocol was approved by the Kobe University Clinical Research Ethical Committee (C180067). Findings of this study will be widely disseminated through conference presentations, reports, factsheets and academic publications; further generalisation will also be discussed.Trial registration numberUMIN000027873.


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