• Shaan Dudani, Jeffrey Graham, J Connor Wells, Ziad Bakouny, Sumanta K Pal, Nazli Dizman, Frede Donskov, Camillo Porta, Guillermo de Velasco, Aaron Hansen, Marco Iafolla, Benoit Beuselinck, Ulka N Vaishampayan, Lori A Wood, Elizabeth Liow, Flora Yan, Takeshi Yuasa, Georg A Bjarnason, Toni K Choueiri, and Heng Daniel Y C DYC Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada. Electronic address: daniel.heng@albertahealthservices.ca..
• Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.
• Eur. Urol. 2019 Dec 1; 76 (6): 861-867.

BackgroundIn metastatic renal-cell carcinoma (mRCC), recent data have shown efficacy of first-line ipilimumab and nivolumab (ipi-nivo) as well as immuno-oncology (IO)/vascular endothelial growth factor (VEGF) inhibitor combinations. Comparative data between these strategies are limited.ObjectiveTo compare the efficacy of ipi-nivo versus IO-VEGF (IOVE) combinations in mRCC, and describe practice patterns and effectiveness of second-line therapies.Design, Setting, And ParticipantsUsing the International Metastatic Renal-cell Carcinoma Database Consortium (IMDC) dataset, patients treated with any first-line IOVE combination were compared with those treated with ipi-nivo.InterventionAll patients received first-line IO combination therapies.Outcome Measurements And Statistical AnalysisFirst- and second-line response rates, time to treatment failure (TTF), time to next treatment (TNT), and overall survival (OS) were analysed. Hazard ratios were adjusted for IMDC risk factors.Results And LimitationsIn total, 113 patients received IOVE combinations and 75 received ipi-nivo. For IOVE combinations versus ipi-nivo, first-line response rates were 33% versus 40% (between-group difference 7%, 95% confidence interval [CI] -8% to 22%, p =  0.4), TTF was 14.3 versus 10.2 mo (p =  0.2), TNT was 19.7 versus 17.9 mo (p =  0.4), and median OS was immature but not statistically different (p = 0.17). Adjusted hazard ratios for TTF, TNT, and OS were 0.71 (95% CI 0.46-1.12, p =  0.14), 0.65 (95% CI 0.38-1.11, p =  0.11), and 1.74 (95% CI 0.82-3.68, p =  0.14), respectively. Sixty-four (34%) patients received second-line treatment. In patients receiving subsequent VEGF-based therapy, second-line response rates were lower in the IOVE cohort than in the ipi-nivo cohort (15% vs 45%; between-group difference 30%, 95% CI 3-57%, p =  0.04; n = 40), though second-line TTF was not significantly different (3.7 vs 5.4 mo; p =  0.4; n = 55). Limitations include the study's retrospective design and sample size.ConclusionsThere were no significant differences in first-line outcomes between IOVE combinations and ipi-nivo. Most patients received VEGF-based therapy in the second line. In this group, second-line response rate was greater in patients who received ipi-nivo initially.Patient SummaryThere were no significant differences in key first-line outcomes for patients with metastatic renal-cell carcinoma receiving immuno-oncology/vascular endothelial growth factor inhibitor combinations versus ipilimumab and nivolumab.Copyright © 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.

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