American Society of Clinical Oncology, Journal of Clinical Oncology, 6_suppl(36), p. 660-660, 2018
DOI: 10.1200/jco.2018.36.6_suppl.660
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660 Background: A significant proportion of RCC patients with localized disease will eventually recur after a curative intent nephrectomy. VEGFR TKIs have significantly improved the outcomes of patients with advanced disease. RCT are ongoing to evaluate the impact of adjuvant VEGFR TKI on clinical outcome of patients with RCC after definitive treatment . Results from 3 RCT have been already published, but data is controversial. Methods: PubMed databases were searched for articles published from January 1996 to October 2017. Eligible studies were limited to phase 3 RCT of US Food and Drug Administration-approved VEGFR TKIs that reported on patients with RCC treated in the adjuvant setting. Statistical analyses were conducted to calculate the summary hazard-ratio (HR) of disease-free survival (DFS), using 95% CIs by random-effects or fixed-effects models on the basis of the heterogeneity of included studies. Results: A total of 4,096 patients from 3 RCT (ASSURE, S-TRAC and PROTECT trials) were included. 2374 patients were randomized to receive sorafenib, sunitinib or pazopanib, and 1722 to receive placebo. The summary HR of DFS for the overall population was 0.88 (95%CI 0.77-1.01; p = 0.0605). When evaluating the report of the ASSURE trial that included only clear cell RCC (n = 3222), the summary HR was 0.85 (95%CI 0.77-0.94; p = 0.0018) favoring adjuvant treatment. No evidence of publication bias was found. Conclusions: This meta-analysis failed to demonstrate a statistically significant improvement in DFS of RCC patients treated with adjuvant VEGFR TKI. However, a statistically significant improvement in DFS was observed when only patients with clear cell histology were evaluated. Longer follow-up of the ongoing trials is necessary in order to better evaluate the impact on overall survival.