Meta-analysis of randomized clinical trials (RCT) for the adjuvant treatment of high-risk clear cell renal carcinoma (RCC) with vascular endothelial growth factor receptor tyrosine-kinase inhibitors (VEGFR TKIs).

Authors

Daniel Vargas Pivato de Almeida

Daniel Vargas Almeida

A Beneficencia Portuguesa de Sao Paulo: BP, São Paulo, Brazil

Daniel Vargas Almeida , Cleyton Z. Oliveira , Andrey Soares , Denis L Jardim , Diogo Assed Bastos , Fernando C. Maluf , Gustavo Werutsky , Fernando Sabino M Monteiro , Vinicius Carrera Souza , Andre Poisl Fay , Fabio A. B. Schutz

Organizations

A Beneficencia Portuguesa de Sao Paulo: BP, São Paulo, Brazil, Centro Paulista De Oncologia, Sao Paulo, Brazil, Centro de Oncologia do Paraná, Curitiba, Brazil, Hospital Sírio-Libanês, São Paulo, Brazil, Latin American Cooperative Oncology Group, Porto Alegre, Brazil, Hospital Santa Lucia, Brasilia, Brazil, Clinica AMO, Salvador, Brazil, Hospital São Lucas da PUCRS, Porto Alegre, Brazil

Research Funding

Other

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.

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Abstract Details

Meeting

2018 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer

Track

Renal Cell Cancer

Sub Track

Renal Cell Cancer

Citation

J Clin Oncol 36, 2018 (suppl 6S; abstr 660)

DOI

10.1200/JCO.2018.36.6_suppl.660

Abstract #

660

Poster Bd #

J11

Abstract Disclosures