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Overall survival in patients with metastatic renal cell carcinoma initially treated with bevacizumab plus interferon-alpha2a and subsequent therapy with tyrosine kinase inhibitors: a retrospective analysis of the phase III AVOREN trial.

Author(s): Bracarda S, Bellmunt J, Melichar B, Negrier S, Bajetta E, Ravaud A, Sneller V, Escudier B

Affiliation(s): Department of Oncology, Ospedale San Donato, Arezzo, Italy. sergio.bracarda@usl8.toscana.it

Publication date & source: 2011-01, BJU Int., 107(2):214-9. Epub 2010 Oct 13.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: * To retrospectively evaluate the effect of subsequent tyrosine kinase inhibitors (TKIs) after first-line bevacizumab + interferon-alpha2a (IFN) or IFN + placebo in the phase III AVOREN (Avastin and Roferon in Renal Cell Carcinoma) trial. PATIENTS AND METHODS: * A total of 649 patients with untreated metastatic renal cell carcinoma (mRCC) were randomized to receive IFN (9 MIU three times a week for up to 1 year) in combination with bevacizumab (10 mg/kg every 2 weeks) or placebo until disease progression. * The protocol allowed the use of any post-protocol anti-cancer therapy for patients with progressive disease or those in whom the trial therapy was discontinued. Data regarding the timing and type of subsequent therapy were recorded and overall survival (OS) analysed. RESULTS: * Patients were randomized to bevacizumab + IFN (n= 327) or IFN + placebo (n= 322); 180 (55%) patients in the bevacizumab + IFN, and 202 (63%) in the IFN + placebo arm, received post-protocol anti-cancer therapy. * TKIs were the most common post-protocol therapy, received by 113 (35%) and 120 (37%) patients in the bevacizumab + IFN and IFN + placebo arms, respectively. * The median OS in patients who received any subsequent TKI was 38.6 months in the bevacizumab + IFN arm and 33.6 months in IFN + placebo arm [hazard ratio (HR), 0.80; 95% confidence interval (CI), 0.56-1.13; P= 0.203]. In an additional retrospective analysis that censored patients who received subsequent TKIs, median OS was 25.0 and 20.7 months, respectively, in the bevacizumab + IFN and IFN + placebo arms (HR, 0.84; 95% CI, 0.67-1.05; P= 0.123). CONCLUSIONS: * These retrospective exploratory data of sequential bevacizumab + IFN followed by TKIs in patients able to receive multiple lines of therapy suggest that sequential therapy could be a promising approach to improve patient outcomes in mRCC. (c) 2010 THE AUTHORS. BJU INTERNATIONAL (c) 2010 BJU INTERNATIONAL.

Page last updated: 2011-12-09

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