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BJU Int. 2011 Jan;107(2):214-9. doi: 10.1111/j.1464-410X.2010.09707.x. Epub 2010 Oct 13.

Overall survival in patients with metastatic renal cell carcinoma initially treated with bevacizumab plus interferon-α2a and subsequent therapy with tyrosine kinase inhibitors: a retrospective analysis of the phase III AVOREN trial.

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1
Department of Oncology, Ospedale San Donato, Arezzo, Italy. sergio.bracarda@usl8.toscana.it

Abstract

OBJECTIVE:

• To retrospectively evaluate the effect of subsequent tyrosine kinase inhibitors (TKIs) after first-line bevacizumab + interferon-α2a (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.

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