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A randomized, double-blind phase III study of Bevacizumab in combination with cisplatin and gemcitabine in chemotherapy-naïve patients with advancedor recurrent non-squamous NSCL cancer

(AVAiL).

Authors: Manegold et al.

Reviewer: Dr. Charles Butts

Date posted: June 21, 2007

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R

Treatment A: Cisplatin 80 mg/m2 Day 1/Gem 1250 mg/m2 Day 1,8+ Placebo

Treatment B:Cisplatin/Gem + Bevacizumab

7.5 mg/m2 weekly or15 mg/m2 weekly

Advanced or recurrentNon-squamous

ECOG 0-1

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RESULTS

Chemo + Placebo

Chemo + Bevac. 7.5

mg/m2

Chemo + Bevac 15 mg/m2

Response Rate (%)

20 34 30

PFS/TTP (median,

mos) 6.1

6.7

(p=.0026)

6.5

(p= .03)

OS

(median, mos)

NA NA NA

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STUDY COMMENTARY•This randomized trial of chemo +/- bevacizumab at 2 doses was designed to confirm the benefit seen in the ECOG 4599 trial.

•It included the same study population and had similar exclusion criteria as ECOG 4599. The major difference was the use of cisplatin/gemcitabine versus carboplatin/paclitaxel and the testing of the 7.5 mg/m2 bevac dose versus the 15 mg/m2 dose used in the ECOG trial.

•In this trial (AVAiL) there was less toxicity concern with the addition of bevacizumab.

•There did not appear to be an additional benefit from 15 mg/m2 of bevac versus 7.5 mg/m2 ( although the trial was not designed for a formal comparison of these arms)

•Although the primary end point of improvement in PFS was met, the absolute difference seen with the addition of Bevac was .6 months (18 days).

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BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS

•This trial does confirm the results of the ECOG trial in that a statistically significant improvement in response and PFS were seen.

•However, the magnitude of the PFS benefit seen with bevac is very small and of questionable clinical significance.

•I doubt that these results will have cancer agencies rushing to fund bevacizumab in the NSCL cancer setting.