[HTML][HTML] Overall survival with cisplatin–gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a …

M Reck, J Von Pawel, P Zatloukal, R Ramlau… - Annals of oncology, 2010 - Elsevier
M Reck, J Von Pawel, P Zatloukal, R Ramlau, V Gorbounova, V Hirsh, N Leighl, J Mezger…
Annals of oncology, 2010Elsevier
Background Bevacizumab, the anti-vascular endothelial growth factor agent, provides
clinical benefit when combined with platinum-based chemotherapy in first-line advanced
non-small-cell lung cancer. We report the final overall survival (OS) analysis from the phase
III AVAiL trial. Patients and methods Patients (n= 1043) received cisplatin 80 mg/m 2 and
gemcitabine 1250 mg/m 2 for up to six cycles plus bevacizumab 7.5 mg/kg (n= 345),
bevacizumab 15 mg/kg (n= 351) or placebo (n= 347) every 3 weeks until progression …
Background
Bevacizumab, the anti-vascular endothelial growth factor agent, provides clinical benefit when combined with platinum-based chemotherapy in first-line advanced non-small-cell lung cancer. We report the final overall survival (OS) analysis from the phase III AVAiL trial.
Patients and methods
Patients (n = 1043) received cisplatin 80 mg/m2 and gemcitabine 1250 mg/m2 for up to six cycles plus bevacizumab 7.5 mg/kg (n = 345), bevacizumab 15 mg/kg (n = 351) or placebo (n = 347) every 3 weeks until progression. Primary end point was progression-free survival (PFS); OS was a secondary end point.
Results
Significant PFS prolongation with bevacizumab compared with placebo was maintained with longer follow-up {hazard ratio (HR) [95% confidence interval (CI)] 0.75 (0.64–0.87), P = 0.0003 and 0.85 (0.73–1.00), P = 0.0456} for the 7.5 and 15 mg/kg groups, respectively. Median OS was >13 months in all treatment groups; nevertheless, OS was not significantly increased with bevacizumab [HR (95% CI) 0.93 (0.78–1.11), P = 0.420 and 1.03 (0.86–1.23), P = 0.761] for the 7.5 and 15 mg/kg groups, respectively, versus placebo. Most patients (∼62%) received multiple lines of poststudy treatment. Updated safety results are consistent with those previously reported.
Conclusions
Final analysis of AVAiL confirms the efficacy of bevacizumab when combined with cisplatin–gemcitabine. The PFS benefit did not translate into a significant OS benefit, possibly due to high use of efficacious second-line therapies.
Elsevier