Overall survival with cisplatin–gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL)
By M. Reck, J. Pawel, P. Zatloukal, R. Ramlau, V. Gorbounova, V. Hirsh, N. Leighl, J. Mezger, V. Archer, N. Moore and 1 more. Annals of Oncology, 2010
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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.
Subfields: Complementary and alternative medicine, Pulmonary and Respiratory Medicine
View Paper: https://www.semanticscholar.org/paper/6cd269b925e90f2e6abbb3be60901678b59724b1
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In Pulmonary and Respiratory Medicine
Citations in the corpus
- ANTIANGIOGENESIS STRATEGIES REVISITED: FROM STARVING TUMORS TO ALLEVIATING HYPOXIA (2014, neutral): “However, there was no statistically significant difference in PFS or OS in non-small-cell lung cancer patients treated with 15 or 7.5 mg/kg bevacizumab with chemotherapy (Reck et al., 2010).”
- Anti-angiogenic therapy for cancer: current progress, unresolved questions and future directions (2014, background): “In non-squamous non-small cell lung cancer (NSCLC), two phase III trials have shown an improvement in PFS for the addition of bevacizumab to chemotherapy [32–34] although only one study reported an improvement in OS [32].”
- Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. (2016, result): “The results were not statistically significantly different and therefore do not provide support for changing the current recommendation.(76) One trial that compared bevacizumab plus erlotinib versus bevacizumab plus placebo resulted in a 1.”
- Targeted therapy for non-small cell lung cancer: current standards and the promise of the future. (2015, background): “Toxicities with bevacizumab include bleeding, thromoboembolism, and hypertension (164,165).”