Elsevier

Journal of Thoracic Oncology

Volume 5, Issue 12, December 2010, Pages 1970-1976
Journal of Thoracic Oncology

Original Article
Efficacy and Safety of Bevacizumab-Based Therapy in Elderly Patients with Advanced or Recurrent Nonsquamous Non-small Cell Lung Cancer in the Phase III BO17704 Study (AVAiL)

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Introduction

The placebo-controlled, phase III AVAiL trial evaluated bevacizumab plus cisplatin and gemcitabine as first-line therapy in patients with advanced, nonsquamous non-small cell lung cancer. A retrospective subgroup analysis was performed to assess the efficacy and safety of bevacizumab-based therapy in elderly patients aged 65 years or older in AVAiL.

Methods

Patients received cisplatin 80 mg/m2 and gemcitabine 1250 mg/m2 for up to six cycles plus 7.5 mg/kg bevacizumab, 15 mg/kg bevacizumab, or placebo every 3 weeks until disease progression. The primary end point was progression-free survival. Secondary endpoints included objective response rate, overall survival, and safety.

Results

Data were evaluated for 304 patients aged 65 years or older (median age 68 years). Most of the patients were Caucasian (87%) and the majority had adenocarcinoma (83%). In the combined bevacizumab arms, 143 patients (79%) completed ≥4 cycles of chemotherapy. Patients who received bevacizumab derived an improvement in progression-free survival compared with placebo (7.5 mg/kg bevacizumab: hazard ratio [HR] = 0.71, p = 0.023; 15 mg/kg bevacizumab: HR = 0.84, p = 0.25). Objective response rates were 40, 29, and 30% in the 7.5 mg/kg bevacizumab, 15 mg/kg bevacizumab, and placebo arms, respectively. Overall survival was similar for each bevacizumab arm versus placebo (7.5 mg/kg bevacizumab: HR = 0.84, p = 0.31; 15 mg/kg bevacizumab: HR = 0.88, p = 0.44). There were no particular safety signals of concern in elderly patients.

Conclusions

This analysis of the randomized, phase III AVAiL trial shows that bevacizumab-based therapy improves outcomes for elderly patients with non-small cell lung cancer. Furthermore, bevacizumab-based therapy is well tolerated in elderly patients.

Key Words

Non-small cell lung cancer
Bevacizumab
Elderly
Safety

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Disclosure: Nicola Moore, MSc, is employed by and holds stock in F. Hoffman-La Roche. Martin Reck, MD, PhD, received consulting fees and speaking fees from AstraZeneca, Eli Lilly, F. Hoffman-La Roche, and Merck. Christian Manegold, MD, received consulting fees and speaking fees from F. Hoffman-La Roche. All other authors report no involvements that might raise the question of bias.

All authors made substantial contributions to the conception and design, acquisition of data, or analysis and interpretation of data, critically reviewed all drafts of the manuscript, and approved the final manuscript for submission. The academic authors vouch for the veracity and completeness of the data and data analysis. The sponsor did not influence the content of the manuscript or place any restrictions on the academic authors regarding statements made in the final manuscript. The authors did not receive financial compensation for authoring the manuscript.