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)

J Thorac Oncol. 2010 Dec;5(12):1970-6. doi: 10.1097/JTO.0b013e3181f49c22.

Abstract

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/m and gemcitabine 1250 mg/m 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.

Trial registration: ClinicalTrials.gov NCT00806923.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bevacizumab
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / mortality
  • Cisplatin / administration & dosage
  • Cisplatin / therapeutic use*
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use
  • Disease-Free Survival
  • Female
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / mortality
  • Male
  • Neoplasm Recurrence, Local / drug therapy*
  • Neoplasm Staging

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Deoxycytidine
  • Bevacizumab
  • gemcitabine
  • Cisplatin

Associated data

  • ClinicalTrials.gov/NCT00806923