Erlotinib and bevacizumab in newly diagnosed performance status 2 or elderly patients with nonsquamous non-small-cell lung cancer, a phase II study of the hoosier oncology group: LUN04-77

Heather Riggs, Shadia I. Jalal, Tareq Al Baghdadi, Sumeet Bhatia, John McClean, Cynthia Johnson, Menggang Yu, David Taber, Wael Harb, Nasser Hanna

Research output: Contribution to journalArticle

6 Scopus citations


Optimal therapy for poor performance status (PS) patients or elderly with advanced nonsmall-cell lung cancer (NSCLC) is unclear. This study evaluated the combination of erlotinib and bevacizumab in this population. Twentyfive patients were enrolled with the rate of nonprogressive disease at 4 months selected as the primary end point. The results were disappointing and will not be pursued in this biologically unselected patient population. Background: Poor PS is a negative prognostic factor for survival and a risk factor for treatment-related toxicity with standard platinum-doublet chemotherapy for advanced NSCLC. A phase II study combining erlotinib and bevacizumab for treatment of recurrent NSCLC showed encouraging efficacy and acceptable toxicity. Patients and Methods: This single-arm phase II study evaluated erlotinib and bevacizumab as first-line therapy for newly diagnosed nonsquamous advanced NSCLC patients with Eastern Cooperative Oncology Group PS ≥ 2 or age 70 or older. Only patients eligible for bevacizumab per label were enrolled. Patients received erlotinib 150 mg orally daily and bevacizumab 15 mg/kg intravenously on day 1 every 21 days for up to 6 cycles. The primary end point was the rate of nonprogressive disease at 4 months (alternative hypothesis > 60%). Results: Twenty-five patients were enrolled, with median age 77 years (range, 52-90 years), 44% female, 20% never- or remote-smokers. Ninety-two percent of patients enrolled had PS of 2 per investigator assessment. The rate of nonprogressive disease at 4 months was 28%. There were no complete responses, 1 patient achieved a partial response, and 11 patients (44%) experienced stable disease as best response. Rash, fatigue, and diarrhea were the most common toxicities. Conclusion: The combination of erlotinib and bevacizumab had insufficient activity in the absence of known activating epidermal growth factor receptor gene mutations to warrant study in newly diagnosed elderly or poor PS patients with nonsquamous NSCLC.

Original languageEnglish (US)
Pages (from-to)224-229
Number of pages6
JournalClinical Lung Cancer
Issue number3
StatePublished - Jul 15 2013



  • Advanced
  • Biological therapy
  • First-line
  • Nonsquamous NSCLC
  • Unselected population

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this