title: 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.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Hoosier Oncology Group, Indianapolis, IN, USA. heather.riggs@reidhospital.org
authors.forename: Heather
authors.initials: H
authors.lastname: Riggs
authors.forename: Shadia I
authors.initials: SI
authors.lastname: Jalal
authors.forename: Tareq Al
authors.initials: TA
authors.lastname: Baghdadi
authors.forename: Sumeet
authors.initials: S
authors.lastname: Bhatia
authors.forename: John
authors.initials: J
authors.lastname: McClean
authors.forename: Cynthia
authors.initials: C
authors.lastname: Johnson
authors.forename: Menggang
authors.initials: M
authors.lastname: Yu
authors.forename: David
authors.initials: D
authors.lastname: Taber
authors.forename: Wael
authors.initials: W
authors.lastname: Harb
authors.forename: Nasser
authors.initials: N
authors.lastname: Hanna
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D011799:Quinazolines; D000068258:Bevacizumab; D000069347:Erlotinib Hydrochloride