title: Paclitaxel plus bevacizumab in patients with chemosensitive relapsed small cell lung cancer: a safety, feasibility, and efficacy study from the Hoosier Oncology Group.
abstract: BACKGROUND
  Bevacizumab when combined with carboplatin and paclitaxel improves response rates (RRs) and overall survival in patients with advanced non-small cell lung cancer. Paclitaxel has single-agent activity in relapsed small cell lung cancer (SCLC). Angiogenesis seems to play an important role in the pathogenesis of SCLC. This study evaluated the safety and efficacy of paclitaxel plus bevacizumab in patients with chemosensitive relapsed SCLC.
  
  
  METHODS
  Patients with relapsed chemosensitive SCLC with an Eastern Cooperative Oncology Group performance status of 0 to 1 were eligible. They received paclitaxel 90 mg/m intravenously on days 1, 8, and 15. Bevacizumab was administered at 10 mg/kg intravenously on days 1 and 15. Cycles were every 28 days. The primary endpoint was progression-free survival (PFS). Secondary endpoints included RRs, toxicity, and overall survival. Correlative studies evaluated vascular endothelial growth factor polymorphisms.
  
  
  RESULTS
  Thirty-four patients were enrolled in the study. Median age was 66.5 (range, 38-88) years, male:female: 61.8%:38.2%, Eastern Cooperative Oncology Group performance status 0:1 47.1%:52.9%. Median progression-free survival was 14.7 weeks (equivalent to historical controls). Median survival time was 30 weeks. The overall RR was 18.1%. Stable disease rate was 39.3%, and 45.4% of patients had progressive disease. No unexpected toxicities were noted, and grade 3/4 toxicities were limited to neutropenia, fatigue, and dyspnea. None of the vascular endothelial growth factor polymorphisms evaluated were significantly associated with response.
  
  
  CONCLUSIONS
  The addition of bevacizumab to paclitaxel does not improve outcomes in relapsed chemosensitive SCLC.
authors.affiliation: Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, USA. sjalal@iupui.edu
authors.forename: Shadia
authors.initials: S
authors.lastname: Jalal
authors.forename: Pablo
authors.initials: P
authors.lastname: Bedano
authors.forename: Lawrence
authors.initials: L
authors.lastname: Einhorn
authors.forename: Sumeet
authors.initials: S
authors.lastname: Bhatia
authors.forename: Rafat
authors.initials: R
authors.lastname: Ansari
authors.forename: Naftali
authors.initials: N
authors.lastname: Bechar
authors.forename: Karuna
authors.initials: K
authors.lastname: Koneru
authors.forename: Ramaswamy
authors.initials: R
authors.lastname: Govindan
authors.forename: Jingwei
authors.initials: J
authors.lastname: Wu
authors.forename: Menggang
authors.initials: M
authors.lastname: Yu
authors.forename: Bryan
authors.initials: B
authors.lastname: Schneider
authors.forename: Nasser
authors.initials: N
authors.lastname: Hanna
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D005240:Feasibility Studies; D005260:Female; D005838:Genotype; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality; D042461:Vascular Endothelial Growth Factor A / Q000235:genetics
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab; D017239:Paclitaxel