Italian, multicenter, phase III, randomized study of cisplatin plus etoposide with or without bevacizumab as first-line treatment in extensive-disease small-cell lung cancer: The GOIRC-AIFA FARM6PMFJM trial

GOIRC-AIFA FARM6PMFJM Trial, Erika Rijavec

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose Considering promising results in phase II studies, a randomized phase III trial was designed to assess the efficacy of adding bevacizumab to first-line cisplatin plus etoposide for treatment of extensive-disease (ED) small-cell lung cancer (SCLC). Patients and Methods Treatment-naive patients with ED-SCLC were randomly assigned to receive either cisplatin plus etoposide (arm A) or the same regimen with bevacizumab (arm B) for a maximum of six courses. In the absence of progression, patients in arm B continued bevacizumab alone until disease progression or for a maximum of 18 courses. The primary end point was overall survival (OS). Results Two hundred four patients were randomly assigned and considered in intent-to-treat analyses (103 patients in arm A and 101 patients in arm B). At a median follow-up of 34.9 months in arm A and arm B, median OS times were 8.9 and 9.8 months, and 1-year survival rates were 25% and 37% (hazard ratio, 0.78; 95% CI, 0.58 to 1.06; P = .113), respectively. A statistically significant effect of bevacizumab on OS in patients who received maintenance was seen (hazard ratio, 0.60; 95% CI, 0.40 to 0.91; P = .011). Median progression-free survival times were 5.7 and 6.7 months in arm A and arm B, respectively (P = .030). Regarding hematologic toxicity, no statistically significant differences were observed; for nonhematologic toxicity, only hypertension was more frequent in arm B (grade 3 or 4, 1.0% v 6.3% in arms A v B, respectively; P = .057). Conclusion The addition of bevacizumab to cisplatin and etoposide in the first-line treatment of ED-SCLC had an acceptable toxicity profile and led to a statistically significant improvement in progression-free survival, which, however, did not translate into a statistically significant increase in OS. Further research with novel antiangiogenic agents, particularly in the maintenance setting, is warranted. © 2017 American Society of Clinical Oncology. All rights reserved.
Original languageEnglish
Pages (from-to)1281-1287
Number of pages7
JournalJournal of Clinical Oncology
Volume35
Issue number12
DOIs
Publication statusPublished - 2017

Keywords

  • bevacizumab
  • cisplatin
  • etoposide
  • antineoplastic agent
  • adult
  • aged
  • anemia
  • Article
  • cancer combination chemotherapy
  • cancer survival
  • controlled study
  • disease course
  • drug dose reduction
  • drug efficacy
  • drug withdrawal
  • fatigue
  • female
  • follow up
  • hematologic disease
  • human
  • hypertension
  • intention to treat analysis
  • Italy
  • leukopenia
  • maintenance chemotherapy
  • major clinical study
  • male
  • median survival time
  • multicenter study
  • multiple cycle treatment
  • nausea
  • neutropenia
  • overall survival
  • phase 3 clinical trial
  • priority journal
  • progression free survival
  • randomized controlled trial
  • small cell lung cancer
  • survival rate
  • thrombocytopenia
  • thrombosis
  • treatment outcome
  • vomiting
  • clinical trial
  • disease free survival
  • Lung Neoplasms
  • middle aged
  • Small Cell Lung Carcinoma
  • very elderly
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols
  • Bevacizumab
  • Cisplatin
  • Disease-Free Survival
  • Etoposide
  • Female
  • Humans
  • Male
  • Middle Aged

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