Randomized phase II study of first-line carboplatin-paclitaxel with or without bevacizumab in Japanese patients with advanced non-squamous non-small-cell lung cancer

Seiji Niho, Hideo Kunitoh, Hiroshi Nokihara, Takeshi Horai, Yukito Ichinose, Toyoaki Hida, Nobuyuki Yamamoto, Masaaki Kawahara, Tetsu Shinkai, Kazuhiko Nakagawa, Kaoru Matsui, Shunichi Negoro, Akira Yokoyama, Shinzoh Kudoh, Katsuyuki Kiura, Kiyoshi Mori, Hiroaki Okamoto, Hiroshi Sakai, Koji Takeda, Soichiro YokotaNagahiro Saijo, Masahiro Fukuoka

Research output: Contribution to journalArticlepeer-review

155 Citations (Scopus)

Abstract

Purpose: This multicenter, randomized, open-label, phase II study (JO19907) compared the efficacy and safety of first-line carboplatin-paclitaxel (CP) alone with bevacizumab-CP in Japanese patients with advanced non-squamous non-small-cell lung cancer (NSCLC). Methods: Chemonaïve patients with stage IIIB, IV or recurrent non-squamous NSCLC were eligible for participation. Patients were randomly assigned in a 2:1 ratio to receive bevacizumab-CP or CP alone. Chemotherapy was repeated for up to 6 cycles or until disease progression or unacceptable toxicity. Bevacizumab recipients who completed ≥3 cycles of chemotherapy could continue bevacizumab as monotherapy until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Results: After confirming the tolerability of bevacizumab-CP in a small number of patients, 180 patients were recruited, of whom 121 were assigned to bevacizumab-CP and 59 to CP alone. Hazard ratio (HR) for PFS was 0.61 with bevacizumab-CP versus CP alone (p= 0.0090; median 6.9 versus 5.9 months). Objective response rate was significantly higher with bevacizumab-CP than with CP alone (60.7% versus 31.0%; p= 0.0013). Median overall survival was >22 months in both treatment groups (HR 0.99; p= 0.9526). No new safety signals were detected. Conclusion: Study JO19907 met its primary endpoint, demonstrating that the addition of bevacizumab to first-line CP significantly improves PFS in Japanese patients with advanced non-squamous NSCLC. This prolonged PFS by bevacizumab did not translate into OS benefit with the extremely longer underlying survival compared to historical data. No new safety signals were identified in this population. (Japan Pharmaceutical Information Center [JAPIC] registration number: CTI-060338).

Original languageEnglish
Pages (from-to)362-367
Number of pages6
JournalLung Cancer
Volume76
Issue number3
DOIs
Publication statusPublished - Jun 2012

Keywords

  • Advanced lung cancer
  • Bevacizumab
  • Carboplatin
  • Chemonaïve
  • Non-small cell lung cancer
  • Paclitaxel

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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