Randomized Phase III Study of Continuation Maintenance Bevacizumab With or Without Pemetrexed in Advanced Nonsquamous Non-Small-Cell Lung Cancer: COMPASS (WJOG5610L)

Takashi Seto, Koichi Azuma, Takeharu Yamanaka, Shunichi Sugawara, Hiroshige Yoshioka, Kazushige Wakuda, Shinji Atagi, Yasuo Iwamoto, Hidetoshi Hayashi, Isamu Okamoto, Hideo Saka, Shigeki Mitsuoka, Daichi Fujimoto, Kazumi Nishino, Atsushi Horiike, Haruko Daga, Takashi Sone, Nobuyuki Yamamoto, Kazuhiko Nakagawa, Yoichi Nakanishi

研究成果: ジャーナルへの寄稿学術誌査読

22 被引用数 (Scopus)

抄録

PURPOSE: Patients with non-small-cell lung cancer (NSCLC) have been shown to benefit from maintenance therapy. COMPASS evaluated the efficacy and safety of bevacizumab with or without pemetrexed as continuation maintenance therapy after carboplatin, pemetrexed, and bevacizumab induction therapy. PATIENTS AND METHODS: Patients with untreated advanced nonsquamous NSCLC without confirmed EGFR 19 deletion or L858R mutation received first-line therapy with carboplatin area under the curve 6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg once every 3 weeks for 4 cycles. Patients without disease progression during the induction therapy were randomly assigned 1:1 for maintenance therapy with pemetrexed 500 mg/m2 plus bevacizumab 15 mg/kg or bevacizumab 15 mg/kg once every 3 weeks until disease progression or unacceptable toxicity. The primary end point was overall survival (OS) after random assignment. RESULTS: Between September 2010 and September 2015, 907 patients received induction therapy. Of those, 599 were randomly assigned: 298 received pemetrexed plus bevacizumab, and 301 received bevacizumab. The median OS was 23.3 v 19.6 months (hazard ratio [HR], 0.87; 95% CI, 0.73 to 1.05; 1-sided stratified log-rank P = .069). In the wild-type EGFR subset, the OS HR was 0.82 (95% CI, 0.68 to 0.99; 1-sided unstratified log-rank P = .020). The median progression-free survival (PFS) was 5.7 v 4.0 months (HR, 0.67; 95% CI, 0.57 to 0.79; 2-sided log-rank P < .001). The safety data were consistent with previous reports of treatment regimens. CONCLUSION: In terms of the primary end point of OS, no statistically significant benefit was observed; however, PFS in the total patient population and OS in patients with wild-type EGFR was prolonged with the addition of pemetrexed to bevacizumab maintenance therapy.

本文言語英語
ページ(範囲)793-803
ページ数11
ジャーナルJournal of clinical oncology : official journal of the American Society of Clinical Oncology
38
8
DOI
出版ステータス出版済み - 3月 10 2020

!!!All Science Journal Classification (ASJC) codes

  • 腫瘍学
  • 癌研究

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