論文

査読有り
2010年2月

Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial

LANCET ONCOLOGY
  • Tetsuya Mitsudomi
  • Satoshi Morita
  • Yasushi Yatabe
  • Shunichi Negoro
  • Isamu Okamoto
  • Junji Tsurutani
  • Takashi Seto
  • Miyako Satouchi
  • Hirohito Tada
  • Tomonori Hirashima
  • Kazuhiro Asami
  • Nobuyuki Katakami
  • Minoru Takada
  • Hiroshige Yoshioka
  • Kazuhiko Shibata
  • Shinzoh Kudoh
  • Eiji Shimizu
  • Hiroshi Saito
  • Shinichi Toyooka
  • Kazuhiko Nakagawa
  • Masahiro Fukuoka
  • 全て表示

11
2
開始ページ
121
終了ページ
128
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1016/S1470-2045(09)70364-X
出版者・発行元
ELSEVIER SCIENCE INC

Background Patients with non-small-cell lung cancer harbouring mutations in the epidermal growth factor receptor (EGFR) gene respond well to the EGFR-specific tyrosine kinase inhibitor gefitinib. However, whether gefitinib is better than standard platinum doublet chemotherapy in patients selected by EGFR mutation is uncertain.
Methods We did an open label, phase 3 study (WJTOG3405) with recruitment between March 31, 2006, and June 22, 2009, at 36 centres in Japan. 177 chemotherapy-naive patients aged 75 years or younger and diagnosed with stage IIIB/IV non-small-cell lung cancer or postoperative recurrence harbouring EGFR mutations (either the exon 19 deletion or L858R point mutation) were randomly assigned, using a minimisation technique, to receive either gefitinib (250 mg/day orally; n=88) or cisplatin (80 mg/m(2), intravenously) plus docetaxel (60 mg/m(2), intravenously; n=89), administered every 21 days for three to six cycles. The primary endpoint was progression-free survival. Survival analysis was done with the modified intention-to-treat population. This study is registered with UMIN (University Hospital Medical Information Network in Japan), number 000000539.
Findings Five patients were excluded (two patients were found to have thyroid and colon cancer after randomisation, one patient had an exon 18 mutation, one patient had insufficient consent, and one patient showed acute allergic reaction to docetaxel). Thus, 172 patients (86 in each group) were included in the survival analyses. The gefitinib group had significantly longer progression-free survival compared with the cisplatin plus docetaxel goup, with a median progression-free survival compared with the cisplatin plus docetaxel goup, with a median progression-free survival time of 9.2 months (95% CI 8.0-13.9) versus 6.3 months (5.8-7.8; HR 0.489, 95% CI 0.336-0.710, log-rank p<0.0001). Myelosuppression, alopecia, and fatigue were more frequent in the cisplatin plus docetaxel group, but skin toxicity, liver dysfunction, and diarrhoea were more frequent in the gefitinib group. Two patients in the gefitinib group developed interstitial lung disease (incidence 2.3%), one of whom died.
Interpretation Patients with lung cancer who are selected by EGFR mutations have longer progression-free survival if they are treated with gefitinib than if they are treated with cisplatin plus docetaxel.

リンク情報
DOI
https://doi.org/10.1016/S1470-2045(09)70364-X
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/20022809
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000275152900019&DestApp=WOS_CPL
ID情報
  • DOI : 10.1016/S1470-2045(09)70364-X
  • ISSN : 1470-2045
  • eISSN : 1474-5488
  • PubMed ID : 20022809
  • Web of Science ID : WOS:000275152900019

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