Combined survival analysis of prospective clinical trials of gefitinib for non-small cell lung cancer with EGFR mutations

Satoshi Morita, Isamu Okamoto, Kunihiko Kobayashi, Koichi Yamazaki, Hajime Asahina, Akira Inoue, Koichi Hagiwara, Noriaki Sunaga, Noriko Yanagitani, Toyoaki Hida, Kimihide Yoshida, Tomonori Hirashima, Kosei Yasumoto, Kenji Sugio, Tetsuya Mitsudomi, Masahiro Fukuoka, Toshihiro Nukiwa

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177 Citations (Scopus)


Purpose: Somatic mutations of the epidermal growth factor receptor (EGFR) gene are associated with an increased response to gefitinib in patients with non - small cell lung cancer.We have examined the impact of gefitinib on progression-free survival and overall survival in patients with EGFR mutation - positive non - small cell lungca ncer. Experimental Design:We searched for all clinical trials that prospectively evaluated the efficacy of gefitinib for advanced non - small cell lung cancer with EGFR mutations in Japan.We did a combined analysis based on individual patient data from the identified trials. Results: Seven eligible trialswere identified for a total of148 non - small cell lung cancer patients with EGFR mutations.The overall response rate to gefitinib was 76.4% [95% confidence interval (95% CI), 69.5-83.2].Themedian progression-free survival and overall survivalwere 9.7 months (95% CI, 8.2-11.1) and 24.3 months (95% CI,19.8-28.2), respectively. Good performance status and chemotherapy-naïve status were significantly associated with a longer progression-free survival or overall survival. Of the 148 patients, 87 received gefitinib as a first-line therapy, whereas 61received systemic chemotherapy before gefitinib treatment.The median progression-free survival after the start of first-line therapy was significantly longer in the gefitinib-first group than in the chemotherapy-first group (10.7 versus 6.0 months; P < 0.001), whereas no significant difference inmedian overall survival was apparent between the two groups (27.7 versus 25.7 months; P = 0.782). Conclusions: Gefitinib monotherapy confers substantial clinical benefit in terms of progressionfree survival and overall survival in non - small cell lungca ncer patients with EGFR mutations. Randomized trials comparingc hemotherapy with gefitinib as a first-line treatment are warranted in such patients.

Original languageEnglish
Pages (from-to)4493-4498
Number of pages6
JournalClinical Cancer Research
Issue number13
Publication statusPublished - Jul 1 2009
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • General Medicine


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