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

Full Abstract

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 lung cancer. 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 trials were identified for a total of 148 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]. The median progression-free survival and overall survival were 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 61 received 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 in median 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 progression-free survival and overall survival in non-small cell lung cancer patients with EGFR mutations. Randomized trials comparing chemotherapy with gefitinib as a first-line treatment are warranted in such patients.

Author information

Author/s: Morita, Satoshi (S); Okamoto, Isamu (I); Kobayashi, Kunihiko (K); Yamazaki, Koichi (K); Asahina, Hajime (H); Inoue, Akira (A); Hagiwara, Koichi (K); Sunaga, Noriaki (N); Yanagitani, Noriko (N); Hida, Toyoaki (T); Yoshida, Kimihide (K); Hirashima, Tomonori (T); Yasumoto, Kosei (K); Sugio, Kenji (K); Mitsudomi, Tetsuya (T); Fukuoka, Masahiro (M); Nukiwa, Toshihiro (T);

Affiliation: Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan.

Journal and publication information

Publication Type: Journal Article; Meta-Analysis

Journal: Clinical cancer research : an official journal of the American Association for Cancer Research (Clin Cancer Res), published in United States. (Language: eng)

Reference: 2009-Jul; vol 15 (issue 13) : pp 4493-8

Dates: Created 2009/07/02; Completed 2009/10/19;

PMID: 19531624, status: MEDLINE (last retrieval date: 10/19/2009, IMS Date: )

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