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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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 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
Volume15
Issue number13
DOIs
Publication statusPublished - Jul 1 2009
Externally publishedYes

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Survival Analysis
Epidermal Growth Factor Receptor
Non-Small Cell Lung Carcinoma
Clinical Trials
Mutation
Disease-Free Survival
Survival
Confidence Intervals
Drug Therapy
erbB-1 Genes
gefitinib
Therapeutics
Japan
Research Design

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Combined survival analysis of prospective clinical trials of gefitinib for non-small cell lung cancer with EGFR mutations. / Morita, Satoshi; Okamoto, Isamu; Kobayashi, Kunihiko; Yamazaki, Koichi; Asahina, Hajime; Inoue, Akira; Hagiwara, Koichi; Sunaga, Noriaki; Yanagitani, Noriko; Hida, Toyoaki; Yoshida, Kimihide; Hirashima, Tomonori; Yasumoto, Kosei; Sugio, Kenji; Mitsudomi, Tetsuya; Fukuoka, Masahiro; Nukiwa, Toshihiro.

In: Clinical Cancer Research, Vol. 15, No. 13, 01.07.2009, p. 4493-4498.

Research output: Contribution to journalArticle

Morita, S, Okamoto, I, Kobayashi, K, Yamazaki, K, Asahina, H, Inoue, A, Hagiwara, K, Sunaga, N, Yanagitani, N, Hida, T, Yoshida, K, Hirashima, T, Yasumoto, K, Sugio, K, Mitsudomi, T, Fukuoka, M & Nukiwa, T 2009, 'Combined survival analysis of prospective clinical trials of gefitinib for non-small cell lung cancer with EGFR mutations', Clinical Cancer Research, vol. 15, no. 13, pp. 4493-4498. https://doi.org/10.1158/1078-0432.CCR-09-0391
Morita, Satoshi ; Okamoto, Isamu ; Kobayashi, Kunihiko ; Yamazaki, Koichi ; Asahina, Hajime ; Inoue, Akira ; Hagiwara, Koichi ; Sunaga, Noriaki ; Yanagitani, Noriko ; Hida, Toyoaki ; Yoshida, Kimihide ; Hirashima, Tomonori ; Yasumoto, Kosei ; Sugio, Kenji ; Mitsudomi, Tetsuya ; Fukuoka, Masahiro ; Nukiwa, Toshihiro. / Combined survival analysis of prospective clinical trials of gefitinib for non-small cell lung cancer with EGFR mutations. In: Clinical Cancer Research. 2009 ; Vol. 15, No. 13. pp. 4493-4498.
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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 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-na{\"i}ve 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.",
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T1 - Combined survival analysis of prospective clinical trials of gefitinib for non-small cell lung cancer with EGFR mutations

AU - Morita, Satoshi

AU - Okamoto, Isamu

AU - Kobayashi, Kunihiko

AU - Yamazaki, Koichi

AU - Asahina, Hajime

AU - Inoue, Akira

AU - Hagiwara, Koichi

AU - Sunaga, Noriaki

AU - Yanagitani, Noriko

AU - Hida, Toyoaki

AU - Yoshida, Kimihide

AU - Hirashima, Tomonori

AU - Yasumoto, Kosei

AU - Sugio, Kenji

AU - Mitsudomi, Tetsuya

AU - Fukuoka, Masahiro

AU - Nukiwa, Toshihiro

PY - 2009/7/1

Y1 - 2009/7/1

N2 - 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.

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