Combined Survival Analysis of Prospective Clinical Trials of Gefitinib for Non–Small Cell Lung Cancer with <i>EGFR</i> Mutations
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- Satoshi Morita
- 1Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan;
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- Isamu Okamoto
- 2Department of Medical Oncology, Sakai Hospital, Kinki University School of Medicine;
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- Kunihiko Kobayashi
- 4Department of Respiratory Oncology, Saitama International Medical Center;
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- Koichi Yamazaki
- 6First Department of Medicine, Hokkaido University School of Medicine, Hokkaido, Japan;
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- Hajime Asahina
- 6First Department of Medicine, Hokkaido University School of Medicine, Hokkaido, Japan;
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- Akira Inoue
- 7Department of Respiratory Medicine, Tohoku University Hospital;
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- Koichi Hagiwara
- 5Department of Respiratory Medicine, Saitama Medical University, Saitama, Japan;
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- Noriaki Sunaga
- 9Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Gunma, Japan; Departments of
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- Noriko Yanagitani
- 9Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Gunma, Japan; Departments of
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- Toyoaki Hida
- 10Thoracic Oncology and
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- Kimihide Yoshida
- 10Thoracic Oncology and
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- Tomonori Hirashima
- 3Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, Japan;
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- Kosei Yasumoto
- 13Second Department of Surgery, School of Medicine, University of Occupational and Environmental Health, Fukuoka, Japan
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- Kenji Sugio
- 13Second Department of Surgery, School of Medicine, University of Occupational and Environmental Health, Fukuoka, Japan
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- Tetsuya Mitsudomi
- 11Thoracic Surgery, Aichi Cancer Center Hospital, Aichi, Japan;
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- Masahiro Fukuoka
- 12Department of Medical Oncology, Kinki University School of Medicine, Sakai Hospital, Osaka, Japan; and
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- Toshihiro Nukiwa
- 8Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Miyagi, Japan;
説明
<jats:title>Abstract</jats:title> <jats:p>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.</jats:p> <jats:p>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.</jats:p> <jats:p>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).</jats:p> <jats:p>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.</jats:p>
収録刊行物
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- Clinical Cancer Research
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Clinical Cancer Research 15 (13), 4493-4498, 2009-07-01
American Association for Cancer Research (AACR)
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詳細情報 詳細情報について
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- CRID
- 1361137044417142784
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- ISSN
- 15573265
- 10780432
- http://id.crossref.org/issn/10780432
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- データソース種別
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- Crossref