Randomized Phase III Study of Gefitinib Versus Cisplatin Plus Vinorelbine for Patients With Resected Stage II-IIIA Non–Small-Cell Lung Cancer With <i>EGFR</i> Mutation (IMPACT)
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- Hirohito Tada
- Department of Thoracic Surgery, Suita Tokushukai Hospital, Suita, Japan
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- Tetsuya Mitsudomi
- Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
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- Toshihiro Misumi
- Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan
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- Kenji Sugio
- Department of Thoracic and Breast Surgery, Oita University, Oita, Japan
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- Masahiro Tsuboi
- Division of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan
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- Isamu Okamoto
- Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
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- Yasuo Iwamoto
- Department of Medical Oncology, Hiroshima Citizens Hospital, Hiroshima, Japan
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- Noriaki Sakakura
- Department of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoya, Japan
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- Shunichi Sugawara
- Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan
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- Shinji Atagi
- Department of Thoracic Oncology, Kinki-Chuo Chest Medical Center, Sakai, Japan
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- Toshiaki Takahashi
- Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan
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- Hidetoshi Hayashi
- Division of Medical Oncology, Department of Internal Medicine, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
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- Morihito Okada
- Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan
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- Hidetoshi Inokawa
- Department of Thoracic Surgery, Yamaguchi-Ube Medical Center, Ube, Japan
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- Hiroshige Yoshioka
- Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan
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- Kazuhisa Takahashi
- Department of Respiratory Medicine, Juntendo University, Graduate School of Medicine, Tokyo, Japan
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- Masahiko Higashiyama
- Department of General Thoracic Surgery, Osaka International Cancer Center, Osaka, Japan
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- Ichiro Yoshino
- Department of General Thoracic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan
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- Kazuhiko Nakagawa
- Division of Medical Oncology, Department of Internal Medicine, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
抄録
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> To investigate the efficacy of gefitinib as an adjuvant therapy for non–small-cell lung cancer patients with EGFR mutation. </jats:p></jats:sec><jats:sec><jats:title>PATIENTS AND METHODS</jats:title><jats:p> IMPACT (WJOG6410L; University Hospital Medical Information Network Clinical Trials Registry: UMIN000006252 ), a randomized, open-label, phase III study, included patients with completely resected pathologic stage II-III non–small-cell lung cancer harboring EGFR mutations (exon 19 deletion or L858R) during September 2011 to December 2015. Patients were randomly assigned to receive gefitinib (250 mg once daily) for 24 months or cisplatin (80 mg/m<jats:sup>2</jats:sup> on day 1) plus vinorelbine (25 mg/m<jats:sup>2</jats:sup> on days 1 and 8; cis/vin) once every 3 weeks for four cycles. The primary end point was disease-free survival (DFS). </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> Overall, 234 patients were randomly assigned. Among 232 eligible patients (116 each; excluding two who withdrew consent), the median DFS was 35.9 and 25.1 months in the gefitinib and cis/vin groups, respectively. However, Kaplan-Meier curves crossed around 4 years after surgery with no statistically significant difference (stratified log-rank P = .63; hazard ratio by stratified Cox proportional hazards model = 0.92; 95% CI, 0.67 to 1.28). Overall survival (OS) was also not different (stratified log-rank P = .89; hazard ratio = 1.03; 95% CI, 0.65 to 1.65), with the 5-year OS rates being 78.0% and 74.6% in the gefitinib and cis/vin groups, respectively. Treatment-related deaths occurred in 0 and three patients in the gefitinib and cis/vin groups, respectively. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> Although adjuvant gefitinib appeared to prevent early relapse, it did not prolong DFS or OS. However, similar DFS and OS may justify adjuvant gefitinib in the selected patient subsets, especially those deemed ineligible for platinum-doublet adjuvant therapy; however, this was not a noninferiority trial. </jats:p></jats:sec>
収録刊行物
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 40 (3), 231-241, 2022-01-20
American Society of Clinical Oncology (ASCO)
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詳細情報 詳細情報について
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- CRID
- 1360294643830763904
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- ISSN
- 15277755
- 0732183X
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- データソース種別
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