Gefitinib Alone Versus Gefitinib Plus Chemotherapy for Non–Small-Cell Lung Cancer With Mutated Epidermal Growth Factor Receptor: NEJ009 Study
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- Yukio Hosomi
- Tokyo Metropolitan Komagome Hospital, Tokyo, Japan
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- Satoshi Morita
- Kyoto University Graduate School of Medicine, Kyoto, Japan
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- Shunichi Sugawara
- Sendai Kousei Hospital, Sendai, Japan
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- Terufumi Kato
- Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan
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- Tatsuro Fukuhara
- Miyagi Cancer Center, Natori, Japan
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- Akihiko Gemma
- Nippon Medical School, Tokyo, Japan
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- Kazuhisa Takahashi
- Juntendo University Graduate School of Medicine, Tokyo, Japan
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- Yuka Fujita
- Asahikawa Medical Center, Asahikawa, Japan
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- Toshiyuki Harada
- Japan Community Health Care Organization Hokkaido Hospital, Sapporo, Japan
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- Koichi Minato
- Gunma Prefectural Cancer Center, Ota, Japan
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- Kei Takamura
- Obihiro Kosei General Hospital, Obihiro, Japan
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- Koichi Hagiwara
- Jichi Medical University, Shimotsuke, Japan
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- Kunihiko Kobayashi
- Saitama Medical University, Hidaka, Japan
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- Toshihiro Nukiwa
- Tohoku University, Sendai, Japan
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- Akira Inoue
- Tohoku University School of Medicine, Sendai, Japan
説明
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor combined with cytotoxic chemotherapy is highly effective for the treatment of advanced non–small-cell lung cancer (NSCLC) with EGFR mutations; however, little is known about the efficacy and safety of this combination compared with that of standard therapy with EGFR- tyrosine kinase inhibitors alone. </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> We randomly assigned 345 patients with newly diagnosed metastatic NSCLC with EGFR mutations to gefitinib combined with carboplatin plus pemetrexed or gefitinib alone. Progression-free survival (PFS), PFS2, and overall survival (OS) were sequentially analyzed as primary end points according to a hierarchical sequential testing method. Secondary end points were objective response rate (ORR), safety, and quality of life. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> The combination group demonstrated a better ORR and PFS than the gefitinib group (ORR, 84% v 67% [ P < .001]; PFS, 20.9 v 11.9 months; hazard ratio for death or disease progression, 0.490 [ P < .001]), although PFS2 was not significantly different (20.9 v 18.0 months; P = .092). Median OS in the combination group was also significantly longer than in the gefitinib group (50.9 v 38.8 months; hazard ratio for death, 0.722; P = .021). The rate of grade ≥ 3 treatment-related adverse events, such as hematologic toxicities, in the combination group was higher than in the gefitinib group (65.3% v 31.0%); there were no differences in quality of life. One treatment-related death was observed in the combination group. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> Compared with gefitinib alone, gefitinib combined with carboplatin plus pemetrexed improved PFS in patients with untreated advanced NSCLC with EGFR mutations with an acceptable toxicity profile, although its OS benefit requires further validation. </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 38 (2), 115-123, 2020-01-10
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
- 1361412896815340800
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- ISSN
- 15277755
- 0732183X
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- データソース種別
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- Crossref
- KAKEN