A randomized phase II trial of erlotinib vs. S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002)

Ikezawa, Yasuyuki; Asahina, Hajime; Oizumi, Satoshi; Watanabe, Masahiro; Takamura, Kei; Kawai, Yasutaka; Yamada, Noriyuki; Harada, Toshiyuki; Kinoshita, Ichiro; Fujita, Yuka; Miyauchi, Eisaku; Ogi, Takahiro; Amano, Toraji; Furuta, Megumi; Sakakibara-Konishi, Jun; Nishihara, Hiroshi; Dosaka-Akita, Hirotoshi; Isobe, Hiroshi; Nishimura, Masaharu

A randomized phase II trial of erlotinib vs. S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002)

Ikezawa, Yasuyuki; Asahina, Hajime; Oizumi, Satoshi et al.

Cancer chemotherapy and pharmacology, 2017, 80(5), 955-963

Permalink : https://hdl.handle.net/2115/71783

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論文情報

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アクセス権	open access
URI	https://hdl.handle.net/2115/71783
タイトル	A randomized phase II trial of erlotinib vs. S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002)
その他のタイトル	A randomized phase II trial of erlotinib versus S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002)
著者	Ikezawa, Yasuyuki ; Asahina, Hajime ; Oizumi, Satoshi ; Watanabe, Masahiro ; Takamura, Kei ; Kawai, Yasutaka ; Yamada, Noriyuki ; Harada, Toshiyuki ; Kinoshita, Ichiro ; Fujita, Yuka ; Miyauchi, Eisaku ; Ogi, Takahiro ; Amano, Toraji ; Furuta, Megumi ; Sakakibara-Konishi, Jun ; Nishihara, Hiroshi ; Dosaka-Akita, Hirotoshi ; Isobe, Hiroshi ; Nishimura, Masaharu
著者名 Ikezawa, Yasuyuki
e-Rad_Researcher 90374298 著者名 Asahina, Hajime
e-Rad_Researcher 10421968 著者名 Oizumi, Satoshi
著者名 Watanabe, Masahiro
著者名 Takamura, Kei
著者名 Kawai, Yasutaka
著者名 Yamada, Noriyuki
著者名 Harada, Toshiyuki
e-Rad_Researcher 40343008 著者名 Kinoshita, Ichiro
著者名 Fujita, Yuka
著者名 Miyauchi, Eisaku
著者名 Ogi, Takahiro
著者名 Amano, Toraji
著者名 Furuta, Megumi
e-Rad_Researcher 50374278 著者名 Sakakibara-Konishi, Jun
e-Rad_Researcher 50322805 著者名 Nishihara, Hiroshi
e-Rad_Researcher 70222528 著者名 Dosaka-Akita, Hirotoshi
e-Rad_Researcher 90241322 著者名 Isobe, Hiroshi
e-Rad_Researcher 00208224 著者名 Nishimura, Masaharu
言語	英語
キーワード	Erlotinib
	S-1
	Non-small cell lung cancer
	Third-line therapy
	Fourth-line therapy
発行日	2017-11
出版者	Springer
収録物名	Cancer chemotherapy and pharmacology
巻(号)	80(5)
ページ	955-963
抄録	Purpose: A high proportion of patients with wild-type EGFR non-small cell lung cancer (NSCLC) receive third-line therapy and beyond, with no prospective randomized trials addressing the issue. This study aimed to select the most suitable regimen as a third- or fourth-line therapy for wild-type EGFR NSCLC. Methods: This multicenter, randomized phase II study in Japan included patients with recurrent or advanced NSCLC with wild-type or unknown EGFR, who progressed after two or three previous chemotherapies. The patients were randomly assigned to erlotinib (150 mg/day, days 1-21) or S-1 (80-120 mg/day, days 1-14) every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was disease control rate (DCR). The secondary endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), toxicity, and quality of life (QOL). Results: From 2011 to 2016, 37 patients were randomly assigned to receive erlotinib (E arm, n = 19) and S-1 (S arm, n = 18). This study was terminated prematurely because of poor patient accrual. DCR/ORR were 42.1%/15.8% in the E arm and 66.7%/16.7% in the S arm. Median PFS/OS were 1.6 months/8.0 months in the E arm and 3.3 months/12.2 months in the S arm. In both groups, the most commonly reported grade 3-4 toxicities were fatigue, anorexia, and nausea. One grade 5 pneumonitis occurred in the S arm. No significant difference was seen in QOL. Conclusions: S-1 as a third- or fourth-line therapy for wild-type EGFR NSCLC showed numerically better clinical outcomes than erlotinib. Clinical trial registration no. UMIN000005308.
資源タイプ	学術雑誌論文
出版タイプ	Accepted Manuscript
権利情報	The final publication is available at link.springer.com
PISSN	0344-5704
関連情報	PMID 28905108
関連情報 (isVersionOf)	出版社版DOI https://doi.org/10.1007/s00280-017-3432-4