Phase II Study of Continued Trastuzumab Plus Irinotecan in Patients with HER2-positive Gastric Cancer Previously Treated with Trastuzumab (HGCSG 1201)

Yasuyuki, Kawamoto; Satoshi, Yuki; Takashi, Meguro; Hatanaka, Kazuteru; Uebayashi, Minoru; Nakamura, Michio; Okuda, Hiroyuki; Iwanaga, Ichiro; Kato, Takashi; Nakano, Shintaro; Sato, Atsushi; Harada, Kazuaki; Oba, Koji; Sakata, Yuh; Sakamoto, Naoya; Komatsu, Yoshito

Phase II Study of Continued Trastuzumab Plus Irinotecan in Patients with HER2-positive Gastric Cancer Previously Treated with Trastuzumab (HGCSG 1201)

Yasuyuki, Kawamoto; Satoshi, Yuki; Takashi, Meguro et al.

The Oncologist, 2022, 27(5), 340-e374

Permalink : https://hdl.handle.net/2115/85675

このアイテムのアクセス数:547件（2026-01-24 05:42 集計）

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https://doi.org/10.1093/oncolo/oyab062			1

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アクセス権	metadata only access
URI	https://hdl.handle.net/2115/85675
タイトル	Phase II Study of Continued Trastuzumab Plus Irinotecan in Patients with HER2-positive Gastric Cancer Previously Treated with Trastuzumab (HGCSG 1201)
著者	Yasuyuki, Kawamoto ; Satoshi, Yuki ; Takashi, Meguro ; Hatanaka, Kazuteru ; Uebayashi, Minoru ; Nakamura, Michio ; Okuda, Hiroyuki ; Iwanaga, Ichiro ; Kato, Takashi ; Nakano, Shintaro ; Sato, Atsushi ; Harada, Kazuaki ; Oba, Koji ; Sakata, Yuh ; Sakamoto, Naoya ; Komatsu, Yoshito
e-Rad_Researcher 60755601 著者名 Yasuyuki, Kawamoto
著者名 Satoshi, Yuki
著者名 Takashi, Meguro
著者名 Hatanaka, Kazuteru
著者名 Uebayashi, Minoru
著者名 Nakamura, Michio
著者名 Okuda, Hiroyuki
著者名 Iwanaga, Ichiro
著者名 Kato, Takashi
著者名 Nakano, Shintaro
著者名 Sato, Atsushi
著者名 Harada, Kazuaki
著者名 Oba, Koji
著者名 Sakata, Yuh
e-Rad_Researcher 10334418 著者名 Sakamoto, Naoya
e-Rad_Researcher 60333598 著者名 Komatsu, Yoshito
言語	英語
キーワード	gastric cancer
	HER2
	trastuzumab
	irinotecan
	second-line treatment
発行日	2022-05
出版者	Oxford University Press
収録物名	The Oncologist
巻(号)	27(5)
ページ	340-e374
抄録	Background The efficacy of irinotecan plus continuous trastuzumab beyond progression in patients with gastric cancer previously treated with trastuzumab plus standard first-line chemotherapy has not been reported. Methods Patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer who were previously treated with trastuzumab received trastuzumab every 3 weeks and irinotecan every 2 weeks. The primary endpoint was the overall response rate (ORR), and the secondary endpoints included progression-free survival (PFS), 6-month survival rates, safety, and subgroup analysis by HER2 status. Results Sixteen patients were enrolled in a 3-year pre-planned registration period. This study was prematurely closed due to poor patient accrual. The ORR and disease control rate were 6.7% (95% CI, 0.2-32.0) and 53.3% (95% CI, 26.6-78.7). The median PFS and overall survival (OS) were 2.4 months (95% CI, 0.0-5.2) and 9.7 months (95% CI, 8.2-11.2), respectively. The most frequently reported grades 3-4 adverse events were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%). Conclusion With only 16 patients enrolled, the present study has very low power to detect any clinical benefit of trastuzumab plus irinotecan beyond disease progression in patients with HER2-positive advanced gastric cancer who previously received trastuzumab. Trial Identifier: UMIN000007636.
資源タイプ	学術雑誌論文
出版タイプ	Version of Record
PISSN	1083-7159
関連情報 (isIdenticalTo)	出版社版DOI https://doi.org/10.1093/oncolo/oyab062