エンドウ　シュンジ   Shunji Endo   遠藤　俊治    所属   川崎医科大学  医学部 臨床医学　消化器外科学    職種   准教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Comparison of S-1-cisplatin every 5 weeks with capecitabine-cisplatin every 3 weeks for HER2-negative gastric cancer (recurrent after S-1 adjuvant therapy or chemotherapy-naïve advanced): pooled analysis of HERBIS-2 (OGSG 1103) and HERBIS-4A (OGSG 1105) trials.
掲載誌名	正式名：International journal of clinical oncology 略　 称：Int J Clin Oncol ISSNコード：14377772/13419625
掲載区分	国外
巻・号・頁	25(9),pp.1635-1643
著者・共著者	Kawakami Hisato, Fujitani Kazumasa, Matsuyama Jin, Akamaru Yusuke, Tamura Shigeyuki, Endo Shunji, Kimura Yutaka, Makari Youichi, Tamura Takao, Sugimoto Naotoshi, Sakai Daisuke, Tsujinaka Toshimasa, Goto Masahiro, Kurokawa Yukinori, Shimokawa Toshio, Satoh Taroh,
発行年月	2020/09
概要	BACKGROUND:We previously reported the HERBIS-4A phase II trial comparing S-1 plus cisplatin (SP) with capecitabine plus cisplatin (XP) in chemotherapy-naïve patients with HER2-negative advanced gastric cancer (GC). We performed a pooled analysis of HERBIS-4A and HERBIS-2, the phase II trial comparing SP with XP in HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of ≥ 6 months.PATIENTS AND METHODS:Patients were randomly assigned to receive either SP [S-1 (40-60 mg twice daily for 21 days) plus cisplatin (60 mg/m2 on day 8), every 5 weeks] or XP [capecitabine (1000 mg/m2 twice daily for 14 days) plus cisplatin (80 mg/m2 on day 1), every 3 weeks].RESULTS:In the pooled analysis, SP (n = 44-50) showed a longer progression-free survival [6.4 versus 5.1 months; hazard ratio (HR), 0.666; P = 0.062], overall survival (14.8 versus 10.6 months; HR, 0.695; P = 0.099), and time to treatment failure (4.6 versus 3.6 months; HR, 0.668; P = 0.045) as well as a higher disease control rate (86.4% versus 68.1%, P = 0.149) compared with XP (n = 47-51). A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach.CONCLUSION:Our pooled analysis supports the use of SP in the first-line setting for patients with HER2-negative advanced or recurrent GC with a recurrence-free interval of ≥ 6 months.CLINICAL TRIAL REGISTRATION:The HERBIS-2 trial was registered with UMIN-CTR as UMIN000006105.
DOI	10.1007/s10147-020-01711-z
PMID	32494981