シミズ　キヨウコ   SHIMIZU Kyoko   清水　京子    所属   その他 その他    職種   非常勤嘱託
論文種別	原著
言語種別	英語
査読の有無	査読なし
表題	Randomized phase II study of chemoradiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer: Japan Clinical Oncology Group trial, JCOG1106.
掲載誌名	正式名：Japanese journal of clinical oncology 略　 称：Jpn J Clin Oncol ISSNコード：14653621/03682811
掲載区分	国外
巻・号・頁	51(2),pp.235-243
著者・共著者	Ioka Tatsuya, Furuse Junji, Fukutomi Akira, Mizusawa Junki, Nakamura Satoaki, Hiraoka Nobuyoshi, Ito Yoshinori, Katayama Hiroshi, Ueno Makoto, Ikeda Masafumi, Sugimori Kazuya, Okano Naohiro, Shimizu Kyoko, Yanagimoto Hiroaki, Okusaka Takuji, Ozaka Masato, Todaka Akiko, Nakamori Shoji, Tobimatsu Kazutoshi, Sata Naohiro, Kawashima Yohei, Hosokawa Ayumu, Yamaguchi Taketo, Miyakawa Hiroyuki, Hara Hiroki, Mizuno Nobumasa, Ishii Hiroshi,
発行年月	2021/02
概要	BACKGROUND:Chemoradiotherapy is a treatment option for locally advanced pancreatic cancer. However, the efficacy of induction chemotherapy prior to chemoradiotherapy is uncertain. The aim of this randomized, multicentre phase II study is to evaluate the efficacy and safety of chemoradiotherapy with and without induction chemotherapy to determine the significance of induction chemotherapy.METHODS:Patients with locally advanced pancreatic cancer were randomly assigned to the chemoradiotherapy arm (Arm A) or induction chemotherapy followed by the chemoradiotherapy arm (Arm B). Patients in Arm A underwent radiotherapy with concurrent S-1. Patients in Arm B received induction gemcitabine for 12 weeks, and thereafter, only patients with controlled disease underwent the same chemoradiotherapy as Arm A. After chemoradiotherapy, gemcitabine was continued until disease progression or unacceptable toxicity in both arms. The primary endpoint was overall survival.RESULTS:Amongst 102 patients enrolled, 100 were eligible for efficacy assessment. The probability of survival was greater in Arm B in the first 12 months, but the trend was reversed in the following periods (1-year survival 66.7 vs. 69.3%, 2-year survival 36.9 vs. 18.9%). The hazard ratio was 1.255 (95% confidence interval 0.816-1.930) in favour of Arm A. Gastrointestinal toxicity was slightly more frequent and three treatment-related deaths occurred in Arm A.CONCLUSIONS:This study suggested that the chemoradiotherapy using S-1 alone had more promising efficacy with longer-term survival, compared with induction gemcitabine followed by chemoradiotherapy for locally advanced pancreatic cancer.CLINICAL TRIAL REGISTRATION:The study was registered at the UMIN Clinical Trials Registry as UMIN000006811.
DOI	10.1093/jjco/hyaa198
PMID	33164066