医学
临床终点
食管癌
放化疗
随机对照试验
化疗
内科学
多中心试验
存活率
外科
肿瘤科
癌症
多中心研究
作者
Makoto Yamasaki,Hiroshi Miyata,Kotaro Yamashita,Takuya Hamakawa,Koji Tanaka,Keijiro Sugimura,Tomoki Makino,Atsushi Takeno,Osamu Shiraishi,Masaaki Motoori,Yutaka Kimura,Motohiro Hirao,Kazumasa Fujitani,Toshiko Yasuda,Masahiko Yano,Hidetoshi Eguchi,Yuichiro� Doki
标识
DOI:10.1038/s41416-023-02286-y
摘要
We report the long-term results as primary endpoint in a multicentre randomized prospective Phase 2 trial which compared chemoradiotherapy (CRT) and triplet chemotherapy (CT) as the initial therapy for conversion surgery (CS) in T4b esophageal cancer (EC). Patients with T4b EC were randomly assigned to the CRT group or CT group as initial treatment. CS was performed if resectable after initial or secondary treatment. The primary endpoint was 2-year overall survival, analysed by intention-to-treat. The median follow-up period was 43.8 months. The 2-year survival rate was higher in the CRT group (55.1%; 95% CI: 41.1–68.3%) compared to the CT group (34.7%; 95% CI: 22.8–48.9%), although the difference was not significant (P = 0.11). Local and regional lymph node recurrence in patients undergoing R0 resection was significantly higher in the CT group compared to the CRT group (local: 30% versus 8%, respectively, P = 0.03; regional: 37% versus 8%, respectively, P = 0.002). Upfront CT was not superior to upfront CRT as induction therapy for T4b EC in terms of 2-year survival and was significantly inferior to upfront CRT in terms of local and regional control. The Japan Registry of Clinical Trials (s051180164).
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