• Keijiro Sugimura, Hiroshi Miyata, Koji Tanaka, Tomoki Makino, Atsushi Takeno, Osamu Shiraishi, Masaaki Motoori, Makoto Yamasaki, Yutaka Kimura, Motohiro Hirao, Kazumasa Fujitani, Takushi Yasuda, Masaki Mori, Hidetoshi Eguchi, Masahiko Yano, and Yuichiro Doki.
• Department of Surgery, Osaka International Cancer Institute, Osaka, Japan.
• Ann. Surg. 2021 Dec 1; 274 (6): e465-e472.

ObjectiveWe conducted a multicenter randomized prospective phase 2 trial of chemoradiotherapy (CRT) versus chemotherapy (CT) as initial induction therapy for conversion surgery (CS) in clinical T4b esophageal cancer. We compared treatment effects and adverse events (AEs).Summary Background DataAlthough induction followed by CS is potentially curative for T4b esophageal cancer, the optimal initial induction treatment is unclear.MethodsNinety-nine patients with T4b esophageal cancer were randomly allocated to chemoradiotherapy (Group A, n = 49) or CT (Group B, n = 50) as initial induction treatment. CRT consisted of radiation (50.4 Gy) with cisplatin and 5-fluorouracil. CT consisted of 2 cycles of docetaxel plus cisplatin and 5-fluorouracil (DCF). CRT or CT was followed by CS if resectable. If unresectable, the patient received the other treatment as secondary treatment. CS was performed if resectable after secondary treatment. The primary end point was 2-year overall survival.ResultsIn Group A, CS was performed in 34 (69%) and 7 patients (14%) after initial and secondary treatment. In Group B, CS was performed in 25 (50%) and 17 patients (34%) after initial and secondary treatment. The R0 resection rate after initial and secondary treatment was similar (78% vs 76%, P = 1.000). AEs including leukopenia, neutropenia, febrile neutropenia, and diarrhea were significantly more frequent in Group B. Group A had better histological complete response of the primary tumor (40% vs 17%, P = 0.028) and histological nodal status (P = 0.038).ConclusionUpfront CRT was superior to upfront CT in terms of pathological effects and AEs. The Japan Registry of Clinical Trials (s051180164).Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

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