• Shinichiro Takahashi, Izumi Ohno, Masafumi Ikeda, Masaru Konishi, Tatsushi Kobayashi, Tetsuo Akimoto, Motohiro Kojima, Soichiro Morinaga, Hirochika Toyama, Yasuhiro Shimizu, Atsushi Miyamoto, Moriaki Tomikawa, Norihisa Takakura, Wataru Takayama, Satoshi Hirano, Takehito Otsubo, Masato Nagino, Wataru Kimura, Keishi Sugimachi, and Katsuhiko Uesaka.
• Department of Hepato-biliary Pancreatic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
• Ann. Surg. 2022 Nov 1; 276 (5): e510-e517.

ObjectiveThis study assessed whether neoadjuvant chemoradiotherapy (CRT) with S-1 increases the R0 resection rate in BRPC.Summary Of Background DataAlthough a multidisciplinary approach that includes neoadjuvant treatment has been shown to be a better strategy for BRPC than upfront resection, a standard treatment for BRPC has not been established.MethodsA multicenter, single-arm, phase II study was performed. Patients who fulfilled the criteria for BRPC received S-1 (40 mg/m 2 bid) and concurrent radiotherapy (50.4 Gy in 28 fractions) before surgery. The primary endpoint was the R0 resection rate. At least 40 patients were required, with a 1-sided α = 0.05 and β = 0.05 and expected and threshold values for the primary endpoint of 30% and 10%, respectively.ResultsFifty-two patients were eligible, and 41 were confirmed to have definitive BRPC by a central review. CRT was completed in 50 (96%) patients and was well tolerated. The rate of grade 3/4 toxicity with CRT was 43%. The R0 resection rate was 52% among the 52 eligible patients and 63% among the 41 patients who were centrally confirmed to have BRPC. Postoperative grade III/IV adverse events according to the Clavien-Dindo classification were observed in 7.5%. Among the 41 centrally confirmed BRPC patients, the 2-year overall survival rate and median overall survival duration were 58% and 30.8 months, respectively.ConclusionsS-1 and concurrent radiotherapy seem to be feasible and effective at increasing the R0 resection rate and improving survival in patients with BRPC.Trial RegistrationUMIN000009172.Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

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