Takahashi Shinichiro, Ohno Izumi, Ikeda Masafumi, Konishi Masaru, Kobayashi Tatsushi, Akimoto Tetsuo, Kojima Motohiro, Morinaga Soichiro, Toyama Hirochika, Shimizu Yasuhiro, Miyamoto Atsushi, Tomikawa Moriaki, Takakura Norihisa, Takayama Wataru, Hirano Satoshi, Otsubo Takehito, Nagino Masato, Kimura Wataru, Sugimachi Keishi, Uesaka Katsuhiko
Department of Hepato-biliary Pancreatic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
Clinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan.
Ann Surg. 2022 Nov 1;276(5):e510-e517. doi: 10.1097/SLA.0000000000004535. Epub 2020 Oct 15.
This study assessed whether neoadjuvant chemoradiotherapy (CRT) with S-1 increases the R0 resection rate in BRPC.
Although 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.
A 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.
Fifty-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.
S-1 and concurrent radiotherapy seem to be feasible and effective at increasing the R0 resection rate and improving survival in patients with BRPC.
UMIN000009172.
本研究评估S-1新辅助放化疗（CRT）是否能提高可切除性胰腺癌（BRPC）的R0切除率。
尽管包括新辅助治疗在内的多学科方法已被证明是BRPC比直接手术更好的策略，但BRPC的标准治疗方法尚未确立。
进行了一项多中心、单臂、II期研究。符合BRPC标准的患者在手术前接受S-1（40mg/m²，每日两次）和同步放疗（28次分割，共50.4Gy）。主要终点是R0切除率。至少需要40例患者，单侧α=0.05，β=0.05，主要终点的预期值和阈值分别为30%和10%。
52例患者符合条件，41例经中心评估确诊为明确的BRPC。50例（96%）患者完成了CRT，耐受性良好。CRT导致3/4级毒性的发生率为43%。52例符合条件的患者中R0切除率为52%，41例经中心确诊为BRPC的患者中R0切除率为63%。根据Clavien-Dindo分类，术后III/IV级不良事件发生率为7.5%。在41例经中心确诊的BRPC患者中，2年总生存率和中位总生存时间分别为58%和30.8个月。
S-1和同步放疗似乎在提高BRPC患者的R0切除率和改善生存率方面是可行且有效的。
UMIN000009172
