1. HOPS-R01 phase II trial evaluating neoadjuvant S-1 therapy for resectable pancreatic adenocarcinoma
- Author
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Toru Nakamura, Tsuyoshi Hayashi, Yasutoshi Kimura, Hiroshi Kawakami, Kuniyuki Takahashi, Hirotoshi Ishiwatari, Takuma Goto, Masayo Motoya, Keisuke Yamakita, Yusuke Sakuhara, Michihiro Ono, Eiichi Tanaka, Makoto Omi, Katsuhiko Murakawa, Tomoya Iida, Tamaki Sakurai, Shin Haba, Takehiro Abiko, Yoichi M. Ito, Hiroyuki Maguchi, Satoshi Hirano, and Hokkaido Pancreatic Cancer Study Group (HOPS)
- Subjects
Medicine ,Science - Abstract
Abstract Although neoadjuvant therapy (Nac) is recommended for high-risk resectable pancreatic cancer (R-PDAC), evidence regarding specific regimes is scarce. This report aimed to investigate the efficacy of S-1 Nac for R-PDAC. In a multicenter phase II trial, we investigated the efficacy of Nac S-1 (an oral fluoropyrimidine agent containing tegafur, gimeracil, and oteracil potassium) in R-PDAC patients. The protocol involved two cycles of preoperative S-1 chemotherapy, followed by surgery, and four cycles of postoperative S-1 chemotherapy. Two-year progression-free survival (PFS) rates were the primary endpoint. Overall survival (OS) rates and median survival time (MST) were secondary endpoints. Forty-nine patients were eligible, and 31 patients underwent resection following Nac, as per protocol (31/49; 63.3%). Per-protocol analysis included data from 31 patients, yielding the 2-year PFS rate of 58.1%, and 2-, 3-, and 5-year OS rates of 96.8%, 54.8%, and 44.0%, respectively. MST was 49.2 months. Intention-to-treat analysis involved 49 patients, yielding the 2-year PFS rate of 40.8%, and the 2-, 3-, and 5-year OS rates of 87.8%, 46.9%, and 33.9%, respectively. MST was 35.5 months. S-1 single regimen might be an option for Nac in R-PDAC; however, the high drop-out rate (36.7%) was a limitation of this study.
- Published
- 2022
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