HOPS-R01 phase II trial evaluating neoadjuvant S-1 therapy for resectable pancreatic adenocarcinoma.

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

Journal: Scientific reports 2022;12(1):9966

PMID: 35705607

Free Full Text on Nature Publishing Group View on PubMed

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.

Address: Department of Gastroenterological Surgery II, Faculty of Medicine, Hokkaido University, N-15 W-7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan. [email protected].; Center for Gastroenterology, Teine Keijinkai Hospital, 12-1-40 Maeda 1 Jo, Teine-ku, Sapporo, Hokkaido, 006-0811, Japan.; Department of Medical Oncology, School of Medicine, Sapporo Medical University, S1 W17, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan.; Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, S1 W17, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan.; Department of Gastroenterology and Hepatology, Faculty of Medicine, Hokkaido University, N-15 W-7, Kita-Ku, Sapporo, 060-8638, Japan.; Center for Gastroenterology, Teine Keijinkai Hospital, 12-1-40 Maeda 1 Jo, Teine-ku, Sapporo, Hokkaido, 006-0811, Japan.; Department of Medical Oncology, School of Medicine, Sapporo Medical University, S1 W17, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan.; Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, 1-1-1 Midorigaoka Higashi 2 Jo, Asahikawa, Hokkaido, 078-8510, Japan.; Department of Gastroenterology and Hepatology, School of Medicine, Sapporo Medical University, S1 W17, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan.; Division of Metabolism and Biosystemic Science, Department of Medicine, Asahikawa Medical University, 1-1-1 Midorigaoka Higashi 2 Jo, Asahikawa, Hokkaido, 078-8510, Japan.; Department of Diagnostic and Interventional Radiology, Hokkaido University, N-15 W-7, Kita-Ku, Sapporo, 060-8638, Japan.; Department of Surgery, Hokkaido Gastroenterology Hospital, 1-2-10 Honcho 1 Jo, Higashi-ku, Sapporo, Hokkaido, 065-0041, Japan.; Department of Surgery, Kushiro Red Cross Hospital, 21-14 Shineicho, Kushiro, Hokkaido, 085-8512, Japan.; Department of Surgery, Obihiro Kosei General Hospital, 10-1 Nishi 14 Jominami, Obihiro, Hokkaido, 080-0024, Japan.; Department of Gastroenterology, Muroran City General Hospital, 3-8-1 Yamatecho, Muroran, Hokkaido, 051-8512, Japan.; Department of Gastroenterology, Steel Memorial Muroran Hospital, 1-45 Chiribetsucho, Muroran, Hokkaido, 050-0076, Japan.; Department of Gastroenterology, NTT East Sapporo Hospital, S1 W15 Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan.; Department of Surgery, Asahikawa Red Cross Hospital, 1-1-1 Akebono 1 Jo, Asahikawa, Hokkaido, 070-8530, Japan.; Biostatistics Division, Hokkaido University Hospital Clinical Research and Medical Innovation Center, Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan.; Department of Gastroenterological Surgery II, Faculty of Medicine, Hokkaido University, N-15 W-7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan.

DOI: 10.1038/s41598-022-14094-0

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MeSH Terms: Adenocarcinoma, Antineoplastic Combined Chemotherapy Protocols, Humans, Neoadjuvant Therapy, Pancreatic Neoplasms