HOPS-R01 phase II trial evaluating neoadjuvant S-1 therapy for resectable pancreatic adenocarcinoma
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...
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Nature Portfolio
2022-06-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-022-14094-0 |
| _version_ | 1818237399371612160 |
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| author | 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 Hokkaido Pancreatic Cancer Study Group (HOPS) |
| author_facet | 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 Hokkaido Pancreatic Cancer Study Group (HOPS) |
| author_sort | Toru Nakamura |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T12:25:08Z |
| format | Article |
| id | doaj.art-89410a9d2cbf4f059c43f426b88a7f31 |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-12-12T12:25:08Z |
| publishDate | 2022-06-01 |
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| spelling | doaj.art-89410a9d2cbf4f059c43f426b88a7f312022-12-22T00:24:33ZengNature PortfolioScientific Reports2045-23222022-06-011211910.1038/s41598-022-14094-0HOPS-R01 phase II trial evaluating neoadjuvant S-1 therapy for resectable pancreatic adenocarcinomaToru Nakamura0Tsuyoshi Hayashi1Yasutoshi Kimura2Hiroshi Kawakami3Kuniyuki Takahashi4Hirotoshi Ishiwatari5Takuma Goto6Masayo Motoya7Keisuke Yamakita8Yusuke Sakuhara9Michihiro Ono10Eiichi Tanaka11Makoto Omi12Katsuhiko Murakawa13Tomoya Iida14Tamaki Sakurai15Shin Haba16Takehiro Abiko17Yoichi M. Ito18Hiroyuki Maguchi19Satoshi Hirano20Hokkaido Pancreatic Cancer Study Group (HOPS)Department of Gastroenterological Surgery II, Faculty of Medicine, Hokkaido UniversityCenter for Gastroenterology, Teine Keijinkai HospitalDepartment of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical UniversityDepartment of Gastroenterology and Hepatology, Faculty of Medicine, Hokkaido UniversityCenter for Gastroenterology, Teine Keijinkai HospitalDepartment of Medical Oncology, School of Medicine, Sapporo Medical UniversityDivision of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical UniversityDepartment of Gastroenterology and Hepatology, School of Medicine, Sapporo Medical UniversityDivision of Metabolism and Biosystemic Science, Department of Medicine, Asahikawa Medical UniversityDepartment of Diagnostic and Interventional Radiology, Hokkaido UniversityDepartment of Medical Oncology, School of Medicine, Sapporo Medical UniversityDepartment of Surgery, Hokkaido Gastroenterology HospitalDepartment of Surgery, Kushiro Red Cross HospitalDepartment of Surgery, Obihiro Kosei General HospitalDepartment of Gastroenterology, Muroran City General HospitalDepartment of Gastroenterology, Steel Memorial Muroran HospitalDepartment of Gastroenterology, NTT East Sapporo HospitalDepartment of Surgery, Asahikawa Red Cross HospitalBiostatistics Division, Hokkaido University Hospital Clinical Research and Medical Innovation CenterCenter for Gastroenterology, Teine Keijinkai HospitalDepartment of Gastroenterological Surgery II, Faculty of Medicine, Hokkaido UniversityAbstract 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.https://doi.org/10.1038/s41598-022-14094-0 |
| spellingShingle | 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 Hokkaido Pancreatic Cancer Study Group (HOPS) HOPS-R01 phase II trial evaluating neoadjuvant S-1 therapy for resectable pancreatic adenocarcinoma Scientific Reports |
| title | HOPS-R01 phase II trial evaluating neoadjuvant S-1 therapy for resectable pancreatic adenocarcinoma |
| title_full | HOPS-R01 phase II trial evaluating neoadjuvant S-1 therapy for resectable pancreatic adenocarcinoma |
| title_fullStr | HOPS-R01 phase II trial evaluating neoadjuvant S-1 therapy for resectable pancreatic adenocarcinoma |
| title_full_unstemmed | HOPS-R01 phase II trial evaluating neoadjuvant S-1 therapy for resectable pancreatic adenocarcinoma |
| title_short | HOPS-R01 phase II trial evaluating neoadjuvant S-1 therapy for resectable pancreatic adenocarcinoma |
| title_sort | hops r01 phase ii trial evaluating neoadjuvant s 1 therapy for resectable pancreatic adenocarcinoma |
| url | https://doi.org/10.1038/s41598-022-14094-0 |
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