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Clinical Trial
. 2025 Sep;32(9):6561-6570.
doi: 10.1245/s10434-025-17661-7. Epub 2025 Jun 25.

Perioperative 5-Fluorouracil and Portal Vein Infusion Chemotherapy Followed by Adjuvant S-1 for Resected Pancreatic Cancer (TOSPAC-02): A Phase 2 Clinical Trial

Minoru Kitago  1 , Yutaka Endo  2 , Yosuke Uematsu  2 , Koichi Aiura  3 , Keiichi Suzuki  4 , Junichi Matsui  5 , Yutaka Takigawa  5 , Sojun Hoshimoto  3 , Masatsugu Ishii  6 , Yutaka Nakano  2 , Yuta Abe  2 , Masahiro Shinoda  7 , Osamu Itano  7 , Yuko Kitagawa  2
Affiliations
Clinical Trial

Perioperative 5-Fluorouracil and Portal Vein Infusion Chemotherapy Followed by Adjuvant S-1 for Resected Pancreatic Cancer (TOSPAC-02): A Phase 2 Clinical Trial

Minoru Kitago et al. Ann Surg Oncol. 2025 Sep.

Abstract

Background: Pancreatic ductal adenocarcinoma (PDAC) exhibits a poor prognosis, even after curative resection. Portal vein infusion (PVI) chemotherapy with gemcitabine therapy for resected PDAC has been reported as effective. This study aimed to evaluate the efficacy of PVI chemotherapy followed by S-1 therapy as adjuvant chemotherapy following PDAC resection.

Methods: This multicenter phase II trial included patients with resected PDAC between February 2014 and May 2017. They received PVI chemotherapy with 5-fluorouracil (250 mg/day) and heparin (2000 IU/day) with systemic administration of mitomycin C (4 mg/day on days 6, 13, 20, and 27) and cisplatin (10 mg/day on days 7, 14, 21, and 28) for 4 weeks (PI4W) and S-1 therapy. The primary endpoint was recurrence-free survival (RFS). The secondary endpoints included overall survival (OS), incidence of adverse events, protocol completion rate, and relative dose intensity of S-1.

Results: A total of 50 patients were included in the final analysis. The median RFS and OS were 18.9 months (1-, 3-, and 5-year RFS rates: 63.3, 36.1, and 28.3%, respectively) and 63.9 months (1-, 3-, and 5-year OS rates: 91.9, 57.2, and 51.2%, respectively), respectively. Of the patients, 47 (94.0%) completed PI4W, 44 (88.0%) received S-1 therapy, and 29 (58.0%) completed PI4W plus S-1 therapy. The combination therapy had relatively favorable survival outcomes. Severe adverse events were less prevalent, and the treatment was well-tolerated.

Conclusions: PI4W followed by S-1 therapy may benefit patients after curative resection of PDAC. Clinical trial register: The study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000013430).

Keywords: Adjuvant chemotherapy; Pancreatic ductal adenocarcinoma; Perioperative chemotherapy; Portal vein infusion chemotherapy; S-1.

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Conflict of interest statement

Financial Disclosures: This work was supported via the Japanese Foundation for the Multidisciplinary Treatment of Cancer. Dr. Kitagawa reports grants and personal fees from TSUMURA & CO.; grants and personal fees from Kowa Company, Ltd.; grants and personal fees from Eisai Co., Ltd.; grants and personal fees from Takeda Pharmaceutical Company Limited; grants and personal fees from KAKEN PHARMACEUTICAL CO., LTD.; grants and personal fees from Otsuka Pharmaceutical Factory, Inc.; grants and personal fees from TAIHO PHARMACEUTICAL CO., LTD; grants and personal fees from CHUGAI PHARMACEUTICAL CO., LTD.; grants and personal fees from ASAHI KASEI PHARMA CORPORATION; personal fees from AstraZeneca K.K.; personal fees from Ethicon Inc.; personal fees from ONO PHARMACEUTICAL CO., LTD.; personal fees from Olympus Corporation; personal fees from Cardinal Health K.K.; personal fees from SHIONOGI & CO., LTD.; personal fees from Bristol-Myers Squibb K.K.; personal fees from MSD K.K.; personal fees from Smith & Nephew K.K.; personal fees from ASKA Pharmaceutical Co., Ltd.; personal fees from MIYARISAN PHARMACEUTICAL CO. LTD.; personal fees from Toray Industries, Inc.; personal fees from DAIICHI SANKYO COMPANY, LIMITED; personal fees from Chugai Foundation for Innovative Drug Discovery Science; personal fees from Nippon Kayaku Co., Ltd.; personal fees from EA Pharma Co., Ltd.,; personal fees from Intuitive Surgical G.K.; personal fees from SYSMEX CORPORATION; personal fees from AI Medical Service Inc.; grants from Otsuka Pharmaceutical Co., Ltd.; grants from Sumitomo Pharma Co., Ltd.; grants from Kyouwa Hakkou Kirin Co., Ltd.; grants from TEIJIN PHARMA LIMITED; and grants from Nippon Covidien Inc. outside the submitted work.

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