Evidence map›Paper›PMID 41991754›Full record

Trial reportJournal of gastroenterology2026

Usefulness of an S-1 dosage formula for predicting adverse events in adjuvant chemotherapy for curatively resected pancreatic cancer: an exploratory analysis of the randomized clinical trial (JASPAC-01).

Kazunaga Ishigaki, Yousuke Nakai, Kousuke Kashiwabara, Mitsuhiro Fujishiro, Naoto Gotohda, Hirochika Toyama, Atsuyuki Maeda, Yasuhiro Shimizu, Atsushi Miyamoto, Amane Takahashi and 10 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Kazunaga IshigakiDepartment of Clinical Oncology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan. ishigakikazunaga@gmail.com.ORCID 0000-0001-6773-9465
Yousuke NakaiDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Kousuke KashiwabaraData Science Office, Clinical Research Promotion Center, The University of Tokyo Hospital, Tokyo, Japan.
Mitsuhiro FujishiroDepartment of Clinical Oncology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan.
Naoto GotohdaDepartment of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
Hirochika ToyamaDivision of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.
Atsuyuki MaedaDepartment of Surgery, Ogaki Municipal Hospital, Ogaki, Japan.
Yasuhiro ShimizuDepartment of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
Atsushi MiyamotoDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Amane TakahashiDepartment of Gastrointestinal Surgery, Saitama Cancer Center, Saitama, Japan.
Soichiro MorinagaDepartment of Hepato-Biliary and Pancreatic Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Hiroo YanagibashiDivision of Hepato-Biliary-Pancreatic Surgery, Chiba Cancer Center, Chiba, Japan.
Takuma GotoDivision of Gastroenterology, Department of Internal Medicine, Asahikawa Medical University, Asahikawa, Japan.
Yasunaru SakumaDivision of Gastroenterological, General, and Transplant Surgery, Department of Surgery, Jichi Medical University, Shimotsuke, Japan.
Moriaki TomikawaDepartment of Hepato-Biliary-Pancreatic Surgery, Tochigi Cancer Center, Utsunomiya, Japan.
Hitoshi OjimaGunma Prefectural Cancer Center Department of Gastroenterological Surgery, Ota, Japan.
Yukiyasu OkamuraDivision of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, Shizuoka, Japan.
Akira FukutomiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Narikazu BokuDepartment of Oncology and General Medicine, IMSUT Hospital, Institute of Medical Science, University of Tokyo, Bunkyo-ku, Japan.
Katsuhiko UesakaDivision of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, Shizuoka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdverse events (AEs) of S-1 are affected by renal function. A dosage formula for S-1 based on renal function and body surface area (BSA) has been developed, indicating the dose required to achieve a target blood concentration of 5-fluorouracil. This study aimed to explore the usefulness of this formula in adjuvant chemotherapy with S-1 for pancreatic cancer (PC).

methodsIn the JASPAC-01 trial, the actual initial dose of S-1 was calculated based on the BSA. Patients were divided into three groups by comparing the actual initial S-1 dose with the dose recommended by the S-1 dosage formula: underdose (UD), equal dose (ED), and overdose (OD). The recurrence rate, prognosis, and AEs in each group were evaluated.

resultsAmong 187 eligible patients, 27 (14%), 43 (23%), and 117 (63%) patients were classified into the UD, ED, and OD groups. The incidence of all-grade and grade ≥ 3 anemia during the all-time periods were significantly higher in the OD group (94.9/18.8%) compared to the ED (93.0/4.7%) and UD (81.5/7.4%) groups (P = 0.04). In the UD/ED/OD groups, the planned adjuvant S-1 therapy for 6 months was completed in 77.8/72.1/70.9% (P = 0.51), whereas dose reduction was required in 0/14.0/22.2% (P = 0.01). The 5-year overall survival was slightly worse in OD group (41.9%) than those in the UD/ED groups (48.1/47.6%).

conclusionsIn the adjuvant S-1 therapy for PC, AEs and dose reduction were more common in the OD group. The S-1 dosage formula may be useful for reducing AEs.

Indexed as

Antimetabolites, AntineoplasticOxonic AcidPancreatic NeoplasmsTegafurAgedAnemiaBody Surface AreaChemotherapy, AdjuvantDose-Response Relationship, DrugDrug CombinationsFemaleFluorouracilHumansMaleMiddle AgedNeoplasm Recurrence, LocalAntimetabolites, AntineoplasticDrug CombinationsFluorouracilOxonic AcidS 1 (combination)TegafurAdjuvant chemotherapyPancreatic cancerRenal functionS-1S-1 dosage formula

Identifiers

PMID41991754

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.