Evidence map›Paper›PMID 37552354›Full record

Trial reportInternational journal of clinical oncology2023

Effect of duration of adjuvant chemotherapy with S-1 (6 versus 12 months) for resected pancreatic cancer: the multicenter clinical randomized phase II postoperative adjuvant chemotherapy S-1 (PACS-1) trial.

Hiroto Kayashima, Shinji Itoh, Mototsugu Shimokawa, Hiromitsu Hayashi, Hiroshi Takamori, Kengo Fukuzawa, Mizuki Ninomiya, Kenichiro Araki, Yo-Ichi Yamashita, Keishi Sugimachi and 7 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
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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

17 authors.

Hiroto KayashimaDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Fukuoka, 812-8582, Japan.
Shinji ItohDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Fukuoka, 812-8582, Japan. itoh.shinji.453@m.kyushu-u.ac.jp.ORCID http://orcid.org/0000-0003-0382-2520
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University, 1677-1 Yoshida, Yamaguchi, 753-8511, Japan.
Hiromitsu HayashiDepartment of Gastroenterological Surgery, Kumamoto University, 1-1-1 Honjo, Kumamoto, 860-8556, Japan.
Hiroshi TakamoriDepartment of Surgery, Saiseikai Kumamoto Hospital, 5-3-1 Chikami, Kumamoto, 861-4193, Japan.
Kengo FukuzawaDepartment of Surgery, Oita Red Cross Hospital, 3-2-37 Chiyo-machi, Oita, 870-0033, Japan.
Mizuki NinomiyaDepartment of Surgery, Matsuyama Red Cross Hospital, 1 Bunkyocho, Matsuyama, Ehime, 790-8524, Japan.
Kenichiro ArakiDivision of Hepatobiliary and Pancreatic Surgery, Department of General Surgical Science, Gunma University, 4-2 Aramaki-machi, Maebashi, Gunma, 371-8510, Japan.
Yo-Ichi YamashitaDepartment of Surgery, Iizuka Hospital, 3-83 Yoshio-machi, Iizuka, Fukuoka, 820-8505, Japan.
Keishi SugimachiDepartment of Hepatobiliary-Pancreatic Surgery, Kyushu Cancer Center, 3-1-1 Notame, Fukuoka, 811-1395, Japan.
Hideaki UchiyamaDepartment of Surgery, Saiseikai Fukuoka General Hospital, 1-3-46 Tenjin, Fukuoka, 810-0001, Japan.
Yuji MorineDepartment of Surgery, Tokushima University, 2-24 Shinkuracho, Tokushima, 770-0855, Japan.
Tohru UtsunomiyaDepartment of Surgery, Oita Prefectural Hospital, 2-8-1 Bunyo, Oita, 870-8511, Japan.
Tadashi UwagawaDepartment of Hepato-Biliary-Pancreatic Surgery, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.
Takashi MaedaDepartment of Surgery, Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, 1-9-6 Senda-machi, Hiroshima, 730-8619, Japan.
Hideo BabaDepartment of Gastroenterological Surgery, Kumamoto University, 1-1-1 Honjo, Kumamoto, 860-8556, Japan.
Tomoharu YoshizumiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Fukuoka, 812-8582, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSix-month adjuvant chemotherapy with S-1 is standard care for resected pancreatic cancer in Japan; however, the optimal duration has not been established. We aimed to evaluate the impact of duration of adjuvant chemotherapy with S-1.

methodsWe performed a multicenter, randomized, open-label, phase II study. Patients with histologically proven invasive pancreatic ductal carcinoma, pathological stage I-III, and no local residual or microscopic residual tumor were eligible. Patients were randomized 1:1 to receive 6- or 12-month adjuvant chemotherapy with S-1. The primary endpoint was 2-year overall survival (OS). Secondary endpoints were disease-free survival (DFS) and feasibility.

resultsA total of 170 patients were randomized (85 per group); the full analysis set was 82 in both groups. Completion rates were 64.7% (6-month group) and 44.0% (12-month group). Two-year OS was 71.5% (6-month group) and 65.4% (12-month group) (hazard ratio (HR): 1.143; 80% confidence interval CI 0.841-1.553; P  =  0.5758). Two-year DFS was 46.4% (6-month group) and 44.9% (12-month group) (HR: 1.069; 95% CI 0.727-1.572; P = 0.6448). In patients who completed the regimen, 2-year DFS was 56.5% (6-month group) and 75.0% (12-month group) (HR: 0.586; 95% CI 0.310-1.105; P  = 0.0944). Frequent (≥ 5%) grade ≥ 3 adverse events comprised anorexia (10.5% in the 6-month group) and diarrhea (5.3% vs. 5.1%; 6- vs. 12-month group, respectively).

conclusionsIn patients with resected pancreatic cancer, 12-month adjuvant chemotherapy with S-1 was not superior to 6-month therapy regarding OS and DFS.

Indexed as

Chemotherapy, AdjuvantPancreatic NeoplasmsDisease-Free SurvivalHumansAdjuvant chemotherapyCarcinomaMulticenter studyPancreasProspective study

Identifiers

PMID37552354

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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.