Evidence map›Paper›PMID 39375260›Full record

Trial reportAnnals of surgical oncology2025

Phase II Trial of Adjuvant S-1 Following Neoadjuvant Chemotherapy and Surgery in Patients with Locally Advanced Esophageal Squamous Cell Carcinoma: The PIECE Trial.

Motoo Nomura, Toshifumi Yamaguchi, Keisho Chin, Shinji Hato, Ken Kato, Eishi Baba, Hisahiro Matsubara, Hidenori Mukaida, Takako Yoshii, Masahiro Tsuda and 5 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Annals of surgical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
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

15 authors.

Motoo NomuraDepartment of Clinical Oncology, Kyoto University Hospital, Kyoto, Japan. excell@hkg.odn.ne.jp.ORCID http://orcid.org/0000-0002-5967-0610
Toshifumi YamaguchiCancer Chemotherapy Center, Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Japan.
Keisho ChinGastroenterological Chemotherapy Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan.
Shinji HatoDepartment of Gastroenterological Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Ken KatoDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Eishi BabaDepartment of Comprehensive Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Hisahiro MatsubaraDepartment of Frontier Surgery, Graduated School of Medicine, Chiba University, Chiba, Japan.
Hidenori MukaidaDepartment of Surgery, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan.
Takako YoshiiDepartment of Gastroenterology, Saitama Cancer Center, Kitaadachi-gun, Saitama, Japan.
Masahiro TsudaDepartment of Gastroenterological Oncology, Hyogo Cancer Center, Akashi, Japan.
Yasuhiro TsubosaDivision of Esophageal Surgery, Shizuoka Cancer Center Hospital, Sunto-gun, Shizuoka, Japan.
Yuko KitagawaDepartment of Surgery, Keio University School of Medicine, Minato-ku, Tokyo, Japan.
Isao OzeDivision of Cancer Information and Control, Aichi Cancer Center Research Institute, Nagoya, Japan.
Hideki IshikawaDepartment of Molecular-Targeting Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Manabu MutoDepartment of Clinical Oncology, Kyoto University Hospital, Kyoto, Japan.

Funding

Taiho Pharmaceutical Research funding (sponsored research program)
6 · The paper itself

Abstract

backgroundNeoadjuvant chemotherapy followed by surgery (NAC-S) is the standard therapy for locally advanced esophageal squamous cell carcinoma (ESCC) in Japan.

objectiveThe aim of this phase II trial was to assess the efficacy and safety of the addition of adjuvant S-1 after R0 resection in ESCC patients who received NAC-S. PATIENTS AND

methodsKey eligibility criteria included clinical stage IB-III (without T4 disease) ESCC, age 20-75 years, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients received adjuvant therapy with four cycles of S-1 (80 mg/m

resultsA total of 52 patients were enrolled between January 2016 and January 2019. Two patients were excluded from analysis; five patients were determined to have R1 or R2 resection, and seven patients did not receive adjuvant S-1. The 3-year RFS and overall survival rates in the intention-to-treat population were 72.3% (90% confidence interval [CI] 59.9-81.5) and 85.0% (90% CI 73.9-91.6), indicating that the primary endpoint was met. Grade ≥3 adverse events with an incidence ≥10% included neutropenia (13.2%), anorexia (13.2%), and diarrhea (10.5%). There were no treatment-related deaths.

conclusionAdjuvant S-1 after NAC-S showed promising efficacy with a manageable safety profile for patients with resectable ESCC and warrants further evaluation in larger studies.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaEsophagectomyNeoadjuvant TherapyAdultAgedAntimetabolites, AntineoplasticChemotherapy, AdjuvantDrug CombinationsFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm Recurrence, LocalAntimetabolites, AntineoplasticDrug CombinationsOxonic AcidS 1 (combination)TegafurAdjuvant chemotherapyEsophageal squamous cell carcinomaNeoadjuvant chemotherapyS-1Surgery

Identifiers

PMID39375260
PMCPMC11659372

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Registered trials

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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.