Evidence map›Paper›PMID 38990441›Full record

Trial reportEsophagus : official journal of the Japan Esophageal Society2024

A phase 3, randomized, double-blind, multicenter, placebo-controlled study of S-588410, a five-peptide cancer vaccine as an adjuvant therapy after curative resection in patients with esophageal squamous cell carcinoma.

Tomoki Makino, Hiroshi Miyata, Takushi Yasuda, Yuko Kitagawa, Kei Muro, Jae-Hyun Park, Tetsuro Hikichi, Takahiro Hasegawa, Kenji Igarashi, Motofumi Iguchi and 3 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Esophagus : official journal of the Japan Esophageal Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Article
  2. Review
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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

13 authors.

Tomoki MakinoDepartment of Surgery, Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Hiroshi MiyataDepartment of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
Takushi YasudaDepartment of Surgery, Kindai University Faculty of Medicine, 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan. takushi-yasuda6008@med.kindai.ac.jp.ORCID 0000-0003-4025-8113
Yuko KitagawaDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan.
Jae-Hyun ParkOncoTherapy Science, Inc., Kawasaki, Kanagawa, Japan.
Tetsuro HikichiLaboratory Department, Cancer Precision Medicine, Inc., Kawasaki, Kanagawa, Japan.
Takahiro HasegawaBiostatistics Center, Shionogi & Co., Ltd., Osaka, Japan.
Kenji IgarashiProject Management, Shionogi & Co., Ltd., Osaka, Japan.
Motofumi IguchiMedical Affairs Department, Shionogi & Co., Ltd, Osaka, Japan.
Yasuhide MasaokaClinical Development, Shionogi & Co., Ltd, Osaka, Japan.
Masahiko YanoDepartment of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
Yuichiro DokiDepartment of Surgery, Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundS-588410, a cancer peptide vaccine (CPV), comprises five HLA-A*24:02-restricted peptides from five cancer-testis antigens. In a phase 2 study, S-588410 was well-tolerated and exhibited antitumor efficacy in patients with urothelial cancer. Therefore, we aimed to evaluate the efficacy, immune response, and safety of S-588410 in patients with completely resected esophageal squamous cell carcinoma (ESCC).

methodsThis phase 3 study involved patients with HLA-A*24:02-positive and lymph node metastasis-positive ESCC who received neoadjuvant therapy followed by curative resection. After randomization, patients were administered S-588410 and placebo (both emulsified with Montanide™ ISA 51VG) subcutaneously. The primary endpoint was relapse-free survival (RFS). The secondary endpoints were overall survival (OS), cytotoxic T-lymphocyte (CTL) induction, and safety. Statistical significance was tested using the one-sided weighted log-rank test with the Fleming-Harrington class of weights.

resultsA total of 276 patients were randomized (N = 138/group). The median RFS was 84.3 and 84.1 weeks in the S-588410 and placebo groups, respectively (P = 0.8156), whereas the median OS was 236.3 weeks and not reached, respectively (P = 0.6533). CTL induction was observed in 132/134 (98.5%) patients who received S-588410 within 12 weeks. Injection site reactions (137/140 patients [97.9%]) were the most frequent treatment-emergent adverse events in the S-588410 group. Prolonged survival was observed in S-588410-treated patients with upper thoracic ESCC, grade 3 injection-site reactions, or high CTL intensity.

conclusionsS-588410 induced immune response and had acceptable safety but failed to reach the primary endpoint. A high CTL induction rate and intensity may be critical for prolonging survival during future CPV development.

Indexed as

Cancer VaccinesEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaAgedCarcinoma, Squamous CellDisease-Free SurvivalDouble-Blind MethodEsophagectomyFemaleHLA-A24 AntigenHumansLymphatic MetastasisMaleMiddle AgedNeoadjuvant TherapyT-Lymphocytes, CytotoxicCancer VaccinesHLA-A*24:02 antigenHLA-A24 AntigenVaccines, SubunitAdjuvant therapyCancer peptide vaccineCytotoxic T lymphocytesEsophageal squamous cell carcinomaS-588410

Identifiers

PMID38990441
PMCPMC11405444

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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.