Evidence map›Paper›PMID 38834744›Full record

Trial reportBritish journal of cancer2024

Three-year outcomes of preoperative chemoradiotherapy plus nivolumab in microsatellite stable and microsatellite instability-high locally advanced rectal cancer.

Yuichiro Tsukada, Hideaki Bando, Koji Inamori, Masashi Wakabayashi, Yosuke Togashi, Shohei Koyama, Daisuke Kotani, Satoshi Yuki, Yoshito Komatsu, Shigenori Homma and 13 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in British journal of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02948348 (A Phase 1b/2 Multicenter Study to Investigate the Safety, Efficacy and Proof of Concept), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–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.

NCT02948348 phase1 / phase2unknown statusnot on this map

A Phase 1b/2 Multicenter Study to Investigate the Safety, Efficacy and Proof of Concept (POC) of Nivolumab Monotherapy as a Sequential Therapy Following Preoperative Chemoradiotherapy Patients With Locally Advanced Resectable Rectal Cancer

TypeinterventionalSponsorTakayuki YoshinoRan2016 to 2022Enrolled90ConditionsCancer of RectumArmsNivolumab, Ipilimumab
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  11. Neoadjuvant Chemotherapy Versus Adjuvant Chemotherapy for Very Low-Lying Clinical T3 Rectal Cancer: The NAIR Phase 2/3 Randomized Clinical Trial.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2025
    Article
  12. Targeting tumor metabolism to augment CD8Journal of pharmaceutical analysis · 2025
    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

23 authors.

Yuichiro Tsukada *Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, 277-8577, Japan. yutsukad@east.ncc.go.jp.ORCID http://orcid.org/0000-0001-6261-0152
Hideaki Bando *Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, 277-8577, Japan.
Koji Inamori *Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, 277-8577, Japan.
Masashi WakabayashiClinical Research Support Office, National Cancer Center Hospital East, Kashiwa, 277-8587, Japan.
Yosuke TogashiDivision of Cancer Immunology, Research Institute/Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Tokyo/Kashiwa, 104-0045/277-8587, Japan.ORCID http://orcid.org/0000-0001-9910-0164
Shohei KoyamaDivision of Cancer Immunology, Research Institute/Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Tokyo/Kashiwa, 104-0045/277-8587, Japan.
Daisuke KotaniDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, 277-8577, Japan.ORCID http://orcid.org/0000-0002-4196-555X
Satoshi YukiDepartment of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, 060-8648, Japan.
Yoshito KomatsuDepartment of Cancer chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, 060-8648, Japan.ORCID http://orcid.org/0000-0002-1570-6802
Shigenori HommaDepartment of Gastroenterological Surgery, Hokkaido University Hospital, Sapporo, 060-8648, Japan.
Akinobu TaketomiDepartment of Gastroenterological Surgery, Hokkaido University Hospital, Sapporo, 060-8648, Japan.ORCID http://orcid.org/0000-0002-5238-3678
Mamoru UemuraDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, 540-0006, Japan.
Takeshi KatoDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, 540-0006, Japan.
Makoto FukuiClinical Research Support Office, National Cancer Center Hospital East, Kashiwa, 277-8587, Japan.
Naoki NakamuraDivision of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, Kashiwa, 277-8587, Japan.
Motohiro KojimaDivision of Pathology, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Kashiwa, 277-8587, Japan.
Hiroshi KawachiDepartment of Pathology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, 135-8550, Japan.
Richard KirschDepartment of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, ON, M5G 1×5, Canada.
Tsutomu YoshidaDivision of Molecular Pathology, Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Sagamihara, 252-0374, Japan.
Akihiro SatoClinical Research Support Office, National Cancer Center Hospital East, Kashiwa, 277-8587, Japan.
Hiroyoshi NishikawaDivision of Cancer Immunology, Research Institute/Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Tokyo/Kashiwa, 104-0045/277-8587, Japan.ORCID http://orcid.org/0000-0001-6563-9807
Masaaki ItoDepartment of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, 277-8577, Japan.
Takayuki YoshinoDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, 277-8577, Japan.ORCID http://orcid.org/0000-0002-0489-4756

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreoperative chemoradiotherapy (CRT) followed by surgery is the standard treatment for locally advanced rectal cancer (LARC). We reported the short-term outcomes of the VOLTAGE trial that investigated the safety and efficacy of preoperative CRT followed by nivolumab and surgery. Here, we present the 3-year outcomes of this trial.

methodsThirty-nine patients with microsatellite stable (MSS) LARC and five patients with microsatellite instability-high (MSI-H) LARC underwent CRT (50.4 Gy) followed by five doses of nivolumab (240 mg) and surgery. The 3-year relapse-free survival (RFS), overall survival (OS), and associations with biomarkers were evaluated.

resultsThe 3-year RFS rates in patients with MSS and MSI-H were 79.5% and 100%, respectively, and the 3-year OS rates were 97.4% and 100%, respectively. Of the MSS patients, those with pre-CRT PD-L1 positivity, pre-CRT high CD8 + T cell/effector regulatory T cell (eTreg) ratio, pre-CRT high expression of Ki-67, CTLA-4, and PD-1 had a trend toward better 3-year RFS than those without.

conclusionsThree-year outcomes of patients with MSI-H were better than those of patients with MSS. PD-L1 positivity, elevated CD8/eTreg ratio, and high expression of Ki-67, CTLA-4, and PD-1 could be positive predictors of prognosis in patients with MSS. CLINICAL

trial registrationClinicalTrials.gov Identifier: NCT02948348.

Indexed as

ChemoradiotherapyMicrosatellite InstabilityNivolumabRectal NeoplasmsAdultAgedAntineoplastic Agents, ImmunologicalB7-H1 AntigenCTLA-4 AntigenFemaleHumansMaleMiddle AgedTreatment OutcomeAntineoplastic Agents, ImmunologicalB7-H1 AntigenCD274 protein, humanCTLA-4 AntigenNivolumab

Identifiers

PMID38834744
PMCPMC11263387

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Registered trials

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.