Evidence map›Paper›PMID 39007963›Full record

ArticleJournal of gastrointestinal cancer2024

Efficacy and Safety of Salvage-line Nivolumab Monotherapy for Advanced Esophageal Squamous Cell Carcinoma: Comparison of 240 mg Versus 480 mg Doses.

Yuko Murashima, Shun Yamamoto, Toshiharu Hirose, Toru Kadono, Go Ikeda, Akihiro Ohara, Mai Itoyama, Kazuki Yokoyama, Yoshitaka Honma, Koshiro Ishiyama and 3 more

Abstract readComparative Study
In one paragraph

Article in Journal of gastrointestinal cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

13 authors.

Yuko MurashimaDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Shun YamamotoDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Toshiharu HiroseDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Toru KadonoDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Go IkedaDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Akihiro OharaDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Mai ItoyamaDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Kazuki YokoyamaDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Yoshitaka HonmaDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Koshiro IshiyamaDepartment of Esophageal Surgery, National Cancer Center Hospital, Tokyo, Japan.
Jyunya OgumaDepartment of Esophageal Surgery, National Cancer Center Hospital, Tokyo, Japan.
Hiroyuki DaikoDepartment of Esophageal Surgery, National Cancer Center Hospital, Tokyo, Japan.
Ken KatoDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. kenkato@ncc.go.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNivolumab monotherapy is the standard second-line treatment for advanced esophageal squamous cell carcinoma (ESCC) after failure of platinum-based chemotherapy without anti-PD-1 antibody. Fixed dosing with 240 mg every 2 weeks was approved initially, followed by fixed dosing with 480 mg every 4 weeks based on pharmacokinetics data. However, information on the comparative efficacy and safety of the two doses remains limited.

methodsWe compared progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and the incidence of adverse events (AEs) between the two doses in 117 patients who received second-line (n = 85) or later-line (n = 32) nivolumab monotherapy at our institution between January 2016 and December 2021.

resultsIn the second-line group, patient characteristics for the 240 mg and 480 mg groups were as follows (240 mg vs. 480 mg): performance status (PS) 0/1/2 was 34/61/5% vs. 54/42/4%, and prior fluoropyrimidine plus platinum therapy (FP) was 81.3% vs. 42.3%. In the later-line group, the characteristics were: PS 0/1/2 was 28/60/12% vs. 14/86/0%, and prior FP was 60.0% vs. 42.8%. ORR was 11.9 vs. 24.0% in the second-line group (p = 0.19) and 0 vs. 14.3% in the later-line group (p = 0.22). Median PFS was 1.7 vs. 4.1 months on second-line (hazard ratio [HR] 0.60, 95% confidence interval [CI] 0.35-1.01, p = 0.056) and 1.4 vs. 1.8 months on later-line (HR 0.58, 95% CI 0.23-1.46, p = 0.25); AEs of any grade were observed in 58.3 vs. 69.7%, respectively.

conclusionsThe efficacy and safety of the two doses of nivolumab monotherapy were comparable in patients with advanced ESCC.

Indexed as

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaNivolumabSalvage TherapyAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalFemaleHumansMaleMiddle AgedProgression-Free SurvivalRetrospective StudiesTreatment OutcomeAntineoplastic Agents, ImmunologicalNivolumabChemotherapyEsophageal cancerEsophageal squamous cell carcinomaNivolumab

Identifiers

PMID39007963
PMCPMC11347457

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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.