Evidence map›Paper›PMID 38713408›Full record

ArticleCancer immunology, immunotherapy : CII2024

Clinical outcomes of adjuvant nivolumab in resected stage III melanoma: comparison of CheckMate 238 trial and real-world data.

Justin C Moser, Shailender Bhatia, Asim Amin, Anna C Pavlick, Keith A Betts, Ella Xiaoyan Du, Tayla Poretta, Karishma Shelley, Swetha Srinivasan, Leon Alan Sakkal and 9 more

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

19 authors.

Justin C MoserHonorHealth Research Institute, 10510 North 92nd Street, Suite 100, Scottsdale, AZ, 85258, USA. jmoser@honorhealth.com.
Shailender BhatiaDivision of Hematology and Oncology, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Asim AminMedical Oncology and Immunotherapy, Levine Cancer Institute, Atrium Health, Charlotte, NC, USA.
Anna C PavlickMedical Oncology, Weill Cornell Medicine, New York, NY, USA.
Keith A BettsAnalysis Group, Los Angeles, CA, USA.
Ella Xiaoyan DuAnalysis Group, Los Angeles, CA, USA.
Tayla PorettaBristol Myers Squibb, Princeton, NJ, USA.
Karishma ShelleyBristol Myers Squibb, Princeton, NJ, USA.
Swetha SrinivasanBristol Myers Squibb, Princeton, NJ, USA.
Leon Alan SakkalBristol Myers Squibb, Princeton, NJ, USA.
Jennell PalaiaBristol Myers Squibb, Princeton, NJ, USA.
Maurice LoboBristol Myers Squibb, Princeton, NJ, USA.
Melanie Pe BenitoBristol Myers Squibb, Princeton, NJ, USA.
Joshua A LintonBristol Myers Squibb, Princeton, NJ, USA.
Yan ChenAnalysis Group, Los Angeles, CA, USA.
Churong XuAnalysis Group, Los Angeles, CA, USA.
Lei YinAnalysis Group, Los Angeles, CA, USA.
Manasvi SundarAnalysis Group, Los Angeles, CA, USA.
Jeffrey WeberNYU Langone Health Perlmutter Cancer Center, New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesNivolumab is approved as adjuvant therapy for resected stage III/IV melanoma based on the phase 3 CheckMate 238 trial. This analysis compared outcomes from CheckMate 238 with those from the real-world Flatiron Health electronic health record-derived de-identified database in patients with resected stage III melanoma (per AJCC-8) treated with adjuvant nivolumab. MATERIALS: Outcomes included baseline characteristics, overall survival (OS) in the CheckMate 238 cohort (randomization until death or last known alive), and real-world overall survival (rwOS) in the Flatiron Health cohort (nivolumab initiation until death or data cutoff). rwOS was compared with OS using unadjusted and adjusted Cox proportional hazards models. Inverse probability of treatment weighting (IPTW) was combined with the adjusted model to reduce baseline discrepancies.

resultsThe CheckMate 238 and real-world cohorts included 369 and 452 patients, respectively (median age, 56.0 and 63.0 years; median follow-up, 61.4 vs. 25.5 months). rwOS was not different from OS in the unadjusted (hazard ratio [HR] 1.27; 95% CI 0.92-1.74), adjusted (HR 1.01; 95% CI 0.67-1.54), and adjusted IPTW (HR 1.07; 95% CI 0.70-1.63) analyses. In the adjusted analysis, 2-year OS and rwOS rates were 84%. Median OS and rwOS were not reached. After IPTW, OS and rwOS were not different (HR 1.07; 95% CI 0.70-1.64).

conclusionsIn this comparative analysis, OS in the CheckMate 238 trial was similar to rwOS in the Flatiron Health database after adjustments in patients with resected stage III melanoma (per AJCC-8) treated with adjuvant nivolumab, validating the trial results.

Indexed as

MelanomaNeoplasm StagingNivolumabAdultAgedAntineoplastic Agents, ImmunologicalChemotherapy, AdjuvantFemaleHumansMaleMiddle AgedSkin NeoplasmsTreatment OutcomeAntineoplastic Agents, ImmunologicalNivolumabAdjuvant therapyImmunotherapyMelanomaNivolumabReal-world

Identifiers

PMID38713408
PMCPMC11076438

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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.