Evidence map›Paper›PMID 32946353›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial.

Alexander M M Eggermont, Christian U Blank, Mario Mandala, Georgina V Long, Victoria G Atkinson, Stéphane Dalle, Andrew M Haydon, Andrey Meshcheryakov, Adnan Khattak, Matteo S Carlino and 21 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 140 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
140citing papers in PubMed, 10 pooled it
15.5field-weighted citation impact, top 1% of its field
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

140 citing papers in PubMed, 10 syntheses or guidelines pooled it, 271 citations in OpenAlex.

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  9. SEOM clinical guideline for the management of cutaneous melanoma (2020).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Guideline
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  14. Patient-reported tolerability of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk stage III-IV melanoma in phase III trial E1609.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
    Trial
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  18. Circulating Tumor DNA as a Biomarker for Melanoma Prognosis and Therapy.American journal of clinical dermatology · 2026
    Review
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  20. Article

80 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors at 20 institutions in 12 countries.

Alexander M M EggermontPrincess Máxima Center, Utrecht, the Netherlands.
Christian U BlankNetherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.
Mario MandalaAzienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
Georgina V LongMelanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, New South Wales, Australia.ORCID 0000-0001-8894-3545
Victoria G AtkinsonPrincess Alexandra Hospital, Brisbane, Queensland, Australia.
Stéphane DalleHospices Civils de Lyon Cancer Institute, Lyon, France.
Andrew M HaydonAlfred Hospital, Melbourne, Victoria, Australia.
Andrey MeshcheryakovN.N. Blokhin Cancer Research Center, Moscow, Russian Federation.ORCID 0000-0002-6009-653X
Adnan KhattakFiona Stanley Hospital and Edith Cowan University, Perth, Western Australia, Australia.
Matteo S CarlinoWestmead and Blacktown Hospitals, Melanoma Institute Australia, and The University of Sydney, Sydney, New South Wales, Australia.
Shahneen SandhuPeter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
James LarkinRoyal Marsden Hospital, London, United Kingdom.ORCID 0000-0001-5569-9523
Susana PuigHospital Clinic Universitari de Barcelona, Barcelona, Spain.
Paolo A AsciertoIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.ORCID 0000-0002-8322-475X
Piotr RutkowskiMaria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Dirk SchadendorfUniversity Hospital Essen, Essen, Germany.ORCID 0000-0003-3524-7858
Rutger KoornstraRadboud University Medical Center Nijmegen, Nijmegen, the Netherlands.
Leonel Hernandez-AyaWashington University School of Medicine, St Louis, MO.
Anna Maria Di GiacomoCenter for Immuno-Oncology, University Hospital of Siena, Siena, Italy.
Alfonsus J M van den EertweghAmsterdam University Medical Center, location VUMC, Amsterdam, the Netherlands.
Jean-Jacques GrobAix Marseille University, Hôpital de la Timone, Marseille, France.ORCID 0000-0002-0667-153X
Ralf GutzmerSkin Cancer Center, Hannover Medical School, Hanover, Germany.ORCID 0000-0001-7921-2820
Rahima JamalCentre Hospitalier de l'Université de Montréal (CHUM), Centre de recherche du CHUM, Montreal, Quebec, Canada.
Paul C LoriganChristie NHS Foundation Trust, Manchester, United Kingdom.ORCID 0000-0002-8875-2164
Alexander C J van AkkooiNetherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.
Clemens KreplerMerck & Co, Kenilworth, NJ.
Nageatte IbrahimMerck & Co, Kenilworth, NJ.ORCID 0000-0003-0794-949X
Sandrine MarreaudEuropean Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
Michal KicinskiEuropean Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
Stefan SuciuEuropean Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.ORCID 0000-0003-3281-8256
Caroline RobertGustave Roussy and Paris-Saclay University, Villejuif, France.ORCID 0000-0002-9493-0238
European Organisation for Research and Treatment of Cancer · BEMerck & Co., Inc., Rahway, NJ, USA (United States) · USThe Netherlands Cancer Institute · NLThe University of Sydney · AUAix-Marseille Université · FRAmsterdam University Medical Centers · NLCentre Hospitalier de l’Université de Montréal · CAEdith Cowan University · AUGerman Cancer Research Center · DEHospices Civils de Lyon · FRHospital Universitari de Vic · ESIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITMedizinische Hochschule Hannover · DEOspedale Papa Giovanni XXIII · ITPeter MacCallum Cancer Centre · AUPrincess Alexandra Hospital · AUPrincess Máxima Center · NLRadboud University Nijmegen · NLRoyal Marsden Hospital · GBRussian Cancer Research Center NN Blokhin · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe conducted the phase III double-blind European Organisation for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 trial to evaluate pembrolizumab versus placebo in patients with resected high-risk stage III melanoma. On the basis of 351 recurrence-free survival (RFS) events at a 1.25-year median follow-up, pembrolizumab prolonged RFS (hazard ratio [HR], 0.57; PATIENTS AND

methodsA total of 1,019 patients with complete lymph node dissection of American Joint Committee on Cancer Staging Manual (seventh edition; AJCC-7), stage IIIA (at least one lymph node metastasis > 1 mm), IIIB, or IIIC (without in-transit metastasis) cutaneous melanoma were randomly assigned to receive pembrolizumab at a flat dose of 200 mg (n = 514) or placebo (n = 505) every 3 weeks for 1 year or until disease recurrence or unacceptable toxicity. The two coprimary end points were RFS in the overall population and in those with programmed death-ligand 1 (PD-L1)-positive tumors.

resultsPembrolizumab (190 RFS events) compared with placebo (283 RFS events) resulted in prolonged RFS in the overall population (3-year RFS rate, 63.7%

conclusionIn resected high-risk stage III melanoma, pembrolizumab adjuvant therapy provided a sustained and clinically meaningful improvement in RFS at 3-year median follow-up. This improvement was consistent across subgroups.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenChemotherapy, AdjuvantCutaneous Malignant MelanomaDisease-Free SurvivalDouble-Blind MethodFollow-Up StudiesHumansLymph Node ExcisionLymph NodesMelanomaNeoplasm StagingProto-Oncogene Proteins B-rafRisk FactorsSkin NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBRAF protein, humanCD274 protein, humanpembrolizumabProto-Oncogene Proteins B-raf

Identifiers

PMID32946353
PMCPMC7676886
OpenAlexW3087401339

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.