Evidence map›Paper›PMID 33683919›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451.

Taofeek K Owonikoko, Keunchil Park, Ramaswamy Govindan, Neal Ready, Martin Reck, Solange Peters, Shaker R Dakhil, Alejandro Navarro, Jerónimo Rodríguez-Cid, Michael Schenker and 15 more

Open access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 176 papers, 20 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
176citing papers in PubMed, 20 pooled it
18.0field-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

176 citing papers in PubMed, 20 syntheses or guidelines pooled it, 260 citations in OpenAlex.

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  5. The cardiac-related adverse events of PD-1/PD-L1 immunotherapy in advanced or metastatic lung cancer: a RCT-based meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
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116 more citing papers are in PubMed but not listed here.

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

25 authors at 17 institutions in 9 countries.

Taofeek K OwonikokoWinship Cancer Institute of Emory University, Atlanta, GA.ORCID 0000-0002-7724-7728
Keunchil ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.ORCID 0000-0002-4846-7449
Ramaswamy GovindanAlvin J Siteman Cancer Center at Washington University School of Medicine, St Louis, MO.ORCID 0000-0002-6964-9612
Neal ReadyDuke University Medical Center, Durham, NC.
Martin ReckDepartment of Thoracic Oncology, Airway Research Center North, German Center for Lung Research, LungClinic, Grosshansdorf, Germany.ORCID 0000-0002-5336-9739
Solange PetersOncology Department, Lausanne University Hospital, Lausanne, Switzerland.ORCID 0000-0002-0412-7143
Shaker R DakhilCancer Center of Kansas, Wichita, KS.
Alejandro NavarroVall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Jerónimo Rodríguez-CidCentro Oncológico, Médica Sur-Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico.ORCID 0000-0001-8518-9065
Michael SchenkerCentrul de Oncologie Sf Nectarie, Craiova, Romania.
Jong-Seok LeeSeoul National University Bundang Hospital, Seongnam, South Korea.
Vanesa GutierrezHospital Regional Universitario de Málaga, Málaga, Spain.
Ivor PercentFlorida Cancer Specialists, Punta Gorda, FL.
Daniel MorgenszternAlvin J Siteman Cancer Center at Washington University School of Medicine, St Louis, MO.ORCID 0000-0003-4349-2028
Carlos H BarriosOncology Research Center, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.ORCID 0000-0001-6021-667X
Laurent GreillierAix Marseille Univ, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille, France.ORCID 0000-0002-5807-9503
Sofia BakaInterbalkan European Medical Center, Thessaloniki, Greece.
Miten PatelCancer Specialists of North Florida, Jacksonville, FL.
Wen Hong LinBristol Myers Squibb, Princeton, NJ.
Giovanni SelvaggiBristol Myers Squibb, Princeton, NJ.
Christine BaudeletBristol Myers Squibb, Princeton, NJ.
Jonathan BadenBristol Myers Squibb, Princeton, NJ.
Dimple PandyaBristol Myers Squibb, Princeton, NJ.
Parul DoshiBristol Myers Squibb, Princeton, NJ.
Hye Ryun KimYonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.ORCID 0000-0002-1842-9070
Bristol-Myers Squibb (United States) · USAlvin J. Siteman Cancer Center · USFlorida Cancer Specialists & Research Institute · USCancer Center of Kansas · USCentre National de la Recherche Scientifique · FRDuke Medical Center · USEmory University · USGerman Center for Lung Research · DEHospital Regional Universitario de Málaga · ESInstituto Nacional de Enfermedades Respiratorias · MXInterbalkan Medical Center · GRPontifícia Universidade Católica do Rio Grande do Sul · BRSamsung Medical Center · KRSeoul National University Bundang Hospital · KRUniversity of Lausanne · CHVall d'Hebron Hospital Universitari · ESYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn extensive-disease small-cell lung cancer (ED-SCLC), response rates to first-line platinum-based chemotherapy are robust, but responses lack durability. CheckMate 451, a double-blind phase III trial, evaluated nivolumab plus ipilimumab and nivolumab monotherapy as maintenance therapy following first-line chemotherapy for ED-SCLC.

methodsPatients with ED-SCLC, Eastern Cooperative Oncology Group performance status 0-1, and no progression after ≤ 4 cycles of first-line chemotherapy were randomly assigned (1:1:1) to nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks for 12 weeks followed by nivolumab 240 mg once every 2 weeks, nivolumab 240 mg once every 2 weeks, or placebo for ≤ 2 years or until progression or unacceptable toxicity. Primary end point was overall survival (OS) with nivolumab plus ipilimumab versus placebo. Secondary end points were hierarchically tested.

resultsOverall, 834 patients were randomly assigned. The minimum follow-up was 8.9 months. OS was not significantly prolonged with nivolumab plus ipilimumab versus placebo (hazard ratio [HR], 0.92; 95% CI, 0.75 to 1.12;

conclusionMaintenance therapy with nivolumab plus ipilimumab did not prolong OS for patients with ED-SCLC who did not progress on first-line chemotherapy. There were no new safety signals.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodFemaleHumansIpilimumabLung NeoplasmsMaleMiddle AgedNivolumabSmall Cell Lung CarcinomaIpilimumabNivolumab

Identifiers

PMID33683919
PMCPMC8078251
OpenAlexW3133896744

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.