Evidence map›Paper›PMID 33148693›Full record

Trial reportJournal for immunotherapy of cancer2020

RECIST and iRECIST criteria for the evaluation of nivolumab plus ipilimumab in patients with microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: the GERCOR NIPICOL phase II study.

Romain Cohen, Jaafar Bennouna, Aurélia Meurisse, Christophe Tournigand, Christelle De La Fouchardière, David Tougeron, Christophe Borg, Thibault Mazard, Benoist Chibaudel, Marie-Line Garcia-Larnicol and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03350126 (Interest of iRECIST Radiological Assessment for Disease Control Rate), which is not on this map. Cited by 40 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 4 pooled it
5.8field-weighted citation impact, top 3% 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.

NCT03350126 phase2active not recruitingnot on this map

Interest of iRECIST Radiological Assessment for Disease Control Rate (DCR) for Evaluation of Patients With Metastatic Colorectal Cancer dMMR and/or MSI Treated With Nivolumab and Ipilimumab. A GERCOR Open-label Phase II Study NIPICOL C17-01

TypeinterventionalSponsorGERCOR - Multidisciplinary Oncology Cooperative GroupRan2017 to 2025Enrolled57ConditionsMetastatic Cancer ColorectalArmsIpilimumab 200 MG in 40 ML Injection, Nivolumab 10 MG/ML
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 4 syntheses or guidelines pooled it, 77 citations in OpenAlex.

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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

14 authors at 10 institutions in 2 countries.

Romain CohenSorbonne University, Department of Medical Oncology, Saint-Antoine Hospital, APHP, Paris, France.ORCID 0000-0001-9602-5162
Jaafar BennounaDepartment of Medical Oncology, University Hospital of Nantes, Nantes, France.
Aurélia MeurisseDepartment of Oncology, Besançon University Hospital, Methodology and Quality of Life Unit, Besançon, France.
Christophe TournigandDepartment of Gastroenterology and Digestive Oncology, Henri Mondor University Hospital, APHP, Creteil, France.
Christelle De La FouchardièreDepartment of Medical Oncology, Centre Léon Bérard, Lyon, France.
David TougeronDepartment of Gastroenterology, Poitiers University Hospital and University of Poitiers, Poitiers, France.
Christophe BorgDepartment of Medical Oncology, University Hospital of Besançon, Besançon, France.
Thibault MazardDepartment of Medical Oncology, Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM, Montpellier University, INSERM U1194, Montpellier, France.
Benoist ChibaudelDepartment of Medical Oncology, Franco-British Hospital, Fondation Cognacq-Jay, Levallois-Perret, France.
Marie-Line Garcia-LarnicolMultidisciplinary Group in Oncology (GERCOR), Paris, France.
Magali SvrcekSorbonne University, Department of Pathology, Saint-Antoine Hospital, AP-HP, Paris, France.
Dewi VernereyDepartment of Oncology, Besançon University Hospital, Methodology and Quality of Life Unit, Besançon, France.
Yves MenuSorbonne University, Department of Radiology, Saint-Antoine Hospital, AP-HP, Paris, France.
Thierry AndréSorbonne University, Department of Medical Oncology, Saint-Antoine Hospital, APHP, Paris, France thierry.andre@aphp.fr.ORCID 0000-0002-5103-7095
Sorbonne Université · FRMethodology and Quality of Life Unit in Oncology · FRCentre Hospitalier Universitaire de Besançon · FRCentre Hospitalier Universitaire de Nantes · FRCentre Léon Bérard · FRGERCOR (France) · FRHôpitaux Universitaires Henri-Mondor · FRHospital Británico · UYInserm · FRUniversité de Poitiers · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors (ICIs) are highly effective in patients with microsatellite instability/mismatch repair-deficient (MSI/dMMR) metastatic colorectal cancer (mCRC). Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria may underestimate response to ICIs due to the pseudoprogression phenomenon. The GERCOR NIPICOL phase II study aimed to evaluate the frequency of pseudoprogressions in patients with MSI/dMMR mCRC treated with nivolumab and ipilimumab.

methodsPatients with MSI/dMMR mCRC previously treated with fluoropyrimidines, oxaliplatin, and irinotecan with/without targeted therapies received nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four cycles then nivolumab 3 mg/kg every 2 weeks until progression or a maximum of 20 cycles. Computed tomography scan tumor assessments were done every 6 weeks for 24 weeks and then every 12 weeks. The primary endpoint was disease control rate at 12 weeks according to RECIST 1.1 and iRECIST by central review.

resultsOf 57 patients included between December 2017 and November 2018, 48.0% received ≥3 prior lines of chemotherapy, 18.0% had

conclusionPseudoprogression is rare in patients with MSI/dMMR mCRC treated with nivolumab and ipilimumab. This combined ICI therapy confirms impressive DCR and survival outcomes in these patients. TRIAL REGISTRATION NUMBER: NCT03350126.

Indexed as

Response Evaluation Criteria in Solid TumorsAntineoplastic Agents, ImmunologicalColorectal NeoplasmsDNA Mismatch RepairFemaleHumansIpilimumabMaleMicrosatellite InstabilityMiddle AgedNivolumabAntineoplastic Agents, ImmunologicalIpilimumabNivolumabCTLA-4 antigengastrointestinal neoplasmsimmunotherapyprogrammed cell death 1 receptor

Identifiers

PMID33148693
PMCPMC7640587
OpenAlexW3095042835

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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.