Evidence map›Paper›PMID 32140762›Full record

ArticleCancer immunology, immunotherapy : CII2020

Outcomes associated with immune-related adverse events in metastatic non-small cell lung cancer treated with nivolumab: a pooled exploratory analysis from a global cohort.

Abdul Rafeh Naqash, Biagio Ricciuti, Dwight H Owen, Vaia Florou, Yukihiro Toi, Cynthia Cherry, Maida Hafiz, Andrea De Giglio, Mavish Muzaffar, Sandip H Patel and 8 more

Erratum issuedOpen access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 70 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 8 pooled it
5.9field-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.

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

70 citing papers in PubMed, 8 syntheses or guidelines pooled it, 96 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 3 countries.

Abdul Rafeh NaqashDivision of Cancer Treatment and Diagnosis, Developmental Therapeutics Clinic, National Cancer Institute, Bldg 31/3A44, 31 Centre Drive, Bethesda, MD, 20892, USA. abdulrafeh.naqash@nih.gov.
Biagio RicciutiThoracic Oncology Unit, Santa Maria Della Misericordia Hospital, University of Perugia, Perugia, Italy.
Dwight H OwenDivision of Medical Oncology, Department of Internal Medicine, Ohio State University, Columbus, OH, USA.
Vaia FlorouDivision of Oncology, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.
Yukihiro ToiDepartment of Pulmonary Medicine, Sendai Kousei Hospital, Hirosemachi, Aoba-Ku, Sendai, Japan.
Cynthia CherryDivision of Cancer Treatment and Diagnosis, Developmental Therapeutics Clinic, National Cancer Institute, Bldg 31/3A44, 31 Centre Drive, Bethesda, MD, 20892, USA.
Maida HafizDepartment of Pulmonary Medicine, East Carolina University, Greenville, NC, USA.
Andrea De GiglioThoracic Oncology Unit, Santa Maria Della Misericordia Hospital, University of Perugia, Perugia, Italy.
Mavish MuzaffarDivision of Hematology/Oncology, Department of Internal Medicine, East Carolina University, Greenville, NC, USA.
Sandip H PatelDivision of Medical Oncology, Department of Internal Medicine, Ohio State University, Columbus, OH, USA.
Shunichi SugawaraDepartment of Pulmonary Medicine, Sendai Kousei Hospital, Hirosemachi, Aoba-Ku, Sendai, Japan.
Jarred BurkartDivision of Medical Oncology, Department of Internal Medicine, Ohio State University, Columbus, OH, USA.
Wungki ParkDivision of Oncology, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.
Rita ChiariThoracic Oncology Unit, Santa Maria Della Misericordia Hospital, University of Perugia, Perugia, Italy.
Jun SugisakaDepartment of Pulmonary Medicine, Sendai Kousei Hospital, Hirosemachi, Aoba-Ku, Sendai, Japan.
Gregory A OttersonDivision of Medical Oncology, Department of Internal Medicine, Ohio State University, Columbus, OH, USA.
Gilberto de Lima LopesDivision of Oncology, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.
Paul R WalkerDivision of Hematology/Oncology, Department of Internal Medicine, East Carolina University, Greenville, NC, USA.
The Ohio State University · USEast Carolina University · USSendai Kousei Hospital · JPNational Cancer Institute · USUniversity of Miami · USUniversity of Perugia · ITDana-Farber Cancer Institute · USUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmune-related adverse events (irAEs) comprise a distinct spectrum of auto-inflammatory manifestations triggered due to immune checkpoint inhibitors (ICI). Current data on the association of irAEs with outcomes in NSCLC treated with nivolumab are limited. METHODS AND

objectivesWe pooled data from 531 metastatic NSCLC patients from five centers treated with nivolumab after failing platinum-based chemotherapy. The primary objective was to investigate the relationship between irAEs with clinical benefit to nivolumab as well as to elucidate patterns of irAE-related ICI discontinuations and their impact on survival.

results33.0% (173/531) of patients treated with nivolumab were noted to have an irAE. Patients with irAEs had a significantly longer median PFS [6.1 vs. 3.1 months, HR 0.68 95% CI (0.55-0.85); p = 0.001] and OS [14.9 vs. 7.4 months, HR 0.66 95% CI (0.52-0.82); p < 0.001)] compared to those without irAEs. In multivariate analysis, the presence of irAEs showed a significantly better PFS [HR 0.69, 95% CI (0.55-0.87); p = 0.002] and a trend for better OS [HR 0.62, 95% CI (0.55-1.03); p = 0.057]. Patients with permanent ICI discontinuation secondary to index irAE had a significantly shorter median PFS [2.3 vs. 6.6 months, HR 1.74 95% CI (1.06-2.80); p = 0.02] and median OS [3.6 vs. 17.6 months; HR 2.61 95% CI (1.61-4.21); p < 0.001] compared to those that did not have permanent ICI discontinuation.

conclusionsOur pooled exploratory analysis demonstrates improved clinical benefit to nivolumab in NSCLC patients experiencing irAEs. We also observed negative impact of irAE-related treatment discontinuation on survival in this group of patients.

Indexed as

AgedAntineoplastic Agents, ImmunologicalCarcinoma, Non-Small-Cell LungDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMeta-Analysis as TopicNivolumabPrognosisRetrospective StudiesSurvival RateWithholding TreatmentAntineoplastic Agents, ImmunologicalNivolumabICI discontinuationImmune checkpoint inhibitionImmune-related adverse eventsNivolumabPneumonitis

Identifiers

PMID32140762
PMCPMC11027623
OpenAlexW3009082159

What OpenQuestion holds

Textmetadata
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.