Evidence map›Paper›PMID 39209453›Full record

ArticleJournal for immunotherapy of cancer2024

Nivolumab maintenance improves overall survival of patients with advanced melanoma who experience severe immune-related adverse events on nivolumab plus ipilimumab.

Anna K Maloney, Anita Giobbie-Hurder, Nikita Katukota, Miklos C Fogarasi, Patrick A Ott, F Stephen Hodi, Tamara A Sussman, Ann W Silk, Rizwan Haq, David Liu and 2 more

Abstract read
In one paragraph

Article in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
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

12 authors.

Anna K MaloneyQuinnipiac University Frank H Netter MD School of Medicine, North Haven, Connecticut, USA.
Anita Giobbie-HurderDivision of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Nikita KatukotaDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Miklos C FogarasiQuinnipiac University Frank H Netter MD School of Medicine, North Haven, Connecticut, USA.
Patrick A OttDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.ORCID http://orcid.org/0000-0002-4253-943X
F Stephen HodiDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Tamara A SussmanDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.ORCID http://orcid.org/0000-0003-3429-4468
Ann W SilkDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.ORCID http://orcid.org/0000-0003-3877-3984
Rizwan HaqDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
David LiuDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Megan InscoDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Elizabeth I BuchbinderDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA elizabeth_buchbinder@dfci.harvard.edu.ORCID http://orcid.org/0000-0002-7979-8953

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe combination of ipilimumab and nivolumab is a highly effective treatment for metastatic cutaneous melanoma. However, immune-related adverse events (irAEs) are common, often necessitating treatment interruption and the use of immunosuppressive agents. There is no data on the impact of resuming nivolumab on survival following recovery from the irAE and completion of immunosuppressive treatment. PATIENTS AND

methodsIn this retrospective analysis, we examined a cohort of patients treated with ipilimumab/nivolumab who developed irAEs requiring treatment interruption and immunosuppressive therapy. The differences in physician practice patterns at our institution allowed us to examine the survival effect of restarting single-agent nivolumab. A multivariate analysis of clinical factors associated with improved survival was performed.

resultsWe identified 165 patients who were treated with ipilimumab/nivolumab and developed irAEs requiring treatment interruption and immunosuppressive therapy. Patients with the best overall response of progressive disease were excluded. Of the remaining 122 patients, 46 resumed single-agent nivolumab. When stratified by age and adjusted for sex, M-stage, lactate dehydrogenase (LDH), therapy duration, and irAE type, the effect of resumption of nivolumab on survival was highly significant (p=0.02). Patients who resumed nivolumab had a 68% reduction in the hazard of death compared with patients who had not yet or never resumed nivolumab (HR: 0.32, 95% CI: 0.12 to 0.84). Of the patients who resumed nivolumab, 12 (26%) patients had subsequent irAEs, with five patients having grade 3 irAEs. No grade 4 or 5 irAEs were noted.

conclusionsResuming single-agent nivolumab following a treatment interruption for ipilimumab/nivolumab-associated irAE and completion of immunosuppressive therapy increased overall survival compared with discontinuing nivolumab permanently in patients with metastatic melanoma. Toxicity observed post-resumption of single-agent nivolumab was manageable with no severe irAEs observed.

Indexed as

IpilimumabMelanomaNivolumabAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedRetrospective StudiesIpilimumabNivolumabImmunotherapyNivolumab

Identifiers

PMID39209453
PMCPMC11367326

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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.