Evidence map›Paper›PMID 37730272›Full record

Observational studyJournal for immunotherapy of cancer2023

Sex and anti-inflammatory treatment affect outcome of melanoma and non-small cell lung cancer patients with rheumatic immune-related adverse events.

Karolina Gente, Leonore Diekmann, Lea Daniello, Julia Will, Manuel Feisst, Victor Olsavszky, Janine Günther, Hanns-Martin Lorenz, M Margarida Souto-Carneiro, Jessica C Hassel and 2 more

Abstract readObservational StudyMulticenter Study
In one paragraph

Observational study in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

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

  1. Pooled it
  2. Review
  3. Article
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.

Karolina GenteDepartment of Internal Medicine V - Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany karolina.gente@med.uni-heidelberg.de.ORCID 0000-0003-4544-2753
Leonore DiekmannDepartment of Internal Medicine V - Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.
Lea DanielloDepartment of Thoracic Oncology, Thoraxklinik and National Center for Tumor Diseases (NCT) at University Hospital Heidelberg, Heidelberg, Germany.
Julia WillDepartment of Internal Medicine V - Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.
Manuel FeisstInstitute of Medical Biometry (IMBI), University Hospital Heidelberg, Heidelberg, Germany.
Victor OlsavszkyDepartment of Dermatology, University Medical Centre Mannheim, Mannheim, Germany.
Janine GüntherDepartment of Internal Medicine V - Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.
Hanns-Martin LorenzDepartment of Internal Medicine V - Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.
M Margarida Souto-CarneiroDepartment of Internal Medicine V - Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.
Jessica C HasselDepartment of Dermatology and National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.ORCID 0000-0001-7575-6230
Petros ChristopoulosDepartment of Thoracic Oncology, Thoraxklinik and National Center for Tumor Diseases (NCT) at University Hospital Heidelberg, Heidelberg, Germany.
Jan LeipeDepartment of Medicine V - Division of Rheumatology, University Medical Centre Mannheim, Mannheim, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRheumatic immune-related adverse events (R-irAEs) occur in 5-15% of patients receiving immune checkpoint inhibitors (ICI) and, unlike other irAEs, tend to be chronic. Herein, we investigate the factors influencing cancer and R-irAEs outcomes with particular focus on adverse effects of anti-inflammatory treatment.

methodsIn this prospective, multicenter, long-term, observational study, R-irAEs were comprehensively analyzed in patients with malignant melanoma (MM, n=50) and non-small cell lung cancer (NSCLC, n=41) receiving ICI therapy who were enrolled in the study between August 1, 2018, and December 11, 2022.

resultsAfter a median follow-up of 33 months, progressive disease or death occurred in 66.0% and 30.0% of MM and 63.4% and 39.0% of patients with NSCLC. Male sex (progression-free survival (PFS): p=0.013, and overall survival (OS): p=0.009), flare of a pre-existing condition (vs de novo R-irAE, PFS: p=0.010) and in trend maximum glucocorticoid (GC) doses >10 mg and particularly ≥1 mg/kg prednisolone equivalent (sex-adjusted PFS: p=0.056, OS: p=0.051) were associated with worse cancer outcomes. Patients receiving disease-modifying antirheumatic drugs (DMARDs) showed significantly longer PFS (n=14, p=0.011) and OS (n=20, p=0.018). Effects of these variables on PFS and/or OS persisted in adjusted Cox regression models. Additionally, GC treatment negatively correlated with the time from diagnosis of malignancy and the latency from ICI start until R-irAE onset (all p<0.05). R-irAE features and outcomes were independent of other baseline patient characteristics in both studied cancer entities.

conclusionMale sex, flare of pre-existing rheumatologic conditions and extensive GC treatment appeared to be linked with unfavorable cancer outcomes, while DMARD use had a favorable impact. These findings challenge the current dogma of restrictive DMARD use for R-irAE and thus may pave the way to better strategies and randomized controlled trials for the growing number of patients with R-irAE.

Indexed as

Antirheumatic AgentsCarcinoma, Non-Small-Cell LungLung NeoplasmsMelanomaAnti-Inflammatory AgentsGlucocorticoidsHumansMaleProspective StudiesAnti-Inflammatory AgentsAntirheumatic AgentsGlucocorticoidsImmune Checkpoint InhibitorsImmunotherapyMelanomaNon-Small Cell Lung Cancerrheumatic immune-related adverse event

Identifiers

PMID37730272
PMCPMC10510926

What OpenQuestion holds

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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.