Evidence map›Paper›PMID 39717261›Full record

ArticleEClinicalMedicine2024

When to stop immunotherapy for advanced melanoma: the emulated target trials.

Mathilde Amiot, Laurent Mortier, Stéphane Dalle, Olivier Dereure, Sophie Dalac, Caroline Dutriaux, Marie-Thérèse Leccia, Eve Maubec, Jean-Philippe Arnault, Florence Brunet-Possenti and 13 more

Abstract read
In one paragraph

Article in EClinicalMedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

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

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

23 authors.

Mathilde AmiotAP-HP Dermato-oncology, Cancer Institute APHP Nord Paris Cité, Saint Louis Hospital, Paris, France.
Laurent MortierDermatology Department, University of Lille, ONCO-THAI INSERM, Lille U1189, France.
Stéphane DalleHospices Civils De Lyon, Cancer Research Center of Lyon, Université Claude Bernard Lyon 1, Immucare, Pierre-Bénite, France.
Olivier DereureDermatology Department, University Hospital of Montpellier, Montpellier, France.
Sophie DalacDermatology Department, University Hospital of Dijon, Dijon, France.
Caroline DutriauxDermatology Department, Bordeaux Hospital, Bordeaux, France.
Marie-Thérèse LecciaDermatology Department, University of Grenoble, Grenoble, France.
Eve MaubecAP-HP, Dermatology Department, Hôpital Avicenne, Bobigny, France.
Jean-Philippe ArnaultDermatology Department, CHU Amiens, Amiens, France.
Florence Brunet-PossentiAP-HP, Dermatology, Bichat Hospital, Paris, France.
Julie De QuatrebarbesDermatology Department, CHR Annecy Genevois, Annecy, France.
Florence Granel-BrocardDermatology Department, CHRU Nancy, Vandoeuvre-Les-Nancy, France.
Caroline Gaudy-MarquesteDermatology Department, AP-HM Hopital de la Timone, Marseille, France.
Cecile PagesUniversity Cancer Institute - Oncopole Department of Onco-Dermatology, Toulouse, France.
Pierre-Emmanuel StoebnerDermatology Department, CHU de Nimes, Nîmes, France.
Philippe SaiagAP-HP Dermatology, Ambroise Paré Hospital, EA4340, Paris-Saclay University, Boulogne-Billancourt, France.
Thierry LesimpleEugène Marquis Center, Department of Medical Oncology, Rennes, France.
Alain DupuyDermatology Department, Rennes Hospital, Rennes, France.
Delphine LegoupilDermatology Department, CHU Brest, Brest, France.
Henri MontaudiéDermatology Department, University Hospital of Nice, Nice, France.
Bastien OrianoAP-HP Dermato-oncology, Cancer Institute APHP Nord Paris Cité, Saint Louis Hospital, Paris, France.
Celeste LebbeUniversité Paris Cite, AP-HP Dermato-Oncology, Cancer Institute APHP Nord Paris Cité, INSERM U976, Saint Louis Hospital, Paris, France.
Raphael PorcherAP-HP Hotel-Dieu Hospital, Centre de Recherche épidémiologie et Statistiques (CRESS-UMR1153), Centre d'épidémiologie Clinique, Inserm / Université Paris Cité / AP-HP, Centre Virchow-Villermé, Centre Equator France, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Immune checkpoint inhibitors (ICIs) have demonstrated their efficacy with a 7.5-year overall survival (OS) close to 50% for advanced stages. The design of clinical trials provides for treatment until progression or toxicity, or for a maximum duration of two years. Prolonged follow-up of responders after treatment cessation shows sustained response and a low risk of relapse in the months following cessation. To date, the optimal duration of anti-PD-1 therapy for metastatic melanoma remains unestablished. The objective of this work was to evaluate the optimal duration of ICI administration. Methods: We emulated target trials using the cloning, weighting and censoring approach. Each emulation trial aimed to compare the effect of discontinuing versus continuing ICIs at a specific timepoint, among patients still under treatment and with disease control at that time. Patients were from MelBase between 2015 and 2021. Findings: 435 participants in the MelBase cohort were eligible and were included in the 6-month discontinuation emulated trial. The results showed significantly lower OS when treatment was discontinued, than when treatment was prolonged for at least three months. The 48-month survival difference was 37.8% (95% confidence interval [CI] 19.8-60.5), and the corresponding restricted mean survival time difference was 8.3 months (95% CI: 4.1-12.7). Neither the 12-month nor the 18-month discontinuation emulated trials showed evidence of benefit of either discontinuing or continuing ICIs at either of these timepoints. The 24-month discontinuation emulated trial results were more in favor of discontinuing than continuing treatment at that time point, with an absolute 48-month survival rate that was 10.5% higher (95% CI 4.4-18.1). Interpretation: These results suggest that a one-year course of immunotherapy is both necessary and sufficient for patients with advanced melanoma. Prolonged treatment beyond 2 years does not appear to be beneficial in terms of survival and could even be detrimental. Funding: This work was supported by a grant from Bristol Myers Squibb, Merck Sharp Dhome, Pierre Fabre, Novartis, Sun Pharm, Regeneron, Sanofi, Nektar, Therapeutics and Oncyte.

Indexed as

Advanced melanomaDuration of treatmentEmulated trialImmunotherapy

Identifiers

PMID39717261
PMCPMC11664069

What Socratic 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 Socratic graph.