Avelumab as second-line or later treatment in patients with metastatic Merkel cell carcinoma: Analysis of real-world outcomes in France using the CARADERM database linked to the French national healthcare database.

Avelumab CARADERM Immunotherapy Metastatic Merkel cell carcinoma Overall survival Progression-free survival SNDS Second line

Journal

European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373

Informations de publication

Date de publication:
03 Aug 2024
Historique:
received: 27 03 2024
revised: 10 07 2024
accepted: 31 07 2024
medline: 12 8 2024
pubmed: 12 8 2024
entrez: 11 8 2024
Statut: aheadofprint

Résumé

Avelumab has been approved worldwide for treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. This study evaluated outcomes in patients with mMCC in France who received avelumab as second-line or later (2L+) treatment in routine clinical practice. This retrospective, noninterventional study evaluated all patients diagnosed with mMCC using two databases: CARADERM (French national database of rare dermatological cancers) and SNDS (national healthcare database), identified via probabilistic linkage. Eligible patients initiated avelumab as 2L+ treatment between August 2016 and December 2019 and were followed for 24 months. The primary endpoint was overall survival (OS) at 24 months. Overall, 180 patients who received 2L+ avelumab were identified (112 from CARADERM, 68 after SNDS linkage). Median age at diagnosis was 74.0 years and 177 (98.3 %) had received chemotherapy alone as first-line treatment. Median follow-up was 13.1 months. Median OS from start of avelumab was 14.6 months (95 % CI, 9.9-21.3) in the overall population, 15.9 months (95 % CI, 8.6-28.3) in CARADERM patients, and 13.3 months (95 % CI, 6.7-19.1) in non-CARADERM patients. OS rates at 12 and 24 months were 53.8 % (95 % CI, 46.2 %-60.8 %) and 40.5 % (95 % CI, 33.2 %-47.6 %), respectively. In evaluable patients (CARADERM database), median progression-free survival was 3.6 months (95 % CI, 2.7-7.5) and the objective response rate was 55.3 % (95 % CI, 45.3-65.4), including complete response in 31.9 %. Real-world outcomes with 2L+ avelumab treatment for mMCC are consistent with clinical trial findings, supporting the recommendation of avelumab as a standard of care.

Identifiants

pubmed: 39128185
pii: S0959-8049(24)00917-1
doi: 10.1016/j.ejca.2024.114261
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

114261

Informations de copyright

Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests.

Auteurs

Laurent Mortier (L)

Lille University, INSERM U 1189, CHU de Lille, CARADERM network, Lille Cedex, France.

Astrid Blom (A)

CHU Ambroise-Paré, Boulogne-Billancourt, France. Electronic address: astrid.blom@aphp.fr.

Benoît van Hille (B)

Merck Santé S.A.S. an affiliate of Merck KGaA, Lyon, France.

Mahtab Samimi (M)

CHU de Tours, Hôpital Trousseau, Tours, France.

Laura Luciani (L)

Merck Santé S.A.S. an affiliate of Merck KGaA, Lyon, France.

Capucine Cahuzac (C)

Merck Santé S.A.S. an affiliate of Merck KGaA, Lyon, France.

Caroline Robert (C)

Gustave Roussy et Université Paris-Saclay Villejuif, France.

Gaelle Quereux (G)

CHU de Nantes, Hôpital Hôtel-Dieu, Nantes, France.

Eve Maubec (E)

AP-HP, Hôpital Avicenne et Université Sorbonne Paris Nord, Bobigny, France.

Hakima Miotti (H)

IQVIA Opérations France, La Défense Cedex, France.

Cathy Maillard (C)

IQVIA Opérations France, La Défense Cedex, France.

François Aubin (F)

CHU de Besançon, INSERM 1098 RIGHT, Besançon, France.

Cédric Lenormand (C)

Hôpitaux Universitaires de Strasbourg, Hôpital Civil, France.

Marie-Noëlle Solbes (MN)

Merck Santé S.A.S. an affiliate of Merck KGaA, Lyon, France.

Pascal Joly (P)

CHU de Rouen, Hôpital Charles-Nicolle, Rouen, France.

Isabelle Kachaner (I)

Pfizer, Paris, France.

Céleste Lebbé (C)

Université Paris Cite, AP-HP Dermato-oncology and CIC, Cancer institute APHP.nord Paris cité, INSERM U976, Saint Louis Hospital, Paris, France.

Caroline Dutriaux (C)

CHU de Bordeaux, Hôpital Saint-André, Bordeaux, France.

Philippe Saiag (P)

CHU Ambroise-Paré, Boulogne-Billancourt, France.

Classifications MeSH