Effectiveness and Safety of Nivolumab in Patients with Advanced Melanoma: A Multicenter, Observational Study.

Fiche publication


Date publication

janvier 2021

Journal

International journal of cancer

Auteurs

Membres identifiés du Cancéropôle Est :
Dr DALAC Sophie


Tous les auteurs :
Monestier S, Dalle S, Mortier L, Dutriaux C, Dalac-Rat S, Meyer N, Leccia MT, Mansard S, Montaudié H, Saiag P, Combemale P, Guillot B, Skowron F, Modeste AD, Bénéton N, Hainaut E, Robert C, Arnault JP, Le Corre Y, Jouary T, Ameur N, Varey E, Khammari A, Dréno B,

Résumé

This retrospective, observational study aimed to determine the effectiveness, safety, and patterns of use of nivolumab in patients with advanced melanoma in real-world clinical practice in France using data from a Temporary Authorization for Use Program (ATU). Data were collected from patients with unresectable or metastatic melanoma enrolled in a French national database (Réseau pour la Recherche et l'Investigation Clinique sur le Mélanome: Ric-Mel) and treated with nivolumab during the ATU program (September 12, 2014 to August 31, 2015). The primary objectives of the study were to evaluate the effect of patient characteristics on clinical response and overall survival (OS). Among 400 included patients (median age 66 years), the majority (83%) received nivolumab as second- or subsequent-line therapy. The median durations of progression-free survival and OS were 3.3 and 14.1 months, respectively, and 31.6% of patients achieved an objective response with a median duration of 20.1 months (range 0-34.7). The safety profile of nivolumab was manageable and consistent with those of previous clinical trials, with an incidence of grade 3-5 adverse events of 13.8%. The safety and effectiveness of nivolumab in patients with advanced melanoma in real-world clinical practice in France were in line with the data reported in the phase 3 trials CheckMate 066 and 037 of nivolumab in this patient population. This article is protected by copyright. All rights reserved.

Mots clés

advanced melanoma, effectiveness, nivolumab, real-world, safety

Référence

Int J Cancer. 2021 Jan 11;: