Title :

Effectiveness and safety of nivolumab in patients with advanced melanoma: A multicenter, observational study

Author(s) :

Monestier, Sandrine [Auteur]
Dalle, Stéphane [Auteur]
Mortier, Laurent [Auteur]
Thérapies Laser Assistées par l'Image pour l'Oncologie - U 1189 [ONCO-THAI]
Dutriaux, Caroline [Auteur]
CHU Bordeaux [Bordeaux]
Dalac-Rat, Sophie [Auteur]
Service de Dermatologie (CHU de Dijon)
Meyer, Nicolas [Auteur]
Leccia, Marie Thérèse [Auteur]
Centre Hospitalier Universitaire [Grenoble] [CHU]
Mansard, Sandrine [Auteur]
Montaudié, Henri [Auteur]
Hôpital Archet 2 [Nice] [CHU]
Saiag, Phillippe [Auteur]
Biomarqueurs et essais cliniques en Cancérologie et Onco-Hématologie [BECCOH]
Hôpital Ambroise Paré [AP-HP]
Combemale, Patrick [Auteur]
Centre Léon Bérard [Lyon]
Guillot, Bernard [Auteur]
CHU Montpellier
Skowron, François [Auteur]
Duval Modeste, Anne Bénédicte [Auteur]
Bénéton, Nathalie [Auteur]
Centre Hospitalier Le Mans (CH Le Mans)
Hainaut, Ewa [Auteur]
Centre hospitalier universitaire de Poitiers [CHU Poitiers]
Robert, Caroline [Auteur]
Arnault, Jean Philippe [Auteur]
Service de dermatologie [CHU d'Amiens-Picardie]
Le Corre, Yannick [Auteur]
Centre Hospitalier Universitaire d'Angers [CHU Angers]
Jouary, Thomas [Auteur]
Centre hospitalier de Pau
Ameur, Nabahet [Auteur]
Varey, Emilie [Auteur]
Centre d’Investigation Clinique de Nantes [CIC Nantes]
Khammari, Amir [Auteur]
Centre d’Investigation Clinique de Nantes [CIC Nantes]
Dréno, Brigitte [Auteur correspondant]
Centre d’Investigation Clinique de Nantes [CIC Nantes]

Journal title :

International Journal of Cancer

Pages :

2789-2798

Publisher :

Wiley

Publication date :

2021

ISSN :

0020-7136

English keyword(s) :

advanced melanoma
effectiveness
nivolumab
real-world
safety

HAL domain(s) :

Sciences du Vivant [q-bio]/Cancer

English abstract : [en]

This retrospective observational study aimed to determine the effectiveness, safety and patterns of the use of nivolumab in patients with advanced melanoma in real-world clinical practice in France using data from a Temporary ...
Show more >This retrospective observational study aimed to determine the effectiveness, safety and patterns of the 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 (12 September 2014 to 31 August 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.Show less >

Language :

Anglais

Peer reviewed article :

Oui

Audience :

Internationale

Popular science :

Non

Collections :

• Thérapies Lasers Assistées par l'Image pour l'Oncologie (ONCO-THAI) - U1189

Source :

Harvested from HAL