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Effectiveness and safety of nivolumab in patients with advanced melanoma: A multicenter, observational study
Author(s) -
Monestier Sandrine,
Dalle Stéphane,
Mortier Laurent,
Dutriaux Caroline,
DalacRat Sophie,
Meyer Nicolas,
Leccia Marie Thérèse,
Mansard Sandrine,
Montaudié Henri,
Saiag Philippe,
Combemale Patrick,
Guillot Bernard,
Skowron François,
Duval Modeste AnneBénédicte,
Bénéton Nathalie,
Hainaut Ewa,
Robert Caroline,
Arnault Jean Philippe,
Le Corre Yannick,
Jouary Thomas,
Ameur Nabahet,
Varey Emilie,
Khammari Amir,
Dréno Brigitte
Publication year - 2021
Publication title -
international journal of cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.475
H-Index - 234
eISSN - 1097-0215
pISSN - 0020-7136
DOI - 10.1002/ijc.33467
Subject(s) - nivolumab , medicine , observational study , clinical trial , incidence (geometry) , adverse effect , population , melanoma , clinical practice , metastatic melanoma , oncology , surgery , cancer , physical therapy , immunotherapy , physics , environmental health , cancer research , optics
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.