1. Effectiveness and safety of nivolumab in patients with advanced melanoma: A multicenter, observational study
- Author
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Stéphane Dalle, Patrick Combemale, Yannick Le Corre, Caroline Dutriaux, E. Varey, Nathalie Beneton, Thomas Jouary, Caroline Robert, Henri Montaudié, Jean Philippe Arnault, Sandrine Monestier, Marie Thérèse Leccia, Sandrine Mansard, Laurent Mortier, Amir Khammari, Anne-Bénédicte Duval Modeste, François Skowron, Nicolas Meyer, Brigitte Dréno, Nabahet Ameur, Bernard Guillot, Philippe Saiag, E. Hainaut, Sophie Dalac-Rat, Service de dermatologie, vénéreologie et cancérologie cutanée [Hôpital de la Timone - APHM], Hôpital de la Timone [CHU - APHM] (TIMONE)-Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Thérapies Laser Assistées par l'Image pour l'Oncologie - U 1189 (ONCO-THAI), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, CHU Bordeaux [Bordeaux], Service de Dermatologie (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire [Grenoble] (CHU), CHU Clermont-Ferrand, Hôpital Archet 2 [Nice] (CHU), Biomarqueurs et essais cliniques en Cancérologie et Onco-Hématologie (BECCOH), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay, Hôpital Ambroise Paré [AP-HP], Centre Léon Bérard [Lyon], CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Charles Nicolle [Rouen], Centre Hospitalier Le Mans (CH Le Mans), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR), Service de dermatologie [CHU d'Amiens-Picardie], CHU Amiens-Picardie, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre hospitalier de Pau, Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), Amgen Bristol-Myers Squibb, BMS Pfizer Novartis Roche AbbVie Les Laboratories Pierre Fabre LEO Pharma Research Foundation, Sandrine Monestier has received consultant fees from BMS and Roche, support for travel/congress from BMS, Roche, GSK and MSD, and has participated as an investigator on clinical trials for BMS, Roche‐ Genentech, GSK, Amgen, Novartis, MSD, Merck‐Serono and Astra Zeneca. Stéphane Dalle has received congress invitation and fees coverage from BMS, Pierre Fabre and MSD, translational study grant to institution from BMS and MSD. Laurent Mortier received support to travel to medical congresses from BMS, MSD, Roche and Novartis. Caroline Dutriaux has been a member of advisory boards and received consultancy fees from BMS, MSD, Pierre Fabre and Novartis. Sophie Dalac‐Rat has received honoraria, provided consultancy and been on advisory committees for BMS, MSD, Novartis and Sun pharma. Nicolas Meyer has received honoraria from Sun Pharma, Roche, Novartis and Pierre Fabre, research funding from BMS, MSD, provided consultancy to BMS, MSD, Roche, Novartis and Pierre Fabre, been on advisory committees for Amgen, Incyte, BMS, MSD, Roche, Novartis and Pierre Fabre. Sandrine Mansard has worked on advisory boards for BMS and Novartis, has received congress and travel fees from BMS and Pierre Fabre. Henri Montaudié has worked on advisory boards for BMS, MSD, Pierre Fabre and Novartis, provided consultancy to MSD and Pierre Fabre, received honoraria from BMS, MSD, Pierre Fabre and Novartis, received research funding from BMS and Leo Pharma. Philippe Saiag has received personal fees from Amgen, Bristol‐Myers Squibb, MSD, Merck‐Serono, Pfizer, Roche‐Genentech, Pierre Fabre and Novartis, received nonfinancial support from Bristol‐Myers Squibb, MSD, Roche‐Genentech and Novartis, received a funding grant from Roche‐Genentech. Patrick Combemale has worked on advisory committees for Roche, Pierre Fabre and AstraZenecca. Ewa Hainaut has been a speaker for BMS, Novartis and Sanofi, worked on advisory boards for Novartis and Sanofi, received research funding from Abbvie. Caroline Robert has received consultancy fees from BMS, MSD, Roche, Novartis, Sanofi, Pierre Fabre and Amgen. Yannick Le Corre has provided consultancy to BMS, MSD and Novartis, worked on advisory boards for BMS, MSD, Novartis and Pierre Fabre, received congress invitation from BMS, MSD and Novartis, has received honoraria from BMS. Nabahet Ameur is employee of Bristol‐Myers‐Squibb. Brigitte Dréno has received research funding from Amgen, BMS, Novartis and Roche, provided consultancy to BMS and Roche, worked on advisory boards for BMS, Roche and Pierre Fabre. Jean Philippe Arnault has been a speaker for BMS. Marie Thérèse Leccia, Bernard Guillot, François Skowron, Anne‐Bénédicte Duval Modeste, Nathalie Bénéton, Thomas Jouary, Emilie Varey, and Amir Khammari have no conflicts of interest to declare., Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Rouen, Normandie Université (NU)-Normandie Université (NU), HAL UVSQ, Équipe, and Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)
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Male ,advanced melanoma ,safety ,Cancer Research ,medicine.medical_specialty ,real-world ,Databases, Factual ,effectiveness ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,03 medical and health sciences ,0302 clinical medicine ,Antineoplastic Agents, Immunological ,[SDV.CAN] Life Sciences [q-bio]/Cancer ,Internal medicine ,medicine ,Humans ,In patient ,Adverse effect ,Melanoma ,Advanced melanoma ,Aged ,Retrospective Studies ,Aged, 80 and over ,nivolumab ,business.industry ,Incidence (epidemiology) ,Retrospective cohort study ,Middle Aged ,Survival Analysis ,3. Good health ,Clinical trial ,Treatment Outcome ,Oncology ,030220 oncology & carcinogenesis ,Observational study ,France ,Nivolumab ,business - Abstract
International audience; 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.
- Published
- 2021