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Effectiveness and safety of nivolumab in patients with advanced melanoma: A multicenter, observational study
- Source :
- International Journal of Cancer, International Journal of Cancer, Wiley, 2021, 148 (11), pp.2789-2798. ⟨10.1002/ijc.33467⟩, International Journal of Cancer, 2021, 148 (11), pp.2789-2798. ⟨10.1002/ijc.33467⟩
- Publication Year :
- 2021
- Publisher :
- HAL CCSD, 2021.
-
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.
- Subjects :
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 00207136 and 10970215
- Database :
- OpenAIRE
- Journal :
- International Journal of Cancer, International Journal of Cancer, Wiley, 2021, 148 (11), pp.2789-2798. ⟨10.1002/ijc.33467⟩, International Journal of Cancer, 2021, 148 (11), pp.2789-2798. ⟨10.1002/ijc.33467⟩
- Accession number :
- edsair.doi.dedup.....14f417395eb026535a482cd67ec9bacb