Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival
Jazyk angličtina Země Velká Británie, Anglie Médium print
Typ dokumentu časopisecké články, práce podpořená grantem
PubMed
34452930
PubMed Central
PMC8404438
DOI
10.1136/jitc-2021-003188
PII: jitc-2021-003188
Knihovny.cz E-zdroje
- Klíčová slova
- adjuvants, immunologic, immunotherapy, melanoma, programmed cell death 1 receptor,
- MeSH
- inhibitory kontrolních bodů farmakologie terapeutické užití MeSH
- lidé MeSH
- melanom farmakoterapie mortalita MeSH
- nivolumab farmakologie terapeutické užití MeSH
- přežití bez známek nemoci MeSH
- senioři MeSH
- staging nádorů MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- inhibitory kontrolních bodů MeSH
- nivolumab MeSH
BACKGROUND: Several therapeutic options are now available in the adjuvant melanoma setting, mandating an understanding of their benefit‒risk profiles in order to make informed treatment decisions. Herein we characterize adjuvant nivolumab select (immune-related) treatment-related adverse events (TRAEs) and evaluate possible associations between safety and recurrence-free survival (RFS) in the phase III CheckMate 238 trial. METHODS: Patients with resected stage IIIB-C or IV melanoma received nivolumab 3 mg/kg every 2 weeks (n=452) or ipilimumab 10 mg/kg every 3 weeks for four doses and then every 12 weeks (n=453) for up to 1 year or until disease recurrence, unacceptable toxicity, or consent withdrawal. First-occurrence and all-occurrence select TRAEs were analyzed within discrete time intervals: from 0 to 3 months of treatment, from >3-12 months of treatment, and from the last dose (regardless of early or per-protocol treatment discontinuation) to 100 days after the last dose. Possible associations between select TRAEs and RFS were investigated post randomization in 3-month landmark analyses and in Cox model analyses (including a time-varying covariate of select TRAE), within and between treatment groups. RESULTS: From the first nivolumab dose to 100 days after the last dose, first-occurrence select TRAEs were reported in 67.7% (306/452) of patients. First-occurrence select TRAEs were reported most frequently from 0 to 3 months (48.0%), during which the most common were pruritus (15.5%) and diarrhea (15.3%). Most select TRAEs resolved within 6 months. There was no clear association between the occurrence (or not) of select TRAEs and RFS by landmark analysis or by Cox model analysis within treatment arms or comparing nivolumab to the ipilimumab comparator arm. CONCLUSION: Results of this safety analysis of nivolumab in adjuvant melanoma were consistent with its established safety profile. In the discrete time intervals evaluated, most first-occurrence TRAEs occurred early during treatment and resolved. No association between RFS and select TRAEs was evident. TRIAL REGISTRATION NUMBER: NCT02388906.
Aix Marseille University APHM Hospital Marseille France
Bristol Myers Squibb Princeton New Jersey USA
Center for Immuno Oncology University Hospital of Siena Siena Italy
Clinical Oncology Department Hospital Universitario Virgen Macarena Sevilla Spain
Department of Cutaneous Oncology Moffitt Cancer Center Tampa Florida USA
Department of Medicine Universidad de Sevilla Sevilla Spain
Gallipoli Medical Research Foundation and University of Queensland Brisbane Queensland Australia
General University Hospital Gregorio Marañón CIBERONC Madrid Spain
Hospices Civils de Lyon Pierre Bénite France
Hospital Clínic de Barcelona Barcelona Spain
Istituto Nazionale Tumori IRCCS Fondazione Pascale Napoli Italy
Oncology Center Sf Nectarie Ltd Craiova Romania
Oncology Mount Sinai Medical Center Miami Beach Florida USA
Perlmutter Cancer Center NYU Langone Health New York New York USA
Princess Margaret Hospital Cancer Centre Toronto Ontario Canada
Rogel Cancer Center University of Michigan Ann Arbor Michigan USA
Royal Marsden NHS Foundation Trust London UK
Sir Charles Gairdner Hospital University of Western Australia Perth Western Australia Australia
Tasman Oncology Research Ltd Southport Queensland Australia
Texas Oncology Baylor Charles A Sammons Cancer Center Dallas Texas USA
Unit of Medical Oncology University of Perugia Perugia Italy
Unit of Melanoma Medical Oncology Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy
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ClinicalTrials.gov
NCT02388906