Nivolumab plus ipilimumab in melanoma patients with asymptomatic brain metastases: 7-year outcomes and quality of life from the multicenter phase III NIBIT-M2 trial.
Eur J Cancer
; 199: 113531, 2024 Mar.
Article
em En
| MEDLINE
| ID: mdl-38271746
ABSTRACT
BACKGROUND:
The primary analysis of the phase III NIBIT-M2 study showed a 41% 4-year overall survival (OS) of melanoma patients with asymptomatic brain metastases treated with ipilimumab plus nivolumab.METHODS:
Here, we report the 7-year efficacy outcomes and the Health-Related Quality of Life (HRQoL) analyses of the NIBIT-M2 study.RESULTS:
As of May 1, 2023, at a median follow-up of 67 months (mo), the median OS was 8.5 (95% CI 6.6-10.3), 8.2 (95% CI 2.1-14.3) and 29.2 (95% CI 0-69.9) mo for the fotemustine (F) Arm A, ipilimumab plus fotemustine Arm B, and ipilimumab plus nivolumab Arm C, respectively. The 7-year OS rate was 10.0% (95% CI 0-22.5) in Arm A, 10.3% (95% CI 0-22.6) in Arm B, and 42.8% (95% CI 23.4-62.2) in Arm C. HRQoL was preserved in all treatment arms. Most functional scales evaluated from baseline to W12 were preserved, with a lower mean score decrease for EORTC Quality of Life Questionnaire (QLQ)-C30 and an increase for EORTC QLQ-Brain neoplasm (BN20) in patients receiving ipilimumab plus nivolumab.CONCLUSIONS:
With the longest follow-up available to date in melanoma patients with asymptomatic brain metastases, the NIBIT-M2 study continues to show persistent therapeutic efficacy of I ipilimumab plus nivolumab while preserving HRQoL.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Compostos Organofosforados
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Neoplasias Encefálicas
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Melanoma
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Compostos de Nitrosoureia
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Revista:
Eur J Cancer
Ano de publicação:
2024
Tipo de documento:
Article