Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC).
Clin Lung Cancer
; 22(4): 301-312.e8, 2021 07.
Article
em En
| MEDLINE
| ID: mdl-33775558
ABSTRACT
BACKGROUND:
The phase 3 MYSTIC study of durvalumab ± tremelimumab versus chemotherapy in metastatic non-small-cell lung cancer (NSCLC) patients with tumor cell (TC) programmed cell death ligand 1 (PD-L1) expression ≥ 25% did not meet its primary endpoints. We report patient-reported outcomes (PROs). PATIENTS ANDMETHODS:
Treatment-naïve patients were randomized (111) to durvalumab, durvalumabâ¯+â¯tremelimumab, or chemotherapy. PROs were assessed in patients with PD-L1 TC ≥ 25% using EORTC Quality of Life Questionnaire (QLQ)-C30/LC13. Changes from baseline (12 months) for prespecified PRO endpoints of interest were analyzed by mixed model for repeated measures (MMRM) and time to deterioration (TTD) by stratified log-rank tests.RESULTS:
There were no between-arm differences in baseline PROs (Nâ¯=â¯488). Between-arm differences in MMRM-adjusted mean changes from baseline favored at least one of the durvalumab-containing arms versus chemotherapy (nominal P < .01) for C30 fatigue durvalumab (-9.5; 99% confidence interval [CI], -17.0 to -2.0), durvalumabâ¯+â¯tremelimumab (-11.7; 99% CI, -19.4 to -4.1); and for C30 appetite loss durvalumab (-11.9; 99% CI, -21.1 to -2.7). TTD was longer with at least one of the durvalumab-containing arms versus chemotherapy (nominal P < .01) for global health status/quality of life durvalumab (hazard ratio [HR]â¯=â¯0.7; 95% CI, 0.5-1.0), durvalumabâ¯+â¯tremelimumab (HRâ¯=â¯0.7; 95% CI, 0.5-1.0); and for physical functioning durvalumab (HRâ¯=â¯0.6; 95% CI, 0.4-0.8), durvalumabâ¯+â¯tremelimumab (HRâ¯=â¯0.6; 95% CI, 0.5-0.9) (both C30); as well as for the key symptoms of dyspnea durvalumab (HRâ¯=â¯0.6; 95% CI, 0.5-0.9), durvalumabâ¯+â¯tremelimumab (HRâ¯=â¯0.7; 95% CI, 0.5-1.0) (both LC13); fatigue durvalumabâ¯+â¯tremelimumab (HRâ¯=â¯0.6; 95% CI, 0.4-0.8); and appetite loss durvalumab (HRâ¯=â¯0.5; 95% CI, 0.4-0.7), durvalumabâ¯+â¯tremelimumab (HRâ¯=â¯0.7; 95% CI, 0.5-0.9) (both C30).CONCLUSION:
Durvalumab ± tremelimumab versus chemotherapy reduced symptom burden and improved TTD of PROs, suggesting it had no detrimental effects on quality of life in metastatic NSCLC patients.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Qualidade de Vida
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Protocolos de Quimioterapia Combinada Antineoplásica
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Carcinoma Pulmonar de Células não Pequenas
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Neoplasias Pulmonares
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article