The Relationship Between Health-Related Quality of Life and Overall Survival in Patients With Advanced Renal Cell Carcinoma in CheckMate 214.
Oncologist
; 29(6): 511-518, 2024 Jun 03.
Article
en En
| MEDLINE
| ID: mdl-38280218
ABSTRACT
BACKGROUND:
In CheckMate 214 (median follow-up, 25.2 months), nivolumab plus ipilimumab yielded greater overall survival (OS) benefit than sunitinib in patients with intermediate-/poor-risk advanced renal cell carcinoma (aRCC). Health-related quality of life (HRQoL) assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19) was also more favorable for the nivolumab plus ipilimumab group than the sunitinib group. We investigated whether HRQoL scores can predict OS of patients with 5 years follow-up in CheckMate 214. PATIENTS ANDMETHODS:
CheckMate 214 was an open-label, phase III trial in previously untreated aRCC (Nâ =â 1096). Patients with intermediate-/poor-risk disease (International mRCC Database Consortium prognostic scoreâ ≥â 1; nâ =â 847) were randomized to either nivolumab plus ipilimumab or sunitinib monotherapy. Pooled data for OS and FKSI-19 total and subscales (disease-related symptoms [DRS], DRS-physical [DRS-P], and function/well-being [FWB]) were analyzed. Relationships between HRQoL and OS were assessed using Cox proportional hazard models with baseline and longitudinal scores. Associations between HRQoL changes and OS were assessed by landmark analyses.RESULTS:
Patients with higher FKSI-19 total and subscale scores at baseline had longer OS than patients with lower scores (HRâ ≤â 0.834; Pâ <â .0001). Longitudinal models indicated stronger associations between HRQoL and OS (HRâ ≤â 0.69; Pâ <â .001 for each). At 3 months after randomization, patients with stable/improved HRQoL versus baseline had longer median OS than patients with worsened/unobserved HRQoL versus baseline (55.9 and 26.0 months, respectively; HRâ =â 0.56; 95% CI, 0.46-0.67; Pâ <â .0001). Results at 6-, 9-, and 12-month landmarks were consistent with these findings.CONCLUSION:
In aRCC, patient-reported outcomes are important for HRQoL and prognostic evaluation. CLINICALTRIALS.GOV IDENTIFIER NCT02231749; https//clinicaltrials.gov/ct2/show/NCT02231749.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Calidad de Vida
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Carcinoma de Células Renales
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Neoplasias Renales
Tipo de estudio:
Clinical_trials
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Prognostic_studies
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Oncologist
Asunto de la revista:
NEOPLASIAS
Año:
2024
Tipo del documento:
Article
País de afiliación:
Estados Unidos