Patient-reported outcomes with adjuvant nivolumab versus placebo after complete resection of stage IIB/C melanoma in the randomized phase 3 CheckMate 76K trial
Mené sur des patients atteints d’un mélanome réséqué de stade IIB/C, cet essai randomisé de phase III évalue l'intérêt, du point de vue de la qualité de vie déclarée par les patients entre l’inclusion et la semaine 53, d'un traitement adjuvant par nivolumab
Background: In the phase 3 CheckMate 76K trial, adjuvant nivolumab significantly improved recurrence-free survival and distant metastasis-free survival versus placebo in patients with resected stage IIB/C melanoma. We report patient-reported outcomes from CheckMate 76K.
Methods: Change from baseline to week 53 in health-related quality of life (HRQoL), as measured using the EORTC QLQ-C30 and EQ-5D-5L utility index and visual analog scale (VAS), was compared between treatment groups using linear mixed-effect models. Time to confirmed deterioration (TTCD) in HRQoL was assessed using Cox regression. Bother from side effects, as measured by the FACIT-GP5, was descriptively compared between treatment groups.
Results: There were no clinically meaningful differences in change from baseline between treatment groups in EORTC QLQ-C30 subscales, including global health status (GHS)/quality of life (QoL; least squares mean [LSM] difference: −1.3; 95% confidence interval [CI]: −2.9, 0.4), and EQ-5D-5L utility index (LSM difference: −0.011; 95% CI: −0.025, 0.004) and VAS (LSM difference: −1.3; 95% CI: −2.6, 0.0). There was no difference in TTCD for nivolumab versus placebo in EORTC QLQ-C30 GHS/QoL (hazard ratio [HR]: 1.10; 95% CI: 0.88, 1.36) or EQ-5D-5L utility index (HR: 1.10; 95% CI: 0.86, 1.42); however, TTCD in EQ-5D-5L VAS was longer with placebo (HR: 1.92; 95% CI: 1.39, 2.64). Proportions of patients reporting severe side effect bother (“quite a bit”/“very much”) were minimal (nivolumab: 1%–4%; placebo: 0%–2%).
Conclusions: Patients with resected stage IIB/C melanoma treated with adjuvant nivolumab demonstrated stable HRQoL and minimal bother from side effects.