Patient-reported outcomes with adjuvant nivolumab versus placebo after complete resection of stage IIB/C melanoma in the randomized phase 3 CheckMate 76 K trial

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer Pub Date : 2025-03-19 DOI:10.1016/j.ejca.2025.115371

John M. Kirkwood , Peter Mohr , Christoph Hoeller , Jean-Jacques Grob , Michele Del Vecchio , Jennifer Lord-Bessen , Swetha Srinivasan , Ayman Nassar , Federico Campigotto , Hannah Fairbanks , Fiona Taylor , Rachael Lawrance , Georgina V. Long , Jeffrey Weber

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引用次数: 0

Abstract

Background

In the phase 3 CheckMate 76 K 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 76 K.

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.

Clinical Trial Information

NCT04099251

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在随机3期CheckMate 76 K试验中，完全切除IIB/C期黑色素瘤后，患者报告的辅助nivolumab与安慰剂的结果

在3期CheckMate 76 K试验中，与安慰剂相比，辅助nivolumab显著提高了切除的IIB/C期黑色素瘤患者的无复发生存期和无远处转移生存期。我们报告CheckMate 76 K的患者报告结果。方法采用线性混合效应模型比较两组患者从基线至第53周健康相关生活质量（HRQoL）的变化，采用EORTC QLQ-C30和EQ-5D-5L效用指数和视觉模拟量表（VAS）测量。采用Cox回归评估HRQoL的恶化时间（TTCD）。由FACIT-GP5测量的副作用干扰，在治疗组之间进行描述性比较。结果EORTC QLQ-C30亚量表，包括总体健康状况(GHS)/生活质量（QoL）；最小二乘均值[LSM]差：−1.3；95 %置信区间[CI]:−2.9,0.4)，EQ-5D-5L效用指数(LSM差异：−0.011；95 % CI:−0.025,0.004)和VAS (LSM差：−1.3；95 % ci:−2.6,0.0)。在EORTC QLQ-C30 GHS/QoL方面，纳武单抗与安慰剂的TTCD没有差异(风险比[HR]: 1.10；95 % CI: 0.88, 1.36)或EQ-5D-5L效用指数(HR: 1.10；95 % ci: 0.86, 1.42)；然而，安慰剂组EQ-5D-5L VAS的TTCD更长(HR: 1.92；95 % ci: 1.39, 2.64)。报告严重副作用（“相当多”/“非常多”）的患者比例很小(纳武单抗：1 % -4 %；安慰剂:0 % 2 %)。结论nivolumab辅助治疗的IIB/C期黑色素瘤患者HRQoL稳定，副作用最小。临床试验信息nct04099251

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来源期刊

European Journal of Cancer 医学-肿瘤学

CiteScore

11.50

自引率

4.80%

发文量

953

审稿时长

23 days

期刊介绍： The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.