Abstract：
Aim: To evaluate health-related quality of life (HRQoL) in cemiplimab-treated patients with locally advanced basal cell carcinoma (laBCC).Materials & methods: Eighty-four patients with laBCC received cemiplimab 350 mg every 3 weeks (up to 9 cycles). HRQoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (QLQ-C30) and Skindex-16 questionnaires at baseline and each cycle. Mixed-effects repeated-measures models evaluated change from baseline across cycles.Results: Clinically meaningful improvement or maintenance was reported by 62-90% of patients on QLQ-C30 scales and by approximately 80% on Skindex-16 scales at Cycle 2, with consistent results at Cycle 9 except fatigue.Conclusion: Most cemiplimab-treated patients with laBCC reported improvement or maintenance of HRQoL with low symptom burden except fatigue.Clinical Trial Registration: ClinicalTrials.gov identifier NCT03132636, registered 28 April 2017.
Locally advanced basal cell carcinoma (laBCC) is a type of skin cancer that has the potential to invade surrounding tissues including bone, cartilage, nerve and muscle. Cemiplimab-rwlc is approved in the US for patients with laBCC following a therapy called hedgehog inhibitor (HHI) treatment or for whom HHIs are not appropriate. In a Phase II clinical trial, intravenous (in the vein) cemiplimab 350 mg every 3 weeks for up to nine treatment cycles resulted in clinically meaningful antitumor activity in patients with laBCC who progressed on or were intolerant to HHIs.This analysis evaluated health-related quality of life, symptom burden, emotions and functional status in these patients using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (QLQ-C30) and Skindex-16 questionnaires. Baseline scores (scores at the start of the clinical trial) showed moderate to high levels of functioning and low symptom burden that, except for fatigue, were maintained or improved over the course of cemiplimab treatment. These results show that despite the presence of fatigue, health-related quality of life and functional status were maintained with cemiplimab across the study duration.
Locally advanced basal cell carcinoma (laBCC) is a type of skin cancer that has the potential to invade surrounding tissues including bone, cartilage, nerve and muscle. Cemiplimab-rwlc is approved in the US for patients with laBCC following a therapy called hedgehog inhibitor (HHI) treatment or for whom HHIs are not appropriate. In a Phase II clinical trial, intravenous (in the vein) cemiplimab 350 mg every 3 weeks for up to nine treatment cycles resulted in clinically meaningful antitumor activity in patients with laBCC who progressed on or were intolerant to HHIs.This analysis evaluated health-related quality of life, symptom burden, emotions and functional status in these patients using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (QLQ-C30) and Skindex-16 questionnaires. Baseline scores (scores at the start of the clinical trial) showed moderate to high levels of functioning and low symptom burden that, except for fatigue, were maintained or improved over the course of cemiplimab treatment. These results show that despite the presence of fatigue, health-related quality of life and functional status were maintained with cemiplimab across the study duration.
摘要：
目的：评估cemiplimab治疗的局部晚期基底细胞癌（laBCC）患者的健康相关生活质量（HRQoL）。材料与方法：84例laBCC患者每3周接受cemiplimab350mg（最多9个周期）。在基线和每个周期使用欧洲癌症研究和治疗组织核心生活质量30（QLQ-C30）和Skindex-16问卷评估HRQoL。混合效应重复测量模型评估了跨周期的基线变化。结果：在第2周期，62-90％的患者在QLQ-C30量表上报告有临床意义的改善或维持，在Skindex-16量表上报告了约80％，在第9周期，除疲劳外，结果一致。结论：大多数接受cemiplimab治疗的laBCC患者报告HRQoL改善或维持，除疲劳外，症状负担低。临床试验注册：ClinicalTrials.gov标识符NCT03132636，注册于2017年4月28日。
局部晚期基底细胞癌（laBCC）是一种皮肤癌，有可能侵入包括骨骼在内的周围组织，软骨，神经和肌肉Cemiplimab-rwlc在美国被批准用于在称为hedgehog抑制剂（HHI）治疗或HHI不适合的治疗后患有laBCC的患者。在一项II期临床试验中,每3周静脉(静脉内)cemiplimab350mg,最多9个治疗周期,在对HHIs进展或不耐受的laBCC患者中产生了有临床意义的抗肿瘤活性.这项分析评估了与健康相关的生活质量，症状负担，使用欧洲癌症研究与治疗组织生活质量核心30（QLQ-C30）和Skindex-16问卷对这些患者的情绪和功能状态进行调查。基线评分（临床试验开始时的评分）显示中等至高水平的功能和较低的症状负担，除了疲劳,在cemiplimab治疗过程中保持或改善。这些结果表明，尽管存在疲劳，在整个研究期间,使用cemiplimab维持与健康相关的生活质量和功能状态.
局部晚期基底细胞癌（laBCC）是一种皮肤癌，有可能侵入包括骨骼在内的周围组织，软骨，神经和肌肉Cemiplimab-rwlc在美国被批准用于在称为hedgehog抑制剂（HHI）治疗或HHI不适合的治疗后患有laBCC的患者。在一项II期临床试验中,每3周静脉(静脉内)cemiplimab350mg,最多9个治疗周期,在对HHIs进展或不耐受的laBCC患者中产生了有临床意义的抗肿瘤活性.这项分析评估了与健康相关的生活质量，症状负担，使用欧洲癌症研究与治疗组织生活质量核心30（QLQ-C30）和Skindex-16问卷对这些患者的情绪和功能状态进行调查。基线评分（临床试验开始时的评分）显示中等至高水平的功能和较低的症状负担，除了疲劳,在cemiplimab治疗过程中保持或改善。这些结果表明，尽管存在疲劳，在整个研究期间,使用cemiplimab维持与健康相关的生活质量和功能状态.
