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在一项 II 期临床试验中,接受西普单抗治疗的局部晚期基底细胞癌患者的生活质量。

Quality of life in cemiplimab-treated patients with locally advanced basal cell carcinoma in a Phase II clinical trial.

机构信息

National & Kapodistrian University of Athens, Andreas Sygros Hospital, Athens, 16121, Greece.

Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591, USA.

出版信息

Future Oncol. 2024;20(30):2249-2258. doi: 10.1080/14796694.2024.2358670. Epub 2024 Jul 29.

Abstract

To evaluate health-related quality of life (HRQoL) in cemiplimab-treated patients with locally advanced basal cell carcinoma (laBCC). 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. 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. Most cemiplimab-treated patients with laBCC reported improvement or maintenance of HRQoL with low symptom burden except fatigue. ClinicalTrials.gov identifier NCT03132636, registered 28 April 2017.

摘要

评估 cemiplimab 治疗局部晚期基底细胞癌(laBCC)患者的健康相关生活质量(HRQoL)。84 例 laBCC 患者接受 cemiplimab 350mg 每 3 周(最多 9 个周期)治疗。使用欧洲癌症研究和治疗组织生活质量核心 30 项(QLQ-C30)和 Skindex-16 问卷在基线和每个周期评估 HRQoL。混合效应重复测量模型评估了整个周期中从基线的变化。在第 2 周期,约 62-90%的患者在 QLQ-C30 量表上和约 80%在 Skindex-16 量表上报告了临床有意义的改善或维持,第 9 周期的结果一致,除了疲劳。大多数接受 cemiplimab 治疗的 laBCC 患者报告说,除了疲劳之外,他们的 HRQoL 得到了改善或维持,且症状负担较低。临床试验.gov 标识符 NCT03132636,于 2017 年 4 月 28 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad46/11508947/50a2cf7fbe90/IFON_A_2358670_F0001_C.jpg

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