Fondazione Policlinico Universitario Agostino Gemelli IRCCS, and Catholic University of Sacred Heart, Rome, Italy.
University of Milan-Bicocca, European Institute of Oncology IRCCS, Milan, Italy.
Eur J Cancer. 2023 Jun;186:172-184. doi: 10.1016/j.ejca.2023.03.015. Epub 2023 Mar 23.
Lenvatinib and pembrolizumab (LEN+PEMBRO) demonstrated clinically meaningful and statistically significant improvements in efficacy versus treatment of physician's choice (TPC) in patients with advanced endometrial cancer (aEC) in the phase 3 Study 309/KEYNOTE-775. Health-related quality-of-life (HRQoL) is reported.
Patients were randomly assigned to receive LEN+PEMBRO (n = 411; LEN 20 mg/day; PEMBRO 200 mg Q3W) or TPC (n = 416; doxorubicin 60 mg/m Q3W or paclitaxel 80 mg/m [weekly, 3 weeks on/1 week off]). Impact of treatment on HRQoL assessed by the global health status/quality of life (GHS/QoL) score of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) was a secondary objective; other scales of the Quality-of-Life Questionnaire (QLQ-C30), EORTC QLQ-Endometrial, 24 questions (EORTC QLQ-EN24), and EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) were exploratory objectives. HRQoL was assessed on day 1 of each cycle. Completion/compliance, change from baseline, time to first and definitive deterioration were assessed. No multiplicity adjustments were applied for HRQoL endpoints.
The latest timepoint at which the predefined rates of completion (≥60%) and compliance (≥80%) were met was week 12. HRQoL at week 12 between treatment groups was generally similar. Time to first deterioration symptom scales favoured LEN+PEMBRO for QLQ-C30 dyspnoea, and QLQ-EN24 for poor body image, tingling/numbness, and hair loss; and TPC was favoured for QLQ-C30 pain, appetite loss, and diarrhoea, and QLQ-EN24 muscular pain. While the QLQ-C30 physical functional scale favoured TPC, other functional scales were generally similar between arms. Time to definitive deterioration favoured LEN+PEMBRO on most scales.
HRQoL data from Study 309/KEYNOTE-775, with previously published efficacy and safety results, indicate that LEN+PEMBRO has an overall favourable benefit/risk profile versus TPC for the treatment of patients with aEC.
GOV: NCT03517449.
仑伐替尼联合帕博利珠单抗（LEN+PEMBRO）在晚期子宫内膜癌（aEC）患者中与医生选择的治疗（TPC）相比，在疗效方面具有临床意义和统计学意义的改善，在 3 期 309/KEYNOTE-775 研究中得到了证实。报告了与健康相关的生活质量（HRQoL）。
患者被随机分配接受 LEN+PEMBRO（n=411；LEN 20mg/天；PEMBRO 200mg Q3W）或 TPC（n=416；多柔比星 60mg/m Q3W 或紫杉醇 80mg/m[每周，3 周 ON/1 周 OFF]）。欧洲癌症研究与治疗组织生活质量问卷（EORTC QLQ-C30）的全球健康状况/生活质量（GHS/QoL）评分评估治疗对 HRQoL 的影响是次要目标；其他生活质量问卷（QLQ-C30）、EORTC 子宫内膜问卷，24 个问题（EORTC QLQ-EN24）和 EuroQoL 5 维度，5 个级别（EQ-5D-5L）是探索性目标。在每个周期的第 1 天评估 HRQoL。评估完成/依从性、与基线相比的变化、首次和最终恶化的时间。未对 HRQoL 终点进行多重调整。
最后一个达到规定完成率（≥60%）和依从率（≥80%）的时间点是第 12 周。治疗组在第 12 周的 HRQoL 通常相似。首次恶化症状量表中，QLQ-C30 呼吸困难、QLQ-EN24 体像不良、刺痛/麻木、脱发倾向于 LEN+PEMBRO；QLQ-C30 疼痛、食欲减退和腹泻、QLQ-EN24 肌肉疼痛倾向于 TPC。虽然 QLQ-C30 身体功能量表对 TPC 有利，但其他功能量表在臂间通常相似。大多数情况下，最终恶化时间有利于 LEN+PEMBRO。
来自 309/KEYNOTE-775 研究的 HRQoL 数据，结合之前公布的疗效和安全性结果，表明 LEN+PEMBRO 在治疗 aEC 患者方面与 TPC 相比具有总体有利的获益/风险特征。
政府：NCT03517449。
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