医学
彭布罗利珠单抗
恶心
呕吐
内科学
生活质量(医疗保健)
临床终点
化疗
肿瘤科
乳腺癌
癌症
物理疗法
随机对照试验
护理部
免疫疗法
作者
Peter Schmid,Oleg Lipatov,Seock‐Ah Im,Anthony Gonçalvès,Eva Muñoz-Couselo,Keun Seok Lee,Kenji Tamura,Laura Testa,Isabell Witzel,Shoichiro Ohtani,Nicholas C. Turner,Stefania Zambelli,Nadia Harbeck,Fabrice André,Rebecca Dent,Jaime Mejia,Xuan Zhou,Amin Haiderali,Allison Martin Nguyen,Javier Cortés,Eric P. Winer
标识
DOI:10.1016/j.ejca.2023.113393
摘要
In KEYNOTE-119 (ClinicalTrials.gov, NCT02555657), overall survival (primary end-point) was similar between pembrolizumab and chemotherapy in patients with previously treated metastatic triple-negative breast cancer (TNBC), although the pembrolizumab treatment effect increased with tumour PD-L1 expression. We report results of prespecified health-related quality of life (HRQoL) analyses from KEYNOTE-119.Eligible patients were randomised 1:1 to pembrolizumab 200 mg Q3W intravenously for up to 35 cycles or treatment of physician's choice per local/country guidelines. Prespecified exploratory end-points were the change from baseline in HRQoL (EORTC QLQ-C30, QLQ-BR23) and to characterise utilities (EQ-5D-3L). Time to deterioration (TTD) was the time from start of treatment to first onset of a ≥10-point worsening from baseline.HRQoL analyses included 187 patients with tumour PD-L1 combined positive score (CPS) ≥10. Changes from baseline at 6 weeks (primary analysis time point) were directionally better with pembrolizumab versus chemotherapy for QLQ-C30 GHS/QoL (between-group difference in least-squares mean scores of 4.21 [95% CI, -1.38 to 9.80]), QLQ-C30 functional scales (physical, role, cognitive, social), QLQ-C30 symptom scales/items (fatigue, nausea/vomiting, dyspnoea, appetite loss), and QLQ-BR23 symptom scales/items (systemic therapy side-effects, upset by hair loss). Median TTD was directionally longer for pembrolizumab versus chemotherapy for QLQ-C30 QHS/QoL (4.3 versus 1.7 months), QLQ-C30 nausea/vomiting (7.7 versus 4.8 months), and QLQ-BR23 systemic therapy side-effects (6.1 versus 3.4 months). Minimal treatment differences were observed for other HRQoL end-points.HRQoL results were consistent with clinical outcomes and appeared to be driven by results for patients with tumour PD-L1 CPS ≥10.
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