Karyopharm Therapeutics, Inc., Newton, MA 02459, USA.
Health Economics, Purple Squirrel Economics, Montreal, QC H3J 1M1, Canada.
Future Oncol. 2021 Apr;17(11):1295-1310. doi: 10.2217/fon-2020-0946. Epub 2021 Feb 2.
Evaluate health-related quality of life (HRQoL) and health utility impact of single-agent selinexor in heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma. Functional Assessment of Cancer Therapy (FACT) - Lymphoma and EuroQoL five-dimensions five-levels data collected in the single-arm Phase IIb trial SADAL (NCT02227251) were analyzed with mixed-effects models. Treatment responders maintained higher FACT - Lymphoma (p ≤ 0.05), FACT - General (p < 0.05) and EuroQoL five-dimensions five-levels index scores (p < 0.001) beginning in cycle 3. The estimated difference in health state utilities for treatment response and progressive disease was both statistically significant and clinically meaningful (mean difference: 0.07; p = 0.001). In patients with relapsed/refractory diffuse large B-cell lymphoma, objective response to selinexor was associated with HRQoL maintenance, reduction in disease-related HRQoL decrements and higher health utilities.
评估单药塞利尼索在既往治疗过的复发/难治性弥漫性大 B 细胞淋巴瘤患者中的健康相关生活质量(HRQoL)和健康效用影响。在这项单臂 IIb 期 SADAL 试验(NCT02227251)中收集的癌症治疗功能评估(FACT)-淋巴瘤和欧洲五维健康量表(EQ-5D)数据,使用混合效应模型进行了分析。治疗应答者从第 3 周期开始保持更高的 FACT-淋巴瘤(p ≤ 0.05)、FACT-一般(p < 0.05)和 EQ-5D 五维五分指数评分(p < 0.001)。治疗反应和疾病进展之间的健康状态效用估计差异均具有统计学意义和临床意义(平均差异:0.07;p = 0.001)。在复发/难治性弥漫性大 B 细胞淋巴瘤患者中,塞利尼索的客观缓解与 HRQoL 维持、疾病相关 HRQoL 下降减少和更高的健康效用相关。