期刊
LEUKEMIA & LYMPHOMA
卷 63, 期 2, 页码 304-314出版社
TAYLOR & FRANCIS LTD
DOI: 10.1080/10428194.2021.1986217
关键词
CLL; health-related quality of life; relapsed; refractory; venetoclax
资金
- AbbVie, Inc.
The study shows that venetoclax monotherapy has a positive impact on the health-related quality of life of patients with relapsed/refractory CLL, especially in terms of global health status/quality of life. No new safety signals were reported in the study.
Venetoclax, a potent B-cell lymphoma-2 (BCL-2) inhibitor, has demonstrated clinical efficacy in chronic lymphocytic leukemia (CLL). VENICE II is an open-label, single-arm, phase 3b study (NCT02980731) evaluating the impact of venetoclax monotherapy (400 mg once daily) for <= 2 years on health-related quality of life (HRQoL) of patients with relapsed/refractory CLL. The primary endpoint was mean change in the global health status (GHS)/quality of life (QoL) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) from baseline to Week 48. Overall, 210 patients received >= 1 dose of venetoclax; median treatment duration was 67.4 weeks. The primary endpoint was met with mean improvement of +9.3 points (n = 156, 95% confidence interval 6.1-12.5; p=.004) in GHS/QoL. At Week 48, clinically meaningful improvements were observed for role functioning, fatigue, and insomnia domains of EORTC QLQ-C30, suggesting venetoclax monotherapy has a positive impact on HRQoL. No new safety signals were reported.
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