Impact of venetoclax monotherapy on the quality of life of patients with relapsed or refractory chronic lymphocytic leukemia: results from the phase 3b VENICE II trial

Cochrane, T; Enrico, A; Gomez-Almaguer, D; Hadjiev, E; Lech-Maranda, E; Masszi, T; Nikitin, E; Robak, T; Weinkove, R; Wu, SJ; Sail, KR; Pesko, J; Pai, M; Komlosi, V; Anderson, MA

Author(s): Cochrane, T; Enrico, A; Gomez-Almaguer, D; Hadjiev, E; Lech-Maranda, E; Masszi, T; Nikitin, E; Robak, T; Weinkove, R; Wu, SJ; Sail, KR; Pesko, J; Pai, M; Komlosi, V; Anderson, MA;
Details: Publication Year 2022-02,Volume 63,Issue #2,Page 304-314
Journal Title: Leukemia & Lymphoma
Publication Type: Research article
Abstract: 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.
Keywords: Bridged Bicyclo Compounds, Heterocyclic/therapeutic use; Humans; *Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy; *Neoplasm Recurrence, Local/drug therapy; Quality of Life; Sulfonamides/therapeutic use; Treatment Outcome; Cll; health-related quality of life; relapsed/refractory; venetoclax
Department(s): Clinical Haematology
PubMed ID: 34632935
Publisher's Version: https://doi.org/10.1080/10428194.2021.1986217
Open Access at Publisher's Site: https://doi.org/10.1080/10428194.2021.1986217
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2024-10-16 06:19:41

Last Modified: 2024-10-16 06:21:19