CLL Coverage from Every Angle

Venetoclax and Quality of Life of Patients With Relapsed or Refractory CLL

By: Vanessa A. Carter, BS
Posted: Friday, November 12, 2021

The phase IIIb VENICE II trial evaluated the impact of the BCL2 inhibitor venetoclax monotherapy on health-related quality of life of patients with relapsed or refractory chronic lymphocytic leukemia (CLL); it was performed by Mary Ann Anderson, MBBS, PhD, of the Peter MacCallum Cancer Centre, Parkville, Australia, and colleagues. The results of this trial, published in Leukemia & Lymphoma, demonstrated that venetoclax was associated with “clinically meaningful improvements” regarding quality of life at week 48 of treatment, with consistent efficacy and safety profiles.

This study enrolled a total of 210 patients with relapsed or refractory CLL who were administered at least one dose of venetoclax. Participants received venetoclax once daily, starting at 20 mg and gradually increasing to a maximum of 400 mg after 5 weeks. Quality-of-life questionnaires were administered at baseline; weeks 4, 8, 12, 24, 36, and 48; and every 12 weeks until treatment ended. Individuals were followed for 2 years after treatment discontinuation.

The median patient age was 65, and the median duration of treatment was 67.4 weeks, with 69% of patients remaining on treatment at data cutoff. Of the total, 156 individuals completed their questionnaire at week 48. The remaining 65 patients discontinued treatment because of either progressive disease (12%) or adverse events (10%).

About 54% of patients appeared to have a clinically meaningful quality-of-life improvement, with no subscales demonstrating relevant deterioration. Interestingly, changes were noted as early as week 8 and were sustained until the end of treatment. The overall response rate at data cutoff was 77%, including a complete remission/complete remission with incomplete marrow recovery rate of 19%; 57% of participants reached partial remission, and 10% had stable disease.

The majority (92%) of patients experienced at least one adverse event, with the most common being neutropenia, diarrhea, upper respiratory tract infection, and thrombocytopenia. Approximately 61% of individuals experienced adverse events of grade 3 or higher, and serious adverse events were reported in 38%.

Disclosure: For full disclosures of the study authors, visit

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