Fixed-duration treatment with venetoclax and obinutuzumab was not associated with impaired quality of life (QOL) in patients with chronic lymphocytic leukemia (CLL) enrolled on the CLL14 study, according to research published in the American Journal of Hematology.1
In the phase 3 CLL14 trial (ClinicalTrials.gov Identifier: NCT02242942), patients with previously untreated CLL and co-existing conditions were randomly assigned to receive venetoclax-obinutuzumab or chlorambucil-obinutuzumab.
A recent analysis of CLL14 data showed that patients in the venetoclax arm had significantly longer progression-free survival than patients in the chlorambucil arm.2
For the current analysis, researchers evaluated overall QOL as well as key symptoms and aspects of functioning in the venetoclax (n=197) and chlorambucil (n=198) arms.
Patient-reported outcomes were assessed using the MD Anderson Symptom Inventory (MDASI) core instrument with the CLL module and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
As per the EORTC QLQ-C30 scale scores, changes in physical functioning, role functioning, and global health status (GHS)/QOL were comparable between the treatment arms.
At the start of treatment, the mean scores for physical functioning were 75.9 in the chlorambucil arm and 76.9 in the venetoclax arm. The mean scores for role functioning were 73.6 and 72.6, respectively, and the mean scores for GHS/QOL were 63.6 and 60.3, respectively.
During treatment and follow-up, patients maintained baseline levels of physical and role functioning, with no clinically meaningful improvements or deterioration in either treatment arm.
In the venetoclax arm, patients showed an earlier improvement in GHS/QOL by at least 8 points at cycle 3. Improvement was delayed until cycle 8 in the chlorambucil arm.
The MDASI scores related to symptom burden and interference were generally low and comparable between the treatment arms at baseline and throughout treatment and follow-up.
“The CLL14 trial has shown that it is possible to achieve very deep responses and long-term disease control in elderly and unfit patients,” the study authors wrote. “Given the risk that such efficacy might be achieved at the cost of the patient’s well-being, these results importantly show treatment goals being achieved without compromising patients’ functioning and overall quality of life.”
Disclosures: This research was supported by F. Hoffmann-La Roche and AbbVie. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
- Al-Sawaf O, Gentile B, Devine J, et al. Health-related quality of life with fixed-duration venetoclax obinutuzumab for previously untreated chronic lymphocytic leukemia: Results from the randomized, phase 3 CLL14 trial. Am J Hematol. Published May 29, 2021. doi:10.1002/ajh.26260
- Al-Sawaf O, Zhang C, Robrecht S, et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 4-year follow-up analysis of the randomized CLL14 study. Paper presented at: European Hematology Association 2021 Virtual Congress; June 2021; Abstract S146.