Health-related quality of life with fixed-duration venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: Results from the randomized, phase 3 CLL14 trial

Chronic lymphocytic leukemia (CLL)-related symptoms impair the well-being of patients, making improvement of health-related quality of life (QoL) a goal of treatment. The CLL14 trial demonstrated higher efficacy of fixed-duration venetoclax-obinutuzumab (Ven-Obi) compared to chlorambucil-obinutuzumab (Clb-Obi) in patients with previously untreated CLL. To assess patients' QoL, the following patient-reported outcomes (PRO) measures were assessed: the M.D. Anderson Symptom Inventory (MDASI) core instrument and CLL module and the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). At treatment start, physical functioning (mean 75.9 [standard deviation (SD) +/- 20.1] in the Clb-Obi arm and 76.9 [+/- 19.4] in the Ven-Obi arm), role functioning (73.6 [+/- 27.86] and 72.6 [+/- 26.9]) and GHS/QoL (63.6 [+/- 21.0] and 60.3 [+/- 20.5]) were comparable between treatment arms per EORTC QLQ-C30 scale scores. Baseline levels of physical and role functioning were maintained throughout treatment and follow-up, with no relevant improvement or deterioration. On average, patients treated with Ven-Obi showed a meaningful improvement of GHS/QoL during treatment and follow-up by at least eight points at cycle three, whereas improvement was delayed until cycle eight with Clb-Obi. According to MDASI scores, CLL symptoms (1.5 [+/- 1.2] and 1.6 [+/- 1.3]), core cancer symptoms (1.5 [+/- 1.4] and 1.8 [+/- 1.7]) and symptom interference (2.1 [+/- 2.3] and 2.3 [+/- 2.3]) were generally low and comparable between treatment arms at baseline and were maintained throughout treatment and follow-up. This analysis demonstrates that the higher efficacy of Ven-Obi is not associated with QoL impairment and that Ven-Obi achieves early relief of CLL-related symptoms in elderly unfit patients.

Automated summary

In the treatment of chronic lymphocytic leukemia, fixed-duration venetoclax-obinutuzumab (Ven-Obi) demonstrated higher efficacy compared to chlorambucil-obinutuzumab (Clb-Obi) without impairing quality of life (QoL). Ven-Obi provided early relief of CLL-related symptoms in elderly unfit patients.