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

• DOI: 10.1002/ajh.26260
• Publication Date: 2021-06-01T06:33:37Z
• Authors: Othman Al‐Sawaf; Brittany Gentile; Jacob Devine; Can Zhang; Kavita Sail; Maneesh Tandon; Anna‐Maria Fink; Nadine Kutsch; Clemens‐Martin We...; Barbara Eichhorst; Michael Hallek; Kirsten Fischer
• Keywords: Sulfonamides; Antineoplastic Agents; Antibodies, Monoclonal, Humanized; Bridged Bicyclo Compounds, Heterocyclic; Leukemia, Lymphocytic, Chronic, B-Cell; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Antineoplastic Combined Chemotherapy Protocols; Quality of Life; Humans; Patient Reported Outcome Measures; Aged

AbstractChronic 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.