Patient-reported outcomes among patients with mantle cell lymphoma or chronic lymphocytic leukemia receiving pirtobrutinib in the BRUIN phase 1/2 study: final analysis
- Author(s)
- Coombs, CC; Woyach, JA; Brown, JR; Ghia, P; Roeker, LE; Patel, K; Eyre, TA; Tam, CS; Seymour, JF; Shah, NN; Flinn, I; Cheah, CY; Ma, S; Rhodes, JM; Izutsu, K; Jurczak, W; Wierda, WG; Hess, LM; Bhandari, NR; Loubert, A; Abada, PB; Lamanna, N;
- Journal Title
- Current Medical Research and Opinion
- Publication Type
- Online publication before print
- Abstract
- BACKGROUND: This study presents patient-reported outcomes (PROs) from the phase 1/2 BRUIN (NCT03740529) trial of pirtobrutinib monotherapy for the treatment of B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL). METHODS: PROs were collected at each cycle using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and item library (IL) sets for CLL/SLL- and MCL-related symptoms and an Expanded Fatigue measure. Prespecified analyses included descriptive change from baseline, time to worsening (TTW) using Kaplan-Meier method, and longitudinal analyses using a mixed model for repeated measures. RESULTS: A total of 263 patients with CLL/SLL and 124 with non-blastoid MCL who received pirtobrutinib monotherapy after prior BTKi were included in the final PRO analysis. The proportion of patients with CLL/SLL who improved or remained stable from baseline through Cycle 31 remained above 80% for physical function (PF), CLL/SLL-related symptoms, fatigue, and global health status/quality of life (GHS/QoL). The proportion of patients with MCL who improved or remained stable through Cycle 20 remained above 70% for PF, MCL-related symptoms, fatigue, and GHS/QoL. Median TTW was not reached in either CLL or MCL. Longitudinal analyses for PF, CLL/SLL-related symptoms, fatigue, and GHS/QoL consistently met statistically significant and clinically-meaningful improvement from baseline for CLL. PRO assessments remained stable over time for MCL. CONCLUSIONS: The final analysis from the BRUIN trial demonstrates stability in PROs throughout the duration of treatment with pirtobrutinib. Most patients with CLL/SLL and MCL reported stable or improved outcomes throughout the study.; This study presents the final analysis of patient-reported outcomes (PROs) from the phase 1/2 BRUIN trial (NCT03740529) investigating pirtobrutinib monotherapy for the treatment of B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL). PRO instruments were collected using paper forms at each patient visit to the study site. This study found that throughout treatment with pirtobrutinib, more than 80% of patients with CLL reported maintained or improved physical function, CLL/SLL-related symptoms, fatigue, and global health status/quality of life. More than 70% of patients with MCL reported maintained or improved outcomes on similar measures. Overall, this final analysis of data from the BRUIN trial demonstrates stability in PROs throughout the duration of treatment with pirtobrutinib for both patients with CLL and those with MCL.; eng
- Keywords
- b-cell lymphoma; clinical trial; leukemia; patient-reported outcomes; physical function; pirtobrutinib; quality of life
- Department(s)
- Haematology
- Publisher's Version
- https://doi.org/10.1080/03007995.2025.2607542
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2026-02-03 06:11:41
Last Modified: 2026-02-03 06:11:50