Τίτλος:
Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
In the phase 3 POLLUX trial, daratumumab in combination with lenalidomide and dexamethasone (D-Rd) significantly improved progression-free survival in patients with relapsed/refractory multiple myeloma (RRMM) compared with lenalidomide and dexamethasone (Rd) alone. Here, we present patient-reported outcomes (PROs) from POLLUX, assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and the EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaires. Changes from baseline are presented as least-squares mean changes with 95% confidence intervals (CIs) derived from a mixed-effects model. PRO assessment compliance rates were high and similar in both D-Rd and Rd groups through cycle 40 (week 156). In this on-treatment analysis, mean changes from baseline were significantly greater in EORTC QLQ-C30 global health status, physical functioning, and pain scores in the D-Rd group versus the Rd group at multiple time points; however, magnitude of changes was low, suggesting no meaningful impact on health-related quality of life (HRQoL). Subgroup results were similar to those in the overall population. In the POLLUX study, baseline HRQoL was maintained with prolonged D-Rd treatment. These findings complement the sustained and significant improvement in progression-free survival observed with D-Rd and supports its use in patients with RRMM. Clinical trial registration: NCT02076009. © 2021 British Society for Haematology and John Wiley & Sons Ltd.
Συγγραφείς:
Plesner, T.
Dimopoulos, M.A.
Oriol, A.
San-Miguel, J.
Bahlis, N.J.
Rabin, N.
Suzuki, K.
Yoon, S.-S.
Ben-Yehuda, D.
Cook, G.
Goldschmidt, H.
Grosicki, S.
Qin, X.
Fastenau, J.
Garvin, W.
Carson, R.
Renaud, T.
Gries, K.S.
Περιοδικό:
British Journal of Haematology
Εκδότης:
John Wiley and Sons Inc
Λέξεις-κλειδιά:
daratumumab; dexamethasone; lenalidomide; antineoplastic agent; daratumumab; dexamethasone; lenalidomide; monoclonal antibody, adult; aged; Article; cancer recurrence; controlled study; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; European Quality of Life 5 Dimensions questionnaire; female; follow up; human; long term care; major clinical study; male; minimal residual disease; multicenter study; multiple cycle treatment; multiple myeloma; open study; patient-reported outcome; phase 3 clinical trial; progression free survival; quality of life; randomized controlled trial; treatment response; clinical trial; middle aged; multiple myeloma; pain measurement; psychology; quality of life; questionnaire; recurrent disease; salvage therapy; treatment outcome, Adult; Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Female; Humans; Lenalidomide; Male; Middle Aged; Multiple Myeloma; Pain Measurement; Patient Reported Outcome Measures; Progression-Free Survival; Quality of Life; Recurrence; Salvage Therapy; Surveys and Questionnaires; Treatment Outcome
