Treatment with daratumumab, bortezomib, and dexamethasone (D-Vd) does not appear to negatively impact health-related quality of life (HRQoL), according to an analysis of patient-reported outcomes (PROs) for patients with relapsed/refractory multiple myeloma (RRMM) who participated in the phase 3 CASTOR trial. The results of this analysis were recently published in the British Journal of Haematology.
The randomized, open-label, multicenter CASTOR trial (ClinicalTrials.gov Identifier: NCT02136134) evaluated outcomes with D-Vd in comparison with bortezomib and dexamethasone (Vd) in treatment of RRMM. In this analysis of PROs, HRQoL was assessed at multiple time points using the EORTC QLQ-C30 and EQ-5D-5L questionnaire-based tools.
A total of 251 patients were enrolled in the D-Vd arm and 247 were in the Vd arm. Patient compliance with PRO assessments was reportedly high across both treatments. Overall compliance was more than 87% at baseline and remained fairly high, at greater than 85% during an assessment at day 1 of cycle 8. Only the D-Vd group had continued PRO assessments beyond cycle 8 and compliance for a period covering cycles 9 to 44 was more than 80% in this group.
The D-Vd and Vd treatment groups showed similar results on the EORTC QLQ-C30 questionnaire across functional and symptom-based analyses, and in terms of global health status (P =.1565 for global health status from baseline to cycle 8). For global health scores, median times to meaningful change and meaningful worsening were similar between treatment groups.
Overall, across the initial 8 cycles of treatment, neither treatment group showed changes in HRQoL that met a clinically meaningful threshold. Similar results overall were obtained with the EQ-5D-5L.
Analyses after cycle 8 using the EORTC QLQ-C30 suggested that patients in the D-Vd group had improvements over time in both pain and global health status. A clinically meaningful improvement also was seen for the mean score on the EQ-5D-5L visual analogue scale with this group. Analyses after cycle 8 reflect the period during which patients in the D-Vd group were treated with daratumumab alone, while study treatment had ceased for the Vd group.
“In patients with RRMM treated with D-Vd and Vd, HRQoL was unchanged from baseline, with no significant between-group differences for the first eight cycles of therapy,” the study investigators concluded in their report. Furthermore, daratumumab treatment over time was associated with HRQoL improvements.
Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of authors’ disclosures.
Hungria V, Beksac M, Weisel KC, et al. Health-related quality of life maintained over time in patients with relapsed or refractory multiple myeloma treated with daratumumab in combination with bortezomib and dexamethasone: results from the phase III CASTOR trial. Br J Haematol. Published online February 8, 2021. doi:10.1111/bjh.17321