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

Abstract

In the phase III CASTOR trial, daratumumab, bortezomib and dexamethasone (D-Vd) significantly extended progression-free survival compared with bortezomib and dexamethasone (Vd) alone in patients with relapsed/refractory multiple myeloma (RRMM). Here, we present patient-reported outcomes (PROs) from the CASTOR trial. PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and the EuroQol 5dimensional descriptive system questionnaire. Treatment effects through Cycle 8 were measured by a repeated measures mixed-effects model. After Cycle 8, PROs were only collected for patients in the D-Vd group who continued on daratumumab monotherapy. Compliance rates for PRO assessments were high and similar between treatment groups. Mean changes from baseline were generally similar between treatment groups for EORTC QLQ-C30 global health status (GHS), functioning and symptoms, and did not exceed 10 points for either treatment group. Subgroup analyses were consistent with the results observed in the overall population. There was no change in patients' health-related quality of life for the first eight cycles of therapy; thereafter, patients treated with daratumumab over the long-term reported improvements in GHS and pain. These results complement the significant clinical benefits observed with D-Vd in patients with RRMM and support its use in this patient population.

Health‐related quality of life in patients with relapsed/refractory multiple myeloma treated with pomalidomide and dexamethasone ± subcutaneous daratumumab: Patient‐reported outcomes from the APOLLO trial

“…In the phase 3 CASTOR study, patients (median of 2 prior LOT; range, 1-10) treated with daratumumab, bortezomib, and dexamethasone maintained baseline levels of HRQoL throughout eight treatment cycles; thereafter, patients receiving longterm daratumumab treatment reported improvements in some PROs, including GHS, pain, and VAS scores. 36,37 In the phase 3 POLLUX study, patients (median of 1 prior LOT; range, 1-11) with RRMM treated with daratumumab, lenalidomide, and dexamethasone (D-Rd) experienced significant between-group differences from baseline in EORTC QLQ-C30 GHS, functional, and symptom scores, and EQ-5D-5L VAS scores at several time points over the course of treatment compared with patients treated with Rd alone. 38,39 Notably, the lack of negative impact of long-term therapy illustrates that the clinical benefits observed with D-Rd were not at the expense of patients' HRQoL.…”

Daratumumab Treatment for “Truly Frail” Elderly Myeloma Patients

“…In the CASTOR trial, during the initial eight cycles, there were no changes in patients’ HRQOL in either of the treatment groups. However, patients receiving long-term DARA therapy reported improvements in GHS and pain following this point [ 99 ]. Furthermore, a post hoc analysis stratified by age (<65 years vs. ≥65 years) was conducted, showing that the benefits of incorporating DARA were observed regardless of age.…”

Pharmacy considerations: Use of anti-CD38 monoclonal antibodies in relapsed and/or refractory multiple myeloma

“…A post hoc analysis of patient-reported health-related quality of life (HRQoL) data from the ICARIA-MM study revealed that HRQoL was maintained in patients with RRMM treated with isatuximab plus Pd versus Pd. 40 Similarly, patient-reported outcomes from the phase 3 POLLUX and CASTOR studies showed no significant change in HRQoL with the addition of daratumumab to dexamethasone plus lenalidomide 41 or bortezomib, 42 respectively, in patients with RRMM.…”