Abstract
We examined effects of carfilzomib-dexamethasone (Kd56) versus bortezomib-dexamethasone (Vd) on health-related quality of life (HR-QoL) in relapsed/refractory multiple myeloma (MM) patients from the ENDEAVOR study. HR-QoL was assessed by the European Organisation for Research and Treatment of Cancer QoL Questionnaire (QLQ-C30), MM-specific module (QLQ-MY20), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-Ntx) “Additional Concerns” neurotoxicity subscale. The QLQ-C30 Global Health Status (GHS)/QoL scale and seven prespecified subscales were compared between groups using mixed model for repeated measures. Of 929 randomized patients, 911 with ≥1 post-baseline assessment were included. Kd56 was associated with statistically significant improvements in GHS/QoL, fatigue, pain, side effects, and FACT/GOG-Ntx scores versus Vd, although mean differences did not meet thresholds for clinical significance. The Kd56 group had longer time to deterioration (TTD) in GHS/QoL (median 3.7 versus 2.8 months, p = 0.0046), physical function (5.6 versus 3.7 months, p = 0.0390), nausea/vomiting (17.6 versus 8.2 months, p = 0.0358), side effects (6.4 versus 3.7 months p < 0.0001), and FACT/GOG-Ntx (11.1 versus 5.5 months, p = 0.0004). Overall, Kd56 resulted in statistically but not clinically significant improvements in mean GHS/QoL scores versus Vd. Treatment with Kd56 versus Vd also significantly prolonged TTD in GHS/QoL, physical function, nausea/vomiting, side effects, and FACT/GOG-Ntx.
Highlights
Novel treatment options for multiple myeloma are associated with improvements in survival[1], corresponding improvements in health-related quality of life (HR-QoL) have been limited[2]
For the multi-item subscales, we proposed to use the standard error of measurement (SEM) as a proxy for the MID21,22
A baseline mean difference larger than the MID was observed for insomnia, with patients in the Kd56 group reporting more problems than
Summary
Novel treatment options for multiple myeloma are associated with improvements in survival[1], corresponding improvements in health-related quality of life (HR-QoL) have been limited[2]. Among the most distressing issues reported at diagnosis are reduced physical functioning, pain and fatigue, impairments in role functioning, and reduced overall HR-QoL3. As patients with multiple myeloma live longer with the disease and have increased access to a variety of new therapies, HR-. QoL has grown in importance as an endpoint in clinical studies[2,4]. Carfilzomib is an epoxyketone proteasome inhibitor that binds selectively and irreversibly to the proteasome. The combination of carfilzomib with dexamethasone (twice-weekly carfilzomib dose of 56 mg/m2; Kd56) is approved for the treatment of adult patients with relapsed or refractory multiple myeloma.
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