The addition of carfilzomib to lenalidomide and dexamethasone improved health-related quality of life compared with treatment with lenalidomide/dexamethasone alone among patients with relapsed multiple myeloma enrolled in the ASPIRE trial.
The addition of carfilzomib to lenalidomide and dexamethasone (KRd) improved health-related quality of life (QoL) compared with treatment with lenalidomide/dexamethasone alone (Rd) among patients with relapsed multiple myeloma enrolled in the ASPIRE trial. These improvements were achieved without any negative affect on patient-reported symptoms, according to a study published in the Journal of Clinical Oncology.
A. Keith Stewart, MB, ChB, of Mayo Clinic, Scottsdale, Arizona, and colleagues determined the effects of KRd on health-related QoL by looking at 792 patients with relapsed multiple myeloma from the ASPIRE trial, which randomly assigned patients to KRd or Rd. Results of the primary analysis of the trial showed that patients assigned to KRd had significantly longer progression-free survival compared with patients assigned to Rd.
In the study, patients completed the EORTC Quality of Life Questionnaire C30 (QLQ-C30) and the myeloma-specific module at baseline, day 1 of cycle 3, 6, 12, and 18, and after completion of treatment. Among these patients, 713 had one or more post-baseline patient-reported outcomes assessments and were included in this analysis. The researchers looked at the percentage of responders who achieved a 5-point or greater improvement, or a 15-point Global Health Status/Quality of Life (GHS/QoL) improvement at each cycle.
“The aims of multiple myeloma treatment are to control disease, prolong survival, and maximize patient well-being,” wrote Stewart and colleagues. “Moreover, if survival is extended, it is equally important that efficacy gains are not at the cost of impaired QoL, particularly with the use of triplet combination therapies.”
These QoL results showed that patients assigned to the triplet regimen had significantly higher GHS/QoL over 18 months compared with patients assigned to the doublet regimen (P < .001). The minimal important difference of at least a 5-point improvement was met by cycle 12 (5.6 points) and was approached at cycle 18 (4.8 points). More patients assigned to carfilzomib achieved the 5-point improvement at cycle 12 (25.5% vs 17.4%) and cycle 18 (24.2% vs 12.9%) than did patients assigned to Rd.
“Between-group improvements in health-related QoL are not routinely observed in oncology clinical trials, particularly when comparing triplet and doublet regimens, as in the ASPIRE trial,” the researchers wrote. “However, the QLQ-C30 GHS/QoL subscale scores significantly increased with KRd treatment compared with Rd.”
In addition, patients assigned to carfilzomib had a longer time to deterioration in GHS/QoL compared with patients assigned to Rd alone (HR, 0.80 [95% CI, 0.65–0.98]; P = .03). The median time to deterioration, defined as a 5-point or greater reduction, was 10.3 months for patients assigned KRd compared with 4.8 months for patients assigned Rd. When the researchers used a 15-point threshold for deterioration, the median time to deterioration for patients assigned KRd was 16.6 months compared with 11.9 months for patients assigned Rd (HR, 0.79 [95% CI, 0.63–0.99]; P = .04).
“Although no statistically significant differences were observed between the KRd and Rd groups for the seven prespecified subscales, these results are important for demonstrating that the addition of carfilzomib to Rd improves GHS/QoL without negatively affecting patient-reported fatigue, nausea and vomiting, disease symptoms, or adverse effects of treatment when compared with Rd,” the researchers wrote. “Importantly, KRd treatment did not result in a decline of physical functioning or role functioning scores, suggesting that combining the intravenous administration of carfilzomib with an oral regimen of Rd did not affect daily living or patients’ ability to perform work.”