Adding the proteasome inhibitor Kyprolis (carfilzomib) to the standard two-drug regimen of Revlimid (lenalidomide) and dexamethasone significantly improves health-related quality of life in relapsed multiple myeloma patients, according to a secondary analysis of the ASPIRE clinical trial.
These findings, published in the Journal of Clinical Oncology, further support the benefits of adding Kyprolis to the standard therapy. The study was titled, “Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma.”
“Patients with multiple myeloma typically report significant impairment of health-related quality of life, including reduced physical function, fatigue and pain,” the researchers wrote, concluding that improvements in therapy “have made health-related quality of life an increasingly important endpoint in clinical trials and [a] factor in treatment decisions.”
The Phase 3 ASPIRE trial (NCT01080391) evaluated the combination of Kyprolis plus Revlimid and dexamethasone (whose brand names include Decadron), versus standard therapy alone, in relapsed multiple myeloma patients who had received one to three prior treatment regimens. Results from this trial were already reported to show promising improvements in progression-free survival in patients treated with the triple combo, compared to the standard regimen.
Now, the research team — led by A. Keith Stewart, MB, ChB, professor of cancer research at Mayo Clinic in Rochester, Minnesota — sought to address whether their health-related quality of life was superior to control group patients, one of the study’s pre-specified secondary endpoints. Patients were assessed with the Global Health Status/Quality of Life scale of the EORTC’s Quality of Life Questionnaire C30 at baseline, then again on the first day of treatment cycles 3, 6, 12, and 18, and, finally, after treatment ended.
Nearly all patients completed the questionnaire at baseline and a total of 713 finished at least one patient-reported outcome assessment after baseline.
Results showed that Global Health Status/Quality of Life scores were significantly higher in the Kyprolis combination arm, with the minimal difference having been met at cycle 12 (5.6 points) and approached at cycle 18 (4.8 points).
The percentage of patients reporting an improvement of more than five points in these scores was also higher in the Kyprolis arm, both at cycle 12 (25.5% vs. 17.4%) and at cycle 18 (24.2% vs. 12.9%).
Researchers also found that the combination significantly delayed the time to deterioration in life quality, with those in the Kyprolis arm taking a median of 10.3 months to note a quality of life reduction score of five or more points, and those on the control arm taking 4.8 months.
A deterioration of 15 or more points in quality of life scores followed the same trend, a median of 16.6 months in the Kyprolis arm compared to 11.9 months in the control arm.
Although the results strongly suggest that Kyprolis improves quality of life for relapsed myeloma patients, the researchers noted that the open-label study design may have limited observations, because patients were already aware of their treatment before completing their baseline questionnaires.
“The aims of multiple myeloma treatment are to control disease, prolong survival and maximize patient well-being,” the researchers wrote. “Results from the ASPIRE study confirm that the clinical benefits of the KRd [Kyprolis-Revlimid- dexamethasone] triplet regimen, compared with the Rd doublet regimen, are associated with significant improvements in [quality of life], and there was no evidence of a detrimental impact.”