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Carfilzomib-based triplet improves quality of life in relapsed multiple myeloma
The addition of carfilzomib to lenalidomide and dexamethasone improved health-related quality of life in patients with relapsed multiple myeloma, according to a secondary analysis from the ASPIRE trial.
“Patients with multiple myeloma typically report significant impairment of health-related quality of life, including reduced physical function, fatigue and pain,” A. Keith Stewart, MB, ChB, professor of cancer research at Mayo Clinic in Rochester, Minnesota, and colleagues wrote. “Improvements in the efficacy of multiple myeloma treatments ... have made health-related quality of life an increasingly important endpoint in clinical trials and factor in treatment decisions.”
The randomized, phase 3 ASPIRE trial evaluated the addition of carfilzomib (Kyprolis, Onyx) to lenalidomide (Revlimid, Celgene) and dexamethasone in patients with relapsed multiple myeloma. The researchers observed a significant increase in median PFS among patients assigned the triplet regimen (26.3 months vs. 17.6 months; P < .001).
Health-related quality of life served as a prespecified secondary endpoint of the ASPIRE trial. The researchers hypothesized that patients assigned carfilzomib would have superior outcomes based on the Global Health Status/Quality of Life scale of the EORTC’s Quality of Life Questionnaire C30.
Patients completed quality-of-life questionnaires at baseline; on day 1 of treatment cycles 3, 6, 12 and 18; and after treatment.
The study population had a baseline questionnaire compliance rate of 94.1%, and a total of 713 patients (carfilzomib, n = 365; control, n = 348) completed at least one patient-reported outcome assessment after baseline.
Patients assigned carfilzomib had significantly improved Global Health Status/Quality of Life scores over 18 treatment cycles (P < .001). The minimal important difference was met at cycle 12 (5.6 points) and approached at cycle 18 (4.8 points).
More patients in the carfilzomib group met the Global Health Status/Quality of Life responder definition of an improvement of five or more points. The difference was significant at cycle 12 (25.5% vs. 17.4%) and cycle 18 (24.2% vs. 12.9%).
Patients in the carfilzomib group had a longer time to deterioration, defined as a reduction of five or more points (median time to deterioration, 10.3 months vs. 4.8 months; HR = 0.8; 95% CI, 0.65-0.98).
Similar results occurred based on a 15-point deterioration threshold (median time to deterioration, 16.6 months vs. 11.9 months; HR = 0.79; 95% CI, 0.63-0.99).
The researchers acknowledged study limitations. Because of the study’s open-label design, patients were aware of their treatment allocation prior to completing baseline questionnaires.
Additionally, rates of attrition remained different across groups.
“The aims of multiple myeloma treatment are to control disease, prolong survival and maximize patient well-being,” Stewart and colleagues wrote. “Moreover, if survival is extended, it is equally important that efficacy gains are not at the cost of impaired quality of life, particularly with the use of triplet combination therapies. Results from the ASPIRE study confirm that the clinical benefits of the [carfilzomib, lenalidomide and dexamethasone] triplet regimen, compared with the lenalidomide and dexamethasone doublet regimen, are associated with significant improvements in Global Health Status/Quality of Life, and there was no evidence of a detrimental impact from the triplet regimen on other aspects of health-related quality of life.” – by Cameron Kelsall
Disclosure: The ASPIRE trial was funded by Onyx Pharmaceuticals, an Amgen subsidiary. Stewart reports consultant roles with Amgen, Bristol-Myers Squibb, Celgene, Janssen, Novartis and Takeda. Please see the full study for a list of all other researchers’ relevant financial disclosures.