ScholarWorks@성균관대학교

초록

In the phase 3 OCTANS study, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved response rates and progression-free survival versus VMP alone in transplant-ineligible Asian patients with newly diagnosed multiple myeloma (NDMM). Understanding the impact of treatment on patient-reported outcomes (PROs) is of increasing interest. Here, we report on the impact of D-VMP and VMP on PROs in OCTANS. PROs were a secondary endpoint and 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 5-dimensional descriptive system (EQ-5D-5L) questionnaire, administered at screening, every 3 months (Year 1), every 6 months thereafter (until disease progression), and 8 and 16 weeks post disease progression. Treatment effects were estimated using a mixed-effects model with repeated measures. Overall, 220 patients were randomized (D-VMP, n = 146; VMP, n = 74). Compliance rates were 100% at baseline in both treatment groups and remained relatively high by Month 12 (D-VMP, 82.6%; VMP, 67.4%). Comparable improvements from baseline were generally observed between treatment groups across most PRO scores. Significant improvements were observed with D-VMP versus VMP in Global Health Status (GHS) score at 9 months (p = 0.0443) and in social functioning and nausea and vomiting symptom scores at 12 months (p = 0.0042 and p = 0.0012, respectively). In summary, transplant-ineligible Asian patients with NDMM demonstrated improvements in PROs following treatment with D-VMP and VMP; however, greater improvements were observed in GHS, social functioning, and nausea and vomiting symptoms with D-VMP. ClinicalTrials.gov Identifier: NCT03217812; submitted July 13, 2017.

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