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- Title
Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE.
- Authors
Mateos, Maria-Victoria; Dimopoulos, Meletios A.; Cavo, Michele; Suzuki, Kenshi; Knop, Stefan; Doyen, Chantal; Lucio, Paulo; Nagy, Zsolt; Pour, Ludek; Grosicki, Sebastian; Crepaldi, Andre; Liberati, Anna Marina; Campbell, Philip; Yoon, Sung-Soo; Iosava, Genadi; Fujisaki, Tomoaki; Garg, Mamta; Iida, Shinsuke; Bladé, Joan; Ukropec, Jon
- Abstract
• Patients with transplant-ineligible NDMM received D-VMP or VMP. • Frailty was assessed retrospectively using age, CCI, and baseline ECOG PS. • Improved efficacy with D-VMP versus VMP was observed across frailty subgroups. • Safety by frailty was generally consistent with the overall ALCYONE population. • Results support the use of D-VMP in transplant-ineligible NDMM patients. In the phase 3 ALCYONE study, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) versus bortezomib/melphalan/prednisone (VMP) significantly improved progression-free survival (PFS) and overall survival (OS) in transplant-ineligible, newly diagnosed multiple myeloma (NDMM) patients. We present a subgroup analysis of ALCYONE by patient frailty status. Frailty assessment was performed retrospectively using age, Charlson comorbidity index, and baseline Eastern Cooperative Oncology Group performance status score. Patients were classified as fit (0), intermediate (1), or frail (≥2); a nonfrail category combined fit and intermediate patients. Among randomized patients (D-VMP, n = 350; VMP, n = 356), 391 (55.4%) were nonfrail (D-VMP, 187 [53.4%]; VMP, 204 [57.3%]) and 315 (44.6%) were frail (163 [46.6%]; 152 [42.7%]). After 40.1-months median follow-up, nonfrail patients had longer PFS and OS than frail patients, but benefits of D-VMP versus VMP were maintained across subgroups: PFS nonfrail (median, 45.7 vs. 19.1 months; hazard ratio [HR], 0.36; P <.0001), frail (32.9 vs. 19.5 months; HR, 0.51; P <.0001); OS nonfrail (36-month rate, 83.6% vs. 74.5%), frail (71.4% vs. 59.0%). Improved greater than or equal to complete response and minimal residual disease (10−5)-negativity rates were observed for D-VMP versus VMP across subgroups. The 2 most common grade 3/4 treatment-emergent adverse events were neutropenia (nonfrail: 39.2% [D-VMP] and 42.4% [VMP]; frail: 41.3% and 34.4%) and thrombocytopenia (nonfrail: 32.8% and 36.9%; frail: 36.9% and 39.1%). Our findings support the clinical benefit of D-VMP in transplant-ineligible NDMM patients enrolled in ALCYONE, regardless of frailty status. In the global phase 3 ALCYONE study, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved outcomes versus VMP in transplant-ineligible patients with newly diagnosed multiple myeloma. In this subgroup analysis of ALCYONE, frailty was assessed retrospectively among all randomized patients (D-VMP, n = 350; VMP, n = 356). Improved efficacy with D-VMP versus VMP was observed across frailty subgroups, with no new safety concerns.
- Publication
Clinical Lymphoma, Myeloma & Leukemia, 2021, Vol 21, Issue 11, p785
- ISSN
2152-2650
- Publication type
Article
- DOI
10.1016/j.clml.2021.06.005