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Age-based subgroup analysis of CASTOR and POLLUX
AB
CD
Figure 2. PFS of patients aged 65 to 74 years and ≥75 years in POLLUX and CASTOR. PFS in the ITT populations compared with patients aged ≥75 years (A) and 65 to 74 years (B) in POLLUX and with patients aged ≥75 years (C) and 65 to 74 years (D) in CASTOR. PFS is based on Kaplan-Meier estimates. PFS: progression- free survival; ITT: intent-to-treat; Med: median; NR: not reached; HR: hazard ratio; CI: confidence interval; Rd: lenalidomide/dexamethasone; D-Rd: daratumumab/lenalidomide/dexamethasone; Vd: bortezomib/dexamethasone; D-Vd: daratumumab/bortezomib/dexamethasone.
TEAE were reported in 18 (90.0%) and 26 (74.3%) patients in the D-Vd and Vd treatment groups, respective- ly (Table 3). Thrombocytopenia was the most common grade 3/4 TEAE in both treatment groups among patients aged ≥75 years (D-Vd: 45.0%; Vd: 37.1%) and in patients aged 65 to 74 years (D-Vd: 52.1%; Vd: 32.6%).
In POLLUX, IRR of any grade were reported in 12 (41.4%) patients aged ≥75 years and 57 (46.3%) patients aged 65 to 74 years (Table 4). The most common IRR in both age groups was dyspnea (≥75 years: 13.8%; 65-74 years: 10.6%). The majority of IRR were mild, with grade 3/4 IRR occurring in four (13.8%) patients aged ≥75 years and six (4.9%) patients aged 65 to 74 years. Among patients aged ≥75 years, all IRR occurred with the first infusion, with the exception of one IRR that occurred in a subsequent infusion. Among patients aged 65 to 74 years, two (1.6%) patients reported an IRR in the second infu- sion, and seven (5.9%) patients reported an IRR in subse-
quent infusions. In CASTOR, 13 (65.0%) patients aged ≥75 years and 43 (45.7%) patients aged 65 to 74 years reported an IRR of any grade (Table 4). IRR were generally mild, with grade 3/4 IRR occurring in 2 (10.0%) and 8 (8.5%) patients aged ≥75 and 65 to 74 years, respectively. Among patients aged ≥75 years, no IRR in the second or subsequent infusions were reported; only one patient (aged 65-74 years) had an IRR in the second infusion. In both studies, IRR were manageable and did not result in treatment discontinuations in these populations.
Discussion
MM is a disease of the elderly, and patients are a hetero- geneous population with the potential for various comor- bidities, reduced functional status, and increased risk of frailty.6 Approximately 35% to 40% of patients with MM
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