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S. Bringhen et al.
During maintenance, 31% of patients in the RP group and 20% of patients in the R group had an improvement in their quality of response. In the RP group, the partial response (PR) rate increased from 87% to 95%, the very good PR (VGPR) rate from 33% to 58%, and the complete response (CR) rate from 5% to 9%. In the R group, the PR rate increased from 83% to 88%, the VGPR rate from 33% to 47%, and the CR rate from 2% to 7%.
After a median follow-up of 62 months from the ran- dom assignment to maintenance treatment arms, progres- sion or death occurred in 153 patients (77%) in the RP group and in 164 (80%) in the R group. The median PFS was 22.2 months with RP and 18.6 months with R (HR
0.85, 95% CI: 0.68-1.06, P=0.14) (Figure 3A). The median TNT was 32.4 months with RP and 29.8 months with R (HR 0.95, 95% CI: 0.75-1.20, P=0.67) (Figure 3B). In both groups, maintenance therapy delayed the median time to next therapy (clinical progression) by approximately 10 months in comparison with the median PFS (biochemical progression). The median PFS-2 was 53.3 months with RP and 42.3 months with R (HR 1.04, 95% CI: 0.80-1.35, P=0.79) (Figure 3C). Death occurred in 92 patients (46%) in the RP group and 78 (38%) in the R group. The median OS was 72.3 months with RP and not reached with R ther- apy (HR 1.21, 95% CI: 0.89-1.64, P=0.22) (Figure 3D). Subgroup analysis of maintenance treatment in patients
AB
CD
Figure 1. Survival outcomes according to induction treatment arm. (A) Progression-free survival, (B) time to next treatment, (C) progression-free survival 2 and (D) overall survival are shown. All time to events were calculated from the time of random assignment to induction treatment arms. MPR: melphalan-prednisone-lenalido- mide; CPR: cyclophosphamide-prednisone-lenalidomide; Rd: lenalidomide-dexamethasone; PFS: progression-free survival; PFS-2: progression-free survival 2; TNT: time to next treatment; OS: overall survival; HR: hazard ratio; CI: confidence interval; P: P value.
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haematologica | 2020; 105(7)