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S. Bringhen et al.
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Figure 3. Survival outcomes according to maintenance treatment arm. (A) Progression-free survival, (B) time to next treatment, (C) progression-free survival 2 and (D) overall survival. All time to events were calculated from the time of random assignment to maintenance treatment arms (_m). R: lenalidomide; RP: lenalidomide- prednisone; PFS: progression-free survival; PFS-2: progression-free survival 2; TNT: time to next treatment; OS: overall survival; _m: from the random assignment to maintenance treatment arms; HR: hazard ratio; CI: confidence interval; P: P value.
with standard- or high-risk cytogenetics showed the same trends observed in the overall population (Online Supplementary Figure S4).
A post-hoc analysis according to patients’ frailty was also performed for the maintenance phase (Figure 4) and no significant advantage of one regimen over the other was found. In fit patients, the median PFS from start of maintenance was 24.4 months with RP and 19.6 months with R (HR 0.84, 95% CI: 0.60-1.16, P=0.29) (Figure 4A). Not even in intermediate-fit and frail patients was one reg- imen found to be superior to the other (Figure 4C, E). No difference in OS was detected (Figure 4B, D, F).
Safety profiles of induction were reported in the initial analysis.10 Briefly, the most frequent grade ≥3 toxicities were hematologic. At least one grade ≥3 hematologic adverse event was reported in 29% of patients treated
with Rd, 68% of those treated with MPR and 32% of patients treated with CPR (P<0.001). The rate of at least one grade ≥3 non-hematologic adverse event did not exceed 31% in any of the three arms. The most frequent grade ≥3 non-hematologic toxicities were infections (9% with Rd, 11% with MPR and 6.5% with CPR), constitu- tional adverse events (5% with Rd, 9.5% with MPR and 3.5% with CPR) and cardiac toxicities (6% with Rd, 4.5% with MPR and 6% with CPR); no significant differences were detected among the three arms. The rate of discon- tinuation due to adverse events was similar in the three arms: 14% in the Rd arm, 18% in the MPR arm and 15% in the CPR arm. Lenalidomide was reduced in 16% of patients treated with Rd, 21% of those treated with MPR and 18% of CPR-treated patients, without significant dif- ferences among the three arms.
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haematologica | 2020; 105(7)