Table 1.
Incidence of SPMs with lenalidomide (Len) maintenance versus placebo in prospective, randomized phase 3 trials.
| Trial | Reference | N | F/ua (mo) | Treatment prior to randomization | Randomized arms | Invasive SPMs (no.) | Solid cancers (no.) | Heme cancers (no.) | Nonmelanoma skin cancers (no.) | Cumulative incidence of invasive cancers (%) | Incidence (per 100 patient-years) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IFM 2005-002 | [54] | 614 | 45 | Induction then SCT | Len | 23 | 10 | 13 | 5 | 7.5 | 3.1 |
| Placebo | 9 | 4 | 5 | 3 | 2.9 | 1.2 | |||||
|
| |||||||||||
| CALGB 100104 | [55] | 460 | 34 | Induction then SCT | Len | 18 | 10 | 8 | 4 | 7.8 | N/A |
| Placebo | 6 | 5 | 1 | 3 | 2.6 | N/A | |||||
|
| |||||||||||
| MPR-R | 12 | 5 | 7 | 1 | 7 | 1.4 | |||||
| MM-015 | [56, 57] | 459 | 30 | MPR or MP | MPR | 9 | 4 | 5 | 4 | 7 | 2.1 |
| MP | 4 | 3 | 1 | 5 | 3 | 0.7 | |||||
a Median followup from the time from randomization.