Περίληψη:
Data from two randomized pivotal, phase 3 trials evaluating the
combination of lenalidomide and dexamethasone in relapsed/refractory
multiple myeloma (RRMM) were pooled to characterize the subset of
patients who achieved long-term benefit of therapy (progression-free
survival >= 3 years). Patients with long-term benefit of therapy (n =
45) had a median duration of treatment of 48.1 months and a response
rate of 100%. Humoral improvement (uninvolved immunoglobulin A) was
more common in patients with long-term benefit of therapy (79% vs 55%;
P = 0.002). Significant predictors of long-term benefit of therapy in
multivariate analysis were age <65 years (P = 0.03), beta
2-microglobulin <2.5 mg/l (P = 0.002) and fewer prior therapies (P =
0.002). The exposure-adjusted incidence rate (EAIR) of grade 3-4
neutropenia was lower in patients with long-term benefit of therapy
(13.9 vs 38.2 per 100 patient-years). The EAIR for invasive second
primary malignancy was the same in patients with long-term benefit of
therapy and other patients (1.7 per 100 patient-years). These findings
indicate that patients with RRMM can experience long-term benefit with
lenalidomide and dexamethasone treatment with manageable side effects.
Συγγραφείς:
Dimopoulos, M. A.
Swern, A. S.
Li, J. S.
Hussein, M. and
Weiss, L.
Nagarwala, Y.
Baz, R.