Abstract
Lenalidomide in combination with dexamethasone (Len‐dex) represents a highly effective treatment in relapsed/refractory multiple myeloma (RRMM) patients. However, an increased risk of secondary primary malignancies (SPMs), including myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) has been described in patients receiving lenalidomide. In order to assess the incidence and features of this complication, we reviewed 195 patients with RRMM treated with Len‐dex at our institution. The median follow‐up time from diagnosis of MM was 73 months (10–234 months) and from initiation of Len‐dex was 19 months (1–104 months). The median duration of Len‐dex for all patients was 7.8 months (range 1–90 months). The incidence rate (IR) for all SPMs from start of Len‐dex was 2.37 per 100 patient‐years, which reflected an IR of 1.29 for MDS/AML and 1.08 for nonhematologic malignancies (NHM). MDS was the most common SPM noted. The cumulative IR of SPM at 5 years was 1.54% from the time of MM diagnosis and 5.24% from starting Len‐dex. Multivariable cumulative incidence of SPM analysis identified older age (P = 0.005) and prior number of regimens (P = 0.026) as adverse risk factors. We found more concomitant G‐CSF use (P = 0.029) in patients with MDS/AML, however, causal association is not clear. The progression‐free survival after Len‐dex was the longest for patients in MDS/AML group, and the 5‐year overall survival did not differ among groups. Although the rate of SPM was relatively low with Len‐dex, concomitant G‐CSF should be used judiciously and patients receiving this regimen should be observed for the development of this complication.
Highlights
The introduction of new agents, primarily immunomodulatory agents and proteasome inhibitors, has changed the course of multiple myeloma (MM) from a fatal disease with short life expectancy to a chronic cancer characterized by sequential remissions and relapses that, in turn, require multiple lines of treatment
All 195 refractory multiple myeloma (RRMM) patients who received at least one cycle of Len-d ex between the years of 2006–2009 at PMH were included in the analysis
There has been particular interest in the risk related to lenalidomide, one of the most effective anti- myeloma agents available, prompted by the unanticipated increased incidence of secondary primary malignancies (SPMs) noted in several large trials utilizing single-agent lenalidomide maintenance after induction therapy in elderly patients or after autologous stem cell transplant (ASCT) in younger patients [10, 11]
Summary
The introduction of new agents, primarily immunomodulatory agents and proteasome inhibitors, has changed the course of multiple myeloma (MM) from a fatal disease with short life expectancy to a chronic cancer characterized by sequential remissions and relapses that, in turn, require multiple lines of treatment. An increasing number of MM patients are on protracted anti-m yeloma therapy and are living longer. Concomitant with this observation, there is emerging data describing an increased risk of developing secondary primary malignancies (SPMs) in MM survivors [1, 2]. The combination of lenalidomide and dexamethasone (Len-dex) is well-tolerated and produces significant survival benefits in heavily pretreated, relapsed and/or refractory multiple myeloma (RRMM) patients [3]. Two large phase 3 trials (MM-009 and MM-010) showed that Len-dex prolonged both progression-free and overall survival (OS) compared with placebo plus dexamethasone (OS: 38 vs 31.6 months, P = 0.045) after a median follow-up of 48 months [3,4,5,6,7].
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