Lenalidomide performance in the real world: patterns of use and effectiveness in a Medicare population with myelodysplastic syndromes

Abstract

Background: Lenalidomide is approved for the treatment of anemia with transfusion dependence (TD) in patients with lower-risk myelodysplastic syndrome (MDS) with 5q deletion (del5q-MDS), but its "real-life" use and effect on transfusion needs are unclear. In the current study, the authors examined its use in the Medicare population.

Methods: Patients with MDS who were enrolled in Medicare Parts A, B, and D were identified using International Classification of Diseases 9-Clinical Modification (ICD-9) codes from 100% Medicare claims from 2006 through 2008. Patients were followed until the end of the study or death. Claims were used to determine time to initiation of lenalidomide, daily dose, duration, and other MDS therapies. Transfusion status was defined each week based on transfusion use in rolling 8-week period: TD, required transfusions during 2 weeks, separated by ≥ 3 weeks; transfusion user (TU), 1 transfusion; and transfusion independence (TI), no transfusions.

Results: A total of 753 of 23,855 patients (3.2%) received lenalidomide, including 31% of 470 patients with del5q-MDS. At the time of lenalidomide initiation, 33% of patients were TD, 31% were TU, and 36% were TI. The median time to lenalidomide initiation was shorter for patients with del5q-MDS than for other lower-risk patients (8 weeks vs 20 weeks; P < .01). The percentage of patients with del5q-MDS receiving lenalidomide increased over time. Lenalidomide initiation was found to be negatively associated with older age and baseline diabetes, stroke, and renal disease. During the observation period, 44% of TU/TD patients (53% of the patients with del5q-MDS) achieved reductions in transfusion use; among TD patients receiving ≥ 3 cycles, 77% reduced their transfusion use and 40% achieved TI.

Conclusions: To the authors' knowledge, the current study is the first report of lenalidomide use in a large Medicare-enrolled population with MDS. Reductions in transfusion rates were overall consistent with data from clinical trials. Response rates were higher when ≥ 3 lenalidomide cycles were received.

Keywords: 5q deletion; Medicare population; lenalidomide; myelodysplastic syndromes.

Figure 1

Generation of the database and the specific cohort of the study. MDS: Myelodysplastic syndromes, W/O: without, LIS: low income subsidy.

Figure 2

Change in transfusion status with lenalidomide therapy. The bar in the middle reports the distribution of patients by transfusion status at lenalidomide therapy initiation , while the pie charts represent the change in transfusion status during observation period. A: For all patients. B: for patients who received ≥3 cycles of lenalidomide. TI: transfusion-independent, TD: transfusion-dependent, TU: transfusion-user.

Figure 2

Change in transfusion status with lenalidomide therapy. The bar in the middle reports the distribution of patients by transfusion status at lenalidomide therapy initiation , while the pie charts represent the change in transfusion status during observation period. A: For all patients. B: for patients who received ≥3 cycles of lenalidomide. TI: transfusion-independent, TD: transfusion-dependent, TU: transfusion-user.