International study of lenalidomide in relapsed/refractory aggressive non-Hodgkin’s lymphoma

Abstract

8509 Background: Lenalidomide is active with manageable side effects in non-Hodgkin’s lymphoma (NHL). This study aims to confirm the activity, safety, and predictors of response previously reported for lenalidomide in patients with relapsed/refractory (r/r) aggressive NHL in an international setting. Methods: Patients with r/r aggressive NHL with measurable disease (≥2 cm) after ≥1 prior treatment regimen were eligible. Patients received 25 mg lenalidomide orally once daily on Days 1- 21 every 28 days and continued therapy as tolerated or until disease progression. Response and progression were evaluated using the IWLRC methodology. Predictors of response were investigated by univariate analyses using Fisher’s exact test. Results: As of August 25, 2007, 46 patients were eligible for response assessment and 79 for safety evaluation. Median age was 65 (21–84) years, 74% were male, and 96% had received prior rituximab. Median time from diagnosis was 2 (0.2–12) years and median number of prior treatment regimens was 3.5 (1–13). An objective response was observed in 13 patients (28%); 10 patients had stable disease. Lenalidomide response was associated with low tumor burden (33% for <50 cm2 v 17% for ≥50 cm2) and time from last rituximab dose to lenalidomide treatment (44% for ≥230 days v 5% for <230 days). The response rate in patients with favorable values for these predictive factors (n=20) was 50% versus 12% in patients with unfavorable values (n=26; P=0.007). Most common grade 3/4 adverse events were neutropenia (24%), thrombocytopenia (16%), leukopenia (9%), anemia (6%), dehydration (5%), and fatigue (5%). Conclusions: Lenalidomide has activity in r/r aggressive NHL with a favorable safety profile. Early data appear to confirm that patients with low tumor burden and longer duration from prior rituximab are more likely to respond. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Celgene Corporation Celgene Corporation Celgene Corporation