Abstract

8573 Background: Small lymphocytic lymphoma (SLL) is an indolent B-cell neoplasm that is histologically and immunophenotypically identical to chronic lymphocytic leukemia (CLL), but has less peripheral blood involvement. Treatment is similar to other indolent lymphomas. Lenalidomide (Revlimid®) is approved for treatment of patients with transfusion-dependent myelodysplastic syndromes associated with a deletion 5q [31] cytogenetic abnormality in the US and previously treated multiple myeloma in both the US and the EU. The aim of this subgroup analysis was to determine the safety and efficacy of lenalidomide monotherapy in patients with relapsed/refractory (r/r) SLL. Methods: Patients with r/r indolent non-Hodgkin’s lymphoma (NHL) with measurable disease after at least 1 prior treatment regimen were eligible; patients with SLL were included in this analysis. Patients received 25 mg lenalidomide orally once daily on Days 1–21 every 28 days and continued therapy for 52 weeks as tolerated or until disease progression. Response and disease progression were evaluated using the IWLRC methodology. Results: Eighteen patients with SLL were enrolled. Median age was 65 (55–85) years and 7 were female. Median time from diagnosis to lenalidomide therapy was 4.1 (0.4–15.8) years and median number of prior treatment regimens was 3 (1–15). Four patients (22%) exhibited an objective response (1 unconfirmed complete response and 3 partial responses), 7 had stable disease, 5 had progressive disease and 2 were not evaluated. Progression-free survival is >6.5 months and ongoing. Grade 4 adverse events were neutropenia (28%) and thrombocytopenia (6%). The most common Grade 3 adverse events were neutropenia (33%) and thrombocytopenia (22%). Three patients (14%) experienced Grade 1/2 tumor flare. Conclusions: Lenalidomide oral monotherapy is active with manageable side effects in r/r SLL. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Celgene Corporation Celgene Corporation Celgene Corporation Celgene Corporation Celgene Corporation

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