Dennis Pietronigro

Lenalidomide Monotherapy in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

PURPOSE The major cause of death in aggressive lymphoma is relapse or nonresponse to initial therapy. Lenalidomide has activity in a variety of hematologic malignancies, including non-Hodgkins lymphoma (NHL). We report the results of a phase II, single-arm, multicenter trial evaluating the safety and efficacy of lenalidomide oral monotherapy in patients with relapsed or refractory aggressive NHL. PATIENTS AND METHODS Patients were treated with oral lenalidomide 25 mg once daily on days 1 to 21, every 28 days, for 52 weeks, until disease progression or intolerance. The primary end point was response; secondary end points included duration of response, progression-free survival (PFS), and safety. RESULTS Forty-nine patients with a median age of 65 years received lenalidomide in this study. The most common histology was diffuse large B-cell lymphoma (53%), and patients had received a median of four prior treatment regimens for NHL. An objective response rate of 35% was observed in 49 treated patients, including a 12% rate of complete response/unconfirmed complete response. Responses were observed in each aggressive histologic subtype tested (diffuse large B-cell, follicular center grade 3, mantle cell, and transformed lymphomas). Of patients with stable disease or partial response at first assessment, 25% improved with continued treatment. Estimated median duration of response was 6.2 months, and median PFS was 4.0 months. The most common grade 4 adverse events were neutropenia (8.2%) and thrombocytopenia (8.2%); the most common grade 3 adverse events were neutropenia (24.5%), leukopenia (14.3%), and thrombocytopenia (12.2%). CONCLUSION Oral lenalidomide monotherapy is active in relapsed or refractory aggressive NHL, with manageable side effects.

Safety of lenalidomide monotherapy in patients with relapsed or refractory aggressive non-Hodgkin’s lymphom

8603 Background: Lenalidomide is active in non-Hodgkin s Lymphoma (NHL). The aim of this analysis was to evaluate the safety of lenalidomide monotherapy in patients with relapsed/refractory aggressive NHL enrolled in 2 phase II clinical trials (NHL-002 and NHL-003). Methods: Patients with relapsed/refractory aggressive NHL with measurable disease after ≥1 prior treatment regimen were treated with oral lenalidomide (25 mg) once daily on Days 1–21 every 28 days and continued therapy as tolerated or until disease progression. Safety was evaluated using the NCI CTC criteria. Results: The intent-to-treat population (n=136) was used to report data, except for dosage data (safety population n=131). The median age was 66 (21–86) years, 63% were male, 52% had an international prognostic index score of ≤2, and 23% had prior stem cell transplantation. The median dose of lenalidomide was 25.0 (8.8–25.0) mg/day. Common (≥10%) adverse events (AEs; all grades) were fatigue, neutropenia, rash, thrombocytopenia, constipat...