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

Authors:
  • ILIzidore S. Lossos
    Izidore S. Lossos
  • JTJoseph M. Tuscano
    Joseph M. Tuscano
  • GJGlen Justice
    Glen Justice
  • JVJulie M. Vose
    Julie M. Vose
  • CCCraig E. Cole
    Craig E. Cole
  • WLWendy Lam
    Wendy Lam
  • KMKyle McBride
    Kyle McBride
  • KWKenton Wride
    Kenton Wride
  • DPDennis Pietronigro
    Dennis Pietronigro
  • KTKenichi Takeshita
    Kenichi Takeshita
  • AEAnnette Ervin-Haynes
    Annette Ervin-Haynes
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Abstract
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-Hodgkin's 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.

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