Originally published as JCO Early Release 10.1200/JCO.2007.15.3429 on July 7 2008

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

Peter H. Wiernik, Izidore S. Lossos, Joseph M. Tuscano, Glen Justice, Julie M. Vose, Craig E. Cole, Wendy Lam, Kyle McBride, Kenton Wride, Dennis Pietronigro, Kenichi Takeshita, Annette Ervin-Haynes, Jerome B. Zeldis, Thomas M. Habermann

From Our Lady of Mercy Cancer Center, New York Medical College, Bronx, NY; Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL; University of California, Davis Cancer Center, Sacramento; Pacific Coast Hematology/Oncology Medical Group, Fountain Valley, CA; University of Nebraska, Nebraska Medical Center, Omaha, NE; Gundersen Clinic, La Crosse, WI; BC Community Oncology Trialists, Burnaby, British Columbia, Canada; Instat Services, Chatham; Celgene Corporation, Summit, NJ; and Mayo Clinic, Rochester, MN

Corresponding author: Thomas M. Habermann, MD, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: habermann.thomas{at}mayo.edu

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.

published online ahead of print at www.jco.org on July 7, 2008.

Supported by Celgene Corporation, Summit, NJ. Editorial/writing support from Excerpta Medica (funded by Celgene).

Presented in part as oral presentations at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, FL, and the 3rd International Conference of Innovative Therapies for Lymphoid Malignancies, September 28, 2006, Palermo, Italy; and as poster presentations at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, FL, the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and the Pan Pacific Lymphoma Conference, June 11-15, 2007, Maui, HI.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00179660 [ClinicalTrials.gov]

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