title: Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma.
abstract: OBJECTIVE
  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.
  
  
  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%).
  
  
  CONCLUSIONS
  Oral lenalidomide monotherapy is active in relapsed or refractory aggressive NHL, with manageable side effects.
authors.affiliation: Our Lady of Mercy Cancer Center, New York Medical College, Bronx, NY, USA.
authors.forename: Peter H
authors.initials: PH
authors.lastname: Wiernik
authors.forename: Izidore S
authors.initials: IS
authors.lastname: Lossos
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Tuscano
authors.forename: Glen
authors.initials: G
authors.lastname: Justice
authors.forename: Julie M
authors.initials: JM
authors.lastname: Vose
authors.forename: Craig E
authors.initials: CE
authors.lastname: Cole
authors.forename: Wendy
authors.initials: W
authors.lastname: Lam
authors.forename: Kyle
authors.initials: K
authors.lastname: McBride
authors.forename: Kenton
authors.initials: K
authors.lastname: Wride
authors.forename: Dennis
authors.initials: D
authors.lastname: Pietronigro
authors.forename: Kenichi
authors.initials: K
authors.lastname: Takeshita
authors.forename: Annette
authors.initials: A
authors.lastname: Ervin-Haynes
authors.forename: Jerome B
authors.initials: JB
authors.lastname: Zeldis
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Habermann
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D000077269:Lenalidomide; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011446:Prospective Studies; D012074:Remission Induction; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide