title: Lenalidomide oral monotherapy produces durable responses in relapsed or refractory indolent non-Hodgkin's Lymphoma.
abstract: OBJECTIVE
  Lenalidomide is a novel immunomodulatory agent with antiproliferative activities. Given its efficacy in a wide range of hematologic malignancies, we conducted a phase II trial (NHL-001) of single-agent lenalidomide in indolent non-Hodgkin's lymphoma (NHL).
  
  
  METHODS
  Patients with relapsed/refractory indolent NHL were eligible, with no limit on the number of previous therapies. Oral lenalidomide 25 mg was self-administered once daily on days 1 to 21 of every 28-day cycle for up to 52 weeks as tolerated, or until disease progression. The primary end point was objective response rate (ORR), with secondary end points of duration of response (DR), progression-free survival (PFS), and safety.
  
  
  RESULTS
  Forty-three enrolled patients were assessable for response and safety. Patients received a median of three prior systemic therapies (range, 1 to 17) and half were refractory to last therapy. ORR was 23% (10 of 43), including a 7% complete response (CR) or unconfirmed CR rate. Twenty-seven percent (six of 22) of patients with follicular lymphoma grade 1 or 2, and 22% (four of 18) with small lymphocytic lymphoma responded to therapy. Median DR was not reached, but was longer than 16.5 months with seven of 10 responses ongoing at 15 to 28 months. Median PFS for the whole group was 4.4 months (95% CI, 2.5 to 10.4 months). Adverse events were predictable and manageable; the most common grade 3 or 4 adverse events were neutropenia (30% and 16%, respectively) and thrombocytopenia (14% and 5%, respectively).
  
  
  CONCLUSIONS
  Oral lenalidomide monotherapy produces durable responses with manageable adverse events in patients with relapsed/refractory indolent NHL, warranting further investigation of treatment for indolent NHL.
authors.affiliation: Mayo Clinic, Rochester, MN 55905, USA. witzig@mayo.edu
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Witzig
authors.forename: Peter H
authors.initials: PH
authors.lastname: Wiernik
authors.forename: Timothy
authors.initials: T
authors.lastname: Moore
authors.forename: Craig
authors.initials: C
authors.lastname: Reeder
authors.forename: Craig
authors.initials: C
authors.lastname: Cole
authors.forename: Glen
authors.initials: G
authors.lastname: Justice
authors.forename: Henry
authors.initials: H
authors.lastname: Kaplan
authors.forename: Michael
authors.initials: M
authors.lastname: Voralia
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: Julie M
authors.initials: JM
authors.lastname: Vose
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003248:Constipation / Q000139:chemically induced; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D000077269:Lenalidomide; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D012008:Recurrence; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide