title: Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma.
abstract: BACKGROUND
  Patients with T-cell lymphomas face a poorer prognosis compared with patients with B-cell lymphomas. New therapeutic approaches need to be developed to improve outcomes for these patients.
  
  
  METHODS
  Forty patients with recurrent and refractory T-cell lymphomas other than mycosis fungoides and patients with untreated T-cell lymphoma who were not candidates for combination chemotherapy were prescribed oral lenalidomide at a dose of 25 mg daily on days 1 to 21 of each 28-day cycle, with standardized dose reductions for toxicity. The primary endpoint was overall response rate (ORR), and secondary endpoints were complete and partial response rates, progression-free survival (PFS), overall survival (OS), and safety. The authors also determined duration of response (DoR).
  
  
  RESULTS
  A total of 40 patients were enrolled in the current study; 1 patient was subsequently deemed ineligible. The ORR was 10 of 39 patients (26%); 3 patients (8%) achieved complete responses and 7 patients achieved partial responses. Three patients had stable disease for ≥5 cycles. The median OS was 12 months (range <1 month to ≥69 months), the median PFS was 4 months (range, <1 month to ≥50 months), and the median DoR was 13 months (range 2 months to ≥37 months), including 5 responses that lasted >1 year. Toxicity was in keeping with the known safety profile of lenalidomide. Among the patients who had recurrent/refractory peripheral T-cell lymphoma (29 patients), the ORR was 24%, the median OS was 12 months, the median PFS was 4 months, and the median DoR was 5 months (range, 2 months to ≥37 months).
  
  
  CONCLUSIONS
  In the current study, the use of oral lenalidomide monotherapy demonstrated clinically relevant efficacy among patients with systemic T-cell lymphomas. It appears to have excellent potential as an agent in combination therapy for patients with T-cell lymphoma.
authors.affiliation: Department of Medicine, Dalhousie University, Saint John, New Brunswick, Canada.
authors.forename: Ethan
authors.initials: E
authors.lastname: Toumishey
authors.forename: Angeli
authors.initials: A
authors.lastname: Prasad
authors.forename: Greg
authors.initials: G
authors.lastname: Dueck
authors.forename: Neil
authors.initials: N
authors.lastname: Chua
authors.forename: Daygen
authors.initials: D
authors.lastname: Finch
authors.forename: James
authors.initials: J
authors.lastname: Johnston
authors.forename: Richard
authors.initials: R
authors.lastname: van der Jagt
authors.forename: Doug
authors.initials: D
authors.lastname: Stewart
authors.forename: Darrell
authors.initials: D
authors.lastname: White
authors.forename: Andrew
authors.initials: A
authors.lastname: Belch
authors.forename: Tony
authors.initials: T
authors.lastname: Reiman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D056747:Immunomodulation / Q000187:drug effects; D000077269:Lenalidomide; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D012074:Remission Induction; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents; D007155:Immunologic Factors; D013792:Thalidomide; D000077269:Lenalidomide
keywords: T-cell lymphoma; immunomodulation; lenalidomide; phase 2 clinical trial