title: Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study.
abstract: BACKGROUND
  Mantle cell lymphoma (MCL) is an uncommon type of non-Hodgkin lymphoma with poor overall prognosis, requiring the development of new therapies. Lenalidomide is an immunomodulatory agent demonstrating antitumor and antiproliferative effects in MCL. We report results from a long-term subset analysis of 57 patients with relapsed/refractory MCL from the NHL-003 phase II multicenter study of single-agent lenalidomide in patients with aggressive lymphoma
  
  
  METHODS
  Lenalidomide was administered orally 25 mg daily on days 1-21 every 28 days until progressive disease (PD) or intolerability. The primary end point was overall response rate (ORR).
  
  
  RESULTS
  Fifty-seven patients with relapsed/refractory, advanced-stage MCL had a median of three prior therapies. The ORR was 35% [complete response (CR)/CR unconfirmed (CRu) 12%], with a median duration of response (DOR) of 16.3 months (not yet reached in patients with CR/CRu) by blinded independent central review. The median time to first response was 1.9 months. Median progression-free survival was 8.8 months, and overall survival had not yet been reached. The most common grade 3/4 adverse events (AEs) were neutropenia (46%), thrombocytopenia (30%), and anemia (13%).
  
  
  CONCLUSIONS
  These results show the activity of lenalidomide in heavily pretreated, relapsed/refractory MCL. Responders had a durable response with manageable side-effects. Clinical trial number posted on www.clinicaltrials.gov NCT00413036.
authors.affiliation: Institute of Hematology 'Seràgnoli', University of Bologna, Bologna, Italy.
authors.forename: P L
authors.initials: PL
authors.lastname: Zinzani
authors.forename: J M
authors.initials: JM
authors.lastname: Vose
authors.forename: M S
authors.initials: MS
authors.lastname: Czuczman
authors.forename: C B
authors.initials: CB
authors.lastname: Reeder
authors.forename: C
authors.initials: C
authors.lastname: Haioun
authors.forename: J
authors.initials: J
authors.lastname: Polikoff
authors.forename: H
authors.initials: H
authors.lastname: Tilly
authors.forename: L
authors.initials: L
authors.lastname: Zhang
authors.forename: K
authors.initials: K
authors.lastname: Prandi
authors.forename: J
authors.initials: J
authors.lastname: Li
authors.forename: T E
authors.initials: TE
authors.lastname: Witzig
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D000077269:Lenalidomide; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D012008:Recurrence; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D000077269:Lenalidomide
keywords: lenalidomide; mantle cell lymphoma; non-Hodgkin lymphoma
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