title: An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.
abstract: BACKGROUND
  Lenalidomide is an immunomodulatory agent with antitumor activity in B-cell malignancies. This phase II trial aimed to demonstrate the safety and efficacy of lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular grade 3 lymphoma (FL-III), or transformed lymphoma (TL).
  
  
  METHODS
  Patients received oral lenalidomide 25 mg on days 1-21 every 28 days as tolerated or until progression. The primary end point was overall response rate (ORR).
  
  
  RESULTS
  Two hundred and seventeen patients enrolled and received lenalidomide. The ORR was 35% (77/217), with 13% (29/217) complete remission (CR), 22% (48/217) partial remission, and 21% (45/217) with stable disease. The ORR for DLBCL was 28% (30/108), 42% (24/57) for MCL, 42% (8/19) for FL-III, and 45% (15/33) for TL. Median progression-free survival for all 217 patients was 3.7 months [95% confidence interval (CI) 2.7-5.1]. For 77 responders, the median response duration lasted 10.6 months (95% CI 7.0-NR). Median response duration was not reached in 29 patients who achieved a CR and in responding patients with FL-III or MCL. The most common adverse event was myelosuppression with grade 4 neutropenia and thrombocytopenia in 17% and 6%, respectively.
  
  
  CONCLUSIONS
  Lenalidomide is well tolerated and produces durable responses in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma.
authors.affiliation: Department of Medicine, Division of Hematology, Mayo Clinic, Rochester. Electronic address: witzig@mayo.edu.
authors.forename: T E
authors.initials: TE
authors.lastname: Witzig
authors.affiliation: Section of Hematology/Oncology, University of Nebraska, Omaha, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Vose
authors.affiliation: Institute of Hematology and Oncology Seragnoli, University of Bologna, Bologna, Italy.
authors.forename: P L
authors.initials: PL
authors.lastname: Zinzani
authors.affiliation: Department of Medicine, Division of Hematology, Mayo Clinic, Scottsdale, USA.
authors.forename: C B
authors.initials: CB
authors.lastname: Reeder
authors.affiliation: Department of Hematology, Sunnybrook Odette Cancer Center, Toronto, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Buckstein
authors.affiliation: Department of Hematology/Oncology, Kaiser Permanente Medical Group, San Diego, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Polikoff
authors.affiliation: Department of Hematology, Institut Paoli Calmettes, Marseilles.
authors.forename: R
authors.initials: R
authors.lastname: Bouabdallah
authors.affiliation: Department of Hôpital Henri Mondor-AP-HP, Créteil.
authors.forename: C
authors.initials: C
authors.lastname: Haioun
authors.affiliation: Department of Centre Henri Becquerel, Rouen, France.
authors.forename: H
authors.initials: H
authors.lastname: Tilly
authors.affiliation: Department of Celgene Corporation, Summit.
authors.forename: P
authors.initials: P
authors.lastname: Guo
authors.affiliation: Department of Celgene Corporation, Summit.
authors.forename: D
authors.initials: D
authors.lastname: Pietronigro
authors.affiliation: Department of Celgene Corporation, Summit.
authors.forename: A L
authors.initials: AL
authors.lastname: Ervin-Haynes
authors.affiliation: Department of Medicine, Lymphoma/Myeloma Service, Roswell Park Cancer Institute, Buffalo, USA.
authors.forename: M S
authors.initials: MS
authors.lastname: Czuczman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007390:International Agencies; D000077269:Lenalidomide; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000473:pathology; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000473:pathology; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D013792:Thalidomide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide