title: Phase II study of bendamustine in relapsed and refractory Hodgkin lymphoma.
abstract: OBJECTIVE
  Limited data exist regarding the activity of bendamustine in Hodgkin lymphoma (HL). This phase II study evaluated the efficacy of bendamustine in relapsed and refractory HL.
  
  
  METHODS
  Patients with relapsed and refractory HL who were ineligible for autologous stem-cell transplantation (ASCT), or for whom this treatment failed, received bendamustine 120 mg/m(2) as a 30-minute infusion on days 1 and 2 every 28 days with growth factor support. The primary end point was overall response rate (ORR). A secondary end point was referral rate to allogeneic stem-cell transplantation (alloSCT) for patients deemed eligible for alloSCT at the time of enrollment.
  
  
  RESULTS
  Of the 36 patients enrolled, 34 were evaluable for response. Patients had received a median of four prior treatments, and 75% had relapsed after ASCT. The ORR by intent-to-treat analysis was 53%, including 12 complete responses (33%) and seven partial responses (19%). The response rate among evaluable patients was 56%. Responses were seen in patients with prior refractory disease, prior ASCT, and prior alloSCT; however, no responses were seen in patients who relapsed within 3 months of ASCT. The median response duration was 5 months. Five patients (20% of those eligible) proceeded to alloSCT after treatment with bendamustine. Grade ≥ 3 adverse events were infrequent and most commonly included thrombocytopenia (20%), anemia (14%), and infection (14%).
  
  
  CONCLUSIONS
  This study confirms the efficacy of bendamustine in heavily pretreated patients with HL. These results support current and future studies evaluating bendamustine combinations in relapsed and refractory HL.
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York, NY, 10065, USA. moskowia@mskcc.org
authors.forename: Alison J
authors.initials: AJ
authors.lastname: Moskowitz
authors.forename: Paul A
authors.initials: PA
authors.lastname: Hamlin
authors.forename: Miguel-Angel
authors.initials: MA
authors.lastname: Perales
authors.forename: John
authors.initials: J
authors.lastname: Gerecitano
authors.forename: Steven M
authors.initials: SM
authors.lastname: Horwitz
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Matasar
authors.forename: Ariela
authors.initials: A
authors.lastname: Noy
authors.forename: Maria Lia
authors.initials: ML
authors.lastname: Palomba
authors.forename: Carol S
authors.initials: CS
authors.lastname: Portlock
authors.forename: David J
authors.initials: DJ
authors.lastname: Straus
authors.forename: Tricia
authors.initials: T
authors.lastname: Graustein
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Zelenetz
authors.forename: Craig H
authors.initials: CH
authors.lastname: Moskowitz
mesh_terms: D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D000069461:Bendamustine Hydrochloride; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride