title: Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease: a randomised trial.
abstract: BACKGROUND
  High-dose chemotherapy followed by transplantation of autologous haemopoietic stem cells (BEAM-HSCT) is frequently used to treat patients with relapsed Hodgkin's disease. We aimed to compare this treatment with conventional aggressive chemotherapy without stem-cell transplantation (Dexa-BEAM).
  
  
  METHODS
  161 patients between 16 and 60 years of age with relapsed Hodgkin's disease were randomly assigned two cycles of Dexa-BEAM (dexamethasone and carmustine, etoposide, cytarabine, and melphalan) and either two further courses of Dexa-BEAM or high-dose BEAM and transplantation of haemopoietic stem cells. Only patients with chemosensitive disease (complete or partial remission after two courses of Dexa-BEAM) proceeded to further treatment. The primary endpoint was freedom from treatment failure for patients with chemosensitive disease. Analysis was per protocol.
  
  
  RESULTS
  17 patients were excluded from the study after randomisation (ten given Dexa-BEAM and seven given BEAM-HSCT). Median follow-up was 39 months (IQR 3-78). Freedom from treatment failure at 3 years was significantly better for patients given BEAM-HSCT (55%) than for those on Dexa-BEAM (34%; difference -21%, 95% CI -39.87 to -2.13; p=0.019). Overall survival of patients given either treatment did not differ significantly.
  
  
  CONCLUSIONS
  High-dose BEAM and transplantation of haemopoietic stem cells improves freedom from treatment failure in patients with chemosensitive first relapse of Hodgkin's disease irrespective of length of initial remission.
authors.affiliation: Department of Internal Medicine II, University of Kiel, Kiel, Germany
authors.forename: Norbert
authors.initials: N
authors.lastname: Schmitz
authors.forename: Beate
authors.initials: B
authors.lastname: Pfistner
authors.forename: Michael
authors.initials: M
authors.lastname: Sextro
authors.forename: Markus
authors.initials: M
authors.lastname: Sieber
authors.forename: Angelo M
authors.initials: AM
authors.lastname: Carella
authors.forename: Matthias
authors.initials: M
authors.lastname: Haenel
authors.forename: Friederike
authors.initials: F
authors.lastname: Boissevain
authors.forename: Reinhart
authors.initials: R
authors.lastname: Zschaber
authors.forename: Peter
authors.initials: P
authors.lastname: Müller
authors.forename: Hartmut
authors.initials: H
authors.lastname: Kirchner
authors.forename: Andreas
authors.initials: A
authors.lastname: Lohri
authors.forename: Susanne
authors.initials: S
authors.lastname: Decker
authors.forename: Bettina
authors.initials: B
authors.lastname: Koch
authors.forename: Dirk
authors.initials: D
authors.lastname: Hasenclever
authors.forename: Anthony H
authors.initials: AH
authors.lastname: Goldstone
authors.forename: Volker
authors.initials: V
authors.lastname: Diehl
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002330:Carmustine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002423:Cause of Death; D003561:Cytarabine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005047:Etoposide / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006689:Hodgkin Disease / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D012008:Recurrence; D016879:Salvage Therapy / Q000379:methods*
chemical_list: D003561:Cytarabine; D005047:Etoposide; D003907:Dexamethasone; D008558:Melphalan; D002330:Carmustine