title: High-dose therapy and autologous stem-cell transplantation versus conventional therapy for patients with advanced Hodgkin's lymphoma responding to front-line therapy.
abstract: OBJECTIVE
  To determine whether high-dose therapy (HDT) with autologous stem-cell transplantation (ASCT) should be included in the initial consolidative treatment of patients with advanced, unfavorable Hodgkin's lymphoma (HL).
  
  
  METHODS
  One hundred sixty-three patients achieving complete remission (CR) or partial remission (PR) with four initial courses of doxorubicin, bleomycin, vinblastine, and dacarbazine, or other doxorubicin-containing regimens, were randomly assigned to receive HDT plus ASCT (83 patients) versus four courses of conventional chemotherapy (80 patients). Unfavorable HL was defined as the presence of at least two of the following poor prognostic factors: high lactate dehydrogenase level, large mediastinal mass (greater than at least 33% of the thoracic diameter), more than one extranodal site, low hematocrit level, and inguinal involvement.
  
  
  RESULTS
  At the end of the treatment program, 92% of patients in arm A and 89% in arm B achieved a CR (P =.6). After a median follow-up of 48 months, the 5-year failure-free survival rates were 75% (95% confidence interval [CI], 65 to 85) in arm A and 82% (95% CI, 73 to 90) in arm B (P =.4). The 5-year overall survival rates were 88% (95% CI, 80 to 96) in arm A and 88% (95% CI, 79 to 96) in arm B (P =.99). The 5-year relapse-free survival rates were 88% in arm A (95% CI, 80 to 96) and 94% in arm B (95% CI, 88 to 100), and the difference was not significant (P =.3).
  
  
  CONCLUSIONS
  Patients with advanced unfavorable HL achieving CR or PR after four courses of doxorubicin-containing regimens have a favorable outcome with conventional chemotherapy. No benefit from an early intensification with HDT and ASCT was shown.
authors.affiliation: Dipartimento di Oncologia ed Ematologia, Università di Modena e Reggio Emilia, Centro Oncologico Modenese, via del Pozzo, 71 41100 Modena, Italy. federico@unimore.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Federico
authors.forename: Monica
authors.initials: M
authors.lastname: Bellei
authors.forename: Pauline
authors.initials: P
authors.lastname: Brice
authors.forename: Maura
authors.initials: M
authors.lastname: Brugiatelli
authors.forename: Arnon
authors.initials: A
authors.lastname: Nagler
authors.forename: Christian
authors.initials: C
authors.lastname: Gisselbrecht
authors.forename: Luciano
authors.initials: L
authors.lastname: Moretti
authors.forename: Philippe
authors.initials: P
authors.lastname: Colombat
authors.forename: Stefano
authors.initials: S
authors.lastname: Luminari
authors.forename: Francesco
authors.initials: F
authors.lastname: Fabbiano
authors.forename: Nicola
authors.initials: N
authors.lastname: Di Renzo
authors.forename: Anthony
authors.initials: A
authors.lastname: Goldstone
authors.forename: Angelo Michele
authors.initials: AM
authors.lastname: Carella
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin; D016009:Chi-Square Distribution; D003131:Combined Modality Therapy; D003606:Dacarbazine; D004317:Doxorubicin; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006689:Hodgkin Disease / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008130:Lomustine; D008297:Male; D008466:Mechlorethamine; D008875:Middle Aged; D011241:Prednisone; D011344:Procarbazine; D016019:Survival Analysis; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014747:Vinblastine; D014750:Vincristine
chemical_list: D001761:Bleomycin; D011344:Procarbazine; D008466:Mechlorethamine; D014750:Vincristine; D014747:Vinblastine; D008130:Lomustine; D003606:Dacarbazine; D004317:Doxorubicin; D011241:Prednisone