title: Treatment of patients with advanced or bulky Hodgkin disease with a 12-week doxorubicin, bleomycin, vinblastine, and dacarbazine-like chemotherapy regimen followed by extended-field, full-dose radiotherapy: long-term results of the Groupe Ouest et Est des Leucémies et Autres Maladies de Sang H90-A/B Multicenter Randomized Trial.
abstract: BACKGROUND
  This Phase II study was performed in patients with advanced or bulky Hodgkin disease (HD) to evaluate the results of a 7-drug chemotherapy (CT) regimen that was administered over 12 weeks according to 2 randomized modalities followed by high-dose lymph node irradiation.
  
  
  METHODS
  From 1990 to 1996, 162 patients with HD at clinical stages (CS) I-III with bulky disease (mediastinal mass ratio >or= 0.45 and/or unilateral or bilateral pelvic plus lumboaortic disease; 86 patients) or CS IV (76 patients) were randomized to receive the same cumulated dose of a CT regimen consisting of epirubicin (240 mg/m(2)), bleomycin (60 mg/m(2)), vinblastine (20 mg/m(2)), vincristine (4 mg/m(2)), cyclophosphamide (4000 mg/m(2)), etoposide (900 mg/m(2)), and methotrexate (180 mg/m(2)) plus methylprednisolone (1500 mg/m(2)) over 12 weeks either every 4 weeks (Arm Y, 79 patients) or every 3 weeks (Arm Z, 83 patients). Patients with disease in complete remission (CR) or partial remission after CT received extended-field lymph node irradiation (involved areas, 40 grays [Gy]; noninvolved areas, 30 Gy).
  
  
  RESULTS
  Forty-two percent of patients achieved a post-CT CR, and 86% of patients achieved a CR after the completion of irradiation (there was no difference between Arm Y and Arm Z). Thirty-five patients developed recurrent disease; most of those patients were in post-CT partial remission. The 10-year freedom from first progression rate was 63.9% (there was no difference between Arm Y and Arm Z). Thirty-eight patients died: 24 patients from HD, 3 patients from CT-related early sepsis, 1 patient from radiation-induced pneumonitis, 6 patients from a second malignancy, and 4 patients from causes unrelated to treatment. The overall 10-year survival rate was 76.7%. Survival was slightly higher among patients in Arm Y (83.3%) compared with patients in Arm Z (70.2%; P = 0.12).
  
  
  CONCLUSIONS
  No differences were found when the same amount of CT was delivered in three courses or in four courses. In 1997, because most recurrences of the H90-A/B trial occurred in patients who achieved a post-CT partial remission, the authors decided to reinforce the intensity of the initial CT and designed a new randomized study comparing two modalities of more intensive CT plus consolidative radiotherapy (H97-LM trial).
authors.affiliation: Cancérologie, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Malika
authors.initials: M
authors.lastname: Djeridane
authors.forename: Stéphane
authors.initials: S
authors.lastname: Oudard
authors.forename: Martine
authors.initials: M
authors.lastname: Escoffre-Barbe
authors.forename: Laurence
authors.initials: L
authors.lastname: Lacotte-Thierry
authors.forename: Bernard
authors.initials: B
authors.lastname: Desablens
authors.forename: Jean
authors.initials: J
authors.lastname: Briére
authors.forename: Mamoun
authors.initials: M
authors.lastname: Dib
authors.forename: Philippe
authors.initials: P
authors.lastname: Cassasus
authors.forename: Christiane
authors.initials: C
authors.lastname: Ghandour
authors.forename: Thierry
authors.initials: T
authors.lastname: Lamy
authors.forename: Françoise
authors.initials: F
authors.lastname: Lejeune
authors.forename: Marc
authors.initials: M
authors.lastname: Simon
authors.forename: Catherine
authors.initials: C
authors.lastname: Traullé
authors.forename: Magda
authors.initials: M
authors.lastname: Vigier
authors.forename: Henri
authors.initials: H
authors.lastname: Maisonneuve
authors.forename: Josette
authors.initials: J
authors.lastname: Briére
authors.forename: Pierre
authors.initials: P
authors.lastname: Colonna
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Andrieu
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D016896:Treatment Outcome
chemical_list: D001761:Bleomycin; D003606:Dacarbazine; D004317:Doxorubicin