Preliminary results of the EORTC-GPMC controlled clinical trial H7 in early-stage Hodgkin's disease. EORTC Lymphoma Cooperative Group. Groupe Pierre-et-Marie-Curie

Ann Oncol. 1994:5 Suppl 2:107-12. doi: 10.1093/annonc/5.suppl_2.s107.

Abstract

In this phase III trial, 770 patients with clinical stage I-II Hodgkin's disease (HD) have been enrolled since November 1988. Preliminary results are given for the 605 (79%) patients who have completed their initial therapy. Patients were grouped according to 6 pretreatment prognostic characteristics. In the very favourable (VF) group, treatment consisted of mantle field alone. In the favourable (F) group, patients were randomized to either subtotal nodal irradiation (STNI), or 6 cycles of EBVP (epirubicin, bleomycin, vinblastine, prednisone) followed by involved-field irradiation (IF-RT). Unfavourable (U) patients were randomized to either 6 cycles of EBVP plus IF-RT, or to 6 cycles of MOPP/ABV hybrid plus IF-RT. Of the 35 VF patients, none have progressed during radiotherapy. Four patients relapsed and were salvaged. Three-year failure-free survival (FFS) was 82%; overall survival (OS) was 100%. Of the 254 F patients, 130 were treated with STNI and 124 with EBVP plus IF-RT. At 3 years, FFS rates were 81% (1 progression, 14 relapses) and 79% (5 progressions, 8 relapses), respectively. Corresponding OS rates were 99% and 100%. Of the 316 U patients, 160 received EBVP and 156 MOPP/ABV. At 3 years, FFS rates were 72% (18 progressions, 20 relapses) and 88% (7 progressions, 6 relapses), respectively (p < 0.001). Although OS rates were identical (92%), the entry in the U-EBVP arm was stopped in November 1992. We conclude that a treatment strategy based on prognostic factors allows the use of less aggressive treatment in favourable patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bleomycin / administration & dosage
  • Bleomycin / adverse effects
  • Combined Modality Therapy
  • Doxorubicin / administration & dosage
  • Doxorubicin / adverse effects
  • Epirubicin / administration & dosage
  • Epirubicin / adverse effects
  • Female
  • Hodgkin Disease / drug therapy
  • Hodgkin Disease / mortality
  • Hodgkin Disease / pathology
  • Hodgkin Disease / radiotherapy*
  • Humans
  • Male
  • Mechlorethamine / administration & dosage
  • Mechlorethamine / adverse effects
  • Middle Aged
  • Neoplasm Staging
  • Prednisone / administration & dosage
  • Prednisone / adverse effects
  • Procarbazine / administration & dosage
  • Procarbazine / adverse effects
  • Prognosis
  • Radiotherapy / adverse effects
  • Salvage Therapy
  • Survival Rate
  • Treatment Outcome
  • Vinblastine / administration & dosage
  • Vinblastine / adverse effects
  • Vincristine / administration & dosage
  • Vincristine / adverse effects

Substances

  • Bleomycin
  • Procarbazine
  • Epirubicin
  • Mechlorethamine
  • Vincristine
  • Vinblastine
  • Doxorubicin
  • Prednisone

Supplementary concepts

  • EBVP protocol
  • MOPP-ABV protocol