Intensification thérapeutique et autogreffe de cellules souches hématopoïétiques (CSH) dans le traitement des cancers du sein métastatiques : résultats du programme national Pegase 04

Abstract

We report hereby the results of the french multicentric randomized PEGASE 04 protocol established to evaluate the impact on survival of high-dose chemotherapy over conventional chemotherapy for MBC patients.

Patients and methods:Inclusion criteria were : age < 60 year, PS < 2, adenocarcinoma initially metastatic or in first relapse, chemosensitive disease. Randomization was done after 4-6 courses of conventionnal chemotherapy between high-dose (Mitoxantrone, 45 mg/m², Cyclophosphamide 120 mg/kg, Melphalan 140 mg/m²), and the pursuit of the same conventionnal chemotherapy. Between 09/92 and 12/96, 61 chemosensitive patients were enrolled 29 were referred to standard chemotherapy, 32 to intensive therapy. At randomization, 13 pts (21.3%) were in complete response and 48 in partial response.

ResultsThe median progression-free survivals were 20 and 35.3 months in the standard and intensive groups (p=0.06). The relapse rates were respectively 79.3% vs 50.8% at 3 years and 90.8% vs 90.7% at 5 years. The median overall survivals were 20 and 43.4 months, with an overall survival rate of 18.5% vs 29.8% at 5 years (p=0.12).

Conclusion The CMA regimen could prolong the progression-free survival of MBC patients, however without any significant impact on overall survival.