High-dose chemotherapy with autologous hematopoietic stem cell support formetastatic breast cancer: Results of the French Pegase 04 protocol

We report hereby the results of the french multicentric randomized PEGASE 0 4 protocol established to evaluate the impact on survival, of high-dose che motherapy over conventional chemotherapy for MBC patients. Patients and methods: inclusion criteria were : age less than or equal to 6 0 year, PS < 2, adenocarcinoma initially metastatic or in first relapse, ch emosensitive disease. Randomization was done after 4-6 courses of conventio nnal chemotherapy between high-dose (Mitoxantrone, 45 mg/m(2), Cyclophospha mide: 120 mg/kg, Melphalan: 140 mg/m(2)), and the pursuit of the same conve ntionnal chemotherapy. Between 09/92 and 12/96, 61 chemosensitive patients were enrolled: 29 were referred to standard chemotherapy, 32 to intensive t herapy. At randomization, 13 pts (21.3%) were in complete response and 48 i n partial response. Results: The median progression-free survivals were 20 and 35.3 months in t he standard and intensive groups (p=0.06). The relapse rates were respectiv ely 79.3% vs 50.8% at 3 years and 90.8% vs 90.7% at 5 years. The median ove rall 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.