High-dose chemotherapy for breast cancer: the French PEGASE experience.

BACKGROUND Early studies of high-dose chemotherapy (HDC) for breast cancer were limited by small numbers and the lack of adequate control groups. The French PEGASE Group was founded to perform larger and properly randomized comparative studies of this approach. METHODS The program was created to determine the effects of intensive chemotherapy for breast cancer. The seven PEGASE protocols addressed HDC as adjuvant therapy (01 and 06) and as treatment for inflammatory nonmetastatic disease (02, 05, and 07) and metastatic disease (03 and 04). Two of these protocols are ongoing. RESULTS The PEGASE 01 adjuvant therapy trial showed that 3-year disease-free survival was significantly better in the HDC arm but overall survival was unchanged. The ongoing phase III 06 trial is studying a higher dosage regimen. The HDC trials for metastatic and inflammatory nonmetastatic disease are encouraging. CONCLUSIONS Many clinicians no longer subscribe to the concept of HDC for breast cancer. Overall outcomes from management of poor-risk breast cancer remain poor, however, and it is possible that some selected subgroups of patients may benefit from such an approach.