High-Dose Chemotherapy for Breast Cancer: The French PEGASE Experience

Henri Roché, MD, PhD, Patrice Viens, MD, Pierre Biron, MD, Jean-Pierre Lotz, MD, and Bernard Asselain, MD, PhD, for the PEGASE Group


Cancer Control. 2003;10(1) 

In This Article

Abstract and Introduction

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.

In the early 1990s, tremendous enthusiasm developed for the application of intensive chemotherapy in treating breast cancer. Based on experience of high-dose chemotherapy (HDC) with hematologic diseases, HDC demonstrated some unexpected responses in patients with advanced breast cancer. Many small, open phase II studies were conducted first with alkylating agents alone, then with multidrug combinations as salvage therapy for nonresponding metastatic patients, and finally for patients responding to conventional treatments.[1] An extension to the adjuvant setting was then initiated in nonrandomized trials.[2] A confusing debate within the oncology community and with patients' associations and insurance companies led to the organization of consensus conferences on efficacy and cost, as in Lyon in 1993.[3] The requirement that phase III adjuvant studies must be large enough to detect survival differences in the magnitude of 10% to 20% was the basis for the formation of national and intergroup programs.


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