Scandinavian Study Finds No Overall Survival Benefit to High-Dose Chemotherapy in Primary Breast Cancer

University of Pennsylvania Cancer Center
Last Modified: May 17, 1999

A randomized Scandinavian study of 525 women with high-risk breast cancer, conducted over a four year period betwen 1994-1998 at a constant inclusion rate, indicates that there is no overall benefit to high-dose chemotherapy with bone marrow stem cell support versus those who received "tailored" chemotherapy doses tailored according to blood counts. The trials were conducted by Jonas Bergh, MD, and colleagues with the Scandinavian Breast Cancer Study Group.

Women in this study were randomized to receive either:

  • "tailored" FEC (5-FU 300-600 mg/m2, epirubicin 38-120 mg/m2, cyclophosphamide 450-1200 mg/m2 x 9 cycles, supported by prophylactic G-CSF (filagrastim) and ciprofloxacin; or

  • two cycles of "standard" FEC followed by a modified FEC (5-FU 600 mg/m2, epirubicin 60 mg/m2, cyclophosphamide 1200 mg/m2) for mobilization of peripheral blood stem cells, followed by high-dose chemotherapy (cyclophosphamide 6g/m2, thiotepa 0.5g/m2, carboplatin 0.8g/m2) with stem cell support.
After a median 20 months of follow-up, 55 relapses and 15 deaths occurred with the "tailored" FEC therapy compared with 78 relapses and 25 deaths in the high-dose arm. There were 8 patients who developed acute myeloid leukemia/myelodysplastic syndrome in the "tailored" FEC arm. Two fatal outcomes were directly related to therapy in the high-dose arm.