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The role of high-dose chemotherapy in the adjuvant treatment of high-dose breast cancer has not been established. Results have been reported from six randomized studies with a symmetrical study design (Table ​(Table1).1). All show a lower relapse rate in the high-dose arm, but in only one study was this result statistically significant.    Table 1  Randomized studies evaluating the role of high-dose chemotherapy in high-risk breast cancer     Methods Patients below 56 years of age who had undergone surgery for stage II or III breast cancer were eligible if they had at least four tumor-positive axillary lymph nodes. Patients in the conventional dose (CD) arm received five courses of FEC (fluorouracil 500 mg/m2, epirubicin 90 mg/m2 and cyclophosphamide 500 mg/m2; every 3 weeks) followed by radiation therapy and tamoxifen. The high-dose (HD) arm was identical, except that high-dose chemotherapy (CTC [cyclophosphamide 6 g/m2, thiotepa 480 mg/m2 and carboplatin 1600 mg/m2]) with peripheral blood progenitor cell reinfusion was given instead of the fifth FEC course.

breast cancer research

Efficacy of high-dose alkylating chemotherapy in the adjuvant treatment of HER2/neu-negative primary breast cancer: update of the Dutch randomized trial