Introduction: Based on the variable benefit of taxanes in the adjuvant setting of early breast cancer in certain tumor phenotypes, especially in human epidermal growth factor receptor (HER)2-positive and triple-negative disease, and with the observation of a lesser benefit in luminal A, this research article aimed at exploring the value of docetaxel in patients with an estrogen receptor-positive, HER2-negative disease phenotype, who might not derive the same benefits as those with other phenotypes.
Patients and methods: This was a randomized prospective study comparing disease-free survival (DFS) and safety profile of sequential adjuvant three cycles Fluorouracil, Epirubicin, Cyclophosphamide followed by three cycles Docetaxel (FEC-D) versus six cycles classic Fluorouracil, Epirubicin, Cyclophosphamide (FEC)-100 in 60 Egyptian women who presented to Dar Al Fouad Hospital during the period June 2007 to July 2008 with (pT1-2 pN0-3 M0). The primary end point was DFS in a follow-up period of 4 years. The secondary end point was toxicity profile.
Results: Four-year DFS rates were comparable in both arms: 73.3% ± 8.1% in the FEC-D arm versus 76.5% ± 7.8% in the FEC-100 arm (P = 0.83). N3 and grade III subgroups achieved the worst DFS in both subgroups (P = 0.001 and P = 0.214, respectively). The rate of nausea and vomiting was higher in the FEC-100 arm (P = 0.49), while grade III-IV neutropenia and febrile neutropenia incidence was similar between both arms.
Conclusion: Sequential adjuvant chemotherapy with FEC followed by docetaxel achieved comparable DFS results to FEC alone in luminal A phenotype subgroups of breast cancer.
Keywords: adjuvant; breast cancer; epirubicin; taxane.