A randomized trial of four cycles of adjuvant AC (adriamycin plus cyclophosphamide) +/- two cycles of EP (etoposide plus cisplatin) in node positive patients with breast cancer

Background: Four cycles of AC have been accepted as the standard chemothera py in breast cancer. In the present randomized study we aimed to assess the efficacy of adjuvant etoposide + cisplatin (EP) combination following four cycles of standard adriamycin + cyclophosphamide (AC) in premenopausal pat ients with operable breast cancer and axillary lymph node metastasis. Patients and methods: Premenopausal patients with positive axillary lymph n odes following curative modified radical mastectomy were randomized to eith er four cycles of AC (82 patients) or four cycles of AC + two cycles of EP (83 patients). Results: Median follow-up is 72 months. All randomized and eligible patient s are included in the analysis (AC: 80 patients, AC + EP: 78 patients). The five-year disease-free survival (DFS) for the AC + EP group was significan tly better when compared to AC group (45.5% vs. 30.4%; P = 0.048). Again, t he five-year overall survival (OS) of the whole group was in favor of AC EP arm, though without statistical significance (68.6% vs. 59.1%; P = 0.247 ). Conclusion: Two cycles of EP following four cycles of AC decreased the rela pse rate in operable breast cancer patients.