OBJECTIVETo evaluate tolerance and toxicity of high-dose epirubicin regimen CEF-100 as adjuvant therapy for breast cancer.

METHODSFrom March 2005 to October 2006, 98 patients with stage I - III a breast cancer were randomly assigned to receive postoperative chemotherapy with CEF-100 regimen (epirubicin 100 mg/m2, dl per 21 days for 6 cycles, n =48) or CEF-60 regimen (epirubicin 60 mg/m2, dl per 21 days for 6 cycles, n = 50). Blood routine test were done every cycle, liver and kindey function were examined and adverse effects were recorded after every cycle.

RESULTSNo difference of average leucocyte or neutrophil count (P >0.05) was observed in every cycle. Adverse effects of digestive tract and damage of liver function in CEF-100 group were more severe than that in CEF-60 group (P <0.05), but all adverse effects could be relieved by treatment. No severe non-hematological toxicity and cardiac toxicity in both groups were observed (P <0.05). There was no death caused by chemotherapy.

CONCLUSIONOur data shows that high dose epirubicin-containing CEF regimen is safe and tolerable for postoperative chemotherapy of breast cancer patient, and the adverse effects could be relieved by marrow support and liver-protection therapy. Further observation and longer follow-up is still needed in order to evaluate the efficacy of this high dose regimen.