Multimodal treatment with primary single-agent epirubicin in operable breast cancer: 5-year experience of the Michelangelo Cooperative Group

Background: To assess the efficacy of primary single-agent epirubicin (120 mg/m(2) every 3 weeks for three cycles) in reducing tumor burden in operable breast cancer greater than or equal to2.5 cm in largest diameter at diagnosis and its effect on the rate of conservative surgery. Patients and methods: A total of 3 19 eligible patients, who were all candidates for mastectomy, were enrolled on to a multicenter prospective non-randomized study. Tumor response was assessed clinically and pathologically. Relapse-free and overall Survival were assessed on major prognostic variables. Results: After primary epirubicin, complete disappearance of invasive neoplastic cells accounted for only 2.6% of patients, but 40% of patients had their primary tumor downstaged to less than or equal to2 cm in diameter. Conservative surgery was performed in 67% of patients. At a median follow-up of 5 years, both primary tumor size at diagnosis (P <0.01) and pathological nodal involvement (P <0.01) significantly influenced treatment outcome. After conserving surgery and breast irradiation, local recurrences accounted for -4% of patients. Conclusions: This multicenter study confirms that three cycles of full-dose epirubicin can avoid mutilating surgery in a high proportion of patients with tumors not amenable to primary conservative surgery. This multimodal treatment can be safely administered outside of clinical trials in patients presenting with large tumors and with a desire to preserve their body integrity.