Amifostine has shown to selectively protect normal tissues against cytotoxic and 
mutagenic effects of several anti-neoplastic drugs, such as alkylating agents, 
organoplatinum compounds, anthracyclines, taxanes, and ionising radiation. This 
cytoprotection is broad-spectrum and selective, without loss of therapeutic 
efficacy. In this study we have treated 31 patients affected with inoperable or 
metastatic breast cancer, not previously submitted to chemotherapy for advanced 
disease, with amifostine 910 mg/m(2) followed by doxorubicin 75 mg/m(2). The 
overall response rate was 52% with a median response duration of 13 months 
(range 6-53+) and a median overall survival of 21 months (range 3-59+). With 
regard to toxicity, 14 patients (45%) experienced transient g4 neutropenia which 
was febrile only in one case (3%). Grade 3-4 thrombocytopenia was not recorded. 
Nausea and vomiting occurred in 14% of cycles. Grade 3 mucositis was observed in 
only 1 patient, whereas 2 patients (6%) developed an asymptomatic drop of left 
ventricular ejection fraction (LVEF) >10% below basal value. In conclusion, this 
study suggests that amifostine can reduce doxorubicin related toxicity, thus 
improving the patients' quality of life and the efficacy/toxicity ratio of this 
drug.