HIGH-DOSE BUSULFAN, MELPHALAN, THIOTEPA AND PERIPHERAL-BLOOD STEM-CELL INFUSION FOR THE TREATMENT OF METASTATIC BREAST-CANCER

The purpose of this study was to determine the outcome of patients wit h metastatic breast cancer treated with high-dose busulfan (Bu), melph alan (Mel) and thiotepa (TT) followed by peripheral blood stem cell (P BSC) infusion, Fifty-one patients with chemotherapy refractory (n = 32 ) or responsive (n = 19) metastatic breast cancer received Bu (12 mg/k g), Mel (100 mg/m(2)) and TT (500 mg/m(2)) followed by PBSC collected after chemotherapy and growth factor (n = 43) or growth factor alone ( n = 8), The 100 day treatment-related mortality was 8% including one d eath from cytomegalovirus pneumonia, one from aspiration pneumonia and two from regimen-related toxicity (RRT), Seven of 28 refractory (25%) and 5/7 (71%) responsive patients with evaluable disease achieved a c omplete response of all measurable disease or all soft tissue disease with at least improvement in bone lesions (PR), Fifteen of 51 patient s (29%) are alive and progression-free a median of 423 days (range 353 -934) after treatment, 5/32 (16%) with refractory disease and 10/19 (5 3%) with responsive disease, The probabilities of progression-free sur vival (PFS) at 1.5 years for the patients with refractory (n = 32) and responsive (n = 19) disease were 0.24 and 0.53, respectively, These p reliminary data suggest that high-dose Bu/Mel/TT has significant activ ity in patients with advanced breast cancer and may be superior to som e previously published regimens.