The purpose of this study was to determine the efficacy, engraftment kineti
cs, effect of bone marrow tumor contamination, and safety of high-dose ther
apy and granulocyte-colony stimulating factor (G-CSF) mobilized peripheral
blood progenitor cell (PBPC) support for patients with responding metastati
c breast cancer. Forty two patients underwent G-CSF (10 mu g/kg) stimulated
PBPC harvest. PBPC and bone marrow aspirates were analyzed by histologic a
nd immunocytochemical methods for tumor contamination. Thirty-seven patient
s received high-dose therapy consisting of cyclophosphamide 6 g/m(2), thiot
epa 500 mg/m(2), and carboplatin 800 mg/m(2) (CTCb) given as an infusion ov
er 4 d followed by PBPC reinfusion and G-CSF (5 mu g/kg) support. No transp
lant related deaths or grade 4 toxicity was recorded. CD34+ cells/kg infuse
d was predictive of neutrophil and platelet recovery. With a median follow-
up of 38 months, three year survival was 44% with relapse-free survival of
19%. Histological bone marrow involvement, found in 10 patients, was a nega
tive prognostic factor and was associated with a median relapse-free surviv
al of 3.5 months. Tumor contamination of PBPC by immunohistochemical staini
ng was present in 22.5% of patients and found not to be correlated with dec
reased survival. G-CSF stimulated PBPC collection followed by a single cour
se of high dose chemotherapy and stem cell infusion with G-CSF stimulated m
arrow recovery leads to rapid, reliable engraftment with low toxicity and p
romising outcome in women with responding metastatic breast cancer.