HIGH-DOSE CHEMOTHERAPY FOLLOWED BY REINFUSION OF SELECTED CD34(-BLOODCELLS IN PATIENTS WITH POOR-PROGNOSIS BREAST-CANCER - A RANDOMIZED MULTICENTER STUDY() PERIPHERAL)

Seventy-one patients with poor-prognosis breast cancer were enrolled a fter informed consent in a multicentre randomized study to evaluate th e use of selected peripheral blood CD34(+) cells to support haematopoi etic recovery following high-dose chemotherapy. Patients who responded to conventional chemotherapy were mobilized with chemotherapy (mainly high-dose cyclophosphamide) and/or recombinant human granulocyte colo ny-stimulating factor (rhG-CSF). Patients who reached the threshold of 20 CD34(+) cells per mu l of peripheral blood underwent apheresis and were randomized at that time to receive either unmanipulated mobilize d blood cells or selected CD34(+) cells. For patients in the study arm , CD34(+) cells were selected from aphereses using the Isolex(R)300 de vice. Fifteen patients failed to mobilize peripheral blood progenitors and nine other patients were excluded for various reasons. Forty-seve n eligible patients were randomized into two comparable groups. CD34() cells were selected from aphereses in the study group. Haematopoieti c recovery occurred at similar times in both groups. No side-effect re lated to the infusion of selected cells was observed. The frequency of epithelial tumour cells in aphereses was low (8 out of 42 evaluated p atients), as determined by immunocytochemistry. We conclude that selec ted CD34(+) cells safely support haematopoietic recovery following hig h-dose chemotherapy in patients with poor-prognosis breast cancer.