RANDOMIZED COMPARISON OF PROGENITOR-CELL MOBILIZATION USING CHEMOTHERAPY, STEM-CELL FACTOR, AND FILGRASTIM OR CHEMOTHERAPY PLUS FILGRASTIM ALONE IN PATIENTS WITH OVARIAN-CANCER

Purpose: This was the first randomized study to investigate the effica cy of peripheral-blood progenitor cell (PBPC) mobilization using stem- cell factor (SCF) in combination with filgrastim (G-CSF) following che motherapy compared with filgrastim alone following chemotherapy. Patie nts and Methods: Forty-eight patients with ovarian cancer were treated with cyclophosphamide and randomized to receive filgrastim 5 mu g/kg alone or filgrastim 5 mu g/kg plus SCF. The dose of SCF was cohort-dep endent (5, 10, 15, and 20 mu g/kg), with 12 patients in each cohort, n ine of whom received SCF plus filgrastim and the remaining three patie nts who received filgrastim alone, On recovery from the WBC nadir, pat ients underwent a single apheresis. Results: SCF in combination with f ilgrastim following chemotherapy enhanced the mobilization of progenit or cells compared with that produced by filgrastim alone following che motherapy. This enhancement was dose-dependent for colony-forming unit -granulocyte-macrophage (CFU-GM), burst-forming unit-erythrocyte (BFU- E), and CD34(+) cells in both the peripheral blood and apheresis produ ct. In the apheresis product, threefold to fivefold increases in media n CD34(+) and progenitor cell yields were obtained in patients treated with SCF 20 mu g/kg plus filgrastim compared with yields obtained in patients treated with filgrastim alone. Peripheral blood values of CFU -GM, BFU-E, and CD34(+) cells per milliliter remained above defined th reshold levels longer with higher doses of SCF. The higher doses of SC F offer a greater window of opportunity in which to perform the aphere sis to achieve high yields. Conclusion: SCF (15 or 20 mu g/kg) in comb ination with filgrastim following chemotherapy is an effective way of increasing progenitor cell yields compared with filgrastim alone follo wing chemotherapy. J Clin Oncol 16:2601-2612. (C) 1998 by American Soc iety of Clinical Oncology.