Mobilization o f P eripheral-Blood S tem C ells b y C oncurrent Administration o f D aniplestim a nd G ranulocyte Colony-Stimulati ng F actor i n P atients W ith Breast C ancer o r L ymphoma

Purpose: To evaluate the safety and hematopoietic activity of daniplestim administered concurrently with granulocyte colony-stimulating factor (G-CSF) for peripheral-blood stem-cell (PBSC) mobilization. Patients and Methods: In the initial dose-escalation phase, 25 patients with adenocarcinoma of the breast (AB; 13 patients) or lymphoma (12 patients) were given daniplestim at doses ranging from 0.1 to 3.75 mg/kg/d plus G-CSF 10 mg/kg/d. In the randomized phase, 52 patients with AB (27 patients) or lymphoma (25 patients) were randomized within disease categories to the daniplestim dose chosen in the dose-escalation phase plus G-CSF 10 mg/kg/d (D1G) or placebo plus G-CSF 10 mg/kg/d (P1G) for up to 7 days. Results: A daniplestim dose of 2.5 mg/kg/d was chosen for further study because it was hematopoietically active and had an acceptable side-effect profile. In the randomized phase, in patients with AB, D1G was associated with a higher probability (P 5 .0696) of collecting > 2.5 3 10 6 CD34 1 cells/kg and significantly higher circulating CD34 1 cell counts (P 5 .0498) on days 6 through 9 after the initiation of dosing. The target level was more likely to be reached with additional leukaphereses in the patients given D1G. Patients given P1G did not benefit from additional leukaphereses beyond the first procedure. The type of mobilization did show a trend toward a shorter duration of neutropenia in the D1G group. The adverse events with D1G consisted largely of mild to moderate flu-like symptoms, including headache and fever, and occurred more frequently than with P1G. Conclusion: Daniplestim administered at 2.5 mg/ kg/d is tolerable and active when combined with GCSF, and the combination may prove more effective than G-CSF alone in promoting the collection of adequate numbers of CD34 1 cells for PBSC infusion in patients with AB. J Clin Oncol 18:2762-2771. © 2000 by American Society of Clinical Oncology.