Mobilization of peripheral-blood stem cells by concurrent administration of daniplestim and granulocyte colony-stimulating factor in patients with breast cancer or lymphoma

Purpose: To evaluate the safety and hematopaietic activity of daniplestim a dministered concurrently with granulacyte calony-stimulating factor (G-CSF) for peripheral-blood stem-cell (PBSC) mobilization. Patients and Methods: In the initial dose-escalation phase, 25 patients wit h adenocarcinoma of the breast (AB; 13 patients) or lymphoma (12 patients) were given daniplestim at doses ranging from 0.1 to 3.75 mu g/kg/d plus G-C SF 10 mu g/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 mu g/kg /d (D+G) or placebo plus G-CSF 10 mu g/kg/d (P+G) for up to 7 days. Results: A daniplestim dose of 2.5 mu g/kg/d was chosen for further study b ecause it was hematopoietically active and had an acceptable side-effect pr ofile. In the randomized phase, in patients with AB, D+G was associated wit h a higher probability (P =.0696) of collecting greater than or equal to 2. 5 x 10(6) CD34(+) cells/kg and significantly higher circulating CD34+ cell counts (P =.0498) on days 6 through 9 after the initiation of dosing. The t arget level was more likely to be reached with additional leukaphereses in the patients given D+G, patients given P+O 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 D-G group. The adv erse events with D+G consisted largely of mild to moderate fly-like symptom s, including headache and fever, and occurred more frequently than with P G. Conclusion: Daniplestim administered at 2.5 mu g/kg/d is tolerable and acti ve when combined with G-CSF, and the combination may prove more effective t han G-CSF alone in promoting the collection of adequate numbers of CD34(+) cells for PBSC infusion in patients with AB. (C) 2000 by American Society o f Clinical Oncology.