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

John F. DiPersio, Michael W. Schuster, Camille N. Abboud, Jane N. Winter, Vicki R. Santos, Denise M. Collins, Jeffrey W. Sherman, Charles M. Baum

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

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 μg/kg/d plus G-CSF 10μg/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 μg/kg/d (D+G) or placebo plus G- CSF 10 μg/kg/d (P+G) for up to 7 days. Results: A daniplestim dose of 2.5 μg/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, D+G was associated with a higher probability (P = .0696) of collecting ≥ 2.4 x 106 CD34+ cells/kg and significantly higher circulating CD34+ cell counts (P = .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 D+G. Patients given P+G 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 adverse events with D+G consisted largely of mild to moderate flu-like symptoms, including headache and fever, and occurred more frequently than with P+G. Conclusion: Daniplestim administered at 2.5 μg/kg/d is tolerable and active when combined with G-CSF, and the combination may prove more effective than 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 of Clinical Oncology.

Original languageEnglish
Pages (from-to)2762-2771
Number of pages10
JournalJournal of Clinical Oncology
Volume18
Issue number14
DOIs
StatePublished - Jul 2000
Externally publishedYes

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