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


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 microgram/kg/d plus G-CSF 10 microgram/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 microgram/kg/d (D+G) or placebo plus G-CSF 10 microgram/kg/d (P+G) for up to 7 days.


RESULTS
A daniplestim dose of 2. 5 microg/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 >/= 2.5 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 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.


CONCLUSIONS
Daniplestim administered at 2.5 microgram/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.
DiPersio
J F
JF
Division of Bone Marrow Transplantation and Stem Cell Biology, Washington University School of Medicine, St Louis, MO, USA. jdipersi@imgate.wustl.edu
Schuster
M W
MW
Abboud
C N
CN
Winter
J N
JN
Santos
V R
VR
Collins
D M
DM
Sherman
J W
JW
Baum
C M
CM
D000230:Adenocarcinoma / Q000276:immunology / Q000628:therapy*; D000328:Adult; D018952:Antigens, CD34; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000276:immunology / Q000628:therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D019650:Hematopoietic Stem Cell Mobilization; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007377:Interleukin-3 / Q000031:analogs & derivatives; D018655:Lymphocyte Count; D008223:Lymphoma / Q000276:immunology / Q000628:therapy*; D010446:Peptide Fragments; D010455:Peptides / Q000008:administration & dosage*
D018952:Antigens, CD34; D000970:Antineoplastic Agents; D007377:Interleukin-3; D010446:Peptide Fragments; D010455:Peptides; D016179:Granulocyte Colony-Stimulating Factor; C093340:daniplestim