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

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 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.

CONCLUSION:

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.

• Authors: J F DiPersio, M W Schuster, C N Abboud, J N Winter, V R Santos, D M Collins, J W Sherman, C M Baum
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 18 Issue 14 Pg. 2762-71 (Jul 2000) ISSN: 0732-183X [Print] United States
• PMID: 10894877 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antigens, CD34
• Antineoplastic Agents
• Interleukin-3
• Peptide Fragments
• Peptides
• Granulocyte Colony-Stimulating Factor
• daniplestim

Topics

• Adenocarcinoma (immunology, therapy)
• Adult
• Antigens, CD34
• Antineoplastic Agents (therapeutic use)
• Breast Neoplasms (immunology, therapy)
• Double-Blind Method
• Drug Administration Schedule
• Granulocyte Colony-Stimulating Factor (administration & dosage)
• Hematopoietic Stem Cell Mobilization
• Hematopoietic Stem Cell Transplantation
• Humans
• Interleukin-3
• Lymphocyte Count
• Lymphoma (immunology, therapy)
• Peptide Fragments
• Peptides (administration & dosage)