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- W1916865995 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 10 μg/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 ≥ 2.5 × 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 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." @default.
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- W1916865995 date "2000-07-14" @default.
- W1916865995 modified "2023-09-26" @default.
- W1916865995 title "Mobilization of Peripheral-Blood Stem Cells by Concurrent Administration of Daniplestim and Granulocyte Colony-Stimulating Factor in Patients With Breast Cancer or Lymphoma" @default.
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- W1916865995 doi "https://doi.org/10.1200/jco.2000.18.14.2762" @default.
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