A dose-finding study of lenograstim (glycosylated rHuG-CSF) for peripheral blood stem cell mobilization during postoperative adjuvant chemotherapy in patients with breast cancer. Lenograstim/Breast Cancer Study Group
| Autor: | M, Narabayashi, K, Takeyama, T, Fukutomi, Y, Tokuda, T, Tajima, A, Okumura, T, Chou, M, Sano, H, Makino, T, Igarashi, Y, Sasaki, S, Imoto, M, Ogura, Y, Morishima, H, Murai, S, Okamoto, T, Ikeda, M, Kasai, T, Yokozawa, K, Tobinai |
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| Rok vydání: | 1999 |
| Předmět: |
Adult
Antimetabolites Antineoplastic Injections Subcutaneous Antigens CD34 Breast Neoplasms Lenograstim Adjuvants Immunologic Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor Humans Prospective Studies Antineoplastic Agents Alkylating Cyclophosphamide Mastectomy Postoperative Care Antibiotics Antineoplastic Dose-Response Relationship Drug Macrophages Middle Aged Hematopoietic Stem Cells Recombinant Proteins Chemotherapy Adjuvant Doxorubicin Blood Component Removal Female Fluorouracil Granulocytes |
| Zdroj: | Japanese journal of clinical oncology. 29(6) |
| ISSN: | 0368-2811 |
| Popis: | The optimum dose of granulocyte colony-stimulating factor (G-CSF) for peripheral blood stem cell (PBSC) mobilization after disease-oriented, conventional-dose chemotherapy remains unknown.A multicenter dose-finding study of glycosylated G-CSF (lenograstim) for the mobilization of PBSCs following adjuvant CAF chemotherapy (cyclophosphamide, doxorubicin and 5-fluorouracil) was performed in 38 patients with postoperative breast cancer. Each 10, ten and eight patients were sequentially allocated to one of the three dose groups (2, 5 and 10 micrograms/kg, respectively) of lenograstim. Lenograstim was administered subcutaneously (s.c.) daily from day 8 to the day of the last apheresis and CD34+ cells and colony-forming units-granulocyte macrophage (CFU-GMs) in peripheral blood were measured serially. Additionally, 10 patients who received adjuvant CAF chemotherapy alone also participated in the study, as a control.Lenograstim was well tolerated up to 10 micrograms/kg, except for one patient given 10 micrograms/kg who developed transient grade 3 hepatic enzyme elevation. The peak levels of CD34+ cells and CFU-GMs in peripheral blood showed dose-response relationships. The median peak CD34+ cells for the 0, 2, 5 and 10 micrograms/kg dose groups were 5.4, 34.3, 55.0 and 127.6 cells/microliter, respectively, and those of CFU-GMs for the 0, 2, 5 and 10 micrograms/kg dose groups were 0.01, 0.33, 1.32 and 3.30 CFU-GMs/microliter, respectively.Considering the previous reports suggesting that a pre-apheresis number of 40-50 CD34+ cells/microliter in peripheral blood is highly predictive for achievement of more than 2.5 x 10(6) CD34+ cells/kg in a standard apheresis procedure of 10 litres, the optimum dose of lenograstim for PBSC mobilization following CAF chemotherapy in patients with postoperative breast cancer is 5 micrograms/kg/day s.c. |
| Databáze: | OpenAIRE |
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