Randomized, Controlled, Dose-Range Study of Ro 25-8315 Given Before and After a High-Dose Combination Chemotherapy Regimen in Patients With Metastatic or Recurrent Breast Cancer Patients
| Autor: | P, Viens, C, Chabannon, P, Pouillard, M, Janvier, W, Brugger, J Y, Blay, F, Oberling, R, Capdeville, C, Newman, V, Méresse, Z X, Xu, E, Platzer, P, Van der Auwera, D, Maraninchi |
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| Rok vydání: | 2002 |
| Předmět: |
Adult
Cancer Research Neutropenia Dose-Response Relationship Drug Neutrophils Antigens CD34 Breast Neoplasms Middle Aged Hematopoietic Stem Cell Mobilization Recombinant Proteins Polyethylene Glycols Oncology Consumer Product Safety Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor Humans Female Neoplasm Metastasis Neoplasm Recurrence Local |
| Zdroj: | Journal of Clinical Oncology. 20:24-36 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | PURPOSE: To evaluate the safety, pharmacokinetics, and efficacy of three different dose levels of pegylated granulocyte colony-stimulating factor (Ro 25-8315) on progenitor cell mobilization and hematologic recovery in cancer patients. PATIENTS AND METHODS: Breast cancer patients (n = 36) were randomly assigned to receive before (part I) and after (part II) chemotherapy either a single-dose injection of Ro 25-8315 (20 μg/kg, n = 9; 60 μg/kg, n = 9; 100 μg/kg, n = 10) or a standard daily dose of filgrastim (part I, 10 μg/kg/d; part II, 5 μg/kg/d) (control group, n = 8). RESULTS: Overall, Ro 25-8315 was well tolerated. In part I, more progenitor cell mobilization was observed with Ro 25-8315 100 μg/kg. The peak of circulating CD34+ cells was obtained at day +5 in the four groups, and the absolute neutrophil count (ANC) returned to less than 20 × 109/L by day +15. In part II, high levels of circulating CD34+ cells (> 20 cells/μL) were obtained in all four groups. The chemotherapy-induced neutropenia (< 1 × 109/L) was similar in the four groups. Ro 25-8315 100 μg/kg was more effective than filgrastim in reducing the number of patients with an ANC less than 0.5 × 109/L on day +12 after chemotherapy. CONCLUSION: A single injection of Ro 25-8315 100 μg/kg might be the optimal dose for steady-state peripheral-blood progenitor cell mobilization. A single injection of 20, 60, or 100 μg/kg could be as efficient as daily administration of filgrastim to correct chemotherapy-induced cytopenia. The optimal dose of Ro 25-8315 should be determined according to the planned chemotherapy regimen. |
| Databáze: | OpenAIRE |
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