Weaver C H, Schwartzberg L S, Zhen B, Franco C, Moore M, Smith R, White L, Van Amburg A, Hazelton B, Buckner C D
Clinical Research Division of Response Oncology, Inc, Memphis, TN, USA.
Bone Marrow Transplant. 1999 Mar;23(5):421-5. doi: 10.1038/sj.bmt.1701599.
The purpose of this study was to develop a regimen of docetaxel, cyclophosphamide (CY) and filgrastim for mobilization of peripheral blood stem cells (PBSC) in patients with metastatic breast cancer (n = 66). A phase I trial of CY 2, 3 or 4 g/m2 with docetaxel 100 mg/m2, in consecutive cohorts of four patients each, did not reveal any dose-limiting toxicities and subsequent patients were randomized to receive 3 or 4 g/m2 of CY. The median yield of CD34+ cells from all patients was 11.06x10(6)/kg (range, 0.03-84.77) from a median of two aphereses (range, 1-7); 6.52x10(6) CD34+ cells/kg/apheresis (range, 0.01-52.07). Target CD34+ cell doses > or =2.5 and > or =5.0x10(6)/kg were achieved in 89% and 79%, respectively. There were no statistically significant differences in CD34+ cell yields or target CD34+ cell doses achieved following 3 or 4 g/m2 of CY. Patients with only one prior chemotherapy regimen yielded a median of 12.82x10(6) CD34+ cells/kg/apheresis compared to 5.85 for those receiving > or =2 regimens (P = 0.03). It was concluded that the combination of docetaxel, 100 mg/m2, CY 3 g/m2 without mesna could be administered with acceptable toxicity with collection of adequate quantities of PBSC from the majority of patients.
本研究的目的是制定一种多西他赛、环磷酰胺（CY）和非格司亭方案，用于动员转移性乳腺癌患者（n = 66）的外周血干细胞（PBSC）。对连续每组4例患者进行的CY 2、3或4 g/m²联合多西他赛100 mg/m²的I期试验未发现任何剂量限制性毒性，随后的患者被随机分配接受3或4 g/m²的CY。所有患者CD34⁺细胞的中位产量为11.06×10⁶/kg（范围为0.03 - 84.77），中位采集次数为2次（范围为1 - 7次）；每次采集的CD34⁺细胞为6.52×10⁶/kg（范围为0.01 - 52.07）。分别有89%和79%的患者达到了≥2.5×10⁶/kg和≥5.0×10⁶/kg的目标CD34⁺细胞剂量。接受3或4 g/m² CY后，CD34⁺细胞产量或达到的目标CD34⁺细胞剂量无统计学显著差异。仅接受过一种既往化疗方案的患者每次采集的CD34⁺细胞中位产量为12.82×10⁶/kg，而接受≥2种化疗方案的患者为5.85×10⁶/kg（P = 0.03）。得出的结论是，多西他赛100 mg/m²、CY 3 g/m²且不加美司钠的联合方案在多数患者中采集到足够数量的PBSC时，毒性可接受。
