Valero V
University of Texas M. D. Anderson Cancer Center, Houston, USA.
Oncology (Williston Park). 1997 Jun;11(6 Suppl 6):21-3.
This trial was designed to determine the recommended maximum tolerated dose (MTD), toxicity, pharmacokinetics, and efficacy of docetaxel (Taxotere) and cyclophosphamide (Cytoxan, Neosar) for phase II studies. Both drugs were administered to 39 patients with advanced solid tumors, 26 of whom had breast cancer. Docetaxel doses ranged from 60 to 85 mg/m2 and cyclophosphamide doses ranged from 600 to 800 mg/m2. All patients received steroid prophylaxis. The MTDs for patients with a history of prior chemotherapy were 75 mg/m2 of docetaxel and 700 mg/m2 of cyclophosphamide. For patients with no prior chemotherapy, the MTDs were 75 mg/m2 of docetaxel and 800 mg/m2 of cyclophosphamide. The dose-limiting toxicity was neutropenic fever, observed in 41% of patients and 13% of cycles. Addition of granulocyte colony-stimulating factor (G-CSF, filgrastim [Neupogen]) did not permit further dose escalation, although it did result in briefer periods of neutropenia.
本试验旨在确定多西他赛（泰索帝）和环磷酰胺（癌得星、尼奥肉瘤）用于II期研究的推荐最大耐受剂量（MTD）、毒性、药代动力学及疗效。两种药物给予39例晚期实体瘤患者，其中26例为乳腺癌患者。多西他赛剂量范围为60至85mg/m²，环磷酰胺剂量范围为600至800mg/m²。所有患者均接受类固醇预防。既往有化疗史患者的MTD为多西他赛75mg/m²和环磷酰胺700mg/m²。无既往化疗史患者的MTD为多西他赛75mg/m²和环磷酰胺800mg/m²。剂量限制性毒性为中性粒细胞减少性发热，在41%的患者和13%的周期中观察到。添加粒细胞集落刺激因子（G-CSF，非格司亭[惠尔血]）虽未允许进一步提高剂量，但确实使中性粒细胞减少期缩短。
