Greco F A, Hainsworth J D
Sarah Cannon (Minnie Pearl) Cancer Center, Nashville, TN 37203.
Semin Oncol. 1994 Oct;21(5 Suppl 8):3-8.
This phase I/II study was done to evaluate the safety and feasibility of two schedules of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) administered by 1-hour infusion in the outpatient setting. Fifty-six patients with advanced, refractory malignancies received one of two paclitaxel schedules by random assignment: 135 mg/m2 given as a single dose over 1 hour or 135 mg/m2 given in divided hourly daily doses for 3 days. All patients were premedicated with dexamethasone, diphenhydramine, and cimetidine. No serious acute hypersensitivity reactions were seen with either schedule of paclitaxel. Other adverse effects were usually mild and easily tolerated. Other than alopecia, which was universal, myelosuppression was the most common severe toxicity. However, grades 3 and 4 leukopenia occurred in only 19% and 2% of treatment courses, respectively. Nine patients required hospitalization for treatment of fever associated with neutropenia. There were no significant differences in toxicity observed when comparing the two paclitaxel regimens. It is too early to adequately assess tumor response, but thus far 11 of 56 patients (20%) had partial or complete response to therapy. Responses were observed in patients with breast, ovarian, and lung cancers. Paclitaxel can be safely given by 1-hour infusion in the outpatient setting, both as a single dose and in divided doses for 3 days. Severe acute hypersensitivity reactions did not occur in 162 courses. Neutropenia was mild in most patients and severe thrombocytopenia was rare. The use of this dose and these schedules of paclitaxel as a component of combination chemotherapy regimens should be possible. Investigation of paclitaxel at 200 mg/m2 given by 1-hour infusion is currently in progress.
本I/II期研究旨在评估在门诊环境中通过1小时输注给予两种紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）给药方案的安全性和可行性。56例晚期难治性恶性肿瘤患者通过随机分配接受两种紫杉醇给药方案之一：135mg/m²在1小时内单次给药或135mg/m²分3天每日按小时分次给药。所有患者均接受地塞米松、苯海拉明和西咪替丁预处理。两种紫杉醇给药方案均未出现严重的急性过敏反应。其他不良反应通常较轻且易于耐受。除了普遍出现的脱发外，骨髓抑制是最常见的严重毒性反应。然而，3级和4级白细胞减少分别仅发生在19%和2%的治疗疗程中。9例患者因与中性粒细胞减少相关的发热需要住院治疗。比较两种紫杉醇方案时，观察到的毒性无显著差异。目前充分评估肿瘤反应还为时过早，但到目前为止，56例患者中有11例（20%）对治疗有部分或完全反应。在乳腺癌、卵巢癌和肺癌患者中观察到了反应。紫杉醇在门诊环境中通过1小时输注无论是单次给药还是分3天给药都可以安全给予。162个疗程中未发生严重的急性过敏反应。大多数患者的中性粒细胞减少较轻，严重血小板减少罕见。将这种剂量和这些紫杉醇给药方案作为联合化疗方案的一个组成部分使用应该是可行的。目前正在进行关于1小时输注给予200mg/m²紫杉醇的研究。
