Bunn P A, Kelly K
Division of Medical Oncology, University of Colorado Cancer Center, Denver 80262, USA.
Semin Oncol. 1995 Aug;22(4 Suppl 9):2-6.
This phase I study was designed to determine the maximal tolerated doses of carboplatin and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), as well as the safety and efficacy of these agents, in patients with advanced, nonresectable stages IIIB and IV non-small cell lung cancer. Paclitaxel was given as a 3-hour intravenous infusion followed by a 30-minute infusion of carboplatin. Patients were assigned to one of seven treatment groups in which paclitaxel and carboplatin were given in doses ranging from 135 to 225 mg/m2 and from 250 to 400 mg/m2, respectively. Overall, the two-drug combination has been well tolerated. The major dose-limiting toxicity has not been reached but will likely be neutropenia. There appears to be a dose-response relationship: two partial responses (12%) were observed among 17 patients assigned to the lower-dose groups, whereas six (50%) of 12 evaluable patients in the higher-dose groups achieved partial responses. The maximal tolerated doses have not been reached yet, and will be at least 200 mg/m2 for paclitaxel and 400 mg/m2 for carboplatin.
这项I期研究旨在确定卡铂和紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）在晚期、不可切除的IIIB期和IV期非小细胞肺癌患者中的最大耐受剂量，以及这些药物的安全性和有效性。紫杉醇采用3小时静脉输注，随后30分钟输注卡铂。患者被分配到七个治疗组之一，其中紫杉醇和卡铂的给药剂量分别为135至225mg/m²和250至400mg/m²。总体而言，两药联合耐受性良好。主要剂量限制性毒性尚未达到，但可能是中性粒细胞减少。似乎存在剂量反应关系：在分配到低剂量组的17名患者中观察到2例部分缓解（12%），而在高剂量组的12例可评估患者中有6例（50%）达到部分缓解。最大耐受剂量尚未达到，紫杉醇至少为200mg/m²，卡铂至少为400mg/m²。
