Rowinsky E, Smith L, Rodriguez G, White L, Drengler R, Von Hoff D, Peacock N, Aylesworth C, Burris H, Ravdin P, Bellet R
Cancer Therapy and Research Center, Institute for Drug Development, San Antonio, Texas, USA.
Oncology (Williston Park). 1997 Jun;11(6 Suppl 6):33-5.
The relatively recent introduction of a new class of chemotherapeutic agents--the taxoids--has raised hope of improved survival for patients with advanced or metastatic cancer. Following encouraging preclinical results of taxoid combinations, this phase I, nonrandomized trial was designed to evaluate a 1-hour intravenous infusion of docetaxel (Taxotere) on day 1 combined with fluorouracil (5-FU) as a daily intravenous bolus for 5 consecutive days. To date, 27 patients with advanced solid neoplasms have received 86 courses of docetaxel/5-FU at the following dose levels: 25/100, 35/150, 50/200, 60/200, and 60/300 mg/m2. Preliminary results showed no unexpected toxicities, and the principal toxicity was neutropenia of short duration. A treatment regimen of 60 mg/m2 docetaxel on day 1 and 300 mg/m2 of 5-FU given for 5 days, with a single course length of 28 days, is projected as the maximum tolerated dose.
一类相对较新的化疗药物——紫杉烷类药物的引入，让晚期或转移性癌症患者提高生存率的希望大增。在紫杉烷类药物联合使用的临床前结果令人鼓舞之后，开展了这项I期非随机试验，旨在评估第1天静脉输注1小时多西他赛（泰索帝）并联合5天每日静脉推注氟尿嘧啶（5-FU）的疗效。截至目前，27例晚期实体瘤患者已接受了86个疗程的多西他赛/5-FU治疗，剂量水平如下：25/100、35/150、50/200、60/200和60/300mg/m²。初步结果显示无意外毒性，主要毒性为短期中性粒细胞减少。预计最大耐受剂量为第1天使用60mg/m²多西他赛，5天内每日使用300mg/m² 5-FU，单个疗程时长为28天。
