A phase I study of paclitaxel and 5-fluorouracil in advanced gastric cancer
A phase I study of paclitaxel and 5-fluorouracil in advanced gastric cancer
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DOI：
10.1016/s0959-8049(97)00134-2
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发表时间：
1997-09-01
影响因子：
8.4
通讯作者：
Cellerino, R
中科院分区：
文献类型：
--
作者：
Cascinu, S;Ficarelli, R;Cellerino, R
这是一项I期研究，旨在确定紫杉醇和5-氟尿嘧啶（5-FU）联合治疗晚期胃癌患者的最大耐受剂量（MTD）和毒性。对PELF方案（5-FU、亚叶酸素、顺铂、epidoxorubicin）难治的患者，每周接受固定剂量500 mg/m(2)的5-FU治疗，并每3周增加剂量紫杉醇，起始剂量为150 mg/m(2)，按3小时输注。剂量每3例增加25mg /m(2)。15名患者参加了这项研究。6例患者给予紫杉醇上剂量（225 mg/m(2)）。在此剂量之前，没有记录到严重毒性（3-4级）。除脱发外，5例发生1-2级白细胞减少，2例发生1-2级神经毒性。所有患者均可评估反应（至少2个周期）：2例患者达到客观反应（200和225 mg/m）。6例患者经治疗后症状明显缓解。门诊紫杉醇给予超过3小时和5-FU可以安全地联合治疗晚期胃癌患者。II期研究推荐剂量为紫杉醇225 mg/m(2)和5-FU 500 mg/m(2)。1997爱思唯尔科学有限公司
This is a phase I study to determine the maximum tolerated dose (MTD) and toxicity of a combination of paclitaxel and 5-Fluorouracil (5-FU) in advanced gastric cancer patients. The patients, refractory to the PELF regimen (5-FU, leucovorin, cisplatin, epidoxorubicin), received weekly 5-FU at the fixed dose of 500 mg/m(2), and escalating doses of paclitaxel every 3 weeks with a starting dose of 150 mg/m(2) given as in 3-h infusion. The dose was escalated by 25 mg/m(2) every 3 patients. Fifteen patients entered the study. The upper paclitaxel dose (225 mg/m(2)) was given to 6 patients. Up to this dose, no severe toxicity (grade 3-4) was recorded. Apart from alopecia, grade 1-2 leukopenia occurred in 5 patients and grade 1-2 neurotoxicity in 2 patients. All patients were evaluable for response (at least 2 cycles): 2 patients achieved an objective response (200 and 225 mg/m(2)). In 6 patients, treatment resulted in notable relief from symptoms. Out-patient paclitaxel given over 3 h and 5-FU may be combined safely for the treatment of patients with advanced gastric cancer. The recommended doses for phase II study are paclitaxel 225 mg/m(2) and 5-FU 500 mg/m(2). (C) 1997 Elsevier Science Ltd.