Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.
Oncology. 2010;79(3-4):269-72. doi: 10.1159/000323272. Epub 2011 Mar 4.
A phase I study of biweekly intravenous (IV) paclitaxel (PTX) plus intraperitoneal (IP) cisplatin (CDDP) and PTX was performed to determine the maximum tolerated dose (MTD) and recommended dose (RD) in gastric cancer patients.
Nine gastric cancer patients with peritoneal metastasis were enrolled. PTX was administered intravenously at a dose of 100 mg/m(2) and intraperitoneally with an initial dose of 20 mg/m(2) (level 1), stepped up to 30 or 40 mg/m(2) depending on observed toxicity. CDDP was administered intraperitoneally at a dose of 30 mg/m(2) over 24 h. PTX and CDDP were administered on days 1 and 15 in 4-week cycles.
The MTD was determined to be dose level 1, as 2 of 3 patients experienced dose-limiting toxicities (DLTs), grade 4 leukopenia and grade 3 vomiting. Therefore, the doses of IV PTX, IP CDDP and IP PTX were reduced to 80, 25 and 20 mg/m(2), respectively (level 0). Consequently, the RD was determined to be dose level 0, as only 1 of 6 patients experienced DLT, grade 3 nausea.
Combination chemotherapy of IV PTX plus IP CDDP and PTX was shown to be a safe regimen that should be further explored in clinical trials.
一项每周两次静脉注射紫杉醇（PTX）联合腹腔注射顺铂（CDDP）和 PTX 的 I 期研究旨在确定胃癌患者的最大耐受剂量（MTD）和推荐剂量（RD）。
入组 9 例腹膜转移的胃癌患者。PTX 静脉注射剂量为 100 mg/m²，腹腔注射初始剂量为 20 mg/m²（1 级），根据观察到的毒性反应逐渐增加至 30 或 40 mg/m²。CDDP 腹腔注射剂量为 30 mg/m²，持续 24 小时。PTX 和 CDDP 于每 4 周周期的第 1 天和第 15 天给药。
MTD 确定为 1 级，因为 3 例患者中有 2 例出现剂量限制毒性（DLT），即 4 级白细胞减少和 3 级呕吐。因此，静脉注射 PTX、腹腔注射 CDDP 和腹腔注射 PTX 的剂量分别降低至 80、25 和 20 mg/m²（0 级）。因此，RD 确定为 0 级，因为 6 例患者中有 1 例出现 DLT，即 3 级恶心。
IVPTX 联合 IP CDDP 和 PTX 的联合化疗是一种安全的方案，应在临床试验中进一步探索。
