Iwase Hiroaki, Shimada Masaaki, Tsuzuki Tomoyuki, Okeya Masayuki, Kobayashi Keiko, Hibino Yuichi, Watanabe Hisanori, Goto Hidemi
Department of Gastroenterology, National Organization, Nagoya Medical Center, 4-1-1 Sannomaru Naka-ku, Nagoya 460-0001, Japan.
Anticancer Res. 2006 Mar-Apr;26(2B):1605-9.
The objective of this study was to determine the dose-limiting toxicity (DLT), the maximum tolerated dose (MTD), the recommended dose (RD) and the preliminary antitumor activity of S-1, oral dihydropyrimidine dehydrogenase inhibitory fluoropyrimide, in combination with cisplatin and paclitaxel for advanced gastric cancer.
Paclitaxel was administered on day 1. A fixed dose of S-1 (70 mg/m2/day) was orally administered for 14 consecutive days from day 1 and a 24-h infusion of a fixed dose of cisplatin (60 mg/m2) was administered on day 14 of every 28-day cycle. Four dose escalation levels of paclitaxcel were studied (120, 140, 160 and 180 mg/m2).
Twenty patients were enrolled. The toxicities were generally mild no grade 4 hematological toxicity or grade 3 non-hematological toxicity were observed. Level 4 was considered as the MTD because of a treatment delay of more than 2 weeks in 3 out of 6 patients. The RD of paclitaxcel was 160 mg/m2. The overall response rate was 75%.
A triple combination chemotherapy consisting of S-1, cisplatin and paclitaxel showed a tolerable level of adverse reactions and favorable antitumor activity.
本研究旨在确定口服二氢嘧啶脱氢酶抑制性氟嘧啶S-1联合顺铂和紫杉醇治疗晚期胃癌的剂量限制性毒性（DLT）、最大耐受剂量（MTD）、推荐剂量（RD）及初步抗肿瘤活性。
紫杉醇于第1天给药。从第1天起，连续14天口服固定剂量的S-1（70mg/m²/天），每28天为一个周期，在第14天给予24小时固定剂量的顺铂（60mg/m²）静脉滴注。研究了四个剂量递增水平的紫杉醇（120、140、160和180mg/m²）。
共纳入20例患者。毒性一般较轻，未观察到4级血液学毒性或3级非血液学毒性。由于6例患者中有3例治疗延迟超过2周，因此将4级视为MTD。紫杉醇的RD为160mg/m²。总缓解率为75%。
由S-1、顺铂和紫杉醇组成的三联化疗显示出可耐受的不良反应水平和良好的抗肿瘤活性。
