多西他赛、顺铂和5-氟尿嘧啶联合化疗用于晚期食管癌患者的I期剂量递增研究
Phase I Dose-Escalation Study of Docetaxel, Cisplatin, and 5-Fluorouracil Combination Chemotherapy in Patients With Advanced Esophageal Carcinoma.
作者信息
Satomura Hitoshi, Nakajima Masanobu, Sasaki Kinro, Yamaguchi Satoru, Domeki Yasushi, Takahashi Masakazu, Muroi Hiroto, Kubo Tsukasa, Kikuchi Maiko, Otomo Haruka, Ihara Keisuke, Kato Hiroyuki
机构信息
Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
出版信息
Int Surg. 2015 Jun;100(6):1153-8. doi: 10.9738/INTSURG-D-14-00233.1.
A dose-escalation study of docetaxel (DOC), cisplatin (CDDP), and 5-fluorouracil (5-FU; DCF combination regimen) was performed to determine the maximum-tolerated dose (MTD), recommended dose (RD) and dose-limiting toxicities (DLT) in advanced esophageal carcinoma. Eighteen patients with esophageal carcinoma were enrolled and received DCF combination therapy at different dose levels. DLTs included febrile neutropenia and oral mucositis. DLT occurred in 2 out of 6 patients at level 2 and 3. The study proceeded to level 4, according to the protocol. The level 4 dose was defined as the MTD and the level 3 dose was defined as the RD. The RD for DCF combination chemotherapy for advanced esophageal carcinoma in the present study was 70 mg/m(2) DOC plus 70 mg/m(2) CDDP on day 1 plus 700 mg/m(2) 5-FU on days 1-5 at 4-week intervals. This regimen was tolerable and highly active. A phase II study has been started.
开展了一项多西他赛（DOC）、顺铂（CDDP）和5-氟尿嘧啶（5-FU；DCF联合方案）的剂量递增研究，以确定晚期食管癌的最大耐受剂量（MTD）、推荐剂量（RD）和剂量限制性毒性（DLT）。纳入了18例食管癌患者，并接受不同剂量水平的DCF联合治疗。DLT包括发热性中性粒细胞减少和口腔黏膜炎。在第2和3剂量水平的6例患者中有2例出现DLT。根据方案，研究进入第4剂量水平。第4剂量水平被定义为MTD，第3剂量水平被定义为RD。本研究中晚期食管癌DCF联合化疗的RD为第1天70mg/m² DOC加70mg/m² CDDP，第1 - 5天加700mg/m² 5-FU，每4周为一个周期。该方案耐受性良好且活性高。一项II期研究已经启动。
Zotero 插件