Fujiwara Yoshiyuki, Fujita Jyunya, Kan Kazuomi, Tsukahara Kousei, Takiguchi Shuji, Miyata Hiroshi, Yasuda Takushi, Doki Yuichirou, Monden Morito
Dept. of Gastroenterological Surgery, Graduate School of Medicine, Osaka University.
Gan To Kagaku Ryoho. 2006 Jan;33(1):45-8.
The safety of chemotherapy combining TS-1 and weekly paclitaxel for the treatment of unresectable and recurrent gastric cancer was evaluated in this study. Paclitaxel was administered by intravenous drip infusion at a starting dose (level 1) of 50 mg/m2 on days 1, 8, and 15. TS-1 was administered orally at a dose of 40 mg/m2twice a day for 2 weeks (days 1-14) followed by 2 weeks rest. A total of 9 patients were enrolled in this study. Two out of 6 patients treated with level 1 suffered from leukocytopenia and neutropenia, which were determined as dose-limiting toxicity (DLT). Three patients were treated with level 2, in which the dose of paclitaxel was increased up to 60 mg/m2. One of 3 patients suffered from grade 3 diarrhea and one patient from grade 4 leukocytopenia, eutrocytopenia, anemia, and stomatitis, which were determined as DLT. According to these results,level 1 of this regimen was recommended as a safe treatment for gastric cancer patients. A phase II study will be performed to evaluate the efficacy of the combination chemotherapy.
本研究评估了替吉奥（TS-1）与每周紫杉醇联合化疗治疗不可切除复发性胃癌的安全性。紫杉醇于第1、8和15天静脉滴注给药，起始剂量（1级）为50mg/m²。替吉奥口服给药，剂量为40mg/m²，每日2次，共2周（第1 - 14天），随后休息2周。本研究共纳入9例患者。6例接受1级治疗的患者中有2例出现白细胞减少和中性粒细胞减少，被确定为剂量限制性毒性（DLT）。3例患者接受2级治疗，其中紫杉醇剂量增加至60mg/m²。3例患者中有1例出现3级腹泻，1例出现4级白细胞减少、嗜酸性粒细胞减少、贫血和口腔炎，被确定为DLT。根据这些结果，推荐该方案的1级治疗作为胃癌患者的安全治疗方法。将进行II期研究以评估联合化疗的疗效。
