Chen Jen-Shi, Rau Kun-Ming, Chen Yen-Yang, Huang Jen-Seng, Yang Tsai-Shen, Lin Yung-Chang, Liau Chi-Ting, Lee Kuan-Der, Su Yu-Cheih, Kao Ruey-Ho
Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, 199 Dun-Hwa North Road, Taipei, Taiwan.
Cancer Chemother Pharmacol. 2009 Apr;63(5):819-25. doi: 10.1007/s00280-008-0797-4. Epub 2008 Jul 29.
The current study assessed the efficacy and safety of biweekly oxaliplatin combining oral tegafur-uracil/leucovorin in treating chemonaive patients with advanced gastric cancer.
Eligible patients were 18-75 years old, had stage IV disease or post-surgery recurrence, no prior palliative chemotherapy, and an ECOG performance status of 0-2. Patients in the current study received 2-h i.v. infusion of oxaliplatin at a dose of 100 mg/m(2) after diluting in 500 mL 5% dextrose/water (dexan premedication), and 5-HT3 antagonist biweekly. Oral tegafur-uracil and leucovorin was given at a dose of 300 mg/m(2)/day and 60 mg/day three times daily from day 1 to 21, respectively, followed by a 1-week rest. Response assessment was based on the RECIST criteria and was performed every two courses. Toxicity was assessed according to NCI common toxicity criteria version 2.
From October 2003 to April 2006, 57 patients were evaluated (55 eligible) with a median age of 61 years (range 31-75). According to the assessment of response in 48 evaluable patients, partial response rate was 24/48 (50.0%) (95% CI: 35.23-64.73%) and stable disease was observed in 11 patients (22.92%), and diseased progressed in 13 patients (27.08%). Mean number of oxaliplatin cycles was 3 (0.5-6.5). Median time to progression was 177 days. Median overall survival was 318 days. Major-grade (III/IV) toxicities were diarrhea 25.5%, vomiting 16.5%, anemia 10.9%, numbness 12.7%, thrombocytopenia 7.3%, neutropenia 3.6% and leucopenia 1.8%.
Biweekly, oxaliplatin combining oral tegafur-uracil/leucovorin in treating patients with advanced gastric cancer showed acceptable activity and manageable toxicity.
本研究评估了每两周一次的奥沙利铂联合口服替加氟-尿嘧啶/亚叶酸钙治疗初治晚期胃癌患者的疗效和安全性。
符合条件的患者年龄在18至75岁之间，患有IV期疾病或术后复发，未曾接受过姑息化疗，且东部肿瘤协作组（ECOG）体能状态为0至2。本研究中的患者在500 mL 5%葡萄糖/水中稀释后接受2小时静脉输注奥沙利铂，剂量为100 mg/m²（地塞米松预处理），每两周一次，同时给予5-羟色胺3（5-HT3）拮抗剂。口服替加氟-尿嘧啶和亚叶酸钙的剂量分别为300 mg/m²/天和60 mg/天，每日三次，从第1天至第21天给药，随后休息1周。疗效评估基于实体瘤疗效评价标准（RECIST），每两个疗程进行一次。毒性根据美国国立癌症研究所（NCI）通用毒性标准第2版进行评估。
从2003年10月至2006年4月，共评估了57例患者（55例符合条件），中位年龄为61岁（范围31至75岁）。根据对48例可评估患者的疗效评估，部分缓解率为24/48（50.0%）（95%置信区间：35.23至64.73%），11例患者（22.92%）病情稳定，13例患者（27.08%）病情进展。奥沙利铂的平均疗程数为3（0.5至6.5）。中位疾病进展时间为177天。中位总生存期为318天。主要（III/IV级）毒性为腹泻25.5%、呕吐16.5%、贫血10.9%、麻木12.7%、血小板减少7.3%、中性粒细胞减少3.6%和白细胞减少1.8%。
每两周一次的奥沙利铂联合口服替加氟-尿嘧啶/亚叶酸钙治疗晚期胃癌患者显示出可接受的活性和可管理的毒性。
