CAJ | 학술논문

目的评价紫杉醇每周方案联合氟特嗪胶囊与氟尿嘧啶(5-Fu)一线治疗晚期胃癌的临床疗效和安全性.方法 240例未经治疗的晚期胃癌患者,随机分为试验组和对照组,每组各120例患者.试验组采用紫杉醇联合氟特嗪胶囊,紫杉醇60 mg/m2,静脉滴注,第1、8、15天；氟特嗪胶囊80～ 120 mg/d,口服,第1～14天.对照组采用紫杉醇联合5-Fu,5-Fu 500 mg/m2,持续静脉输注,第1～5天;亚叶酸钙20 mg/m2,静脉滴注,第1～5天.两组均为每28天重复.结果 240例患者中,228例患者进入全分析集,192例患者可评价疗效,其中试验组100例,对照组92例.试验组和对照组的客观缓解率分别为50.0％和28.3％ (P =0.002),疾病控制率分别为82.0％和70.7％(P=0.064).试验组患者的中位无进展生存时间为153 d,对照组为129 d(P =0.006).试验组Ⅲ～Ⅳ级骨髓抑制发生率高于对照组,但两组发热发生率差异无统计学意义(P =0.439).结论口服氟特嗪胶囊可以替代静脉输注5-Fu,紫杉醇每周方案联合氟特嗪疗效较高,安全性良好.
목적 평개자삼순매주방안연합불특진효낭여불뇨밀정(5-Fu)일선치료만기위암적림상료효화안전성.방법 240례미경치료적만기위암환자,수궤분위시험조화대조조,매조각120례환자.시험조채용자삼순연합불특진효낭,자삼순60 mg/m2,정맥적주,제1、8、15천；불특진효낭80～ 120 mg/d,구복,제1～14천.대조조채용자삼순연합5-Fu,5-Fu 500 mg/m2,지속정맥수주,제1～5천;아협산개20 mg/m2,정맥적주,제1～5천.량조균위매28천중복.결과 240례환자중,228례환자진입전분석집,192례환자가평개료효,기중시험조100례,대조조92례.시험조화대조조적객관완해솔분별위50.0％화28.3％ (P =0.002),질병공제솔분별위82.0％화70.7％(P=0.064).시험조환자적중위무진전생존시간위153 d,대조조위129 d(P =0.006).시험조Ⅲ～Ⅳ급골수억제발생솔고우대조조,단량조발열발생솔차이무통계학의의(P =0.439).결론 구복불특진효낭가이체대정맥수주5-Fu,자삼순매주방안연합불특진료효교고,안전성량호.
Objective To evaluate the efficacy and safety of weekly paclitaxel combined with S-1 or fluorouracil in the first line treatment of advanced gastric carcinoma.Methods Two hundred and forty patients with untreated advanced gastric carcinoma were randomized into two arms,patients in the experimental arm were given paclitaxel and S-1,while those in the control arm received paclitaxel and fluorouracil.The regimen of experimental arm was paclitaxel 60 mg/m2 by intravenous infusion,day1,8,15 ;S-1 80-120 mg/day given by oral administration,day 1-14.The regimen of control arm was fluorouracil 500 mg/m2 by intravenous infusion continuously,day1-5;CF 20 mg/m2 by intravenous infusion,day1-5.The regimens in both arms were repeated every 28 days.The efficacy and safety of both arms were assessed.Results Two hundred and twenty-eight patients were analyzed in the full analysis set,and 192 patients were analyzed in per-protocol set (experimental arm 100 patients,control arm 92 patients).The overall response rates of experimental and control arms were 50.0％ and 28.3％ (P =0.002),and the disease control rates were 82.0％ and 70.7％ (P =0.064),respectively.The primary endpoints of experimental arm were non-inferior to that of the control arm.The secondary endpoint of experimental arm in terms of median progression free survival was significantly better than that of control arm (5 months versus 4 months,P =0.006).The experimental arm had a higher incidence of grade Ⅲ-Ⅳ bone marrow suppression than the control arm,but the incidence of fever in both arms was not significantly different.Conclusions Oral administration of S-1 is an alternative option of venous infusional fluorouracil.Weekly paclitaxel combined with S-1 is a safe regimen and has a promising efficacy.