洛铂联合5-氟尿嘧啶与亚叶酸钙治疗晚期食管癌的Ⅱ期临床研究  

Phase Ⅱ trail of Lobaplatin, leucovorin and fluorouracil in patients with advanced carcinoma of the esophagus

作　　者：李醒亚[1] 周芳[1] 任中海[2] 赵永福 路平[4] 王俊生[5] 郑安平[5] 库建伟 

机构地区：[1]郑州大学第一附属医院肿瘤科,河南郑州450052 [2]南阳市中心医院肿瘤科,河南南阳473009 [3]林州市人民医院肿瘤科,河南林州456500 [4]新乡医学院第一附属医院肿瘤科,河南新乡453100 [5]安阳市肿瘤医院内科,河南安阳455000 [6]南阳医专附属医院肿瘤科,河南南阳473058

出　　处：《中华肿瘤防治杂志》2007年第1期64-66,共3页Chinese Journal of Cancer Prevention and Treatment

摘　　要：目的:评价洛铂联合5-FU与亚叶酸钙治疗晚期食管癌患者的疗效及安全性。方法:对40例未经化疗的晚期食管癌患者。给予以下方案化疗:洛铂50mg,静脉滴注,2h;亚叶酸钙200mg/m2,静脉滴注,2h,d1～d3;5-FU400mg/m2,静脉推注,d1～d3;5-FU600mg/m2,持续静脉滴注,22h,d1～d3。每21d重复。完成2个周期后行疗效评价。结果:可评价疗效病例37例,其中CR1例,PR16例,SD15例,PD5例,总有效率为45.9%(17/37)(95%CI为30%～63%),其中初治患者的总体疗效为68.2%(15/22),复治患者中总体疗效为13.3%(2/15);中位疾病进展时间为6个月。主要不良反应为骨髓抑制,其中白细胞下降Ⅲ,Ⅳ度为21.1%,血红蛋白下降Ⅲ,Ⅳ度为10.0%,血小板下降Ⅲ度为3.3%,未发现Ⅳ度反应。结论:该联合方案显示明显的抗肿瘤作用,与其他含铂方案相比,洛铂不良反应相对较轻,耐受性好。OBJECTIVE： To evaluate the efficacy and tolerability of the combination of lobaplatin, fluorouracil and leucovorin to patients with advanced carcinoma of the esophagus. METHODS： 40 patients with advanced carcinoma of the esophagus were enrolled. All patients had measurable lesions and never had any chemotherapy and radiotherapy before. Patients received lobaplatin 50 mg,as a 2 h infusion on day 1; Leucovion （200 mg/m^2） followed by fiuorouracil bolus （400 mg/m^2） and 22 h continuous infusion fluorouracil （600 mg/m2） was administered on day 1, 2 and 3. Treatment was repeated every 21 days. More than 2 cycles were given for each patient. Efficacy was evaluated after 2 cycles. RESULTS： There were 37 cases can be assessed. 1patient achieved CR, 16 patients achieved PR, 15 SD and 5 PD. Overall response rate （ORR） was 45.9% （17/37） （95% confidence interval , 30% - 63%） and the response rate for chemotherapy naive and pretreated patients were 68.2%（15/22） and 13.3%（2/15）, respectively. Median time to progress is 6 months. The maior toxicity noted was myelotoxisity. The rate of grade Ⅲ, Ⅳ of neutropenia is 21.1%, thrombocytopenia is 3.3% and anemia is 10.0%. CONCLUSIONS： Comparing with other regimens involves cisplatin, the combination of Lobaplatin, leucovorin and fluorouracil shows significant antitumor activity and a favorable toxicity profile in patients with advanced carcinoma of the esophagus.

关 键 词：食管肿瘤/药物疗法 洛铂/治疗应用 5-氟脲嘧啶/治疗应用 亚叶酸钙/治疗应用 药物疗法 多剂联用 

分 类 号：R735.1[医药卫生—肿瘤]