洛铂联合醛氢叶酸、氟尿嘧啶治疗晚期食管癌的临床研究  

Clinical study of lobaplatin combined with fluorouracil and leucovorin for advanced esophageal carcinoma

作　　者：杨柳青[1] 秦叔逵[1] 钱军[1] 马胜林[2] 熊建萍[3] 张映红[4] 王华庆[5] 张贺龙[6] 蒋芹[7] 王宁菊[8] 

机构地区：[1]解放军八一医院全军肿瘤中心,南京210002 [2]浙江省肿瘤医院,310022 [3]江西医学院第一附属医院,330006 [4]厦门市第一医院,361022 [5]天津肿瘤医院,300060 [6]西安第四军医大学唐都医院,710038 [7]江苏省连云港市第一医院,222002 [8]宁夏医学院附属医院,750004

出　　处：《临床肿瘤学杂志》2006年第12期895-897,900,共4页Chinese Clinical Oncology

摘　　要：目的：观察评价新一代铂类抗癌药物洛铂（LBP）联合醛氢叶酸（CF）及氟尿嘧啶（5-FU）组成LLF方案治疗国人晚期食管癌的有效性和安全性。方法：开放性、单研究组、多中心Ⅱ期Ⅰ临床研究，共入组33例，其中男性28例，女性5例；年龄42～74岁（中位年龄61岁）。病理类型为食管鳞癌27例，食管腺鳞癌1例，贲门腺癌5例；TNM分期：Ⅲ期9例，Ⅳ期24例。应用LBP30mg／m^2，静滴，d1；CF200mg／m^2，静滴，d1-d5；5-FU500mg／m^2，静滴，d1-d5，21天为1周期。至少接受2个周期化疗，按照WHO标准评价客观疗效和毒性，定期随访。结果：33例患者中，可评价疗效患者为30例，获得PR4例，NC13例，PD13例，有效率（RR）为13．3％；疾病控制率（DCR）为56．7％。其中食管癌的有效率为11．5％，DCR为57．7％；贲门腺癌为25．0％，DCR为75．0％。主要毒性反应为可逆性的骨髓抑制和胃肠道反应，3／4度少见，未见明显肝肾毒性。结论：初步研究表明，LBP、CF、5-FU组成LLF方案治疗国人晚期食管癌疗效和安全性均较好，毒性反应可以耐受，值得进一步研究和观察。Objective：To observe the efficacy and safety of LLF regimen consisted of lobaplatin （LBP） combined with 5-fluorouracil（5-FU） and leucovorin （CF） for the Chinese patients with advanced esophageal carcinoma. Methods： In this open-label, multi-centre, phase Ⅱ study, Thirty-three patients with histologically proven esophageal carcinoma and cardiac carcinoma were enrolled, including 28 male patients and 5 female patients. The median age was 61 （ range from 42 to 74） years old. 9 patients presented with stage Ⅲ, 24 patients with stage Ⅳ. All patients were administrated intravenously with LBP 30mg/m^2 on d1, CF 200mg/m^2 on d1 - d5 and 5-FU 500mg/m^2 on d1 - d5. Cycle was repeated every 21 days. The response rate （RR） was evaluated after at least two cycles of chemotherapy and the toxicity was evaluated according to WHO criteria. Results：Thirty patients were evaluatable for recent objective response, in which 4 partial response（PR） were achieved, namely the RR was 13.3% ; 13 patients had no change（NC） and 13 progressive diseases（PD）. The disease control rate （DCR） was 56.7%. In esophageal carcinoma, the RR was 11.5% and the DCR was 57.7%. In cardiac carcinoma, the RR was 25.0% and the DCR was 75.0%. The major toxicities were reversible bone marrow suppression and gastrointestinal tract reaction. The incidence rate of Grade 3/4 toxicities was low. No obvious renal and hepatic function toxicities were observed. Conclusion：The LLF regimen, that is LBP combined with 5-FU and CF is effective and well tolerated for the Chinese patients with advanced esophageal carcinoma. It is worth for further clinical research and observation.

关 键 词：洛铂 氟尿嘧啶 食管癌 化疗 

分 类 号：R730.51[医药卫生—肿瘤]