摘要
目的 :评价表柔比星、氟尿嘧啶、亚叶酸钙以及顺铂 (ECF L)联合化疗方案对无法手术切除或术后复发的晚期胃癌的疗效与安全性。方法 :本研究入选对象为经病理学证实的具有至少一个可测量病灶的原发性或转移至其他部位的无法手术切除的胃癌患者。所用化疗方案为 :表柔比星 50mg/m2 第一天 ,亚叶酸钙 2 0 0mg/m2 第1～ 3天 ,氟尿嘧啶 60 0mg/m2 第 1～ 3天 ,以及顺铂 2 0mg/m2 第 1～ 3天静脉给药。 3周为 1周期 ,3个周期为一次疗程。治疗过程中允许必要的支持治疗。结果 :2 0 0 0年 3月～ 2 0 0 1年 8月期间 ,各院共有 79例患者入选并接受化疗 (1 6例为Ⅲ期 ,63例为Ⅳ期 ;37例为初治患者 ,42例为复治患者 ;53例为术后复发患者 )。最终 66例患者可以评价疗效 ,其中CR 4例、PR 1 8例 ,总缓解率为 33 .3 % (2 2 /66) ;初治患者缓解率为 36 .7% (1 1 /30 ) ,复治患者缓解率为 30 .6 % (1 1 /36) ,具有淋巴软组织转移的患者其缓解率为 50 .0 % (1 5/30 )。除缓解病例外 ,NC患者 2 5例 ,PD患者 1 9例 ,以及治疗过程中出组患者 1 3例 (出组率 1 6 .4 % ,1 3/79)。化疗过程中发生的毒副反应 (WHO标准 )Ⅲ度～Ⅳ度主要为骨髓抑制 2 0 .1 %、脱发 5 .1 %和恶心、呕吐 2 .3 %。结论 :本研究提示ECF
Purpose:To evaluate the efficacy and safety of combination regimen of Epirubicin, Leucovorin, 5 Fluorouracil and Cisplatin (ECF L) in treatment of patients with unresectable or recurrent gastric carcinoma, a phase IV study was conducted.Methods:Patient who was pathologically confirmed as primary gastric carcinoma or its metastatic foci with at least one measurable focus was enrolled in nine sites. The chemotherapy regimen was composed of Epirubicin 50mg/m 2 d1, Lecuovorin 200mg/m 2 d1～3, 5 Fu 600mg/m 2 d1～3, and Cisplatin 20mg/m 2 d1～3 given intravenously, which was designed to be three cycles (three weeks per cycle) per patient. Supportive treatment is allowed if necessary. Written informed consent form was obtained from each patient.Results:From 2000 March to 2001 August a total of 79 patients (16/79 of stage Ⅲ, 63/79 of stage Ⅳ; 37/79 of initial chemotherapy, 42/79 of secondary chemotherapy, and 53/79 of recurrent after surgical intervention) were enrolled and finally there were 66 evaluable patients. Among them 4 achieved CR and 18 of PR, the overall response rate (RR) was 33.3% (22/66), the RR of initial patient was 36.7% (11/30), secondary patient was 30.6% (11/36), and subject with lymph node and/or soft tissue metastasis achieved 50.0% (15/30). There were 25 patients with NC, 19 of PD, and 13 withdrew during the study. Most common adverse event occurred was bone marrow suppression (WHO standard degree Ⅲ～Ⅳ, 20.1%), alopecia (Ⅲ～Ⅳ, 5.1%), and nausea/vomiting (Ⅲ～Ⅳ, 2.3%).Conclusions:Current data indicated the ECF L regimen was feasible to treat the unresectable gastric carcinoma with tolerable toxicity.
出处
《中国癌症杂志》
CAS
CSCD
2003年第2期102-105,共4页
China Oncology
