CEF-100方案与CEF-60方案对乳腺癌辅助化疗临床耐受性的随机对照研究

Randomized controlled study on toleration and toxicity of CEF-100 regimen versus CEF-60 regimen as adjuvant therapy for breast cancer

目的评价采用CEF-100方案在乳腺癌治疗中的耐受性及毒副反应。方法 98例Ⅰ～ⅢA级乳腺癌患者随机分为2组,大剂量表柔比星(CEF-100)组48例,常规剂量表柔比星(CEF-60)组50例;2组治疗均为术后辅助治疗,21 d为1个周期,共6个周期,治疗时给予相应的骨髓支持和保肝治疗;化疗期间每周复查血常规,每周期化疗后复查肝肾功能,并详细观察记录化疗后的不良反应。结果 2组化疗各周期中白细胞平均数及中性粒细胞平均绝对值变化无显著性差异(P均>0.05);CEF-100组患者化疗中及化疗后消化道反应、肝功能异常的发生率明显高于CEF-60组(P均<0.05),经对症处理均可缓解;2组均未出现严重的髓外不良反应及严重心脏毒性(P均>0.05);治疗后KPS评分CEF-100组100%大于80分,CEF-60组80分以上者占98%(P>0.05);未发生治疗相关死亡。结论国人对大剂量表柔比星联合方案治疗耐受性良好,其远期疗效尚有待进一步随访观察。

Objective It is to evaluate the toleration and toxicity of high dose Epirubicin regimen CEF-100 as adjuvant therapy for breast cancer.Methods 98 patients who had stage Ⅰ to ⅢA breast cancer were randomly divided into CEF-100 group with 48 cases and CEF-60 group with 50 cases,all patients received adjuvant therapy after operation,21 days one period,for 6 periods.Blood routines were tested during every period;liver and kidney function were tested and adverse effects were also recorded after every period.Results There was no difference in average count of leucocytes or neutrophils in every period between both groups;Adverse effects of digestive tract and damage of liver function of CEF-100 group were more serious than that of CEF-60 group（P〈0.05）,and all adverse effects could be relieved by treatment.There was no severe non-hematological toxicity and cardiac toxicity in both groups（P〈0.05）.After chemotherapy,100% patients＇ Karnofsky80 in CEF-100 group and 98% patients＇ Karnofsky80 in CEF-60 group（P〉0.05）.There was no death because of chemotherapy in both groups.Conclusion CEF regimen containing high dose Epirubicin is safe and tolerated.Adverse effects could be treated by marrow support and liver-protection therapy.But prostecdtive efficacy needs longer follow-up time and further observation.