Hui Rui, Zhang Min, Hao Xiao-Meng, Zhang Jin
Department of Breast Cancer, Cancer Hospital, Tianjin Medical University, Tianjin 300060, China.
Zhonghua Zhong Liu Za Zhi. 2007 Nov;29(11):871-4.
To evaluate tolerance and toxicity of high-dose epirubicin regimen CEF-100 as adjuvant therapy for breast cancer.
From March 2005 to October 2006, 98 patients with stage I - III a breast cancer were randomly assigned to receive postoperative chemotherapy with CEF-100 regimen (epirubicin 100 mg/m2, dl per 21 days for 6 cycles, n =48) or CEF-60 regimen (epirubicin 60 mg/m2, dl per 21 days for 6 cycles, n = 50). Blood routine test were done every cycle, liver and kindey function were examined and adverse effects were recorded after every cycle.
No difference of average leucocyte or neutrophil count (P >0.05) was observed in every cycle. Adverse effects of digestive tract and damage of liver function in CEF-100 group were more severe than that in CEF-60 group (P <0.05), but all adverse effects could be relieved by treatment. No severe non-hematological toxicity and cardiac toxicity in both groups were observed (P <0.05). There was no death caused by chemotherapy.
Our data shows that high dose epirubicin-containing CEF regimen is safe and tolerable for postoperative chemotherapy of breast cancer patient, and the adverse effects could be relieved by marrow support and liver-protection therapy. Further observation and longer follow-up is still needed in order to evaluate the efficacy of this high dose regimen.
评估高剂量表柔比星方案CEF - 100作为乳腺癌辅助治疗的耐受性和毒性。
2005年3月至2006年10月,98例Ⅰ - Ⅲa期乳腺癌患者被随机分配接受CEF - 100方案(表柔比星100 mg/m²,第1天,每21天1次,共6个周期,n = 48)或CEF - 60方案(表柔比星60 mg/m²,第1天,每21天1次,共6个周期,n = 50)的术后化疗。每个周期进行血常规检查,每个周期后检查肝肾功能并记录不良反应。
每个周期平均白细胞或中性粒细胞计数无差异(P > 0.05)。CEF - 100组的消化道不良反应和肝功能损害比CEF - 60组更严重(P < 0.05),但所有不良反应均可通过治疗缓解。两组均未观察到严重的非血液学毒性和心脏毒性(P < 0.05)。无化疗导致的死亡。
我们的数据表明,含高剂量表柔比星的CEF方案对乳腺癌患者术后化疗是安全且可耐受的,不良反应可通过骨髓支持和保肝治疗缓解。为评估该高剂量方案的疗效,仍需进一步观察和更长时间的随访。