低剂量卡培他滨治疗晚期乳腺癌药效及安全性评价

Effect and Safety of Capecitabine in Treatment of Advanced Breast Cancer

目的研究低剂量卡培他滨治疗晚期乳腺癌的疗效,评价其药效和安全性。方法将60例晚期乳腺癌患者随机分成高、低剂量组两组各30例,高剂量组卡培他滨服用临床推荐剂量1250mg·m-2;低剂量组为1000 mg·m-2,两组均每天服用2次,服用2周后停药1周,第4周重复此循环。结果 54例可进行疗效评价(高、低剂量组各27例),60例均可进行毒性评价。高、低剂量组总体有效率分别为59.3%和55.6%(P>0.05)。初治患者和非初治患者卡培他滨治疗应答率分别为66.7%和38.5%(P<0.05)。但是毒性方面有显著性差异,高、低组2、3级手足综合征分别为33.4%和26.6%,2、3级乏力分别为40.0%和13.4%,2、3级呕吐分别为40.0%和6.7%,2、3级肝肾毒性分别为3.3%和0,2、3级皮肤反应分别为6.7%和3.3%。结论低剂量卡培他滨长期治疗晚期乳腺癌具有与临床推荐剂量类似的疗效和良好的安全性。

Objective To evaluate the effect and safety of oral capecitabine at lower doses in patients with metastatic breast cancer( MBC). Methods 60 cases of advanced breast cancer were randomly divided into two groups,and each group had 30 cases. The high dose group was treated with capecitabine 1250mg·m-2 and 1000mg·m-2in low one. Both groups were treated for 14 days followed by 7 days of rest,and then continued the cycle from the fourth week. Results 54 patients were evaluable for response( each group had 27 cases) and all for toxicity. Overall objective response rates of the high dose group and the low one were 59. 3% and 55. 6% respectively. The objective response rates of chemotherapy-naive patients and the pretreated ones were 66. 7% and 38. 5%. In the high dose group and the low one respectively,it is 33. 4% vs 26. 6% in 2 /3 palmar-plantar erythrodyses-thesia,40. 0% vs 13. 4% in grade 2 /3 asthenia,40. 0% vs 6. 7% in grade 2 /3 vomiting,3. 3% vs 0 in grade 2 liver or renal toxicity,and6. 7% vs 3. 3% in grade 2 skin reaction. Conclusion Low dose of capecitabine has a good toxicity profile and similar activility in patients with MBC compared with the suggested dose in clinic.