【摘要】 目的:评价希罗达对晚期乳腺癌患者二线化疗的有效率及耐受性。方法:开放性、多中心临床试验,入组病人接受希罗达单药2510mg·(m2·d)-1,分早晚两次餐后口服治疗,连续14天,停药7天,共21天为一个疗程。结果:全组可评价疗效者67例,可评价不良反应者69例。其中CR4例(5.97%),PR21例(31.34%),总有效率37.31%。经4周后复查证实的ITT总有效率为32.86%。主要不良反应为手足综合症、皮肤色素沉着和腹泻。骨髓抑制相对较轻,白细胞下降发生率44.9%,除1例为Ⅳ级外,其余均为Ⅰ-Ⅱ级。结论:应用Xeloda二线治疗晚期乳腺癌与国外临床试验报告疗效相似或稍高。除少数患者发生严重不良反应外,多数病人耐受良好。希罗达可以治疗经阿霉素、紫杉醇等常规治疗失败的晚期乳腺癌。更多还原

【Abstract】 Objective: To evaluate the efficacy and tolerability of Xeloda as second line treatment for the patients with advanced breast cancer. Method:In this open label,multicenter clinical study,patients received oral Xeloda 2510 mg·(m2·d)-1(divided in two doses) days 1-14 with one week of rest and repeated every 3 weeks.Results:Sixty seven patients were evaluable for efficacy and 69 for tolerability. There were 4CR(5.97%), 21PR(31.34%) and the overall response(OR) rate was 37.31%. The confirmed OR rate was 32.86 %(ITT analysis). The most common adverse effects were hand foot syndrome, skin pigmentation and diarrhea. Most patients had a mild(grade Ⅰ/Ⅱ) bone marrow toxicity,however a few cases developed serious myelotoxicity. Conclusion: The response rate of Xeloda in previously treated patients are comparable to the results of others. Most patients tolerated well with a few exceptional cases who developed serious adverse events. Thus,Xeloda is efficacious in advanced breast cancer patiens who failed with Taxane and anthracyclin treatment.更多还原