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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。
Objective: To evaluate the efficacy and tolerability of Xeloda for second-line chemotherapy in patients with advanced breast cancer. METHODS: An open, multi-center clinical trial was conducted in which patients enrolled in the study received Xeloda monotherapy at 2510 mg·(m2·d)-1, two oral doses of morning and evening after meals for 14 consecutive days, 7 days of withdrawal, for a total of 21 days. For a course of treatment. RESULTS: A total of 67 patients were eligible for evaluation in the whole group and 69 patients were evaluated for adverse reactions. Among them CR4 cases (5.97%), PR21 cases (31.34%), the total effective rate of 37.31%. After 4 weeks, the total effective rate of ITT confirmed was 32.86%. The main adverse reactions were hand-foot syndrome, skin pigmentation and diarrhea. Myelosuppression was relatively mild and the incidence of leukopenia was 44.9%. Except for one case of grade IV, the others were grade I-II. Conclusion: The use of Xeloda second-line therapy for advanced breast cancer has been reported to be similar to or slightly higher than that reported in foreign clinical trials. Except for a few patients with serious adverse reactions, most patients were well tolerated. Xeloda can treat advanced breast cancer that has failed conventional treatment such as adriamycin and paclitaxel.