希罗达治疗转移性乳腺癌的疗效和安全性的临床研究

目的：评价希罗达(Xeloda)治疗国人转移性乳腺癌的疗效及其安全性。方法：2001年6月至2002年8月，共入选76例转移性乳腺癌病人。所有病人均予希罗达2500mg／m^2／天，分早晚两次，饭后30分钟内口服，连服14天，间歇7天，即每个治疗周期为2l天；至少治疗2周期。结果：76例中，l例完全缓解，25例部分缓解。病情稳定34例(44．7％)，疾病进展为15例(19.7％)。总有效率为34.2％。肿瘤控制率(CR PR SD)为78．9％。毒性反应Ⅰ／Ⅱ级主要为手足综合征19例(25．0％)、恶心13例(17．1％)和腹泻12例(15．8％)；Ⅲ级主要为恶心2例(2．6％)、呕吐2例(2．6％)、血小板减少2例(2．6％)、GOT升高2例(2．6％)及头晕l例(1．3％)，无Ⅳ级毒性。结论：口服希罗达治疗国人复治的转移性乳腺癌疗效较高，耐受性好，可以失言应用。

Study on the efficacy and safety of capecitabine (Xeloda) in treatment of metastatic breast carcinoma

Objective:To evaluate the efficacy and salety of capecitabine (Xeloda ) in Chinese patients with pretrealed me-tastatic breast carcinoma. Methods:The 76 patients were enrolled from June 2001 to August 2002. Capecitabine was given at 2 500 mg/m2 twice daily, day 1 - 14, followed by a 1-week rest, repeated ever) 3 weeks. Results; Among these patients, the overall response rate was 34. 2% with 1 CK and 25 PR. SD was 34(44. 1% ) , PD was 15 ( 19. 7% ). The tumor control rate ( CR + PR + SD) was 78. 9% . There were few severe adverse events. Grade 3 adverse events included nausea 2(2. 6% ) , vomiting 2(2. 6% ) , thrombocyto-penia 2(2. 6% ) , GOT elevation 2(2. 6% ) and dizziness 1(1. 3% ) ; no grade 4 adverse events occurred. Mosl common grade 1 -2 adverse events were 19 cases (25% ) with the hand-foot syndrome, nausea 13 ( 17. 1% ) and diarrhea 12( 15. 8% ). Conclusion; Capecitabine is effective and well-tolerated oral chemotherapy for Chinese patients with pretrealed metastatic breast carcinoma.