吡柔比星或表柔比星联合紫杉醇新辅助化疗治疗局部晚期乳腺癌的随机对照研究
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Epirubicin or pirarubicin plus paclitaxel for neoadjuvant chemotherapy of locally advanced breast cancer:a randomized controlled trial
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    摘要:

    目的观察吡柔比星或表柔比星联合紫杉醇新辅助化疗治疗局部晚期乳腺癌(LABC)的近期临床疗效和毒副反应。方法采用随机对照研究,40例LABC行吡柔比星联合紫杉醇方案(PT组)或表柔比星联合紫杉醇方案(PE组)行新辅助化疗。记录患者每周期肿块大小、术后病理以及毒副反应分度。结果两组患者均接受共6个疗程的化疗。其中39例新辅助化疗2~4个周期后行手术治疗,手术后完成剩余疗程;1例新辅助化疗6周期后行手术治疗。PT组20例病理完全缓解率(pCR)、临床完全缓解率(cCR)以及临床部分缓解率(cPR)分别为10.0%、20.0%和75.0%,PE组为5.0%、30.0%、70.0%,两组总有效率(RR)无统计学差异。化疗过程中两组心脏毒性和造血系统毒性均为Ⅰ~Ⅱ度,且无统计学差异;PT组Ⅲ度胃肠道反应(恶心、呕吐)发生率45.0%,低于PE组的90.0%(P<0.05)。结论吡柔比星或表柔比星联合紫杉类新辅助化疗治疗LABC近期疗效较好,化疗后手术切除率高,心脏毒性及骨髓抑制较轻,但PT较PE方案胃肠道毒副反应有显著改善。

    Abstract:

    ObjectiveTo observe the short-term clinical efficacy and adverse effects of paclitaxel plus pirarubicin(THP) or epirubicin(EPI) in the neoadjuvant chemotherapy of locally advanced breast cancer (LABC).MethodsForty patients with newly diagnosed LABC were enrolled and were randomly assigned to two neoadjuvant chemotherapy groups(n=20):PT group received THP plus paclitaxel,and PE group received EPI plus paclitaxel.The tumor size,the pathological response,and the adverse reactions were observed on a weekly basis.ResultsAll the patients received six courses of chemotherapy.Thirty-nine of the patients received 2-4 cycles of neoadjuvant chemotherapy before they received operation; the remaining course of treatment was carried out after surgery.One patient received operation 6 weeks after neoadjuvant chemotherapy.The pathological complete response (pCR),clinical complete response (cCR) and partial response (cPR) in PT group were 10.0%,20.0% and 75.0%,respectively,and in PE group were 5.0%,30.0% and 70.0%,respectively.There was no significant difference in the total response rates (RR) between the two groups.Cardiac toxicity and leukopenia in the two groups were grade Ⅰ-Ⅱduring the chemotherapy. The incidence of grade Ⅲ gastrointestinal reaction (nausea and vomiting) was 45.0% in the PT group and 90.0% in the PE group (P<0.05).ConclusionNeoadjuvant chemotherapy with paclitaxel plus THP or EPI has satisfactory short-term clinical efficacy and adverse effects for LABC.The rate of radical surgical resection after chemotherapy is high.The gastrointestinal adverse reaction in the PT group is significantly lower than that in PE group.Cardiac toxicity and leukopenia are weak and bone marrow suppression is slight; PT regimen is improved compared with PE group.

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  • 收稿日期:2009-08-27
  • 最后修改日期:2009-11-28
  • 录用日期:2009-12-14
  • 在线发布日期: 2010-02-01
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