以紫杉醇为基础的化疗在三阴性乳腺癌新辅助治疗中的疗效和安全性评价

Efficacy and safety assessment of neoadjuvant paclitaxel-based chemotherapy in Chinese triple negative breast cancer

目的评价以紫杉醇为基础的化疗方案在可手术的三阴性乳腺癌患者新辅助治疗中的疗效与安全性。方法肿瘤大于2cm，经穿刺病理确诊的ER、PR、Her均阴性的乳腺癌患者，随机分为三组进行治疗：A组为紫杉醇175mg／m2D1，表阿霉素100mg／m。D1q21天；B组为紫杉醇175mg／m2D1，顺铂30mg／m2D1-D3q21天；C组为紫杉醇80mg／m2D1、D8、D15，顺铂30mg／m2D1-D3，q28天。患者均在手术前接受4个周期新辅助治疗后进行根治性手术。比较三组的原发肿瘤病理完全缓解（tpCn）率和总体反应（0R）率，并观察患者不良反应。结果共入组31例患者，所有患者均按计划完成术前4个周期新辅助治疗。A组tpCR率为30．0％，OR率为90％；B组tpCR率为33．3％，OR率为100％；C组tpCR率为83．3％，OR率为91．7％；C组的tpCR率明显高于A、B两组（P〈0．05）。三组患者均无需要调整剂量的严重不良反应。结论紫杉醇联合顺铂每周化疗方案在可手术的三阴性乳腺癌患者新辅助治疗中有较高的tpCR率，同时具有可靠的安全性。

Objective To assess the efficacy and safety of neoadjuvant paclitexal-based chemotherapy in Chinese triple negative breast cancer. Methods Operable breast cancer patients with tumor size over 2 cm, ER negative, PgR negative, and Her-2 negative were enrolled. The included patients were randomized into 3 groups to receive 4 cycles neoadjuvant chemotherapy. Group A were treated with paclitaxel（175 mg/m2, D 1） plus epirubicin （75 mg/m2, D1） chemotherapy every 3 weeks group B were treated with paclitaxel （175 mg/m2, D1） plus cisplatin（30 rag/ m2, D1-D3） chemotherapy every 3 weeks; and group C were treated weekly with paclitaxel（175mg/m2, D1, DS, D15） plus cisplatin（3Omg/m2, D1-D3） chemotherapy erery 4 weeks. The primary end point was primary tumor pathologic complete remission （tpCR） rate, and the secondary end point was overall response （OR） rate. Safety assess- ment was performed according to CTCAE v3.0. Results Thirty-one eligible patients were enrolled and randomized into 3 groups. All patients completed 4 cycles preoperative chemotherapy. In group A,tpCR rate was 30.0%, and OR rate was 90.0%, respectively. In group B, tpCR rate was 33.3%, and OR rate was 100.0%, respectively. In group C, tpCR rate was 83.3%, and OR rate was 91.7%, respectively. The tpCR rate of group C was much the other two groups＇ （P 〈 0.05）. No patient needed to reduce drug doses according to the Adverse Event. Conclusion Using weekly paclitexal plus cisplatin neoadjuvant chemotherapy to treat operable triple negative breast cancer patients has higher pCR rate, good tolerability, and safety.