新辅助紫杉醇联合曲妥珠单抗在表皮生长因子受体2阳性可手术乳腺癌患者中的疗效及安全性评价

Efficacy and safety assessment of neoadjuvant paclitaxel and trastuzumab in Chinese women with Her-2 positive operable breast cancer

目的 评价紫杉醇联合曲妥珠单抗每3周新辅助方案在表皮生长因子受体2（Her-2）过表达且可手术的乳腺癌患者中的疗效及安全性.方法 入组患者术前接受4个周期紫杉醇联合曲妥珠单抗每3周方案新辅助治疗,其中第1周期第1天,紫杉醇175 mg/m2、静脉滴注 第2天,曲妥珠单抗8 ms/kg的首剂负荷量 从第2周期始,紫杉醇剂量不变,曲妥珠单抗改为6 mg/kg的维持剂量 于第4周期末行根治性手术.评价病理完全缓解（pCR）率和总体反应（OR）率,同时比较激素受体状态不同的各亚组间pCR率与OR率的差异,并观察患者不良反应.结果 共40例患者符合入组标准,中位年龄49岁.所有患者均按计划完成术前4个周期新辅助治疗.全组pCR率为52.5%,OR率为87.5%.各亚组间pCR率与OR率的差异均无统计学意义（P〉0.05）.全组无2级或2级以上的心脏毒性反应.结论 紫杉醇联合曲妥珠单抗每3周新辅助方案在Her-2过表达且可手术的乳腺癌患者中有较高的pCR率和OR率,同时具有可靠的安全性.

Objective To assess the efficacy and safety of neoadjuvant 3-weekly paclitaxel plus trastuzumab （TH） in Chinese women with Her-2 overexpressing operable breast cancer. Methods This is a single center open-label phase II clinical trial. The included patients underwent 4 cycles of neoadjuvant 3-weekly TH before surgery. The primary endpoint was pathologic complete response rate （ pCR rate） and the secondary endpoint was overall response rate （OR rate）. Patients were also stratified according to hormone receptor status, and pCR rate and OR rate were compared between subgroups. Adverse events were graded according to CTCAE v3.0. Results There were 40 eligible patients entering this study with median age of 49 years. All patients completed 4 cycles of neoadjuvant treatment. pCR rate was 52.5% and OR rate was 87. 5%. The differences of pCR and OR rates between subgroups were of no statistical significance. No cardiac toxicity event severer than grade 2 was recorded. Conclusion 3-weekly TH regimen has satisfactory pCR rate and OR rate in Chinese patients with Her-2 overexpressing operable breast cancer and reliable safety.