蒽环联合或序贯紫衫类不同给药间期对Luminal B型乳腺癌新辅助化疗疗效的影响

Response and prognosis of neoadjuvant dose-dense or standard schedule chemotherapy with anthracyclines and taxanes for Luminal B breast cancer

目的比较蒽环联合或序贯紫衫类方案以常规间期或剂量密集间期给药对Luminal B（HER2-）型乳腺癌新辅助化疗疗效的影响及安全性。方法2010年1月至2014年12月经病理证实的168例临床分期为ⅡA—ⅢC期Luminal B（HER2-）型乳腺癌患者数字随机分为多西他赛（T）＋表阿霉素（E）＋环磷酰胺（C）（TEC）常规间期组（A组）、EC序贯T（紫杉醇）常规间期组（B组）、TEC剂量密集组（C组）、EC序贯T剂量密集组（D组）接受新辅助化疗。密集组每14天为1个周期，常规间期组每21天为1个周期；A组、C组各化疗4周期，B组、D组EC联合化疗4周期后序贯T4周期。结果4组获得病理完全缓解（pCR）分别为4例（9．5％）、3例（7．1％）、13例（30．9％）、11例（26．1％）。中位随访43个月。3年无病生存（DFS）率4组分别为64．7％、55．5％、87．8％、92．1％；3年总生存（0s）率分别为79．4％、77．7％、95．1％、97．3％。比较pCR率、DFS率及0s率，C组、D组与A组及B组差异均有统计学意义（均P〈0．05）。154例患者可评价不良反应，4组血液学不良反应发生率分别为65．7％、51．3％、29．2％、21．9％，C组、D组与A组及B组差异均有统计学意义（均P〈0．05）．外周神经毒性发生率分别为54．2％、18．9％、60．0％、26．8％，B组、D组与A组及C组差异均有统计学意义（均P〈0．05）。4组间其他不良反应的差异无统计学意义。结论Luminal B（HER2－）乳腺癌新辅助化疗采用剂量密集方案能获得更好的pCR率、3年DFS率及0s率；EC－T剂量密集方案能减少神经毒性发生率。

Objective To evaluate the efficacy and safety of neoadjuvant dose-dense or standard schedule chemotherapy with anthraeyclines and taxanes for Luminal B （HER2 - ）Breast Cancer. Methods From January 2010 to December 2014,168 Luminal B （ HER2 - ） breast cancer patients with stage ⅡA - Ⅲ C confirmed by pathology were randomly assigned to receive one of the following regimens ： （ group A） concurrent TEC × 4 every 3 weeks, （ group B ） sequential EC × 4-T × 4 every 3 weeks, （group C ） dosedense TEC × 4 every× 2 weeks with G-CSF, （ group D） sequential EC x 4 （ dose-dense）-T ×4 with dosedense every 2 weeks . Results A total of 168 patients completed the neoadjuvant chemotherapy as planned. The pathologic complete response （pCR） was 16. 8% in the 4 groups. The pCR were 30. 9% and 26. 1% in the group C and group D respectively, significantly higher than patients with group A and group B（ 9.5% and 7.1% ） （ P 〈 0. 05 ）. Median follow-up was 43 months （ IQR 3 - 63 ）. The 3-year disease free survival （DFS） rate was 64. 7% ,55.5 % , 87.8% and 92. 1% and the 3-year overall survival（OS） rate was 79.4% , 77.7% ,95.1% ,97.3% in the 4 groups respeetiveiy. Patients in the dose-dense group had better 3-year DFS and 3-year OS than those with the regular group. The side-effects could be evaluated in 154 patients. The incidence of neutropenia was 29. 2% and 21.9% in the group C and group D versus 65.7% and 51.3% in the regular group （P 〈 0. 05 ）, the incidence of nervous toxicity was 54. 2%, 18.9 % ,60. 0% ,26. 8 % in the 4 groups respectively. The incidence of nervous toxicity in the dose-dense group was lower than that in the regular regimen group（ P 〈 0. 05 ）. Conclusion Neoadjuvant dose-dense chemotherapy with anthracyclines and taxanes for Luminal B （ HER2 - ） Breast Cancer was effective and can improve the pCR, DFS and OS. Comparing the two dose dense regimens, sequentially with anthracyclines and taxanes, the incidence of nervous toxicity were lower.