紫杉类药物用于可手术乳腺癌的辅助化疗

Adjuvant docetaxel for operable breast cancer

目的:蒽环类药物化疗方案中加入紫杉类药物能否提高可手术乳腺癌患者的生存获益。方法:选择2006年1月至2009年1月的初治乳腺癌患者391例,分为不含紫杉类药物组(CEF组138例,CTF组97例),含紫杉类药物组(TEC组98例,TTC组58例)。以无病生存作为第一观察终点,以死亡作为第二观察终点。结果:中位随访47个月,不含紫杉类药物组患者中无病生存(DFS)占90.1%,总生存(OS)为97.7%,含紫杉类药物化疗组患者中DFS为90.0%,OS为97.6%,均无明显统计学意义。含紫杉类药物组有较高的Ⅲ度以上白细胞下降率和心脏损害发生率(P<0.01)。结论:蒽环类方案中加入紫杉类药物未显著改善患者DFS和OS。

Objective To investigate whether the addition of docetaxel to anthracycline chemotherapy would improve the outcome of patients with operable breast cancer. Methods From Jan 2006 to Jan 2009, 391 patients with operable breast cancer were assigned to nondocetaxel-containing group （CEF： 138 patients, CTF： 97 patients） and docetaxel-containing group （TEC： 98 patients, Trc： 58 patients）. The primary end point was disease free survival （DFS）, and the second end point was death. Results The median follow-up periods was 47 months. The DFS and the overall survival （OS） were 90.0% and 97.6% in docetaxel-containing group, and were 90.1% and 97.7% in nondocetaxel-containing group（P 〉 0.05）. The proportion of patients who reported grade 3 or 4 neutropenia and cadiotoxicity was significantly greater in the docetaxel-containing group （P 〈 0.01）. Conclusion The addition of docetaxel to anthracycline chemotheray can not improve the DFS and OS of patients with operable breast cancer.