Department of Health Statistics, Second Military Medical University, Shanghai, China.
PLoS One. 2011;6(11):e26946. doi: 10.1371/journal.pone.0026946. Epub 2011 Nov 1.
Taxanes have been extensively used as adjuvant chemotherapy for the treatment of early or operable breast cancer, particularly in high risk, node-negative breast cancer. Previous studies, however, have reported inconsistent findings regarding their clinical efficacy and safety. We investigated disease-free survival (DFS), overall survival (OS), and drug-related toxicities of taxanes by a systematic review and meta-analysis.
We systematically searched PubMed, EMBASE, the Cochrane Center Register of Controlled Trials, proceedings of major meetings, and reference lists of articles for studies conducted between January 1980 and April 2011. Randomized controlled trials (RCTs) comparing chemotherapy with and without taxanes in the treatment of patients with early-stage or operable breast cancer were eligible for inclusion in our analysis. The primary endpoint was DFS. Nineteen RCTs including 30698 patients were identified, including 8426 recurrence events and 3803 deaths. Taxanes administration yielded a 17% reduction of hazard ratio (HR) for DFS (HR = 0.83, 95% CI 0.79-0.88, p<0.001) and a 17% reduction of HR for OS (HR = 0.83, 95% CI 0.77-0.90, p<0.001). For high risk, node-negative breast cancer, the pooled HR also favoured the taxane-based treatment arm over the taxane-free treatment arm (HR = 0.82, 95% CI 0.77-0.87, p = 0.022). A significantly increased rate of neutropenia, febrile neutropenia, fatigue, diarrhea, stomatitis, and oedema was observed in the taxane-based treatment arm.
CONCLUSIONS/SIGNIFICANCE: Adjuvant chemotherapy with taxanes could reduce the risk of cancer recurrence and death in patients with early or operable breast cancer, although the drug-related toxicities should be balanced. Furthermore, we also demonstrated that patients with high risk, node-negative breast cancer also benefited from taxanes therapy, a result that was not observed in previous studies.
紫杉烷类药物已广泛用于早期或可手术治疗的乳腺癌的辅助化疗，特别是在高危、淋巴结阴性的乳腺癌中。然而，之前的研究对其临床疗效和安全性的报告结果并不一致。我们通过系统评价和荟萃分析来研究紫杉烷类药物的无病生存（DFS）、总生存（OS）和药物相关毒性。
我们系统地检索了 1980 年 1 月至 2011 年 4 月期间发表的 PubMed、EMBASE、Cochrane 中心对照试验注册库、主要会议记录和文章参考文献，以寻找紫杉烷类药物与单纯化疗比较治疗早期或可手术治疗的乳腺癌患者的研究。纳入我们分析的研究必须是比较化疗联合与不联合紫杉烷类药物治疗的随机对照试验（RCT）。共纳入 19 项 RCT，包括 30698 例患者，其中 8426 例复发事件和 3803 例死亡。紫杉烷类药物治疗可使 DFS 的危险比（HR）降低 17%（HR=0.83，95%CI 0.79-0.88，p<0.001），OS 的 HR 降低 17%（HR=0.83，95%CI 0.77-0.90，p<0.001）。对于高危、淋巴结阴性的乳腺癌，联合紫杉烷类药物治疗组也明显优于不联合紫杉烷类药物治疗组（HR=0.82，95%CI 0.77-0.87，p=0.022）。紫杉烷类药物治疗组中性粒细胞减少症、发热性中性粒细胞减少症、疲劳、腹泻、口腔炎和水肿的发生率显著增加。
结论/意义：辅助化疗联合紫杉烷类药物可降低早期或可手术治疗的乳腺癌患者癌症复发和死亡的风险，但应权衡药物相关毒性。此外，我们还表明，高危、淋巴结阴性的乳腺癌患者也从紫杉烷类药物治疗中获益，这是以前的研究中没有观察到的结果。
