Tao Miaomiao, Chen Shu, Zhang Xianquan, Zhou Qi
Fuling Center Hospital of Chongqing City Chongqing Medical University The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Medicine (Baltimore). 2017 Dec;96(51):e9384. doi: 10.1097/MD.0000000000009384.
A pathological complete response (pCR) after neoadjuvant chemotherapy (NCT) is a strong indicator of the benefit of therapy and presents an early surrogate for a favorable long-term outcome. It remains unclear whether Ki-67, a marker for tumor proliferation, can function as a predictor of the response to NCT in breast cancer. The objective of this meta-analysis was to compare the pCR rate and clinical outcomes in breast cancer patients with different Ki-67 labeling indexes (Ki-67 LI) who received NCT.
Clinical studies were retrieved from the electronic databases of PubMed, Embase, Clinical Trials, Wanfang, and the Chinese National Knowledge Infrastructure, from their inception to July 31, 2017. Meta-analysis was performed on pool eligible studies to determine whether Ki-67 LI was associated with the pCR rate and clinical outcomes of breast cancer patients who were treated with NCT. Pooled analyses were performed using fixed effects models. Two reviewers screened all titles and abstracts and independently assessed all articles.
A total of 36 studies involving 6793 patients were included in the meta-analysis. Pooled analysis results revealed that patients with high Ki-67 LI exhibited significantly higher pCR rates (odds ratio [OR] = 3.94, 95% confidence interval [CI]: 3.33-4.67, P <.001) but poorer relapse-free survival (OR = 1.99, 95% CI: 1.39-2.85, P <.001) than those with low Ki-67 LI, but there was no significant difference in objective tumor response rate.
The meta-analysis reported here demonstrates that pretherapeutic Ki-67 LI is associated with pCR in breast cancer patients undergoing NCT. More phase III randomized clinical trials will be required to confirm our findings.
新辅助化疗（NCT）后的病理完全缓解（pCR）是治疗获益的有力指标，也是良好长期预后的早期替代指标。肿瘤增殖标志物Ki-67是否可作为乳腺癌NCT反应的预测指标仍不清楚。本荟萃分析的目的是比较接受NCT的不同Ki-67标记指数（Ki-67 LI）的乳腺癌患者的pCR率和临床结局。
从PubMed、Embase、Clinical Trials、万方和中国知网的电子数据库中检索自数据库建立至2017年7月31日的临床研究。对纳入的合格研究进行荟萃分析，以确定Ki-67 LI是否与接受NCT的乳腺癌患者的pCR率和临床结局相关。采用固定效应模型进行汇总分析。两名研究者筛选所有标题和摘要，并独立评估所有文章。
荟萃分析共纳入36项研究，涉及6793例患者。汇总分析结果显示，与低Ki-67 LI患者相比，高Ki-67 LI患者的pCR率显著更高（比值比[OR]=3.94，95%置信区间[CI]：3.33-4.67，P<0.001），但无病生存率较差（OR=1.99，95%CI：1.39-2.85，P<0.001），而客观肿瘤反应率无显著差异。
本荟萃分析表明，治疗前Ki-67 LI与接受NCT的乳腺癌患者的pCR相关。需要更多的III期随机临床试验来证实我们的发现。
