新辅助化疗和病理完全缓解对早期乳腺癌患者保乳手术适应证的影响：荟萃分析。
Impact of neoadjuvant chemotherapy and pathological complete response on eligibility for breast-conserving surgery in patients with early breast cancer: A meta-analysis.
机构信息
Division of New Drug Development, European Institute of Oncology, Milan, Italy.
Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, MA, USA; General Surgery, Department of Advanced Biomedical Science, University Federico II, Naples, Italy.
出版信息
Eur J Cancer. 2018 Jul;97:1-6. doi: 10.1016/j.ejca.2018.03.023. Epub 2018 May 17.
PURPOSE
We conducted a meta-analysis of randomised trials evaluating pathological complete response (pCR) and surgical outcomes after neoadjuvant systemic therapy (NST) in patients with early breast cancer (EBC).
PATIENTS AND METHODS
The primary outcome was breast-conserving surgery (BCT) rate. Secondary outcomes were pCR rate and association to BCT. Meta-analyses were performed using random effects models that use inverse-variance weighting for each treatment arm based on evaluable patients. Point estimates are reported with 95% confidence interval (CI), and p < 0.05 was considered statistically significant.
RESULTS
Thirty-six studies were identified (N = 12,311 patients). We selected for the analysis 16 of 36 studies reporting both pCR and BCT for at least one treatment arm. Arms per study ranged from one to six; 42 independent units were available to evaluate the association between pCR and BCT. BCT rate ranged 5-76% across arms with an average BCT of 57% (95% CI 52-62%). Significant heterogeneity was observed among the trials (Cochrane Q = 787, p < 0.001, I = 97%). In the meta-regression model, BCT rates were not significantly associated with year of first patient-in (p = 0.89), grade (p = 0.93) and hormone-receptor status (p = 0.39). Clinical N-stage (p = 0.01) and human epidermal growth factor receptor (HER2) status (p = 0.03) were significantly associated with BCT. pCR rate ranged 3-60% across studies. The average pCR across all study arms was 24% (95% CI 19-29%). No association was observed between pCR rate in a study arm and the resulting BCT rate in a univariate model (p = 0.34) nor after adjusting for HER2 and clinical nodal status (p = 0.82). In the subset of 14 multi-arm studies, no significant association was seen between the differences in pCR and BCT between treatment arms (p = 0.27).
CONCLUSIONS
pCR does not increase BCT in patients receiving NST for EBC.
目的
我们对评估新辅助全身治疗（NST）后早期乳腺癌（EBC）患者病理完全缓解（pCR）和手术结局的随机试验进行了荟萃分析。
患者和方法
主要结局是保乳手术（BCT）率。次要结局是 pCR 率和与 BCT 的关系。使用随机效应模型对每个治疗组进行荟萃分析，根据可评估患者对每个治疗组使用逆方差加权。报告点估计值和 95%置信区间（CI），p<0.05 被认为具有统计学意义。
结果
确定了 36 项研究（N=12311 例患者）。我们选择了 16 项研究进行分析，这些研究报告了至少一个治疗组的 pCR 和 BCT。每项研究的臂数从 1 到 6 不等；有 42 个独立单位可用于评估 pCR 和 BCT 之间的关系。臂间的 BCT 率范围为 5-76%，平均 BCT 为 57%（95%CI 52-62%）。试验间存在显著的异质性（Cochrane Q=787，p<0.001，I=97%）。在多元回归模型中，BCT 率与首次入组患者的年份（p=0.89）、分级（p=0.93）和激素受体状态（p=0.39）无显著相关性。临床 N 期（p=0.01）和人表皮生长因子受体（HER2）状态（p=0.03）与 BCT 显著相关。pCR 率在研究间范围为 3-60%。所有研究组的平均 pCR 为 24%（95%CI 19-29%）。在单变量模型中，研究组中 pCR 率与导致的 BCT 率之间未见相关性（p=0.34），也未见在调整 HER2 和临床淋巴结状态后相关性（p=0.82）。在 14 项多臂研究的亚组中，治疗组间 pCR 和 BCT 的差异之间未见显著相关性（p=0.27）。
结论
在接受 NST 治疗 EBC 的患者中，pCR 不会增加 BCT。
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