Impact of pathologic complete response on survival after neoadjuvant chemotherapy in early-stage breast cancer: a population-based analysis
Impact of pathologic complete response on survival after neoadjuvant chemotherapy in early-stage breast cancer: a population-based analysis
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DOI：
10.1007/s00432-019-03083-y
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发表时间：
2020-02-01
影响因子：
3.6
通讯作者：
Chia, S.
中科院分区：
文献类型：
--
作者：
LeVasseur, Nathalie;Sun, J.;Chia, S.
在临床试验中，获得病理完全缓解（pCR）与改善长期结局相关。然而，在亚型之间实现pCR的益处及其对现实世界结局的预后影响尚未得到很好的描述。方法回顾性分析2005年至2010年不列颠哥伦比亚省乳腺癌结局单位数据库中接受新辅助化疗的I-III期乳腺癌患者。将患者分为两组：pCR患者和乳腺/腋窝淋巴结（RD）残留浸润性疾病患者。主要终点是无复发生存期（RFS）。关键次要终点包括乳腺癌特异性生存期（BCSS）和总生存期（OS）。结果在267例患者中，74例（28%）患者达到pCR，193例（72%）患者发生RD。中位随访时间为7.5年。pCR组的5年RFS高于RD组（84% vs 70%; HR 0.45，p = 0.011）。pCR组的5年BCSS也高于RD组（90% vs 77%; HR 0.39，p = 0.014）。在多变量分析中，pCR与RFS（HR 0.39，p = 0.0077）和BCSS（HR 0.35，p = 0.015）改善相关，而传统病理学预后因素则无关。与RD患者相比，达到pCR的TNBC患者的RFS和BCSS改善（分别为HR 0.26，p = 0.020和HR 0.35，p = 0.090）。在HER-2阳性和ER +亚型中观察到相似但无统计学显著性的趋势。结论：在真实环境中，新辅助化疗后实现pCR与生存参数的临床有意义的改善相关。累积数据支持pCR作为临床试验和基于人群的环境中的有效替代终点。
Background Achieving a pathologic complete response (pCR) has been associated with improved long-term outcomes in clinical trials. However, the benefit of achieving pCR across subtypes and its prognostic effect on real-world outcomes has not been well described. Methods A retrospective analysis of the Breast Cancer Outcomes Unit database was undertaken to identify patients with stage I-III breast cancer treated with neoadjuvant chemotherapy from 2005 to 2010 in British Columbia. Patients were separated into two groups: those with pCR and those with residual invasive disease in the breast/axillary lymph nodes (RD). The primary endpoint was relapse-free survival (RFS). Key secondary endpoints included breast cancer-specific survival (BCSS) and overall survival (OS). Results Of 267 patients identified, 74 patients (28%) achieved pCR and 193 patients (72%) had RD. Median follow-up was 7.5 years. The 5-year RFS was higher in the pCR group compared to the RD group (84% vs 70%; HR 0.45, p = 0.011). The 5-year BCSS was also higher in the pCR group than in the RD group (90% vs 77%; HR 0.39, p = 0.014). In multivariable analyses, pCR was associated with improved RFS (HR 0.39, p = 0.0077) and BCSS (HR 0.35, p = 0.015), whereas traditional pathological prognostic factors were not. Patients with TNBC who achieved pCR had improved RFS and BCSS compared to those with RD (HR 0.26, p = 0.020 and HR 0.35, p = 0.090, respectively). A similar but non-statistically significant trend was seen in the HER-2-positive and ER + subtypes. Conclusions Achieving pCR after neoadjuvant chemotherapy was associated with clinically meaningful improvements in survival parameters in a real-world setting. The cumulative data support pCR as a valid surrogate endpoint in both clinical trials and population-based settings.