Department of Medical Oncology, BC Cancer-Vancouver Centre, Vancouver, V5Z 4E6, Canada.
Breast Cancer Outcomes Unit, British Columbia Cancer Agency, Vancouver, Canada.
J Cancer Res Clin Oncol. 2020 Feb;146(2):529-536. doi: 10.1007/s00432-019-03083-y. Epub 2019 Nov 18.
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.
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).
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.
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.
在临床试验中，达到病理完全缓解（pCR）与长期预后的改善相关。然而，在不同亚型中达到 pCR 的益处及其对真实世界结局的预后影响尚未得到充分描述。
对不列颠哥伦比亚省 2005 年至 2010 年间接受新辅助化疗的 I-III 期乳腺癌患者的乳腺癌结局单位数据库进行回顾性分析。患者分为两组：pCR 组和乳腺/腋窝淋巴结残留浸润性疾病（RD）组。主要终点为无复发生存（RFS）。关键次要终点包括乳腺癌特异性生存（BCSS）和总生存（OS）。
共确定 267 例患者，其中 74 例（28%）达到 pCR，193 例（72%）存在 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）。多变量分析显示，pCR 与改善的 RFS（HR 0.39，p=0.0077）和 BCSS（HR 0.35，p=0.015）相关，而传统的病理预后因素则不然。达到 pCR 的三阴性乳腺癌患者的 RFS 和 BCSS 均优于 RD 患者（HR 0.26，p=0.020 和 HR 0.35，p=0.090）。HER-2 阳性和 ER+ 亚型也观察到类似但无统计学意义的趋势。
在真实环境中，新辅助化疗后达到 pCR 与生存参数的临床显著改善相关。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。
