Division of Breast and Melanoma Surgical Oncology, Department of Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Department of Quantitative Health Sciences , Mayo Clinic, Rochester, MN, USA.
Breast Cancer Res Treat. 2024 Feb;203(3):419-428. doi: 10.1007/s10549-023-07152-2. Epub 2023 Oct 25.
The role of neoadjuvant chemotherapy (NAC) in node-positive (N+) ER+/HER2- breast cancer (BC) is debated, given low total pathologic complete response (pCR) rates. However, the rate and impact of nodal pCR is unknown. We sought to evaluate nodal pCR rates and the impact on overall survival (OS). Further, we sought to validate the association between nodal pCR with age and Ki67.
We queried the National Cancer Database for cN + ER+/HER2- BC patients treated with NAC and surgery. Data from 2010 to 2018 were used to evaluate nodal pCR and OS, with multivariable Cox proportional hazards modeling for OS, as well as Ki67 for the years 2018-2019.
From 2010 to 2018, we identified 19,611 cN + ER+/HER2- BC patients treated with NAC. While total pCR occurred in only 7.4%, nodal pCR rates were nearly double (14.3%). Nodal pCR (+/- breast pCR) was seen in 21.7% and associated with 5-year OS rate of 86.1% (95% CI: 84.9-87.4%) versus 77.1% (95% CI: 76.3-77.9%) in patients without nodal pCR (p < 0.001). On multivariable analysis, nodal pCR had better OS (adjusted HR 0.57, 95% CI 0.52-0.63, p < 0.001) across all age groups. Of 2,444 patients with available Ki67, those with age < 50 and Ki67 ≥ 20% had the highest nodal pCR at 31.6%.
In cN + ER+/HER2- BC treated with NAC, nodal pCR is common, associated with age and Ki67, and prognostic for OS. These data strongly suggest that for cN + patients, eradication of nodal disease is critical for OS, and total pCR may not be the optimal measure of NAC benefit.
新辅助化疗（NAC）在淋巴结阳性（N+）ER+/HER2-乳腺癌（BC）中的作用存在争议，因为总病理完全缓解（pCR）率较低。然而，淋巴结 pCR 的发生率和影响尚不清楚。我们旨在评估淋巴结 pCR 率及其对总生存（OS）的影响。此外，我们试图验证淋巴结 pCR 与年龄和 Ki67 的相关性。
我们在国家癌症数据库中查询了接受 NAC 和手术治疗的 cN+ER+/HER2-BC 患者的数据。使用 2010 年至 2018 年的数据评估淋巴结 pCR 和 OS，采用多变量 Cox 比例风险模型进行 OS 分析，以及 2018-2019 年的 Ki67 分析。
2010 年至 2018 年，我们共确定了 19611 例接受 NAC 治疗的 cN+ER+/HER2-BC 患者。尽管总 pCR 发生率仅为 7.4%，但淋巴结 pCR 率几乎翻了一番（14.3%）。淋巴结 pCR（+/-乳房 pCR）见于 21.7%，5 年 OS 率为 86.1%（95%CI：84.9-87.4%），而无淋巴结 pCR 的患者为 77.1%（95%CI：76.3-77.9%）（p<0.001）。多变量分析显示，淋巴结 pCR 具有更好的 OS（调整后的 HR 0.57，95%CI 0.52-0.63，p<0.001），跨越所有年龄组。在 2444 例可获得 Ki67 的患者中，年龄<50 岁且 Ki67≥20%的患者淋巴结 pCR 率最高，为 31.6%。
在接受 NAC 治疗的 cN+ER+/HER2-BC 患者中，淋巴结 pCR 较为常见，与年龄和 Ki67 相关，与 OS 相关。这些数据强烈表明，对于 cN+患者，消除淋巴结疾病对于 OS 至关重要，总 pCR 可能不是 NAC 获益的最佳衡量标准。
