Herrero-Vicent C, Guerrero-Zotano A, Gavilá-Gregori J, Hernández-Blanquisett A, Sandiego-Contreras S, Samper-Hiraldo J M, Guillem-Porta V, Ruiz-Simón A
Medical Oncology, Valencian Institute of Oncology, Valencia, Spain.
Ecancermedicalscience. 2016 Jun 16;10:647. doi: 10.3332/ecancer.2016.647. eCollection 2016.
The appropriate selection criteria for breast-conserving surgery (BCS) or mastectomy after neoadjuvant chemotherapy (NAC) are poorly defined. The aim of this study is to analyse the incidence and prognostic factors for locoregional recurrence (LRR) in patients with breast cancer (BC) treated with NAC to develop a prognostic score to help with clinical decision-making.
Using our retrospective maintained BC database, we identified 730 patients treated with NAC (327 patients treated with BCS and 403 patients treated with mastectomy) between 1998 and 2014. To identify variables associated with an increased LRR rate, we performed firstly Kaplan-Meier curves, with comparisons among groups using log-rank test, and then, significant variables were included in a multivariate analysis using Cox proportional hazards. The prognostic index was developed by assigning score 0 (favourable) or score 1 (unfavourable) for each significant variable of multivariate analysis and was created separately for patients with BCS and mastectomy.
At a median follow-up of 72 months, the 6-year cumulative incidence of LRR was 7.2% ( ± 3%) for BCS and 7.9% ( ± 3%) for mastectomy. By univariate analysis, variables associated with an increased LRR were for BCS: HER2 positive, grade III, ductal carcinoma in situ (DCIS), No-pCR (ypTis, ypN0), and age < 40 years; and for mastectomy, HER2-positive, DCIS, No-pCR, and LVI. By multivariate analysis, variables associated with an increased LRR were for BCS: HER2 positive (HR: 11.1, p = 0.001), DCIS (HR: 3.1, p = 0.005), and age < 40 years (HR: 2.8, p = 0.02); and for mastectomy: HER2 positive (HR: 9.5, p = 0.03), DCIS (HR: 2.7, p = 0.01), No-pCR (HR: 11.4, p = 0.01), and age < 40 years (HR: 2.8, p = 0.006). The score stratified patients into three subsets with statistically different levels of risk for LRR. For BCS, the six-year LRR rates were 3%, 13%, and 33% for the low (score 0, n = 120), intermediate (score 1, n = 95) and high (score 2-3, n = 27) risk groups, respectively (p = 0.001). For mastectomy, the six-year LRR rates were 0%, 8%, and 27% for the low (score 0, n = 20), intermediate (score 1-2, n 191), and high (score 3-4, n = 30) risk groups, respectively (p = 0.001). Of note, 21 patients that had a LRR event were HER2 positive, all of them had received trastuzumab.
Patients with a score of 0, which made up to 19% of the study population, had very low risk of LRR. The score enabled the identification of a small group (7%) of patients with very high risk of LRR, and who may benefit from alternative treatment.
新辅助化疗（NAC）后保乳手术（BCS）或乳房切除术的合适选择标准尚不明确。本研究旨在分析接受NAC治疗的乳腺癌（BC）患者局部区域复发（LRR）的发生率及预后因素，以制定一个预后评分来辅助临床决策。
利用我们回顾性维护的BC数据库，我们确定了1998年至2014年间730例接受NAC治疗的患者（327例行BCS，403例行乳房切除术）。为了确定与LRR率增加相关的变量，我们首先绘制了Kaplan-Meier曲线，使用对数秩检验进行组间比较，然后将显著变量纳入Cox比例风险多因素分析。通过对多因素分析的每个显著变量赋予0分（有利）或1分（不利）来制定预后指数，并分别为BCS和乳房切除术患者创建。
中位随访72个月时，BCS组LRR的6年累积发生率为7.2%（±3%），乳房切除组为7.9%（±3%）。单因素分析显示，与BCS组LRR增加相关的变量为：HER2阳性、III级、导管原位癌（DCIS）、无病理完全缓解（ypTis，ypN0）以及年龄<40岁；乳房切除组为：HER2阳性、DCIS、无病理完全缓解以及淋巴管浸润（LVI）。多因素分析显示，与BCS组LRR增加相关的变量为：HER2阳性（HR：11.1，p = 0.001）、DCIS（HR：3.1，p = 0.005）以及年龄<40岁（HR：2.8，p = 0.02）；乳房切除组为：HER2阳性（HR：9.5，p = 0.03）、DCIS（HR：2.7，p = 0.01）、无病理完全缓解（HR：11.4，p = 0.01）以及年龄<40岁（HR：2.8，p = 0.006）。该评分将患者分为三个具有统计学上不同LRR风险水平的亚组。对于BCS，低风险（评分0，n = 120）、中风险（评分1，n = 95）和高风险（评分2 - 3，n = 27）组的6年LRR率分别为3%、13%和33%（p = 0.001）。对于乳房切除术，低风险（评分0，n = 20）、中风险（评分1 - 2，n = 191）和高风险（评分3 - 4，n = 30）组的6年LRR率分别为0%、8%和27%（p = 0.001）。值得注意的是，发生LRR事件的21例患者为HER2阳性，他们均接受过曲妥珠单抗治疗。
评分为0的患者占研究人群的19%，其LRR风险非常低。该评分能够识别一小部分（7%）LRR风险非常高的患者，这些患者可能从替代治疗中获益。
