DataSheet_1_Nomogram Predicts the Role of Primary Tumor Surgery on De Novo Stage-IV Breast Cancer Patients: A SEER-Based Competing Risk Analysis Model.csv

ObjectiveThe efficacy of primary tumor surgery on survival in female patients with de novo stage IV breast cancer (BC) remains unclear. Our study endeavored to develop comprehensive competing risk nomograms to predict clinical outcomes and guide precision treatment in these patients.
Participants and MethodsA total of 12281 patients who had distant metastasis at initial BC diagnosis between 2010 and 2017 in the Surveillance Epidemiology and End Results (SEER) database, were enrolled in this study. First, we assessed the impacts of primary tumor surgery on overall survival (OS) and breast cancer-specific survival (BCSS) using the Kaplan-Meier curves. Then subgroup analyses stratified by different metastatic patterns were performed using Cox and competing risk models (CRM). Based on the filtered independent prognostic parameters by CRM, we established two nomograms to predict the probability of breast cancer-specific death (BCSD) at 1-,2- and 3-year intervals. Furthermore, calibration curves and area under the curves (AUC) were conducted for validation.
ResultsKaplan-Meier analysis revealed that surgery was associated with better OS and BCSS (P<0.001). Subgroup analyses demonstrated that in bone-only metastases pattern, relative to breast-conserving surgery (BCS), patients receiving mastectomy had worse prognosis and the poorest survival belonged to non-surgery individuals (BCSS: mastectomy: HR=1.35; 95%CI=1.15-1.60; non-surgery: 2.42; 2.08-2.82; OS: mastectomy: 1.44; 1.23-1.68; non-surgery: 2.40; 2.08-2.78). Additionally, no survival difference was observed between BCS and reconstruction recipients (BCSS: HR=1.10; 95%CI=0.85-1.43; OS: 1.11; 0.86-1.44). Furthermore, patients undergoing BCS possessed similar BCSS with mastectomy recipients as well as reconstruction recipients in viscera metastases pattern, whereas non-surgery individuals had a worse survival (mastectomy: HR=1.04; 95%CI=0.92-1.18; reconstruction: 0.86; 0.69-1.06; non-surgery: 1.83; 1.63-2.05). Two competing risk nomograms of distinct metastatic patterns were established to comprehensively predict the survival of patients. Calibration curves indicated the terrific consistency of the models. Moreover, the AUC values in the training and validation sets were in the range of 0.70–0.80, exhibiting good specificity and sensitivity.
ConclusionThe surgery implementation was associated with a lower probability of BCSD in de novo stage-IV BC patients. Our nomograms could offer a relatively accurate and individualized prediction of the cumulative incidence rate of BCSD after primary tumor resection.

【研究目的】新发IV期女性乳腺癌（breast cancer, BC）患者的原发性肿瘤手术对其生存结局的疗效仍未明确。本研究旨在构建全面的竞争风险列线图，以预测该类患者的临床结局并指导精准治疗。

【研究对象与方法】本研究纳入2010至2017年间，美国监测、流行病学与最终结果（Surveillance, Epidemiology, and End Results, SEER）数据库中12281例初诊时即存在远处转移的乳腺癌患者。首先，采用Kaplan-Meier曲线评估原发性肿瘤手术对总生存期（overall survival, OS）及乳腺癌特异性生存期（breast cancer-specific survival, BCSS）的影响。随后，针对不同转移模式开展分层亚组分析，采用Cox模型及竞争风险模型（competing risk model, CRM）进行建模。基于竞争风险模型筛选出的独立预后参数，本研究构建了两款列线图，以预测患者1、2、3年的乳腺癌特异性死亡（breast cancer-specific death, BCSD）发生概率。此外，通过校准曲线及受试者工作特征曲线下面积（area under the curve, AUC）对模型进行验证。

【研究结果】Kaplan-Meier分析结果显示，手术治疗与更优的总生存期及乳腺癌特异性生存期相关（P<0.001）。亚组分析表明，在仅骨转移亚组中，与保乳手术（breast-conserving surgery, BCS）患者相比，接受乳房切除术的患者预后更差，而非手术患者的生存结局最差（BCSS：乳房切除术HR=1.35，95%CI=1.15~1.60；非手术组HR=2.42，95%CI=2.08~2.82；OS：乳房切除术HR=1.44，95%CI=1.23~1.68；非手术组HR=2.40，95%CI=2.08~2.78）。此外，保乳手术与乳房重建术患者的生存结局无显著差异（BCSS：HR=1.10，95%CI=0.85~1.43；OS：HR=1.11，95%CI=0.86~1.44）。进一步分析显示，在内脏转移亚组中，接受保乳手术的患者与乳房切除术患者及乳房重建术患者的乳腺癌特异性生存期无显著差异，而非手术患者的生存结局更差（乳房切除术HR=1.04，95%CI=0.92~1.18；乳房重建术HR=0.86，95%CI=0.69~1.06；非手术组HR=1.83，95%CI=1.63~2.05）。本研究构建了两款针对不同转移模式的竞争风险列线图，以全面预测患者的生存情况。校准曲线显示模型具有极佳的一致性。此外，训练集与验证集的AUC值介于0.70~0.80之间，表明模型具有良好的特异性与灵敏度。

【研究结论】原发性肿瘤手术可降低新发IV期乳腺癌患者的乳腺癌特异性死亡风险。本研究构建的列线图可对原发肿瘤切除术后的乳腺癌特异性死亡累积发生率提供较为精准的个体化预测。