AJCC 第 8 版乳腺癌预后分期系统在 Legacy Alliance 试验（AFT-01）中的验证。
Validation of the AJCC 8th Edition Breast Cancer Prognostic Staging System in Legacy Alliance Trials (AFT-01).
机构信息
Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Department of Surgery, University of Wisconsin Carbone Cancer Center, Madison, WI, USA.
出版信息
Ann Surg Oncol. 2024 Sep;31(9):5880-5887. doi: 10.1245/s10434-024-15477-5. Epub 2024 Jun 2.
BACKGROUND
The 8th edition American Joint Committee on Cancer staging system combined anatomic stage (AS) with receptor status and grade to create prognostic stage (PS). PS has been validated in single-institution and cancer registry studies; however, missing human epidermal growth factor receptor 2 (HER2) status and variable treatment and follow-up create limitations.
OBJECTIVE
Our objective was to compare the relative prognostic ability of PS versus AS to predict survival using breast cancer clinical trial data.
METHODS
Women with non-metastatic breast cancer enrolled in six Alliance for Clinical Trials in Oncology trials were included (enrollment years 1997-2010). AS and PS were constructed using pathological tumor size, nodal status, estrogen receptor (ER), progesterone receptor (PR), HER2 status, and grade. Unadjusted Cox proportional hazard models were estimated to predict overall survival within 5 years, with AS and PS as predictor variables. The relative predictive power of staging models was assessed by comparing Harrell concordance indices (C-indices). Kaplan-Meier-based mortality estimates were compared by stage.
RESULTS
Overall, 6924 women were included (median age 53 years); 45.2% were diagnosed with ER+/PR+/HER2- tumors, 26.2% with HER2+ tumors, and 17.1% with ER-/PR-/HER2- tumors. Median follow-up time was 5 years (interquartile range 2.95-5.00). PS significantly improved predictive performance (C-index 0.721) for overall survival compared with AS (0.700) (p = 0.020). Kaplan-Meier hazard estimates suggested PS did not distinguish mortality risk between patients with IIB and IIIA or IB and IIA disease.
CONCLUSIONS
PS has significantly improved predictive performance for OS compared with AS. As systemic therapies evolve, it will be important to re-evaluate the prognostic staging system, particularly for patients with intermediate-stage cancers.
CLINICALTRIALS
gov Identifier: NCT02171078.
背景
第八版美国癌症联合委员会（AJCC）分期系统将解剖分期（AS）与受体状态和分级相结合，创建了预后分期（PS）。PS 已在单机构和癌症登记研究中得到验证；然而，HER2 状态缺失以及治疗和随访的差异带来了局限性。
目的
本研究旨在使用乳腺癌临床试验数据比较 PS 与 AS 预测生存的相对预后能力。
方法
纳入了参加六个肿瘤临床联盟临床试验的非转移性乳腺癌女性患者（入组年份为 1997-2010 年）。使用病理肿瘤大小、淋巴结状态、雌激素受体（ER）、孕激素受体（PR）、HER2 状态和分级构建 AS 和 PS。使用未调整的 Cox 比例风险模型估计 5 年内的总生存率，将 AS 和 PS 作为预测变量。通过比较 Harrell 一致性指数（C 指数）来评估分期模型的相对预测能力。通过分期比较 Kaplan-Meier 基于死亡率的估计值。
结果
共纳入 6924 例女性患者（中位年龄为 53 岁）；45.2%诊断为 ER+/PR+/HER2-肿瘤，26.2%为 HER2+肿瘤，17.1%为 ER-/PR-/HER2-肿瘤。中位随访时间为 5 年（四分位距 2.95-5.00）。与 AS（0.700）相比，PS 显著改善了总生存率的预测性能（C 指数 0.721）（p=0.020）。Kaplan-Meier 危险估计表明，PS 并不能区分 IIB 期和 IIIA 期或 IB 期和 IIA 期患者的死亡风险。
结论
与 AS 相比，PS 显著提高了 OS 的预测性能。随着系统治疗的发展，重新评估预后分期系统将非常重要，特别是对于中危癌症患者。
临床试验
gov 标识符：NCT02171078。
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