Department of Surgery, Duke University Medical Center, Durham, NC.
Department of Population Health Sciences, Duke University Medical Center, Durham, NC.
J Clin Oncol. 2023 May 10;41(14):2546-2560. doi: 10.1200/JCO.22.02222. Epub 2023 Mar 21.
Given the heterogeneity and improvement in outcomes for metastatic breast cancer (MBC), we developed a staging system that refines prognostic estimates for patients with metastatic cancer at the time of initial diagnosis, de novo MBC (dnMBC), on the basis of survival outcomes and disease-related variables.
Patients with dnMBC (2010-2016) were selected from the National Cancer Database (NCDB). Recursive partitioning analysis (RPA) was used to group patients with similar overall survival (OS) on the basis of clinical T category, grade, estrogen receptor (ER), progesterone receptor, human epidermal growth factor receptor 2, histology, organ system site of metastases (bone-only, brain-only, visceral), and number of organ systems involved. Three-year OS rates were used to assign a final stage: IVA: >70%, IVB: 50%-70%, IVC: 25 to <50%, and IVD: <25%. Bootstrapping was applied with 1,000 iterations, and final stage assignments were made based on the most commonly occurring assignment. Unadjusted OS was estimated. Validation analyses were conducted using SEER and NCDB.
At a median follow-up of 52.9 months, the median OS of the original cohort (N = 42,467) was 35.4 months (95% CI, 34.8 to 35.9). RPA stratified patients into 53 groups with 3-year OS rates ranging from 73.5% to 5.7%; these groups were amalgamated into four stage groups: 3-year OS, A = 73.2%, B = 61.9%, C = 40.1%, and D = 17% (log-rank < .001). After bootstrapping, the survival outcomes for the four stages remained significantly different (log-rank < .001). This staging system was then validated using SEER data (N = 20,469) and a separate cohort from the NCDB (N = 7,645) (both log-rank < .001).
Our findings regarding the heterogeneity in outcomes for patients with dnMBC could guide future revisions of the current American Joint Committee on Cancer staging guidelines for patients with newly diagnosed stage IV disease. Our findings should be independently confirmed.
鉴于转移性乳腺癌(MBC)的异质性和预后改善,我们开发了一种分期系统,该系统基于生存结果和疾病相关变量,对初始诊断时转移性癌症(新诊断转移性乳腺癌,dnMBC)患者的预后进行了细化评估。
从国家癌症数据库(NCDB)中选择 dnMBC(2010-2016 年)患者。递归分区分析(RPA)用于根据临床 T 分期、分级、雌激素受体(ER)、孕激素受体、人表皮生长因子受体 2、组织学、转移器官系统部位(仅骨、仅脑、内脏)和受累器官系统数量,对具有相似总生存(OS)的患者进行分组。使用 3 年 OS 率对最终分期进行赋值:IVA:>70%,IVB:50%-70%,IVC:25-<50%,IVD:<25%。应用 1000 次迭代进行自举,根据最常见的赋值确定最终分期。未调整的 OS 进行了估计。使用 SEER 和 NCDB 进行了验证分析。
中位随访 52.9 个月时,原始队列(N=42467)的中位 OS 为 35.4 个月(95%CI,34.8 至 35.9)。RPA 将患者分为 53 组,3 年 OS 率从 73.5%到 5.7%不等;这些组合并为四个分期组:3 年 OS,A=73.2%,B=61.9%,C=40.1%,D=17%(对数秩检验<.001)。经过自举后,四个分期的生存结果仍存在显著差异(对数秩检验<.001)。然后使用 SEER 数据(N=20469)和 NCDB 的另一个队列(N=7645)对该分期系统进行了验证(均对数秩检验<.001)。
我们关于 dnMBC 患者结局异质性的发现可以为未来修订新诊断为 IV 期疾病患者的现行美国癌症联合委员会分期指南提供指导。我们的发现应独立确认。