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21 基因复发评分与 III 期多中心 TAILORx 临床试验的生存结局。

21-Gene Recurrence Score and Survival Outcomes in the Phase III Multicenter TAILORx Clinical Trial.

机构信息

Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD.

ELIASSEN Group, Reston, VA.

出版信息

J Natl Compr Canc Netw. 2024 Jul 17;22(6):376-381. doi: 10.6004/jnccn.2024.7008.

DOI:10.6004/jnccn.2024.7008
PMID:39019060
Abstract

BACKGROUND

Recurrence score (RS) based on a 21-gene genomic assay is frequently used to estimate risk of distant recurrence for choice of adjuvant chemotherapy in breast cancer. It remains unclear whether RS is an independent prognostic factor for breast cancer-specific survival (BCSS) and overall survival (OS) in the TAILORx trial population.

METHODS

We evaluated the association of RS with BCSS and OS plus recurrence-free interval (RFI) and invasive disease-free survival (DFS) using multivariable Cox proportional hazards regression analysis, adjusting for clinicopathologic measures, in 8,916 patients with hormone receptor-positive, HER2-negative, node-negative breast cancer. Likelihood ratio (LR) test was used to assess the relative amount of prognostic information provided by RS to BCSS, OS, RFI, and DFS, comparatively.

RESULTS

Event rates for BCSS, OS, RFI, and DFS were 1.7%, 5.2%, 5.6%, and 12.6%, respectively, by up to 11.6 years of follow-up. Compared with low-range RS (0-10), patients with midrange (11-25) and high-range (26-100) RS had inferior BCSS (adjusted hazard ratio [aHR], 5.12 [95% CI, 2.09-16.92] and 8.03 [95% CI, 2.91-28.47], respectively) and RFI (aHR, 1.68 [95% CI, 1.23-2.36] and 3.05 [95% CI, 2.02-4.67], respectively), independent of clinicopathologic factors. High-range score was associated with an increased risk of DFS (aHR, 1.56 [95% CI, 1.20-2.04]) but not significantly associated with OS (aHR, 1.44 [95% CI, 0.95-2.18]). Midrange score was associated with neither DFS (aHR, 1.15 [95% CI, 0.96-1.38]) nor OS (HR 1.14 [95% CI, 0.87-1.52]). LR-χ2 values were 83.0 and 65.1 for RFI and BCSS, respectively, and 17.5 and 33.6 for OS and DFS, respectively (P<.0001).

CONCLUSIONS

RS is an independent measure for BCSS and recurrence prognoses relative to OS in early-stage breast cancer. It carries more prognostic information for breast cancer-specific outcomes.

摘要

背景

基于 21 基因基因组检测的复发评分(RS)常用于估计乳腺癌辅助化疗的远处复发风险。在 TAILORx 试验人群中,RS 是否是乳腺癌特异性生存(BCSS)和总生存(OS)的独立预后因素仍不清楚。

方法

我们使用多变量 Cox 比例风险回归分析评估了 RS 与 BCSS 和 OS 以及无复发生存期(RFI)和无侵袭性疾病生存期(DFS)的相关性,共纳入 8916 例激素受体阳性、HER2 阴性、淋巴结阴性乳腺癌患者,校正了临床病理测量指标。采用似然比(LR)检验评估 RS 对 BCSS、OS、RFI 和 DFS 提供的预后信息的相对量。

结果

在长达 11.6 年的随访中,BCSS、OS、RFI 和 DFS 的事件发生率分别为 1.7%、5.2%、5.6%和 12.6%。与低 RS 范围(0-10)相比,中 RS 范围(11-25)和高 RS 范围(26-100)患者的 BCSS(校正后的危险比[aHR],5.12[95%CI,2.09-16.92]和 8.03[95%CI,2.91-28.47])和 RFI(aHR,1.68[95%CI,1.23-2.36]和 3.05[95%CI,2.02-4.67])较差,独立于临床病理因素。高 RS 与 DFS 风险增加相关(aHR,1.56[95%CI,1.20-2.04]),但与 OS 无显著相关性(aHR,1.44[95%CI,0.95-2.18])。中 RS 与 DFS(aHR,1.15[95%CI,0.96-1.38])和 OS(HR 1.14[95%CI,0.87-1.52])均无相关性。LR-χ2 值分别为 83.0 和 65.1 用于 RFI 和 BCSS,分别为 17.5 和 33.6 用于 OS 和 DFS(P<.0001)。

结论

RS 是早期乳腺癌 OS 相关的 BCSS 和复发预后的独立指标。它对乳腺癌特异性结局具有更多的预后信息。

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