Development and Validation of the RSClinN+ Tool to Predict Prognosis and Chemotherapy Benefit for Hormone Receptor-Positive, Node-Positive Breast Cancer.

IF 42.1 1区 医学 Q1 ONCOLOGY
Journal of Clinical Oncology Pub Date : 2025-03-10 Epub Date: 2024-12-02 DOI:10.1200/JCO-24-01507
Lajos Pusztai, Jess R Hoag, Kathy S Albain, William E Barlow, Salomon M Stemmer, Allison Meisner, Gabriel N Hortobagyi, Steven Shak, James M Rae, Rick Baehner, Priyanka Sharma, Kevin M Kalinsky
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引用次数: 0

Abstract

Purpose: Clinicopathological factors and the 21-gene Oncotype DX Breast Recurrence Score (RS) test both influence prognosis. Our goal was to develop a new tool, RSClinN+, to individualize recurrence risk and chemotherapy benefit predictions by menopausal status for patients with HR+/human epidermal growth factor receptor 2-negative, lymph node-positive breast cancer by integrating the RS result with clinicopathological factors (grade, tumor size, age).

Methods: We used patient-level data from 5,283 patients treated with chemoendocrine therapy (CET) versus endocrine therapy alone (ET) in the S1007 (N = 4,916) and S8814 (N = 367) trials to develop the tool. Cox proportional hazards regression models stratified by trial were used to estimate 5-year invasive disease-free survival for pre- and postmenopausal woman, respectively. The integrated RSClinN+ model was compared with RS alone and clinicopathological models using likelihood ratio tests. Absolute CET benefit was estimated as the difference between ET and CET risk estimates. Validation of RSClinN+ was performed in 592 patients with node-positive disease in the Clalit Health Services registry.

Results: RSClinN+ provides better prognostic information than RS model alone (premenopausal P = .034; postmenopausal P < .001) or clinicopathological model alone (premenopausal P = .002; postmenopausal, P < .001). In postmenopausal women, RS showed interaction with CET benefit (P = .016), with RSClinN+ absolute CET benefit ranging from <0.1% to 21.5% over RS ranges 0-50. In premenopausal patients with RS ≤25, there was no significant interaction between RS and CET benefit. In external validation, RSClinN+ risk estimates were prognostic (hazard ratio, 1.75 [95% CI, 1.38 to 2.20]) and concordant with observed risk (Lin's concordance, 0.92).

Conclusion: RSClinN+ provides improved estimates of prognosis and absolute CET benefit for individual patients compared with RS or with clinical data alone and could be used in patient counseling.

RSClinN+预测激素受体阳性、淋巴结阳性乳腺癌预后和化疗效果的工具的开发和验证。
目的:临床病理因素和21基因Oncotype DX乳腺癌复发评分(RS)检测均影响预后。我们的目标是开发一种新的工具,RSClinN+,通过将RS结果与临床病理因素(分级、肿瘤大小、年龄)相结合,对HR+/人表皮生长因子受体2阴性、淋巴结阳性乳腺癌患者的绝经状态进行个体化复发风险和化疗获益预测。方法:我们在S1007 (N = 4,916)和S8814 (N = 367)试验中使用了5283例化疗内分泌治疗(CET)和单独内分泌治疗(ET)患者的患者水平数据来开发该工具。采用试验分层的Cox比例风险回归模型分别估计绝经前和绝经后妇女的5年无侵袭性疾病生存率。采用似然比检验将RSClinN+综合模型与RS单独模型及临床病理模型进行比较。绝对的CET获益是用ET和CET风险估计值之间的差值来估计的。在Clalit Health Services注册的592例淋巴结阳性疾病患者中进行了RSClinN+的验证。结果:RSClinN+比单独RS模型提供更好的预后信息(绝经前P = 0.034;绝经后P < 0.001)或单独的临床病理模型(绝经前P = 0.002;绝经后,P < 0.001)。在绝经后妇女中,RS显示出与CET获益的相互作用(P = 0.016), RSClinN+绝对CET获益范围如下:结论:与RS或单独的临床数据相比,RSClinN+提供了对个体患者预后和绝对CET获益的更好估计,可用于患者咨询。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Clinical Oncology
Journal of Clinical Oncology 医学-肿瘤学
CiteScore
41.20
自引率
2.20%
发文量
8215
审稿时长
2 months
期刊介绍: The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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