Utility of the 70-Gene MammaPrint Assay for Prediction of Benefit From Extended Letrozole Therapy in the NRG Oncology/NSABP B-42 Trial.

IF 42.1 1区医学 Q1 ONCOLOGY

Journal of Clinical Oncology Pub Date : 2024-10-20 Epub Date: 2024-07-24 DOI:10.1200/JCO.23.01995

Priya Rastogi, Hanna Bandos, Peter C Lucas, Laura J van 't Veer, Jia-Perng J Wei, Charles E Geyer, Louis Fehrenbacher, Stephen K L Chia, Adam M Brufsky, Janice M Walshe, Gamini S Soori, Shaker R Dakhil, Soonmyung Paik, Sandra M Swain, Andrea R Menicucci, M William Audeh, Norman Wolmark, Eleftherios P Mamounas

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引用次数: 0

Abstract

Purpose: MammaPrint (MP) determines distant metastatic risk and may improve patient selection for extended endocrine therapy (EET). This study examined MP in predicting extended letrozole therapy (ELT) benefit in patients with early-stage breast cancer (BC) from the NSABP B-42 trial.

Patients and methods: MP was tested in 1,866 patients randomly assigned to receive ELT or placebo. The primary end point was distant recurrence (DR). Secondary end points were disease-free survival (DFS) and BC-free interval (BCFI). Tumors were classified as MP high risk (MP-HR) or low risk (MP-LR). MP-LR tumors were further classified as ultralow risk (MP-UL) or low non-ultralow risk (MP-LNUL).

Results: There was no statistically significant difference in ELT benefit on DR between MP-HR and MP-LR (interaction P = .38). MP-LR tumors (n = 1,160) exhibited a statistically significant 10-year benefit of 3.7% for DR (hazard ratio [HR], 0.43 [95% CI, 0.25 to 0.74]; P = .002), whereas MP-HR tumors (n = 706) exhibited a nonsignificant 2.4% benefit (HR, 0.65 [95% CI, 0.34 to 1.24]; P = .19). The 10-year ELT benefit was significant for DFS (7.8%) and BCFI (7.0%) for MP-LR tumors, whereas MP-HR tumors did not significantly benefit (interaction DFS: P = .015, BCFI: P = .006). In exploratory analysis, the 10-year ELT benefit was significant and more pronounced in MP-LNUL (n = 908) tumors: 4.0% for DR, 9.5% for DFS, and 7.9% for BCFI; the benefit in MP-UL (n = 252) tumors was not significant: 3% for DR, 1.8% for DFS, and 4.1% for BCFI.

Conclusion: The primary hypothesis of predictive ability of MP on DR was not confirmed. However, the secondary outcomes demonstrated MP was predictive of ELT response and identified a subset of patients with early-stage hormone receptor-positive BC (MP-LR) with improved outcomes from ELT. These data could have important clinical implications in patient selection beyond clinical risk assessment for EET.

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70 基因 MammaPrint 检测在 NRG 肿瘤学/NSABP B-42 试验中预测来曲唑延长治疗获益的实用性。

目的：MammaPrint（MP）可确定远处转移风险，并可改善延长内分泌治疗（EET）的患者选择。本研究考察了 MP 在预测 NSABP B-42 试验中早期乳腺癌（BC）患者延长来曲唑治疗（ELT）获益方面的作用：对随机分配接受ELT或安慰剂治疗的1866名患者进行了MP测试。主要终点是远处复发（DR）。次要终点为无病生存期（DFS）和无 BCFI 间期（BCFI）。肿瘤被分为MP高风险（MP-HR）或低风险（MP-LR）。MP-LR肿瘤又分为超低风险（MP-UL）和非超低风险（MP-LNUL）：MP-HR和MP-LR的ELT对DR的获益无统计学差异（交互作用P = .38）。MP-LR肿瘤（n = 1,160）的10年DR获益率为3.7%，具有统计学意义（危险比[HR]，0.43 [95% CI，0.25至0.74]；P = .002），而MP-HR肿瘤（n = 706）的获益率为2.4%，不具显著性（HR，0.65 [95% CI，0.34至1.24]；P = .19）。MP-LR肿瘤的10年ELT获益在DFS（7.8%）和BCFI（7.0%）方面显著，而MP-HR肿瘤的获益不显著（交互作用DFS：P = .015，BCFI：P = .006）。在探索性分析中，MP-LNUL（n = 908）肿瘤的10年ELT获益显著且更明显：DR为4.0%，DFS为9.5%，BCFI为7.9%；MP-UL（n = 252）肿瘤的获益不显著：DR为3%，DFS为1.8%，BCFI为4.1%：结论：MP 对 DR 的预测能力这一主要假设未得到证实。然而，次要结果表明，MP可预测ELT反应，并确定了早期激素受体阳性BC（MP-LR）患者的子集，这些患者的ELT疗效有所改善。这些数据可能会在患者选择方面产生重要的临床影响，而不仅仅局限于EET的临床风险评估。

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 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.