Adjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT.

IF 42.1 1区 医学 Q1 ONCOLOGY Journal of Clinical Oncology Pub Date : 2024-11-01 Epub Date: 2024-06-27 DOI:10.1200/JCO.23.02170
Paolo Tarantino, Nabihah Tayob, Guillermo Villacampa, Chau Dang, Denise A Yardley, Steven J Isakoff, Vicente Valero, Meredith Faggen, Therese Mulvey, Ron Bose, Douglas Weckstein, Antonio C Wolff, Katherine Reeder-Hayes, Hope S Rugo, Bhuvaneswari Ramaswamy, Dan Zuckerman, Lowell Hart, Vijayakrishna K Gadi, Michael Constantine, Kit Cheng, Audrey Merrill Garrett, P Kelly Marcom, Kathy Albain, Patricia DeFusco, Nadine Tung, Blair Ardman, Rita Nanda, Rachel C Jankowitz, Mothaffar Rimawi, Vandana Abramson, Paula R Pohlmann, Catherine Van Poznak, Andres Forero-Torres, Minetta C Liu, Kathryn J Ruddy, Adrienne G Waks, Michelle DeMeo, Harold J Burstein, Ann H Partridge, Patrizia Dell'Orto, Leila Russo, Emma Krause, Daniel J Newhouse, Busem Binboğa Kurt, Elizabeth A Mittendorf, Bryan Schneider, Aleix Prat, Eric P Winer, Ian E Krop, Sara M Tolaney
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引用次数: 0

Abstract

Purpose: Long-term outcomes of patients with stage I human epidermal growth factor receptor 2 (HER2)-positive breast cancer receiving adjuvant trastuzumab emtansine (T-DM1) remain undefined, and prognostic predictors represent an unmet need.

Methods: In the ATEMPT phase II trial, patients with stage I centrally confirmed HER2-positive breast cancer were randomly assigned 3:1 to adjuvant T-DM1 for 1 year or paclitaxel plus trastuzumab (TH). Coprimary objectives were to compare the incidence of clinically relevant toxicities between arms and to evaluate invasive disease-free survival (iDFS) with T-DM1. Correlative analyses included the HER2DX genomic tool, multiomic evaluations of HER2 heterogeneity, and predictors of thrombocytopenia.

Results: After a median follow-up of 5.8 years, 11 iDFS events were observed in the T-DM1 arm, consistent with a 5-year iDFS of 97.0% (95% CI, 95.2 to 98.7). At 5 years, the recurrence-free interval (RFI) was 98.3% (95% CI, 97.0 to 99.7), the overall survival was 97.8% (95% CI, 96.3 to 99.3), and the breast cancer-specific survival was 99.4% (95% CI, 98.6 to 100). Comparable iDFS was observed with T-DM1 irrespective of tumor size, hormone receptor status, centrally determined HER2 immunohistochemical score, and receipt of T-DM1 for more or less than 6 months. Although ATEMPT was not powered for this end point, the 5-year iDFS in the TH arm was 91.1%. Among patients with sufficient tissue for HER2DX testing (n = 187), 5-year outcomes significantly differed according to HER2DX risk score, with better RFI (98.1% v 81.8%, hazard ratio [HR], 0.10, P = .01) and iDFS (96.3% v 81.8%, HR, 0.20, P = .047) among patients with HER2DX low-risk versus high-risk tumors, respectively.

Conclusion: Adjuvant T-DM1 for 1 year leads to outstanding long-term outcomes for patients with stage I HER2-positive breast cancer. A high HER2DX risk score predicted a higher risk of recurrence in ATEMPT.

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人类表皮生长因子受体 2 阳性乳腺癌 I 期曲妥珠单抗 Emtansine 与紫杉醇加曲妥珠单抗的辅助治疗:ATEMPT 的 5 年结果和相关分析。
目的:I期人类表皮生长因子受体2(HER2)阳性乳腺癌患者接受曲妥珠单抗依姆坦辛(T-DM1)辅助治疗后的长期预后仍未确定,预后预测指标是一项尚未满足的需求:在ATEMPT II期试验中,经中心确诊为HER2阳性的I期乳腺癌患者以3:1的比例随机分配接受为期一年的T-DM1辅助治疗或紫杉醇加曲妥珠单抗(TH)治疗。主要目的是比较两组患者临床相关毒性反应的发生率,并评估T-DM1的侵袭性无病生存期(iDFS)。相关分析包括HER2DX基因组工具、HER2异质性的多组学评估以及血小板减少的预测因素:中位随访5.8年后,T-DM1组观察到11例iDFS事件,5年iDFS为97.0%(95% CI,95.2-98.7)。5年无复发间隔(RFI)为98.3%(95% CI,97.0至99.7),总生存率为97.8%(95% CI,96.3至99.3),乳腺癌特异性生存率为99.4%(95% CI,98.6至100)。无论肿瘤大小、激素受体状态、中心测定的HER2免疫组化评分以及接受T-DM1治疗的时间长于或短于6个月,都能观察到与T-DM1相似的iDFS。虽然 ATEMPT 没有为这一终点提供动力,但 TH 治疗组的 5 年 iDFS 为 91.1%。在有足够组织进行HER2DX检测的患者(n = 187)中,根据HER2DX风险评分,5年结果有显著差异,HER2DX低风险与高风险肿瘤患者的RFI(98.1% v 81.8%,危险比[HR],0.10,P = .01)和iDFS(96.3% v 81.8%,HR,0.20,P = .047)分别更好:结论:对I期HER2阳性乳腺癌患者进行为期1年的T-DM1辅助治疗可获得良好的长期疗效。高HER2DX风险评分预示着ATEMPT的复发风险较高。
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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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