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在一项针对墨西哥绝经前乳腺癌患者的前瞻性决策影响研究中,EndoPredict 检测后治疗管理的变化。

Change in therapeutic management after the EndoPredict assay in a prospective decision impact study of Mexican premenopausal breast cancer patients.

机构信息

Breast Cancer Center, Hospital Zambrano Hellion, Tecnologico de Monterrey, Nuevo Leon, Mexico.

Research and Breast Cancer Department, Instituto Nacional de Cancerologia, Mexico City, Mexico.

出版信息

PLoS One. 2020 Mar 11;15(3):e0228884. doi: 10.1371/journal.pone.0228884. eCollection 2020.

Abstract

OBJECTIVE

To evaluate the change in adjuvant therapeutic decision in a cohort of young women with breast cancer discussed by a multidisciplinary team, before and after EndoPredict testing.

PATIENTS AND METHODS

99 premenopausal women with hormone receptor-positive, HER2-negative, T1-T2, and N0-N1 breast cancer were included. Clinicopathological characteristics were recorded and cases were presented in a multidisciplinary tumor board. Consensual therapeutic decisions before and after EndoPredict results were registered. Medical records were reviewed at six-month follow-up to determine physicians' adherence to therapeutic recommendations. Pearson chi-square and McNemar's tests were used to analyze differences between groups and changes in treatment recommendations, respectively.

RESULTS

Median age at diagnosis was 43 years. The most frequent tumor size was pT2 (53.5%) and 27% of patients had 1-3 positive lymph nodes. 46% of patients had a low-risk EPclin result. Nodal status and tumor grade were significantly associated with EPclin result (p < .00001 and p = .0110, respectively), while Ki67 levels and age ≤40 years were not. A change in chemotherapy decision was registered in 19.2% of patients (p = .066), with the greatest impact in de-escalation (9% net reduction). A change in chemotherapy or endocrine therapy regimen was suggested in 19% and 20% of cases, respectively, after EPclin results were available. A significant difference was found in the median EPclin score between patients with a low- vs. high-intensity chemotherapy and endocrine therapy regimen recommendation (p = 0.049 and p = 0.0001, respectively). Tumor board treatment recommendation adherence with the EndoPredict result was 95% and final treatment adherence to EPclin result was 93%.

CONCLUSIONS

The EndoPredict test successfully assisted the clinical decision-making process in premenopausal patients, with a clinically significant change in overall decision-making, with the greatest impact seen in chemotherapy reduction, and a high rate of therapeutic adherence.

摘要

目的

评估在一个多学科团队讨论的激素受体阳性、HER2 阴性、T1-T2、N0-N1 期乳腺癌年轻女性队列中,在进行 EndoPredict 检测前后辅助治疗决策的变化。

患者和方法

纳入 99 例绝经前激素受体阳性、HER2 阴性、T1-T2、N0-N1 期乳腺癌患者。记录临床病理特征,并在多学科肿瘤委员会上介绍病例。登记了在 EndoPredict 结果之前和之后的共识治疗决策。在 6 个月的随访中回顾病历,以确定医生对治疗建议的依从性。使用 Pearson χ²检验和 McNemar 检验分别分析组间差异和治疗建议的变化。

结果

中位诊断年龄为 43 岁。最常见的肿瘤大小为 pT2(53.5%),27%的患者有 1-3 个阳性淋巴结。46%的患者 EPclin 结果为低风险。淋巴结状态和肿瘤分级与 EPclin 结果显著相关(p<0.00001 和 p=0.0110),而 Ki67 水平和年龄≤40 岁则不相关。19.2%的患者化疗决策发生变化(p=0.066),最大影响是降级(净减少 9%)。在获得 EPclin 结果后,分别有 19%和 20%的患者建议改变化疗或内分泌治疗方案。低强度与高强度化疗和内分泌治疗方案推荐的患者 EPclin 评分中位数之间存在显著差异(p=0.049 和 p=0.0001)。肿瘤委员会治疗建议与 EndoPredict 结果的符合率为 95%,最终治疗对 EPclin 结果的符合率为 93%。

结论

EndoPredict 检测成功地辅助了绝经前患者的临床决策过程,总体决策发生了具有临床意义的变化,化疗减少的影响最大,治疗依从性很高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/348b/7065749/70b721cae3f4/pone.0228884.g001.jpg

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