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Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.利用生物标志物指导早期浸润性乳腺癌女性辅助性全身治疗决策:美国临床肿瘤学会临床实践指南
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2
Validation of new cancer biomarkers: a position statement from the European group on tumor markers.新癌症生物标志物的验证:来自欧洲肿瘤标志物专家组的立场声明。
Clin Chem. 2015 Jun;61(6):809-20. doi: 10.1373/clinchem.2015.239863. Epub 2015 Apr 16.
3
A new initiative on precision medicine.一项关于精准医学的新倡议。
N Engl J Med. 2015 Feb 26;372(9):793-5. doi: 10.1056/NEJMp1500523. Epub 2015 Jan 30.
4
Attitudes toward molecular testing for personalized cancer therapy.对用于个性化癌症治疗的分子检测的态度。
Cancer. 2015 Jan 15;121(2):243-50. doi: 10.1002/cncr.28966. Epub 2014 Sep 10.
5
Experiences and attitudes toward risk of recurrence testing in women with breast cancer: a systematic review.乳腺癌女性对复发风险检测的经历与态度:一项系统综述
Breast Cancer Res Treat. 2014 Apr;144(3):457-65. doi: 10.1007/s10549-014-2900-3. Epub 2014 Mar 5.
6
Prognostic and predictive biomarkers: tools in personalized oncology.预后和预测生物标志物:个性化肿瘤学的工具。
Mol Diagn Ther. 2014 Jun;18(3):273-84. doi: 10.1007/s40291-013-0077-9.
7
Prognostic and predictive value of tumor vascular endothelial growth factor gene amplification in metastatic breast cancer treated with paclitaxel with and without bevacizumab; results from ECOG 2100 trial.紫杉醇联合或不联合贝伐珠单抗治疗转移性乳腺癌中肿瘤血管内皮生长因子基因扩增的预后和预测价值:ECOG 2100 试验的结果。
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8
Interest and attitudes of patients, cancer physicians, medical students and cancer researchers towards a spectrum of genetic tests relevant to breast cancer patients.患者、癌症医生、医学生和癌症研究人员对一系列与乳腺癌患者相关的基因检测的兴趣和态度。
Breast. 2013 Feb;22(1):47-52. doi: 10.1016/j.breast.2012.04.003. Epub 2012 May 4.
9
Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection.前瞻性多中心研究 21 基因复发评分检测对肿瘤内科医生和患者选择辅助乳腺癌治疗的影响。
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10
Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100.在一项晚期乳腺癌中紫杉醇与紫杉醇加贝伐单抗对比试验中,血管内皮生长因子及血管内皮生长因子受体-2基因多态性与预后的关系:东部肿瘤协作组2100研究
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生物标志物信息是否会影响乳腺癌患者对辅助化疗的偏好和医生的推荐?

Does biomarker information impact breast cancer patients' preferences and physician recommendation for adjuvant chemotherapy?

机构信息

Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.

Harvard Medical School, Boston, MA, USA.

出版信息

Breast Cancer Res Treat. 2017 Oct;165(3):545-553. doi: 10.1007/s10549-017-4338-x. Epub 2017 Jun 23.

DOI:10.1007/s10549-017-4338-x
PMID:28646344
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5837858/
Abstract

PURPOSE

This study aimed to examine how biomarker information would impact patients' preferences and physicians' recommendations for adjuvant breast cancer therapy.

METHODS

At the 18-month follow-up, participants in a large, double-blind randomized controlled trial of adjuvant chemotherapy with bevacizumab or placebo (E5103) were surveyed about their preferred treatment (either chemotherapy A alone or chemotherapy A+B) in two hypothetical scenarios: (1) without biomarker information; and (2) after learning that they tested positive for a "B-receptor" which modestly increased both the benefit and toxicity expected with chemotherapy A+B. We performed a cross-sectional analysis of the prospectively collected survey data and used the McNemar's test to examine changes in treatment preferences. A one-time survey of clinical investigators who enrolled patients on the trial evaluated physician recommendations in response to the same biomarker information.

RESULTS

439 patients completed both scenarios on 18-month survey. Most participants preferred A+B in both scenario 1 and 2 (77 and 76% respectively). The increase in benefit and toxicity associated with the positive biomarker information in scenario 2 led 60/439 (14%) of patients to switch their treatment preference. The corresponding physician survey revealed that most physicians chose regimen A+B in scenario 1 (77%), and moreso after the biomarker information was available in scenario 2 (84%).

CONCLUSIONS

Information about a positive biomarker indicating increased benefit and toxicity from additional chemotherapy did not change many participants' preferred treatment. The majority preferred the most effective course in both scenarios. Similarly, most investigators discounted increased toxicity and valued increased benefit. Parent Trial Registration: NCT00433511.

摘要

目的

本研究旨在探讨生物标志物信息将如何影响患者对辅助乳腺癌治疗的偏好以及医生的推荐。

方法

在一项大型、双盲、随机对照试验(E5103)的 18 个月随访中,对接受贝伐珠单抗或安慰剂辅助化疗的患者进行了调查,了解他们在两种假设情况下对治疗的偏好(A 组化疗单独或 A+B 组化疗):(1)没有生物标志物信息;(2)在得知他们检测出“B 受体”阳性后,该受体适度增加了 A+B 化疗的预期获益和毒性。我们对前瞻性收集的调查数据进行了横断面分析,并使用 McNemar 检验来检验治疗偏好的变化。对参与该试验的临床研究者进行了一次性调查,评估了他们在相同生物标志物信息下的推荐治疗方案。

结果

439 名患者完成了 18 个月调查的两个情景。大多数参与者在情景 1 和 2 中都更喜欢 A+B(分别为 77%和 76%)。情景 2 中阳性生物标志物信息所带来的获益和毒性增加,导致 439 名患者中的 60 名(14%)改变了他们的治疗偏好。相应的医生调查显示,大多数医生在情景 1 中选择了 A+B 方案(77%),在情景 2 中提供了生物标志物信息后,更多的医生选择了该方案(84%)。

结论

关于增加化疗获益和毒性的阳性生物标志物信息并没有改变许多参与者的首选治疗方案。在两种情况下,大多数患者都更喜欢最有效的治疗方案。同样,大多数研究者也考虑到了增加的毒性,更看重增加的获益。

原始研究注册

NCT00433511。