Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.
Harvard Medical School, Boston, MA, USA.
Breast Cancer Res Treat. 2017 Oct;165(3):545-553. doi: 10.1007/s10549-017-4338-x. Epub 2017 Jun 23.
This study aimed to examine how biomarker information would impact patients' preferences and physicians' recommendations for adjuvant breast cancer therapy.
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.
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%).
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.
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。
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。
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%)。
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。
NCT00433511。