University of Alabama at Birmingham Heersink School of Medicine, Birmingham, AL, USA.
University of Alabama at Birmingham, Department of Medicine, Division of Hematology and Oncology; Birmingham, AL, USA.
Oncologist. 2024 Jan 5;29(1):e38-e46. doi: 10.1093/oncolo/oyad198.
Tumor biomarkers are regularly used to guide breast cancer treatment and clinical trial enrollment. However, there remains a lack of knowledge regarding physicians' perspectives towards biomarkers and their role in treatment optimization, where treatment intensity is reduced to minimize toxicity.
Thirty-nine academic and community oncologists participated in semi-structured qualitative interviews, providing perspectives on optimization approaches to chemotherapy treatment. Interviews were audio-recorded, transcribed, and analyzed by 2 independent coders utilizing a constant comparative method in NVivo. Major themes and exemplary quotes were extracted. A framework outlining physicians' conception of biomarkers, and their comfortability with their use in treatment optimization, was developed.
In the hierarchal model of biomarkers, level 1 is comprised of standard-of-care (SoC) biomarkers, defined by a strong level of evidence, alignment with national guidelines, and widespread utilization. Level 2 includes SoC biomarkers used in alternative contexts, in which physicians expressed confidence, yet less certainty, due to a lack of data in certain subgroups. Level 3, or experimental, biomarkers created the most diverse concerns related to quality and quantity of evidence, with several additional modulators.
This study demonstrates that physicians conceptualize the use of biomarkers for treatment optimization in successive levels. This hierarchy can be used to guide trialists in the development of novel biomarkers and design of future trials.
肿瘤标志物常用于指导乳腺癌治疗和临床试验入组。然而，对于医生对生物标志物的看法及其在治疗优化中的作用（即降低治疗强度以最大限度减少毒性），我们仍知之甚少。
39 名学术和社区肿瘤学家参与了半结构化定性访谈，提供了有关化疗治疗优化方法的观点。使用 NVivo 中的恒定比较法，由 2 名独立编码员对访谈进行录音、转录和分析。提取主要主题和典型引语。制定了一个框架，概述了医生对生物标志物的概念，以及他们对在治疗优化中使用生物标志物的舒适度。
在生物标志物的层次模型中，第 1 级由标准护理（SoC）生物标志物组成，这些标志物具有强有力的证据、与国家指南一致、并且广泛使用。第 2 级包括在替代情况下使用的 SoC 生物标志物，医生对此类生物标志物表示有信心，但由于某些亚组的数据不足，信心程度较低。第 3 级或实验性生物标志物引起了与证据的质量和数量相关的最多样化的担忧，还有其他几个调节因素。
本研究表明，医生将生物标志物用于治疗优化的概念分为不同级别。该层次结构可用于指导研究人员开发新型生物标志物并设计未来的试验。
