一项定性研究，评估了在新辅助全身治疗（NRG-CC006）对乳腺癌有显著缓解的患者中，医生对手术回避的态度。
A qualitative study to evaluate physician attitudes regarding omission of surgery among exceptional responders to neoadjuvant systemic therapy for breast cancer (NRG-CC006).
机构信息
Department of Radiation Oncology, University of Michigan, 1500 E. Medical Center Drive, Ann Arbor, MI, USA.
Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, MI, USA.
出版信息
Breast Cancer Res Treat. 2021 Jun;187(3):777-784. doi: 10.1007/s10549-021-06172-0. Epub 2021 Mar 19.
PURPOSE
Accrual to clinical trials that challenge well-established treatment paradigms represents a unique challenge. Physician opinions on investigation of a novel approach to breast cancer treatment, in which patients with complete response to neoadjuvant chemotherapy are offered omission of lumpectomy, are unknown. NRG-CC006 sought to describe physician attitudes toward a novel approach to breast cancer treatment.
METHODS
We recruited 18 participants in the fields of surgery, medical oncology, and radiation oncology to participate in the semi-structured telephone interviews. Main outcomes are qualitative themes associated with omission of surgery.
RESULTS
Of 18 interview participants, specialty and gender were evenly represented across surgery, medical oncology, and radiation oncology. Qualitative themes included general attitudes toward treatment de-escalation, stakeholder considerations, and trial/protocol considerations. The vast majority of participants expressed interest in investigation of omission of surgery, with all participants endorsing need for further investigation into treatment de-escalation. Stakeholder considerations in opening such a trial emphasized need for multidisciplinary involvement and, particularly, the unique role of surgeons as gatekeepers in breast cancer treatment. Finally, participants endorsed a need for further foundational studies to develop ways to predict complete pathologic response to chemotherapy without surgical intervention.
CONCLUSIONS
Physicians expressed interest in investigating a novel approach to breast cancer treatment that would omit surgery in complete responders to neoadjuvant chemotherapy. Multidisciplinary input, and specifically surgeon engagement, will be key to the success of future investigations. Ongoing work to develop approaches to predict pathologic complete response accurately is needed to achieve the promise of this idea. ClinTrials #: BR005: NCT03188393 June 13, 2017.
目的
对于挑战既定治疗模式的临床试验而言，入组是一项独特的挑战。对于接受新辅助化疗完全缓解的乳腺癌患者选择免除保乳手术的新治疗方法，医生的意见尚不清楚。NRG-CC006 旨在描述医生对新的乳腺癌治疗方法的态度。
方法
我们招募了 18 名来自外科、肿瘤内科和放射肿瘤学领域的参与者，进行了半结构化电话访谈。主要结局是与手术切除豁免相关的定性主题。
结果
在 18 名访谈参与者中，外科、肿瘤内科和放射肿瘤学的专业和性别分布均匀。定性主题包括对治疗降级的一般态度、利益相关者的考虑因素和试验/方案的考虑因素。绝大多数参与者对研究手术切除豁免的兴趣浓厚，所有参与者都支持进一步研究治疗降级。开展此类试验的利益相关者考虑因素强调需要多学科参与，特别是外科医生作为乳腺癌治疗把关人的独特作用。最后，参与者赞同需要进一步进行基础研究，以开发无需手术干预即可预测化疗完全病理缓解的方法。
结论
医生对探索新的乳腺癌治疗方法表现出兴趣，这种方法可以免除新辅助化疗完全缓解患者的手术。多学科的投入，特别是外科医生的参与，将是未来研究成功的关键。为了实现这一想法的承诺，需要开展进一步的研究以准确预测病理完全缓解的方法。临床试验编号：BR005：NCT03188393 于 2017 年 6 月 13 日注册。
Zotero 插件