Laila A Gharzai1,2, Lauren A Szczygiel2, Dean A Shumway3, Hanna Bandos4,5, Thomas B Julian4,6, Eleftherios P Mamounas4,7, Julia White4,8, Jennifer F De Los Santos9, Mark Basik4,10, Patricia A Ganz4,11, Reshma Jagsi12,13. 1. Department of Radiation Oncology, University of Michigan, 1500 E. Medical Center Drive, Ann Arbor, MI, USA. 2. Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, MI, USA. 3. Department of Radiation Oncology, Mayo Clinic, Rochester, MN, USA. 4. NRG Oncology, Pittsburgh, PA, USA. 5. University of Pittsburgh, Pittsburgh, PA, USA. 6. Allegheny Health Network, Pittsburgh, PA, USA. 7. Orlando Health University of Florida Health Cancer Center, Orlando, FL, USA. 8. The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA. 9. Grandview Medical Center, Birmingham, AL, USA. 10. Jewish General Hospital, Montreal, QC, Canada. 11. Jonsson Comprehensive Cancer Center, University of California, Los Angeles, CA, USA. 12. Department of Radiation Oncology, University of Michigan, 1500 E. Medical Center Drive, Ann Arbor, MI, USA. rjagsi@med.umich.edu. 13. Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, MI, USA. rjagsi@med.umich.edu.
Abstract
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.
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.
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