title: Balloon brachytherapy for breast cancer prove that it works? Or, prove that it doesn't?
abstract: Balloon breast brachytherapy is a catheter-based technique to deliver high local concentration of radiation following breast-sparing surgery. Although this technique is logically appealing--providing more directed radiation to sites at high risk of local failure--there remains little empirical support that this intervention is non-inferior to external beam radiotherapy, a well-established standard. Additionally, observational studies suggest that balloon brachytherapy is associated with high rates of local complications, and higher rates of subsequent mastectomy, a marker of local failure. Here, I explore regulatory and clinical considerations that lead to the widespread adoption of breast brachytherapy. I argue that the therapy spread before its efficacy was confirmed. Breast brachytherapy illustrates ongoing complexities in the approval of novel devices.
authors.affiliation: Medical Oncology Branch, National Cancer Institute, National Institutes of Health, 10 Center Dr. 10/12N226, Bethesda, MD, 20892, USA, vinayak.prasad@nih.gov.
authors.forename: Vinay
authors.initials: V
authors.lastname: Prasad
mesh_terms: D001918:Brachytherapy; D001943:Breast Neoplasms / Q000532:radiotherapy* / Q000601:surgery; D002404:Catheterization; D003131:Combined Modality Therapy; D018795:Device Approval; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental; D064887:Observational Studies as Topic; D018714:Radiotherapy, Adjuvant