Safe and transparent introduction and evaluation of targeted axillary dissection in patients with node-positive breast cancer undergoing primary surgery: International consensus process

Background Axillary node clearance is the current standard of care in patients with node-positive breast cancer undergoing primary surgery, despite a lack of evidence to demonstrate survival benefit and high rates of life-changing morbidity. Targeted axillary dissection (TAD) may be a safe alternative to axillary node clearance, but there is no agreement how primary TAD should be performed. TADPOLE-TOGETHER aimed to use international consensus methods to agree the key components of primary TAD to promote standardized introduction and evaluation of the technique within the TADPOLE trial. Methods A scoping review and key stakeholder interviews were used to generate a longlist of possible procedure steps for inclusion in the Delphi questionnaire. Two rounds of an international online survey were then used to agree the mandatory, optional, and prohibited steps of TAD, together with any standardization and training required. The final approach to primary TAD was agreed at an online consensus meeting. Results Thirteen potential steps of a TAD procedure were identified from the literature and expert interviews, together with information regarding standardization and training. Some 244 surgeons with global representation participated in the Round 1 survey, of whom 161 (66.0%) participated in Round 2. Seven mandatory steps of primary TAD, including localization and removal of the involved node, combined with a sentinel node biopsy, were agreed upon and ratified by 42 surgeons from the UK, Europe, and Asia who attended the consensus meeting. Conclusion Robust international consensus methods have been used to agree how primary TAD should be performed, promoting safe and transparent introduction and evaluation of the technique.