An international consensus process to support the safe and transparent introduction and evaluation of targeted axillary dissection in patients with node positive breast cancer having primary surgery

Introduction: Axillary node clearance (ANC) is current standard of care in patients with node positive breast cancer having 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 ANC 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 standardised introduction and evaluation of the technique within the TADPOLE trial. <br/><br/>Methods: A scoping review and key stakeholder interviews were used to generate a long list of possible procedure steps for inclusion in the Delphi. Two rounds of an international online survey were then used to agree the mandatory/optional/prohibited steps of TAD together with any standardisation and training required. The final approach to primary TAD was agreed at an online consensus meeting. <br/><br/>Results: Thirteen potential steps of a TAD procedure were identified from the literature and expert interviews together with information regarding standardisation 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 localisation and removal of the involved node combined with a sentinel node biopsy were agreed and ratified by 42 surgeons from the UK, Europe and Asia who attended the consensus meeting. <br/><br/>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.