core outcome set for locoregional treatment reporting in neoadjuvant systemic breast cancer treatment trials.
Potter S., Avery K., Ahmed R., de Boniface J., Chatterjee S., Dodwell D., Dubsky P., Federmann J., Finestone S., Gnant M., Hlauschek D., Iwata H., Jiang MY., Kaidar-Person O., Lee H-B., MacKenzie M., Meyn A., Poortmans P., Poulakaki F., Richardson AL., Sepulveda KA., Spillane AJ., Thompson AM., Werutsky G., Wittmann P., Wright JL., Zdenkowski N., Cowan K., McIntosh SA., PRECEDENT Study Group .
Accurate information about locoregional breast cancer treatments following neoadjuvant systemic therapy (NST) is essential for meaningful interpretation of oncological outcomes but reporting is currently poor. We developed a core outcome set (COS) to improve the quality and consistency of locoregional outcome reporting in breast cancer NST trials. The COS was developed in three phases according to COS-STAD guidance, with the generation of a list of relevant outcome domains, prioritisation of outcomes through two rounds of an international online multi-stakeholder Delphi survey and a consensus meeting. 159 unique locoregional outcomes were classified into 101 outcome domains for inclusion in the Delphi survey, which was completed by 470 international professionals. The final 15-item COS, which included the pre-NST surgical plan, details of surgery performed following completion of treatment and details of radiation therapy, was agreed at an in-person consensus meeting. Widespread COS implementation will improve the quality and value of future NST trials.