Abstract
Background
A 2017 meta-analysis of 62 studies (27 superficial X-ray; 18 electron beam; and 17 brachytherapy) of keloid post-excisional radiotherapy treatment (PERT) concluded that, regardless of type of radiation employed, a recurrence rate of approximately 20% was achievable and that PERT was superior to radiation monotherapy (ref. 1). However, a subsequent Report of the 3rd International Keloid Symposium (IKS) in Beijing in 2019 identified that "the biggest obstacle to the development of optimal treatment for patients with keloids is the lack of data-driven treatment pathways" (ref. 2).
In 2022, Guidelines from the German Society for Radiation Oncology (DEGRO) approved radiotherapy after surgical intervention as a viable option for keloid treatment but only at Evidence Level 4 (Case Series), due to a lack of Evidence Level 1 Randomised Controlled Trial (RCT) data. DEGRO also advised that keloid radiotherapy as a monotherapy be only employed exceptionally (ref. 3). However, by 2025, only 4 registered keloid treatment research studies (3 RCTs & 1 Cohort Study) were ongoing, none evaluating PERT (ref. 4).
To overcome this apparent lack of progress, this study aims to consider a novel approach to the analysis of PERT Audit outcome data presented at the 2nd, 3rd & 4th IKS (refs. 5, 6 & 7), with a view to re-formulating it as Evidence Level 2 Cohort Studies. In turn, this evidence will facilitate optimisation of radiotherapy treatment dose regimen for PERT, as well as the development of a related optimal treatment pathway including a cost-effectiveness perspective. The applicability of this study approach to other keloid treatment modalities, e.g. laser therapy, cryotherapy, etc. will also be briefly considered.