The Elekta Esteya® electronic brachytherapy system in non-melanoma skin cancers: A post-market observational study.

Abstract

Purpose: The study was conducted to provide support for the delivery of electronic brachytherapy (EBx) in patients with low-risk non-melanoma skin cancer (NMSC) lesions who prefer and benefit a non-surgical treatment.

Material and methods: This study included 205 patients with a total of 236 lesions. Six centers participated in this study using high-dose-rate EBx in NMSC. Eligible patients had pathologically confirmed basal cell or squamous cell carcinoma of clinical stage Tis, T1, or T2, with two or fewer high-risk clinical or pathologic features. Treatment doses were chosen from a set of fractionation schemes delivering 69-72 Gy (BED). Maximum follow-up was 5 years.

Results: The median age was 74 (range, 56-96) years, and 62% of the subjects were males and 38% females. The median follow-up was 24.2 months, with a maximum of 73.5 months. Healthcare professional (HCP) and patient-rated cosmesis were rated excellent/good (E/G) by both groups at 90-100% rates, except for HCP ratings of 1-3 months post-EBx, where cosmesis was rated 83-87% E/G. Erythema was the most common acute adverse event (34.1% at 1 month), rebounding back to zero by 6 months. There was a single lesion recurrence.

Conclusions: This report provides additional phase IV clinical data on NMSC treated with electronic brachytherapy. With 2-year median follow-up, there was one recurrence (0.42%). Patients tolerated the treatments well, as evidenced by strong and longitudinal scores on the skin cancer index as well as cosmetic evaluations performed by both patients and healthcare providers. Adverse rates were low, except for expected acute erythema, chronic hypopigmentation, and telangiectasia. The study provides additional information on EBx delivery for low-risk NMSC lesions in patents who prefer non-surgical treatment, especially those at risk for surgical complications, surgical cosmesis issues, keloid formation, wound care issues, and use of anticoagulant therapy.