Adverse events after adjuvant radiation therapy for Dupuytren's disease in the DEPART randomized trial.

研究概要

Sixty patients with Dupuytren’s disease were randomized to receive adjuvant radiotherapy (n=28) or observation (n=30) after limited fasciectomy, percutaneous needle fasciotomy, or collagenase injection. The primary outcome of interest was adverse events (AEs) graded by CTCAE. Secondary outcomes of interest included AE prevalence over time, severity distribution, persistence beyond 6–12 months, wound complications, and treatment interruptions. Outcomes were assessed at 6 and 12 months, annually to 60 months, and then biannually to 104 months; at this analysis the median follow-up was 12 months (range 1.5–48). Overall, the results of the study revealed 114 AEs in 39 patients, most of which were mild (grade 1, n=102); grade ≥2 events were uncommon, and persistent late effects attributed to radiotherapy were mainly reduced palmar sweating. These findings suggest adjuvant radiotherapy is generally well tolerated with largely self-limiting toxicity.