Toxicities and Quality of Life following Observation or Radiation Therapy for Dupuytren's Disease: Three-Year Secondary Analysis Data From the Prevention Group of the International Dupuytren's Evaluation of Preventative or Adjuvant Radiation Therapy (DEPART) Randomized Trial.

Abstract

Low-dose radiation therapy (LDRT) has been used for nonmalignant conditions, including Dupuytren's disease (DD). The Dupuytren's Evaluation of Preventative or Adjuvant Radiation Therapy (DEPART) clinical trial randomized hands to either observation (Obs) or LDRT to assess the impact on disease progression (trial registration, ACTRN12618000951257). Here we report toxicity and quality of life (QOL) for the first 36 months of follow-up. Key eligibility criteria included a clinical diagnosis of DD, a patient-reported history of disease progression over the last 6 months, and written informed consent. Hands were randomized 1:1 to Obs or LDRT to a dose of 30 Gy in 10 fractions. Patients were scheduled to be assessed at baseline, 6, 12, 24, 36, 48, 60, 84, and 108 months posttreatment, with specific toxicities graded (National Cancer Institute Common Terminology Criteria for Adverse Events v4.03). For QOL, Quick Disabilities of Arm, Shoulder and Hand, Unité Rhumatologique des Affections de la Main, and pain were recorded at baseline and subsequently scheduled for 6, 12, 36, 60, 84, and 108 months (Ethics committee approval: 2018-02-134-PVR-1). Between 2018 and 2024, 404 hands (202 Obs, 202 LDRT) were randomized, with this analysis at the current median follow-up of 36 months (IQR, 24-48). One hundred sixty-two patients experienced a toxicity (4 Obs, 158 LDRT [most commonly dermatitis, reduced sweating and localized edema]), with 96.6% grade 1 and no grade 3 events. Of the 14 grade 2 (moderate) toxicities recorded, only 1 (reduced sweating) persisted up to 24 months. For QOL, lower scores translate to fewer symptoms. Median baseline scores were equivalent between arms, but improved over time for the LDRT arm. The 36-month scores for Obs versus LDRT were: Quick Disabilities of Arm, Shoulder and Hand (17.8 vs 10.9 [P = .013]), Unité Rhumatologique des Affections de la Main (4.8 vs 3.1 [P = .056]), and pain (2.1 vs 1.0 [P = .001]). Multicenter randomized controlled trials assessing radiation therapy for nonmalignant conditions are feasible and critical to establish efficacy and risks. LDRT for DD is well-tolerated, with minimal ongoing toxicities. QOL is possibly improved by LDRT. Follow-up is ongoing to assess longer-term toxicities, QOL, and LDRT's impact on disease control.