248 - Toxicities and Quality of Life Following Observation or Radiation Therapy for Dupuytren's Disease in the International DEPART Randomized Trial
Presenter(s)
J. M. Martin1,2, T. Burgess3, B. McClelland3, D. Christie4, P. M. N. Werker5, W. Rozen6, R. J. H. M. Steenbakkers7, A. de Haan7, S. Anoora8, D. Sandoz9, J. Sappiatzer10, K. Neville1, S. Sampaio11, D. Schlect4, J. Bucci12, D. Hunter-Smith6, and D. Dilley13; 1GenesisCare Gateshead, Newcastle, NSW, Australia, 2Radiation Oncology Calvary Mater Newcastle Hospital, Newcastle, Australia, 3Hunter Hand Surgery, Newcastle, NSW, Australia, 4GenesisCare, Brisbane, QLD, Australia, 5Department of Plastic Surgery, University Medical Center Groningen, University of Groningen, Groningen, Netherlands, 6Monash University, Melbourne, VIC, Australia, 7Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands, 8GenesisCare Research, Sydney, NSW, Australia, 9Hunter Hand Rehabilitation Centre, Newcastle, NSW, Australia, 10GenesisCare Adelaide, Adelaide, SA, Australia, 11GenesisCare Sydney, Sydney, NSW, Australia, 12GenesisCare Hurstville, Sydney, NSW, Australia, 13Dilley Practice, Sydney, NSW, Australia
Purpose/Objective(s):
Low dose radiotherapy (LDRT) has been used for benign conditions including Dupuytren’s disease (DD), a genetic fibromatosis affecting the hands. In advanced stages, DD causes contractures and functional impairment. DD has an initial proliferative phase, potentially offering an opportunity to intervene with LDRT to reduce the risk of later contracture. The Dupuytren’s disease Evaluation of Preventative or Adjuvant Radiation Therapy (DEPART) clinical trial randomized hands to either Observation (Obs) or LDRT. There is uncertainty regarding toxicities following LDRT. We hypothesize that LDRT has minimal impacts on medium term toxicity and quality of life (QOL) compared with Obs.Materials/Methods:
Key eligibility criteria included a clinical diagnosis of DD, a history of progression over the last six months and written informed consent. Hands were randomized 1:1 to Observation or RT to a dose of 30Gy in 10 fractions with a treatment break of 4-12 weeks mid-treatment. Patients were assessed at baseline, 6, 12, 24, 36, 48 and 60 months post treatment, with LDRT patients also reviewed at the end of LDRT, with specific adverse events (AEs) graded (CTCAE v4.0). For QOL, QuickDash, URAM and pain were recorded at baseline, 6, 12, 36 and 60 months. Due to multiple testings, p<0.01 was considered significant. HREC approval: 2018-02-134-PVR-1.Results:
Between 2018-24, 404 hands (202 Obs, 202 LDRT) were randomized from 12 Australian and Dutch centres with a median patient age of 62 years (range 31-86). 162 patients experienced an AE (4 observation, 158 LDRT [most commonly dermatitis, reduced sweating and localized oedema]), with 96.6% grade 1 (mild). Of the 14 grade 2 (moderate) AEs, only 1 (dermatitis) persisted up to 18 months. No grade 3 (severe) AEs were reported. 7/278 (2.5%) of hands assessed at 24 months had a persistent AE, with 3/7 of these being grade 1 reduced sweating. Regarding QOL measures, for all scales lower scores translate to less symptoms. Median baseline and 36 month scores comparing observation and LDRT were: QuickDASH (100 point scale: baseline - 12.8 Obs v 12.9 LDRT and 36m - 18.4 Obs v 12.1 LDRT), URAM (45 point scale: baseline – 3.6 Obs v 3.5 LDRT and 36m - 5 Obs v 3.4 LDRT) and Pain (10 point scale: baseline – 1.7 Obs v 1.8 LDRT and 36m – 2.0 Obs v 1.1 LDRT). None of these differences over time or between study arms were statistically significant.Conclusion:
Multicenter randomized controlled trials assessing radiotherapy for benign conditions are feasible, and critical to establish efficacy, risks and broader credibility. LDRT for DD is a well-tolerated intervention, with minimal ongoing toxicities or QOL detriment. AEs were expected, mild and largely self-limiting. QOL impacts of early DD are minimal, stable over time, and not affected by LDRT. Follow-up is ongoing to assess longer term AEs, QOL impacts and ultimately the potential of LDRT to improve disease control. (trial registration ACTRN12618000951257)