Radiotherapy optimization in early-stage Dupuytren's contracture: first results of a randomized clinical study.

PURPOSE: Radiotherapy (RT) can prevent progression of Dupuytren's contracture (DC). It is unknown whether there is a dose response and which dose is sufficient. Herein, the 1-year results of a prospective randomized trial are presented which compared two different RT dose concepts with each other.
METHODS: 129 patients (67 males; 62 females) were entered in this study: 69 had bilateral and 60 uni-lateral involvement of DC accounting for 198 irradiated hands. According to Tubiana's classification, 73 hands had Stage N (nodules/cords, no extension deficit = flexion deformity), 61 had Stage N/I (< or = 10 degrees deficit), 59 had Stage I (11-45 degrees deficit), and 5 had Stage II (46-90 degrees deficit) DC. Prophylactic RT was randomly delivered; in Group A, 63 patients (95 hands) received 10 x 3 Gy (total dose, 30 Gy) in 2 series (5 x 3Gy) separated by 8 weeks; in Group B, 66 patients (103 hands) received 7 x 3 Gy (total dose, 21 Gy) in 1 series within 2 weeks. Orthovoltage RT (120 kV) was applied using standard cones and individual shielding of uninvolved areas of the palm. Relevant patient and disease parameters were equally distributed in both groups. Evaluation (toxicity, efficacy) was performed at 3 and 12 months after RT. Subjective (patient's opinion) and objective parameters (palpation, measurements, and comparative photographs) were applied to assess treatment response. Minimum follow-up (FU) was 1 year.
RESULTS: Acute toxicity was minimal, but slightly more pronounced in Group B. Seventy-six (38%) hands developed skin reactions CTC 1 degrees (A, 30; B, 46); and 12 (6%) had skin reactions CTC 2 degrees (A, 4; B, 8). Chronic side effects were limited to dryness, desquamation, skin atrophy, and change of sensation (LENT 1 degrees ) in 9 (5%) sites without differences between the two groups. At 3 and 12 months after RT, subjective and objective reduction of symptoms, nodules, and cords occurred in both groups (p < 0.01) with no differences between the groups: in Group A, 55 (56%) sites regressed, 35 (37%) remained stable, and 7 (7%) progressed, whereas in Group B, 55 (53%) regressed, 39 (38%) remained stable, and 9 (9%) progressed at 12 months FU (NS). Overall and mean number of nodules, cords, and skin changes decreased at 3 and 12 months. The "treatment failure" rate at 1 year was 16 of 198 (8%), but only 4 (2%) sites required hand surgery for disease progression. Seven of 60 patients with unilateral DC received prophylactic RT for the initially uninvolved, contralateral hand due to progression of DC.
CONCLUSION: Both prophylactic RT concepts have been well accepted and tolerated by patients. Within the first year, they were equally effective to prevent further disease progression of DC and obtain considerable symptomatic improvement. Although 1-year results suggest similar response rates for both treatment groups, long-term FU of > 5 years has to be awaited for final assessment and recommendation of an optimized RT treatment schedule.

RCT Entities:   Population Interventions Outcomes