M H Seegenschmiedt1, T Olschewski, F Guntrum. 1. Klinik für Radioonkologie, Strahlentherapie und Nuklearmedizin, Alfried-Krupp-Krankenhaus Essen. seegenschmiedt.heinrich@krupp-krankenhaus.de
Abstract
PURPOSE:Radiotherapy prevents progression of Dupuytren's contracture. Herein, 1-year results of a prospective randomized trial comparing 2 different dose concepts are presented. PATIENTS AND METHODS: 129 patients (67 males, 62 females) were included in the study with a minimum 1-year follow-up: 69 had bilateral and60 unilateral involvement of Dupyutren's disease accounting for 198 irradiated hands. According to Tubiana, 73 hands had Stage N, 61 Stage N/I (< or = 10 degrees flexion deformity), 59 Stage I (11 to 45 degrees) and 5 Stage II disease (46 to 90 degrees). Radiotherapy was randomly delivered: group A (63 patients/95 hands) received 10 times 3 Gy (total: 30 Gy) in 2 series (each 5 times 3 Gy) separated by 8 weeks; group B (66 patients/103 hands) received 7 times 3 Gy (total: 21 Gy) within 2 weeks. Orthovoltage radiotherapy (120 kV) with 40 cm standard cones and individual shielding was applied. Patient and disease parameters were equally distributed in both groups. Evaluation (toxicity, efficacy) was performed at 3 and 12 months with regard to subjective (patient's opinion) and objective parameters (palpation, measurements, comparative photographs--physician). RESULTS:Acute toxicity was minimal: 76 (38%) hands had skin reactions CTC Grade 1, 12 (6%) CTC Grade 2. Chronic side effects (dryness, skin atrophy, change of sensation, LENT Grade 1) occurred in 9 (5%) hands without differences between treatment groups. At 3 and 12 months follow-up, subjective symptoms and objective signs, nodules and cords, were reduced in both groups (p < 0.01) with no differences between groups: a total of 110 (55%) hands (group A: 55, group B: 55) regressed, 74 (37%) hands (group A: 35; group B: 39) were stable. Overall and mean number of nodules, cords and skin changes decreased at 3 and 12 months. 16 of 198 (8%) hands (group A: 7; group B: 9) progressed at 12 months follow-up ("treatment failure"); at 1 year, 7 of 60 patients with unilateral Dupyutren's disease requiredprophylactic radiotherapy for the contralateral hand due to disease progression. CONCLUSIONS:Prophylactic radiotherapy reduces symptoms and prevents disease progression in early-stage Dupyutren's disease. Both treatment concepts are well-tolerated and equally effective. Acute toxicity is slightly increased with treatment concept B (7 times 3 Gy), while chronic sequelae are low in both treatment groups. Long-term evaluation with follow-up of more than 5 years has to be awaited to recommend one or the other dose concept.
RCT Entities:
PURPOSE: Radiotherapy prevents progression of Dupuytren's contracture. Herein, 1-year results of a prospective randomized trial comparing 2 different dose concepts are presented. PATIENTS AND METHODS: 129 patients (67 males, 62 females) were included in the study with a minimum 1-year follow-up: 69 had bilateral and 60 unilateral involvement of Dupyutren's disease accounting for 198 irradiated hands. According to Tubiana, 73 hands had Stage N, 61 Stage N/I (< or = 10 degrees flexion deformity), 59 Stage I (11 to 45 degrees) and 5 Stage II disease (46 to 90 degrees). Radiotherapy was randomly delivered: group A (63 patients/95 hands) received 10 times 3 Gy (total: 30 Gy) in 2 series (each 5 times 3 Gy) separated by 8 weeks; group B (66 patients/103 hands) received 7 times 3 Gy (total: 21 Gy) within 2 weeks. Orthovoltage radiotherapy (120 kV) with 40 cm standard cones and individual shielding was applied. Patient and disease parameters were equally distributed in both groups. Evaluation (toxicity, efficacy) was performed at 3 and 12 months with regard to subjective (patient's opinion) and objective parameters (palpation, measurements, comparative photographs--physician). RESULTS: Acute toxicity was minimal: 76 (38%) hands had skin reactions CTC Grade 1, 12 (6%) CTC Grade 2. Chronic side effects (dryness, skin atrophy, change of sensation, LENT Grade 1) occurred in 9 (5%) hands without differences between treatment groups. At 3 and 12 months follow-up, subjective symptoms and objective signs, nodules and cords, were reduced in both groups (p < 0.01) with no differences between groups: a total of 110 (55%) hands (group A: 55, group B: 55) regressed, 74 (37%) hands (group A: 35; group B: 39) were stable. Overall and mean number of nodules, cords and skin changes decreased at 3 and 12 months. 16 of 198 (8%) hands (group A: 7; group B: 9) progressed at 12 months follow-up ("treatment failure"); at 1 year, 7 of 60 patients with unilateral Dupyutren's disease required prophylactic radiotherapy for the contralateral hand due to disease progression. CONCLUSIONS: Prophylactic radiotherapy reduces symptoms and prevents disease progression in early-stage Dupyutren's disease. Both treatment concepts are well-tolerated and equally effective. Acute toxicity is slightly increased with treatment concept B (7 times 3 Gy), while chronic sequelae are low in both treatment groups. Long-term evaluation with follow-up of more than 5 years has to be awaited to recommend one or the other dose concept.
Authors: A Montero Luis; R Hernanz de Lucas; A Hervás Morón; E Fernández Lizarbe; S Sancho García; C Vallejo Ocaña; A Polo Rubio; A Ramos Aguerri Journal: Clin Transl Oncol Date: 2008-06 Impact factor: 3.405