Radiation therapy for early Dupuytren's disease

4 Efficacy

This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 In a randomised controlled trial (RCT) of 129 patients (198 hands), in which both groups had radiation therapy, objective symptom assessment (number and consistency of cords and nodules, and degree of extension deficit) showed regression of Dupuytren's disease at 1‑year follow-up in 56% (53/95) of hands treated with 30 Gy of radiation and in 53% (55/103) of hands treated with 21 Gy (p<0.01 for the before-after change in both groups; no statistically significant difference between groups). The symptoms remained stable in a further 37% (35/95) of hands treated with 30 Gy of radiation and a further 38% (39/103) of hands treated with 21 Gy (no statistically significant difference between groups). Overall disease progression rate at 1 year was 8% (16/198). New nodules were reported in 6% (11/198) of hands, new cords in 4% (7/198) and increased flexion deformity in 6% (12/198). The same trial reported that subjective symptom assessment (not otherwise defined) showed statistically significant regression of Dupuytren's disease at 1‑year follow-up in 65% (41/63) of patients in the group treated with 30 Gy of radiation, and 53% (35/66) of patients treated with 21 Gy (p<0.01 for the within group change; level of statistical significance between groups not reported). The condition remained stable in a further 30% (19/63) of patients in the 30 Gy group and a further 41% (27/66) of patients in the 21 Gy group (level of statistical significance between groups not reported).

4.2 In a case series of 206 patients treated with 32 Gy of radiation, which collected self-reported questionnaire data at a median follow-up of 40 months, symptoms regressed in 45% (93/206) of patients and there was no further disease progression (including in patients with regression) in 80% (165/206) of patients.

4.3 In a case series of 135 patients (208 hands) treated with 30 Gy of radiation, clinical evaluation after a median follow-up of 13 years showed complete relief of symptoms in 16% (14/87) of patients, good relief in symptoms in 18% (16/87), minor relief in 32% (28/87), unchanged symptoms in 14% (12/87) and progression of symptoms in 20% (17/87). In the same case series, clinical evaluation after a median follow-up of 13 years showed regression of the disease in 10% (20/208) of hands, stable disease in 59% (123/208) of hands and progression in 31% (65/208) of hands.

4.4 In a case series of 33 patients (60 treated sites), which collected self-reported survey data after a median follow-up of 31 months, the disease progressed at any location within or outside the radiation therapy treatment field in 61% (20/33) of patients. In-field progression occurred in 23% (14/60) of sites but 4 sites were successfully re-irradiated with final local control in 83% (50/60) of sites. In the same study, the symptoms improved or remained stable in 93% of sites (relative numbers not given).

4.5 In the RCT of 129 patients (198 hands) treated with 30 Gy or 21 Gy of radiation, 3% (4/129) of patients needed hand surgery for disease progression within 1 year of follow-up. In the case series of 135 patients (208 hands), 20% (42/208) of hands needed surgery within a median follow-up of 13 years. In the case series of 33 patients, 6% (2/33) of patients needed surgery within a median follow-up of 31 months.

4.6 In the case series of 206 patients, the mean (± standard deviation) score for satisfaction with the therapy (measured with a visual analogue scale from 0 [not satisfied] to 10 [extremely satisfied]) was 7.9±2.7 points (n=198 patients) at a median follow-up of 40 months. In the case series of 33 patients, 94% (31/33) of patients considered radiation therapy successful (defined by patient report indicating whether patients felt that radiation therapy had been successful or not) at a median follow-up of 31 months.

4.7 The specialist advisers listed the following key efficacy outcomes: absence of progression, time to recurrence or progression to a functionally significant contracture, and rates of subsequent surgery.

4.8 Thirty four commentaries from patients who had experience of this procedure were received, which were discussed by the committee.