Orbital radiotherapy (Rx) is a commonly used treatment for Graves' ophthalmopathy (GO), but controlled clinical trials evaluating different Rx doses and application forms have not been performed. In euthyroid patients with moderately severe GO, we randomly compared the efficacy and tolerability of three Rx protocols. Orbital Rx (telecobalt) was administered either in 20 divided fractions of 1 Gray (Gy) weekly over 20 weeks (group A) or in 10 fractions of 1 Gy (B) and 2 Gy (C) daily over 2 weeks. Before and 24 weeks after starting Rx, ophthalmic investigation and magnetic resonance imaging were performed. Response to therapy, defined as a significant amelioration of three objective parameters, was noted in 12 A (67%), 13 B (59%), and 12 C (55%) subjects (C vs. A, P = 0.007). Ophthalmic symptoms and signs regressed most in group A; changes in lid fissure width were -1.5, -0.5, and 0 mm in the A, B, and C groups, respectively (A vs. C, P = 0.005), whereas changes in intraocular pressure (upgaze) were -3, +1, and -1.5 mm Hg, respectively (A vs. B, P = 0.002). The median decreases in proptosis were -2 mm (A, P = 0.0001), -1.5 mm (B, P = 0.02), and -1 mm (C, P = 0.007; A vs. C, P = 0.0380. Visual acuity (+0.15; P = 0.02) and eye muscle motility (bulbar elevation, 30 degrees vs. 37 degrees, P = 0.03, A vs. C, P = 0.0020; abduction, 45 vs. 49 degrees, P = 0.02; A vs. C, P = 0.017) improved in group A only. A significant change in all rectus muscle areas was noted in 14 A (78%), 12 B (55%), and 9 C (41%) subjects (C vs. A, P = 0.002). A decrease in the NOSPECS classes was observed in 12 A (67%), 13 B (59%), and 13 C (59%) patients (A vs. B/C, P = 0.01). Rx-induced conjunctivitis was not observed in group A, but was seen in 4 B (18%) and 8 C (36%) subjects (C vs. A, P = 0.003). At 24 weeks, satisfaction rates were 67%, 59%, and 55% in the A, B, and C groups, respectively (C vs. A, P = 0.008). Thus, in patients with moderately severe GO, similar response rates were observed for low and high Rx doses, but the 1 Gy/week protocol was more effective and better tolerated than the short arm regimens.

Twenty-three patients with Graves ophthalmopathy who underwent radiation therapy were monitored by means of magnetic resonance (MR) imaging. T2 relaxation times of extraocular muscles and orbital fat, areas of extraocular muscles, and degree of exophthalmos were measured by means of MR imaging at the beginning, at the end, and 3 months after completion of radiation therapy. As a result, patients with primarily elevated T2 times of extraocular muscles showed a better therapy response regarding muscle thickening than patients with primarily normal T2 times. Elevated T2 times, which probably represent acute inflammatory changes, were markedly decreased at the end of therapy. Therefore, quantitative MR imaging favors the choice of anti-inflammatory therapy regimens in patients with elevated T2 times of extraocular muscles. However, the clinical response (activity scores) to the low-dose treatment protocol that was used did not correlate well with primarily elevated T2 times. Furthermore, T2 times increased again after cessation of therapy. Whether a higher radiation dose or a different fractionation scheme leads to better results must be clarified by means of further study.

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BackgroundOur first trial on radiotherapy for painful heel spur published in 2012 comparing the analgesic effect of a standard dose (6 × 1.0Gy within three weeks) to that of a very low one (6 × 0.1Gy within three weeks) resulted in a highly significant superiority of the standard dose arm. In the meantime, experimental data have shown that lower single doses in the range of 0.5 – 0.7Gy might be even more effective than the current standard dose of 1.0 Gy. Therefore, we conducted a second trial comparing the analgesic effect of standard single doses of 1.0Gy to that of low single doses of 0.5Gy using uniform total doses of 6Gy.Patients and methodsOne hundred twenty-seven patients were randomized to receive radiation therapy either with a total dose of 6.0Gy applied in 6 fractions of 1.0Gy twice weekly (standard dose) or with the same total dose applied in 12 fractions of 0.5Gy three times weekly (experimental dose). In all patients lateral opposing 6MV photon beams were used. The results were measured using Visual analogue scale (VAS), Calcaneodynia score (CS) and SF-12 health survey. The first phase of this trial ended after a three months’ follow-up; it will be continued up to 48 weeks.ResultsNine patients had to be excluded after randomization either due to the withdrawal of informed consent to radiotherapy by the patients or radiotherapy with an incorrect dosage. The groups were comparable concerning biographical and disease data. The mean calcaneodynia score (CS) was higher in the experimental group (p = 0.002). After three months’ follow-up, we saw a very favorable pain relief in both arms (decline of VAS score: standard arm 42 points, experimental arm 44 points (n.s.), but we did not notice any statistically significant difference between the arms neither concerning the pain parameters nor the quality of life parameters. No relevant acute side effects were recorded.ConclusionsFavorable laboratory results could not be translated into an enhanced pain relief in our patients. This trial was terminated after the interim analysis (127 patients randomized). Further trials will be necessary to explore the best fractionation schedule.This trial has been approved by the expert panel of the DEGRO as well as by the Ethics committee of the Saarland Physicians’ chamber.Trial registrationCurrent trial registration at German Clinical Trials Register with the number DRKS00004458