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Methods: From 1991 to 1998, 35 patients with uveal melanoma were enrolled in a phase II prospective randomized trial, Group 1 n = 16, and Group 2 n = 19. The two groups were closely matched for pre-treatment patient and tumor characteristics. The median dose to the tumor apex for Group 1 was 80.0 Gy, and it was 60.8 Gy for Group 2. Episcleral HT was given once for 45 min immediately prior to EPRT with a median temperature of 44°C for either group. The median follow-up was 5.5 years. Tumor response, local recurrence, disease free survival (DFS), overall survival (OS), distant metastasis, and treatment toxicity were the main study outcomes.
Results: The median tumor height decreased 1.7 mm for patients of either Group. The 5- and 8-year probability of local recurrence was 33% for Group 1, and 25% for Group 2, P = 0.73. The 5-year probability of DFS was 54%, for Group 1 and 67% for Group 2, P = 0.51. The 5- and 8-year OS was 68% and 34%, respectively for Group 1, and 83% and 50%, respectively for Group 2, P = 0.60. The rate of distant metastasis at 5- and 8-years for Group 1 was 29% and 62%, respectively, and it was 17% and 17%, respectively for Group 2, P = 0.18. The incidence of enucleation was 4 (25%) in Group 1 vs. 4 (22%) in Group 2. The incidence of late complications was similar in either treatment group. The ambulatory visual acuity (5/200) at last follow-up was slightly better in Group 2 (80%) than Group 1 (64%).
Conclusions: Due to the small size of this study no claim can be made the two dose schedules were equivalent. There was no significant difference in outcomes between the two dose levels. Treatment outcomes were similar despite a 25% difference in radiation dose. In view of these findings and in an attempt to reduce the incidence of late treatment toxicity a still lower radiation dose in combination with HT needs to be studied.
