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The COMS Randomized Trial of Iodine 125 Brachytherapy for Choroidal Melanoma, III: Initial Mortality Findings
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In summary, the COMS Group has documented in a carefully designed and conducted randomized trial of 125I brachytherapy vs enucleation among 1317 patients suitable for either treatment that survival rates were essentially the same over a follow-up period of 2 to 12 years. Possibly the most encouraging finding is that survival of patients who met COMS criteria and were treated and followed according to the COMS protocol is better than projected when the COMS was designed in 1985, with 5-year survival rates of better than 80% in both treatment arms. The combined 5-year survival rate was 82% (95% CI, 80%-84%). Among patients treated with 125I brachytherapy, 85% retained their eyes for 5 years or longer; 37% had visual acuity better than 20/200 in the irradiated eye 5 years after treatment. These findings are applicable to patients who meet the criteria used to select patients for the randomized trial; ophthalmologists should be cautious when considering extrapolation of the findings to other patients with choroidal melanoma. Follow-up of COMS patients will continue through July 2003 to provide data through 5 years of follow-up for all patients and to refine estimates of survival rates, complication rates, and quality of life outcomes during 5 to 15 years after treatment. When the COMS is completed, ophthalmologists will be in a better position to answer with confidence the question posed in 1986: "Do I take the eye out or leave it in?"