[Skip to Navigation]
Clinical Trials
December 2006

The COMS Randomized Trial of Iodine 125 Brachytherapy for Choroidal Melanoma: V. Twelve-Year Mortality Rates and Prognostic Factors: COMS Report No. 28

Author Affiliations

ROY W.BECKMD, PhDAuthors/Writing Committee: This article was prepared by the COMS Steering Committee and other COMS Coordinating Center investigators on behalf of all members of the COMS Group. Group Information: A list of the COMS Group members was published in Ophthalmology. 2001;108:348-366; Arch Ophthalmol. 2001;119:951-965; Control Clin Trials. 1993;14:362-391; and Am J Ophthalmol. 1998;125:745-766.

Arch Ophthalmol. 2006;124(12):1684-1693. doi:10.1001/archopht.124.12.1684

Objectives  To report refined rates of death and related outcomes by treatment arm through 12 years after primary treatment of choroidal melanoma and to evaluate characteristics of patients and tumors as predictors of relative treatment effectiveness and time to death.

Design  Randomized multicenter clinical trial of iodine 125 (125I) brachytherapy vs enucleation conducted as part of the Collaborative Ocular Melanoma Study. Eligible patients were free of metastasis and other cancers at enrollment. All patients were followed up for 5 to 15 years at scheduled examinations for metastasis or another cancer or until death. Decedents were classified by the independent Mortality Coding Committee as having histopathologically confirmed melanoma metastasis, suspected melanoma metastasis without histopathologic confirmation, another cancer but not melanoma metastasis, or no malignancy.

Main Outcome Measures  Deaths from all causes and deaths with histopathologically confirmed melanoma metastasis.

Results  Within 12 years after enrollment, 471 of 1317 patients died. Of 515 patients eligible for 12 years of follow-up, 231 (45%) were alive and clinically cancer free 12 years after treatment. For patients in both treatment arms, 5- and 10-year all-cause mortality rates were 19% and 35%, respectively; by 12 years, cumulative all-cause mortality was 43% among patients in the 125I brachytherapy arm and 41% among those in the enucleation arm. Five-, 10-, and 12-year rates of death with histopathologically confirmed melanoma metastasis were 10%, 18%, and 21%, respectively, in the 125I brachytherapy arm and 11%, 17%, and 17%, respectively, in the enucleation arm. Older age and larger maximum basal tumor diameter were the primary predictors of time to death from all causes and death with melanoma metastasis.

Conclusion  Longer follow-up of patients confirmed the earlier report of no survival differences between patients whose tumors were treated with 125I brachytherapy and those treated with enucleation.

Application to Clinical Practice  Estimated mortality rates by baseline characteristics should facilitate counseling of patients who have choroidal melanoma of a size and in a location suitable for enucleation or 125I brachytherapy and no evidence of metastasis or another malignancy.

Trial Registration  clinicaltrials.gov Identifier: NCT00000124