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COMS Report No. 15

The Collaborative Ocular Melanoma Study Group

Arch Ophthalmol. 2001;119:670-676.

Background  A systematic review and assessment of disease-related mortality as part of standardized prospective patient follow-up and evaluation within a multicenter clinical trial have been lacking in previous studies of choroidal melanoma.

Objective  To describe disease status at death in patients with large choroidal melanoma treated and followed up in the Collaborative Ocular Melanoma Study (COMS).

Design  Analysis of reviews of patient status at death performed by the COMS Mortality Coding Committee using available clinical and histopathologic information.

Setting and Patients  Reviews of deaths as of July 31, 1997, the cutoff date for reporting initial mortality findings.

Interventions  Patients were treated by either enucleation preceded by external beam radiotherapy or enucleation only.

Main Outcome Measures  Disease status at the time of death and certainty associated with the coding of disease status, sites of metastasis, and availability of autopsy.

Results  Of 1003 patients enrolled in the trial, 457 had died; the estimated median survival from time of enrollment was 7.4 years. Disease status at time of death had been reviewed for 435 deaths (95%). The autopsy rate was 6%. A total of 269 patients (62%) had histopathologically confirmed melanoma metastasis at the time of death, and metastasis was suspected in 92 additional patients (21%) on the basis of imaging and tests but without tissue confirmation. The common sites were liver (93%), lung (24%), and bone (16%); multiple sites were identified in 87% of patients with metastasis. The likelihood of 3 or more sites increased more than 4-fold when autopsy results were available.

Conclusions  Detailed mortality coding following a standard protocol provides the most accurate reporting to date of disease-related mortality in patients with choroidal melanoma and also identifies difficulties. Guidelines for the evaluation of future patients in clinical studies of choroidal melanoma are suggested.

Prepared by the COMS Mortality Coding Committee: James K.V. Willson, MD, Daniel M. Albert, MD, Marie Diener-West, PhD, Lee McCaffrey, MA, Claudia S. Moy, PhD, and Robert E. Scully, MD. A complete listing of the COMS Group was published previously (Control Clin Trials. 1993;14:352-391; Am J Ophthalmol. 1998;125:745-766).

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