Assessment of metastatic disease status at death in 435 patients with large choroidal melanoma in the Collaborative Ocular Melanoma Study (COMS)

Background: A systematic review and assessment of disease-related mortality as part of standardized prospective patient follow-up and evaluation withi n a multicenter clinical trial have been lacking in previous studies of cho roidal melanoma. Objective: To describe disease status at death in patients with large choro idal melanoma treated and followed up in the Collaborative Ocular Melanoma Study (COMS). Design: Analysis of reviews of patient status at death performed by the COM S Mortality Coding Committee using available clinical and histopathologic i nformation. Setting and Patients: Reviews of deaths as of July 31, 1997, the cutoff dat e for reporting initial mortality findings. Interventions: Patients were treated by either enucleation preceded by exte rnal beam radiotherapy or enucleation only. Main Outcome Measures: Disease status at the time of death and certainty as sociated with the coding of disease status, sites of metastasis, and availa bility of autopsy. Results: Of 1003 patients enrolled in the trial, 457 had died; the estimate d median survival from time enrollment was 7.4 years. Disease status at tim e of death had been reviewed for 435 deaths (95%). The autopsy rate was 6%. A total of 269 patients (62%) had histopathologically confirmed melanoma m etastasis at the time of death, and metastasis was suspected in 92 addition al patients (21%) on the basis of imaging and tests: but without tissue con firmation The common sites were liver (93%), lung (24%), and bone (16%); mu ltiple sites were identified in 87% of patients with metastasis. The likeli hood of 3 or more sites increased more than 4-fold when autopsy results wer e available. Conclusions: Detailed mortality coding following a standard protocol provid es the most accurate reporting to date of disease-related mortality in pati ents with choroidal melanoma and also identifies difficulties. Guidelines f or the evaluation of future patients in clinical studies of choroidal melan oma are suggested.