Assessment of metastatic disease status at death in 435 patients with large choroidal melanoma in the Collaborative Ocular Melanoma Study (COMS): COMS report no. 15

Abstract

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.