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.
RCT Entities:
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.
Authors: Hasan Danish; Matthew J Ferris; Ehsan Balagamwala; Jeffrey M Switchenko; Kirtesh R Patel; Maria Choudhary; Caroline Craven; Pia Mendoza; John Suh; Chris Bergstrom; Hans E Grossniklaus; Thomas M Aaberg; Arun Singh; Ian R Crocker; Mohammad K Khan Journal: Melanoma Res Date: 2018-04 Impact factor: 3.599
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Authors: Paul R van Ginkel; Soesiawati R Darjatmoko; Dhruv Sareen; Lalita Subramanian; Saswati Bhattacharya; Mary J Lindstrom; Daniel M Albert; Arthur S Polans Journal: Invest Ophthalmol Vis Sci Date: 2008-04 Impact factor: 4.799
Authors: Shinji Ozaki; Raja Vuyyuru; Ken Kageyama; Mizue Terai; Masahiro Ohara; Hanyin Cheng; Tim Manser; Michael J Mastrangelo; Andrew E Aplin; Takami Sato Journal: Am J Pathol Date: 2015-11-25 Impact factor: 4.307
Authors: Jose S Pulido; Norbert G Campeau; Ernst Klotz; Andrew N Primak; Osama Saba; Kaan Gunduz; Herbert Cantrill; Diva Salomão; Cynthia H McCollough Journal: Clin Ophthalmol Date: 2008-06