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CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
Mortality in patients with small choroidal melanoma. COMS report no. 4. The Collaborative Ocular Melanoma Study Group.
Archives of Ophthalmology 1997 July
OBJECTIVE: To describe the clinical characteristics and survival experience of a prospectively followed up group of patients with small choroidal melanoma.
METHODS: The Collaborative Ocular Melanoma Study (COMS) is a set of clinical trials designed to compare the role of radiotherapy and enucleation in the treatment of medium and large-size choroidal melanoma. From December 1986 to August 1989, patients with small choroidal melanoma, not large enough to be eligible for the COMS clinical trials, were offered participation in a nonrandomized prospective follow-up study. Small choroidal melanomas were defined as 1.0 to 3.0 mm in apical height and at least 5.0 mm in basal diameter. A total of 204 patients were enrolled in the study. Patients were followed up annually through August 1989. Two additional assessments of treatment status and mortality were conducted in 1993-1994 and 1995-1996. The median length of follow-up was 92 months. Eight percent of patients were treated at the time of study enrollment and an additional 33% were treated during follow-up.
RESULTS: Twenty-seven patients have died; 6 deaths were reported by the clinical center as due to metastatic melanoma. The Kaplan-Meier estimate of 5-year all-cause mortality was 6.0% (95% confidence interval, 2.7%-9.3%) and 8-year all-cause mortality was 14.9% (95% confidence interval, 9.6%-20.2%).
CONCLUSIONS: Otherwise healthy patients, average age of 60 years, without a previous diagnosis of malignant disease who have small choroidal lesions judged to be melanoma have a low risk of dying within 5 years.
METHODS: The Collaborative Ocular Melanoma Study (COMS) is a set of clinical trials designed to compare the role of radiotherapy and enucleation in the treatment of medium and large-size choroidal melanoma. From December 1986 to August 1989, patients with small choroidal melanoma, not large enough to be eligible for the COMS clinical trials, were offered participation in a nonrandomized prospective follow-up study. Small choroidal melanomas were defined as 1.0 to 3.0 mm in apical height and at least 5.0 mm in basal diameter. A total of 204 patients were enrolled in the study. Patients were followed up annually through August 1989. Two additional assessments of treatment status and mortality were conducted in 1993-1994 and 1995-1996. The median length of follow-up was 92 months. Eight percent of patients were treated at the time of study enrollment and an additional 33% were treated during follow-up.
RESULTS: Twenty-seven patients have died; 6 deaths were reported by the clinical center as due to metastatic melanoma. The Kaplan-Meier estimate of 5-year all-cause mortality was 6.0% (95% confidence interval, 2.7%-9.3%) and 8-year all-cause mortality was 14.9% (95% confidence interval, 9.6%-20.2%).
CONCLUSIONS: Otherwise healthy patients, average age of 60 years, without a previous diagnosis of malignant disease who have small choroidal lesions judged to be melanoma have a low risk of dying within 5 years.
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