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COMS Report No. 18

The Collaborative Ocular Melanoma Study Group

Arch Ophthalmol. 2001;119:969-982.

Objectives  To report initial mortality findings from the Collaborative Ocular Melanoma Study (COMS) randomized clinical trial of iodine 125 brachytherapy vs enucleation for treatment of choroidal melanoma.

Methods  Patients were evaluated for eligibility at 43 participating clinical centers in the United States and Canada. Eligible consenting patients were assigned randomly at the time of enrollment to enucleation or ¹²⁵I brachytherapy. Patients were examined at specified intervals after enrollment for data collection purposes. Findings presented herein are based on data received by September 30, 2000. Data for each patient were analyzed with the treatment group to which the patient was assigned randomly at the time of enrollment.

Results  During the 11-year accrual period, 1317 patients enrolled; 660 were assigned randomly to enucleation and 657 to ¹²⁵I brachytherapy. Only 2 patients in the enucleation arm were found to have been misdiagnosed when histopathology was reviewed centrally. All but 17 patients (1.3%) received the assigned treatment. Adherence to the brachytherapy protocol was excellent, with 91% of patients treated per protocol. Based on time since enrollment, 1072 patients (81%) had been followed for mortality for 5 years and 416 (32%) for 10 years. A total of 364 patients had died: 188 (28%) of 660 patients in the enucleation arm and 176 (27%) of 657 patients in the brachytherapy arm. The unadjusted estimated 5-year survival rates were 81% and 82%, respectively; there was no clinically or statistically significant difference in survival rates overall (P = .48, log-rank test). The adjusted estimated risk ratio for ¹²⁵I brachytherapy vs enucleation was 0.99 (95% confidence interval [CI], 0.80-1.22). Five-year rates of death with histopathologically confirmed melanoma metastasis were 11% and 9% following enucleation and brachytherapy, respectively; after adjustment, the estimated risk ratio was 0.91 (95% CI, 0.66-1.24).

Conclusions  Mortality rates following ¹²⁵I brachytherapy did not differ from mortality rates following enucleation for up to 12 years after treatment of patients with choroidal melanoma who enrolled in this COMS trial. The power of the study was sufficient to indicate that neither treatment is likely to increase or decrease mortality rates by as much as 25% relative to the other.

Members of the writing team who signed authorship responsibility, financial disclosure, and copyright transfer statements for the group are as follows: Marie Diener-West, PhD; John D. Earle, MD; Stuart L. Fine, MD; Barbara S. Hawkins, PhD; Claudia S. Moy, PhD; Sandra M. Reynolds, MS; Andrew P. Schachat, MD; Bradley R. Straatsma, MD.

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REFERENCES
JOURNAL OF THE ICRU 2004;4:165-175.
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Puusaari et al.
IOVS 2004;45:3425-3434.
ABSTRACT | FULL TEXT  

Effectiveness of 1{alpha}-Hydroxyvitamin D2 in Inhibiting Tumor Growth in a Murine Transgenic Pigmented Ocular Tumor Model
Albert et al.
Arch Ophthalmol 2004;122:1365-1369.
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Time trends in personnel certification and turnover in the Collaborative Ocular Melanoma Study
Mobley et al.
Clin Trials 2004;1:377-386.
ABSTRACT  

Interferon {alpha}2b Decreases Hepatic Micrometastasis in a Murine Model of Ocular Melanoma by Activation of Intrinsic Hepatic Natural Killer Cells
Yang et al.
IOVS 2004;45:2056-2064.
ABSTRACT | FULL TEXT  

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Br. J. Ophthalmol. 2004;88:962-967.
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Screening for Metastasis From Choroidal Melanoma: The Collaborative Ocular Melanoma Study Group Report 23
Diener-West et al.
JCO 2004;22:2438-2444.
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Very Long-Term Prognosis of Patients with Malignant Uveal Melanoma
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Uveal Melanoma Survival in Sweden from 1960 to 1998
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IOVS 2003;44:3282-3287.
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Trends in Size and Treatment of Recently Diagnosed Choroidal Melanoma, 1987-1997: Findings From Patients Examined at Collaborative Ocular Melanoma Study (COMS) Centers: COMS Report No. 20
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Chen et al.
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