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Clinical Trials |

The COMS Randomized Trial of Iodine 125 Brachytherapy for Choroidal Melanoma:  V. Twelve-Year Mortality Rates and Prognostic Factors: COMS Report No. 28

Arch Ophthalmol. 2006;124(12):1684-1693. doi:10.1001/archopht.124.12.1684.
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Objectives  To report refined rates of death and related outcomes by treatment arm through 12 years after primary treatment of choroidal melanoma and to evaluate characteristics of patients and tumors as predictors of relative treatment effectiveness and time to death.

Design  Randomized multicenter clinical trial of iodine 125 (125I) brachytherapy vs enucleation conducted as part of the Collaborative Ocular Melanoma Study. Eligible patients were free of metastasis and other cancers at enrollment. All patients were followed up for 5 to 15 years at scheduled examinations for metastasis or another cancer or until death. Decedents were classified by the independent Mortality Coding Committee as having histopathologically confirmed melanoma metastasis, suspected melanoma metastasis without histopathologic confirmation, another cancer but not melanoma metastasis, or no malignancy.

Main Outcome Measures  Deaths from all causes and deaths with histopathologically confirmed melanoma metastasis.

Results  Within 12 years after enrollment, 471 of 1317 patients died. Of 515 patients eligible for 12 years of follow-up, 231 (45%) were alive and clinically cancer free 12 years after treatment. For patients in both treatment arms, 5- and 10-year all-cause mortality rates were 19% and 35%, respectively; by 12 years, cumulative all-cause mortality was 43% among patients in the 125I brachytherapy arm and 41% among those in the enucleation arm. Five-, 10-, and 12-year rates of death with histopathologically confirmed melanoma metastasis were 10%, 18%, and 21%, respectively, in the 125I brachytherapy arm and 11%, 17%, and 17%, respectively, in the enucleation arm. Older age and larger maximum basal tumor diameter were the primary predictors of time to death from all causes and death with melanoma metastasis.

Conclusion  Longer follow-up of patients confirmed the earlier report of no survival differences between patients whose tumors were treated with 125I brachytherapy and those treated with enucleation.

Application to Clinical Practice  Estimated mortality rates by baseline characteristics should facilitate counseling of patients who have choroidal melanoma of a size and in a location suitable for enucleation or 125I brachytherapy and no evidence of metastasis or another malignancy.

Trial Registration  clinicaltrials.gov Identifier: NCT00000124

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Figures

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Figure 1.

Cumulative percentage of patients dead by time since enrollment and treatment arm (iodine 125 [125I] brachytherapy [n = 657] and enucleation [n = 660]). The numbers of patients at risk and censored at the end of each 1-year interval are shown below the horizontal axis. Ellipses indicate not applicable. A, Deaths from all causes. B, Deaths with histopathologically confirmed melanoma metastasis.

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Figure 2.

Cumulative percentage of patients dead by time since enrollment and patient age and maximum basal tumor diameter (MBTD). Treatment arms were combined to estimate cumulative percentages. The numbers of patients at risk and censored at the end of each 1-year interval are shown below the horizontal axis. Ellipses indicate not applicable. A, Deaths from all causes. B, Deaths with histopathologically confirmed melanoma metastasis.

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eFigure 1.

Adjusted risk ratios and 95% confidence intervals (CIs) for iodine 125 (125I) brachytherapy vs enucleation for deaths from any cause during the first 5 years after enrollment and through 10 years within subgroups of patients defined by baseline characteristics. Mortality rates within subgroups based on patient age were adjusted for maximum basal tumor diameter (MBTD); rates within subgroups based on MBTD were adjusted for patient age. Mortality rates in all other subgroups were adjusted for age at enrollment and MBTD. The vertical line for each interval is located at 1.00, the value of the risk ratio (hazard ratio) that indicates no difference between treatment arms with respect to all-cause mortality. Risk ratios less than 1.00 indicate fewer deaths after 125I brachytherapy, whereas risk ratios greater than 1.00 indicate more deaths after 125I brachytherapy, in comparison with enucleation. The overall adjusted risk ratio for the total group of patients enrolled is shown first for comparison. CV indicates cardiovascular. Information required to classify patients was not available for distance from the proximal tumor border to the optic disc (n = 4), days from diagnosis to enrollment (n = 1), and tumor reflectivity (n = 7).

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eFigure 2.

Adjusted risk ratios and 95% confidence intervals (CIs) for iodine 125 (125I) brachytherapy vs enucleation for deaths with histopathologically confirmed melanoma metastasis during the first 5 years after enrollment and through 10 years within subgroups of patients defined by baseline characteristics. Mortality rates within subgroups based on patient age were adjusted for maximum basal tumor diameter (MBTD); rates within subgroups based on MBTD were adjusted for patient age. Mortality rates in all other subgroups were adjusted for age at enrollment and MBTD. The vertical line for each interval is located at 1.00, the value of the risk ratio (hazard ratio) that indicates no difference between treatment arms with respect to death with histopathologically confirmed melanoma metastasis. Risk ratios less than 1.00 indicate fewer deaths after 125I brachytherapy, whereas risk ratios greater than 1.00 indicate more deaths after 125I brachytherapy, in comparison with enucleation. The overall adjusted risk ratio for the total group of patients enrolled is shown first for comparison. CV indicates cardiovascular. Information required to classify patients was not available for distance from the proximal tumor border to the optic disc (n = 4), days from diagnosis to enrollment (n = 1), and tumor reflectivity (n = 7).

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Place holder to copy figure label and caption
Figure 3.

Adjusted cumulative rates of death from all causes by 5 and 10 years after enrollment within patient subgroups defined by baseline characteristics. Treatment arms were combined to estimate adjusted mortality rates. Rates in subgroups defined by patient age at baseline were adjusted for maximum basal tumor diameter (MBTD); rates in subgroups defined by MBTD were adjusted for patient age. Rates in all other subgroups were adjusted for patient age and MBTD. The vertical line shown for each interval indicates the adjusted cumulative all-cause mortality rate for the total group of 1317 patients; the shaded bar shows the 95% confidence interval (CI) associated with that rate. CV indicates cardiovascular. Information required to classify patients was not available for distance from the proximal tumor border to the optic disc (n = 4), days from diagnosis to enrollment (n = 1), and tumor reflectivity (n = 7).

Graphic Jump Location
Place holder to copy figure label and caption
Figure 4.

Adjusted cumulative rates of death with histopathologically confirmed melanoma metastasis by 5 and 10 years after enrollment within patient subgroups defined by baseline characteristics. Treatment arms were combined to estimate adjusted mortality rates. Rates in subgroups defined by patient age at baseline were adjusted for maximum basal tumor diameter (MBTD); rates in subgroups defined by MBTD were adjusted for patient age. Rates in all other subgroups were adjusted for patient age and MBTD. The vertical line for each interval indicates the adjusted cumulative rate of death with histopathologically confirmed melanoma metastasis for the total group of 1317 patients; the shaded bar shows the 95% confidence interval (CI) associated with that rate. CV indicates cardiovascular. Information required to classify patients was not available for distance from the proximal tumor border to the optic disc (n = 4), days from diagnosis to enrollment (n = 1), and tumor reflectivity (n = 7).

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Place holder to copy figure label and caption
Figure 5.

Percentage of patients with specified status at the end of each year of follow-up. Treatment arms were combined. The number of patients who enrolled early enough to be followed up to the end of the specified year is shown at the top of the corresponding bar.

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