| | The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma: IV. Local treatment failure and enucleation in the first 5 years after brachytherapy. COMS report no. 19☆Received 7 September 2001; accepted 20 May 2002.
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Subretinal recombinant tissue plasminogen activator injection and pneumatic displacement of thick submacular hemorrhage in age-related macular degeneration
Ophthalmology
September 2004 (Vol. 111, Issue 9, Page 1640)
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The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma. IV. Local treatment failure and enucleation in the first 5 years after brachytherapy. COMS report no. 19
Ophthalmology
August 2004 (Vol. 111, Issue 8, Page 1514)
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Abstract ObjectiveTo describe the frequency and predictors of local treatment failure and enucleation after iodine 125 (I125) brachytherapy in patients with choroidal melanoma treated and followed up in a large randomized clinical trial. DesignProspective, noncomparative, interventional case series within a randomized, multicenter clinical trial. ParticipantsPatients enrolled in the Collaborative Ocular Melanoma Study (COMS) trial of enucleation versus brachytherapy between February 1987 and July 1998; tumors measured 2.5 to 10.0 mm in apical height and no more than 16.0 mm in longest basal dimension. MethodsI125 brachytherapy was administered via episcleral plaque according to a standard protocol. Follow-up ophthalmic evaluations, including ophthalmic ultrasound and fundus photography, were performed according to a standard protocol at baseline, every 6 months thereafter for 5 years, and subsequently at annual intervals. Survival analysis methods were used to estimate the cumulative risk of postirradiation treatment failure and enucleation. Factors associated with treatment failure and enucleation of plaqued eyes were evaluated using Cox proportional hazards analysis. Main outcome measuresReports of enucleation and of local treatment failure, defined as tumor growth, recurrence, or extrascleral extension, derived from clinical reports based on echographic and photographic documentation. ResultsAs of September 30, 2000, 638 of the 650 patients randomized to brachytherapy and so treated had been followed up for 1 year or longer, and 411 had been followed up for at least 5 years. Sixty-nine eyes were enucleated during the first 5 years after brachytherapy, and treatment failure was reported for 57 eyes. The Kaplan-Meier estimate of proportion of patients undergoing enucleation by 5 years was 12.5% (95% confidence interval [CI], 10.0%–15.6%); the risk of treatment failure was 10.3% (95% CI, 8.0%–13.2%). Treatment failure was the most common reason for enucleation within 3 years of treatment; beyond 3 years, ocular pain was most common. Risk factors for enucleation were greater tumor thickness, closer proximity of the posterior tumor border to the foveal avascular zone, and poorer baseline visual acuity in the affected eye. Risk factors for treatment failure were older age, greater tumor thickness, and proximity of the tumor to the foveal avascular zone. Local treatment failure was associated weakly with reduced survival after controlling for baseline tumor and personal characteristics (adjusted risk ratio, 1.5; P = 0.08). ConclusionsLocal treatment failure and enucleation were relatively infrequent events after I125 brachytherapy within the COMS. Treatment failure typically occurred early and was associated weakly with poorer survival. The COMS randomized trial documented the absence of a clinically or statistically significant difference in survival for patients randomly assigned to enucleation versus brachytherapy. This analysis documents the efficacy of brachytherapy to achieve sustained local tumor control and to conserve the globe. 1 Department of Ophthalmology, Northwestern University Medical School, Chicago, Illinois, USA 2 Wilmer Ophthalmological Institute, Johns Hopkins School of Medicine, Baltimore, Maryland, USA 3 Current affiliation: National Institutes of Health/NINDS, Bethesda, Maryland, USA 4 Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, Florida, USA 5 Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin, USA 6 Doheny Eye Institute, University of Southern California School of Medicine, Los Angeles, California, USA 7 Jules Stein Eye Institute, University of California Los Angeles Medical Center, Los Angeles, California, USA 8 New York Eye Cancer Center, New York, New York, USA 9 Porter Adventist Hospital, Denver, Colorado, USA 10 Retina Associates Southwest, Tucson, Arizona, USA 11 Retina-Vitreous Consultants, Pittsburgh, Pennsylvania, USA 12 Department of Ophthalmology, University of Washington, Seattle, Washington, USA  Correspondence to Claudia S. Moy, PhD, COMS Coordinating Center, NIH/NINDS, Neuroscience Center, Room 2214, 6001 Executive Boulevard, MSC 9520, Bethesda, MD 20892-9520, USA.
☆ Manuscript no. 210753. A complete listing of the COMS Group as of September 30, 2000, may be found in Arch Ophthalmol 2001;119:969–82. Supported by the National Eye Institute and National Cancer Institute, National Institutes of Health, Bethesda, Maryland (cooperative agreement nos.: EY 06253, EY 06257, EY 06258, EY 06260, EY 06264, EY 06265, EY 06266, EY 06269, EY 06270, EY 06274, EY 06275, EY 06276, EY 06279, EY 06280, EY 06282, EY 06283, EY 06284, EY 06287, EY 06288, EY 06289, EY 06291, EY 06839, EY 06843, EY 06844, EY 06848, EY 06858, and EY 06899). The authors have no proprietary interest in any device reported in this paper. Reprint requests to COMS Coordinating Center, Wilmer Clinical Trials and Biometry, 550 North Broadway, Ninth Floor, Baltimore, MD 21205. PII: S0161-6420(02)01277-0 © 2002 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. | |
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