Collaborative Ocular Melanoma Study randomized trial of I-125 brachytherapy

Background Although findings from observational studies published in the 1970s and early 1980s suggested that length of remaining life after a diagnosis of uveal melanoma was similar following enucleation (removal of the eye) and local eye-conserving radiotherapy, the majority of ophthalmologists in the United States were not convinced that saving the eye would not compromise survival. Purpose The Collaborative Ocular Melanoma Study (COMS) was designed to compare enucleation and radiotherapy among similar patients with respect to survival outcomes. Methods A multicenter randomized trial of primary treatment with iodine-125 brachytherapy versus enucleation (i.e., a comparative effectiveness trial) was conducted to provide the evidence required to answer the concerns of ophthalmologists and their patients. Eligibility criteria adopted for the trial were intended to apply to the majority of patients diagnosed with choroidal melanoma who would be suitable candidates for either form of primary treatment. Results Accrual to this COMS trial began in 1986 and ended in 1998. Participating patients were followed for 5 to 15 years, depending upon date of enrollment, before all clinical follow-up ended in 2003. No difference in survival outcomes and little difference in quality-of-life outcomes were observed between patients in the brachytherapy arm and those in the enucleation arm. Five-year survival was substantially better than anticipated based on a review of the literature when the trial was designed. Limitations The choice of brachytherapy for delivery of radiation to the tumor had important advantages but also imposed restrictions regarding eligibility. Conclusions The multidisciplinary COMS Group not only successfully conducted a randomized trial that answered the primary study questions but also has contributed to clinical and epidemiologic knowledge of choroidal melanoma through numerous publications. As a consequence of the COMS, a standard approach to I-125 brachytherapy for treatment of choroidal melanoma became widely available to affected patients. Clinical Trials 2011; 8: 661-673. http://ctj.sagepub.com