Mortality after deferral of treatment or no treatment for choroidal melanoma

Purpoe To report mortality of patient who were eligible for enrollment in the Collaborative Ocular Melanoma tudy (COM) clinical trial of medium-ized choroidal melanoma or large-ized choroidal melanoma but choe to defer treatment or receive no melanoma treatment. Deign Propective nonrandomized multicenter cohort tudy a an adjunct to the COM randomized clinical trial. Method Patient follow-up procedure included examination, correpondence, telephone contact, and National Death Index earche. Primary outcome wa patient death meaured by all-caue mortality. econdary outcome were melanoma treatment and melanoma metatai. Reult Of 77 patient eligible for the COM clinical trial who choe to defer or receive no melanoma treatment, 61 were appropriate candidate and 45 (74%) enrolled in the natural hitory tudy. Forty-two patient (42 eye) had medium melanoma, and median follow-up wa 5.3 year (range, 4–10.7 year). Twenty-two patient (52%) had ubequent melanoma treatment, and 20 (48%) had no melanoma treatment. For the 42 patient, the Kaplan-Meier etimate of 5-year mortality wa approximately 30% (95% confidence interval [CI], 18%–47%). For the COM medium melanoma trial, 5-year mortality wa 18% (95% CI, 16% –20%), not tatitically ignificantly different from the natural hitory tudy patient. After adjuting for difference in age and longet baal diameter, the 5-year rik of death for natural hitory tudy patient v COM trial patient wa 1.54 (95% CI, 0.93–2.56). Three patient had large melanoma. Melanoma metatai wa confirmed or upected in eight (42%) of 19 death. Concluion Greater mortality and higher rik of death for natural hitory tudy patient are probative but not concluive evidence of a beneficial, life-extending effect of medium melanoma treatment.