Mortality after deferral of treatment or no treatment for choroidal melanoma☆

Abstract 

Purpose

To report mortality of patients who were eligible for enrollment in the Collaborative Ocular Melanoma Study (COMS) clinical trials of medium-sized choroidal melanoma or large-sized choroidal melanoma but chose to defer treatment or receive no melanoma treatment.

Design

Prospective nonrandomized multicenter cohort study as an adjunct to the COMS randomized clinical trials.

Methods

Patient follow-up procedures included examinations, correspondence, telephone contacts, and National Death Index searches. Primary outcome was patient death measured by all-cause mortality. Secondary outcomes were melanoma treatment and melanoma metastasis.

Results

Of 77 patients eligible for the COMS clinical trials who chose to defer or receive no melanoma treatment, 61 were appropriate candidates and 45 (74%) enrolled in the natural history study. Forty-two patients (42 eyes) had medium melanoma, and median follow-up was 5.3 years (range, 4–10.7 years). Twenty-two patients (52%) had subsequent melanoma treatment, and 20 (48%) had no melanoma treatment. For the 42 patients, the Kaplan-Meier estimate of 5-year mortality was approximately 30% (95% confidence interval [CI], 18%–47%). For the COMS medium melanoma trial, 5-year mortality was 18% (95% CI, 16% –20%), not statistically significantly different from the natural history study patients. After adjusting for differences in age and longest basal diameter, the 5-year risk of death for natural history study patients vs COMS trial patients was 1.54 (95% CI, 0.93–2.56). Three patients had large melanoma. Melanoma metastasis was confirmed or suspected in eight (42%) of 19 deaths.

Conclusions

Greater mortality and higher risk of death for natural history study patients are probative but not conclusive evidence of a beneficial, life-extending effect of medium melanoma treatment.