Work

Threshold analysis of mortality outcomes in the collaborative ocular melanoma study (COMS)

Year: 2025

Type: article

Abstract: AIM: The collaborative ocular melanoma study (COMS) reported similar survival between plaque brachytherapy (a type of interventional radiotherapy) and enucleation for medium-sized choroidal melanomas. We aimed to quantify the mortality differences required to achieve statistical significance and assess the robustness of these thresholds. METHODS: We reanalyzed 12-year mortality data from COMS using threshold analysis to determine how many additional or fewer deaths in either treatment arm would shift the lower bound of the 95% confidence interval (CI) for the risk ratio above 1. RESULTS: At 12 years, there were 105 melanoma-related deaths in the brachytherapy arm and 98 in the enucleation arm (risk ratio 1.08, 95% CI 0.82-1.42). Achieving statistical significance would have required 31 additional deaths in the brachytherapy arm or 23 fewer in the enucleation arm; conversely, favoring brachytherapy would have necessitated 34 additional deaths in the enucleation arm or 27 fewer in the brachytherapy arm. These thresholds remained consistent across power levels and sensitivity scenarios. CONCLUSIONS: The COMS trial did not reveal a clinically meaningful survival difference. Our findings underscore the substantial mortality shifts required for statistical significance and highlight the challenges in detecting modest treatment effects in uveal melanoma trials.

Source: Melanoma Management

DOI: 10.1080/20450885.2025.2494977

Authors: Viktor T. Gill, Shiva Sabazade, Gustav Stålhammar

Institutions: Karolinska Institutet, Västmanlands sjukhus Västerås, Region Västmanland, S:t Eriks Ögonsjukhus

Language: English

Topic: Ocular Oncology and Treatments

Subfield: Ophthalmology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $1,415