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

IF 0.7 Q4 ONCOLOGY

Melanoma Management Pub Date : 2025-12-01 Epub Date: 2025-05-05 DOI:10.1080/20450885.2025.2494977

Viktor T Gill, Shiva Sabazade, Gustav Stålhammar

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引用次数: 0

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.

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协同眼黑色素瘤研究（COMS）死亡率结果的阈值分析。

目的：眼部黑色素瘤联合研究（COMS）报告了斑块近距离放疗（一种介入放疗）和去核治疗中等脉络膜黑色素瘤的生存率相似。我们的目的是量化达到统计显著性所需的死亡率差异，并评估这些阈值的稳健性。方法：我们使用阈值分析重新分析了COMS的12年死亡率数据，以确定两个治疗组中增加或减少的死亡人数会改变风险比大于1的95%置信区间（CI）的下限。结果：12年时，近距离放疗组有105例黑色素瘤相关死亡，去核组有98例（风险比1.08,95% CI 0.82-1.42）。达到统计学显著性需要近距离放疗组增加31例死亡或去核组减少23例死亡；相反，选择近距离放疗会使去核组增加34例死亡，近距离放疗组减少27例死亡。这些阈值在功率水平和灵敏度情况下保持一致。结论：COMS试验未显示有临床意义的生存差异。我们的研究结果强调了统计显著性所需的大量死亡率变化，并强调了在葡萄膜黑色素瘤试验中检测适度治疗效果的挑战。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Melanoma Management ONCOLOGY-

CiteScore

5.10

自引率

0.00%

发文量

审稿时长

13 weeks

期刊介绍： Skin cancer is on the rise. According to the World Health Organization, 132,000 melanoma skin cancers occur globally each year. While early-stage melanoma is usually relatively easy to treat, once disease spreads prognosis worsens considerably. Therefore, research into combating advanced-stage melanoma is a high priority. New and emerging therapies, such as monoclonal antibodies, B-RAF and KIT inhibitors, antiangiogenic agents and novel chemotherapy approaches hold promise for prolonging survival, but the search for a cure is ongoing. Melanoma Management publishes high-quality peer-reviewed articles on all aspects of melanoma, from prevention to diagnosis and from treatment of early-stage disease to late-stage melanoma and metastasis. The journal presents the latest research findings in melanoma research and treatment, together with authoritative reviews, cutting-edge editorials and perspectives that highlight hot topics and controversy in the field. Independent drug evaluations assess newly approved medications and their role in clinical practice. Key topics covered include: Risk factors, prevention and sun safety education Diagnosis, staging and grading Surgical excision of melanoma lesions Sentinel lymph node biopsy Biological therapies, including immunotherapy and vaccination Novel chemotherapy options Treatment of metastasis Prevention of recurrence Patient care and quality of life.