Objective: To evaluate whether primary tumor treatment provides a survival benefit in uveal melanoma by comparing patients who declined treatment (Natural History Study, NHS) with those who received treatment in the Collaborative Ocular Melanoma Study (COMS) for medium-sized choroidal melanomas. Methods: Individual-level survival data were reverse-engineered from cumulative all-cause mortality curves in the original COMS and NHS publications. Censoring patterns were estimated from numbers at risk and descriptive statistics. A Bonferroni-corrected significance level of 0.017 was applied. Additionally, to ensure a conservative approach, NHS cohort data were iteratively adjusted by reducing the 8-year cumulative mortality by one percentage point if the Cox regression hazard ratio for all-cause mortality, the unadjusted risk ratio for death, and the 95% confidence intervals (CIs) of the Kaplan–Meier curves did not show a smaller survival difference than originally reported. Results: Kaplan–Meier analysis revealed significantly higher cumulative mortality in the NHS cohort compared to the COMS cohort (log–rankp= 0.012). When restricting the analysis to the first 8 years to account for unclear censoring patterns beyond this period, the NHS cohort still demonstrated worse survival (p= 0.008). A sensitivity analysis, varying censoring times by ±25% over 1000 iterations, confirmed worse survival in the NHS cohort in 100% of cases. Conclusions: In this re-evaluation, patients who declined treatment for medium-sized choroidal melanomas had significantly worse survival, suggesting a potential survival benefit of primary tumor treatment.
目的:通过比较拒绝治疗(自然史研究,NHS)的患者与接受中等大小脉络膜黑色素瘤协作眼黑色素瘤研究(COMS)治疗的患者,评估原发性肿瘤治疗是否能提高葡萄膜黑色素瘤患者的生存获益。方法:从原始COMS和NHS出版物中的累积全因死亡率曲线反推个体水平生存数据,并根据风险人数和描述性统计估算删失模式。采用Bonferroni校正后的显著性水平0.017。此外,为确保保守估计,若Cox回归全因死亡率风险比、未校正死亡风险比及Kaplan-Meier曲线的95%置信区间显示的生存差异未小于原始报告,则通过将NHS队列的8年累积死亡率逐次降低1个百分点进行迭代调整。结果:Kaplan-Meier分析显示NHS队列的累积死亡率显著高于COMS队列(对数秩检验p=0.012)。将分析限制在前8年以排除后期不明删失模式的影响后,NHS队列生存率仍更差(p=0.008)。通过1000次迭代将删失时间调整±25%的敏感性分析证实,100%的情况下NHS队列生存结局更差。结论:本次再评估表明,拒绝治疗的中等大小脉络膜黑色素瘤患者生存率显著降低,提示原发性肿瘤治疗可能具有生存获益。