Lobo-Martins S, Martins-Branco D, Semedo P M, Alvim C M, Monteiro A M, Vendrell I, Gouveia E, Passos M J, Costa L, Mansinho A, de Sousa R T
Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal.
Instituto Medicina Molecular João Lobo Antunes, LCosta Lab-Lisbon School of Medicine, Lisbon, Portugal.
Immunooncol Technol. 2025 Feb 3;25:101043. doi: 10.1016/j.iotech.2025.101043. eCollection 2025 Mar.
Immunotherapy has revolutionized advanced melanoma treatment. Several prognostic factors have been studied to predict survival in this setting. We aimed to develop a prognostic score.
A multicentre, retrospective cohort study was conducted including patients with advanced melanoma who started anti-programmed cell death protein 1 (PD-1) monotherapy between January 2016 and October 2019 with ≤2 prior treatment lines. The study endpoint was overall survival (OS). Univariate and multivariate Cox regression identified independent prognostic factors, with 95% confidence intervals (CIs). The predictive accuracy of the model was evaluated by the receiver operating characteristic (ROC) curve model.
We identified 147 patients with a median follow-up of 28.9 months (95% CI 22.5-33.5 months). The median OS (mOS) for the whole cohort was 14.8 months (95% CI 10.8-18.7 months). Overall, 43 and 104 patients were treated with nivolumab and pembrolizumab, respectively. We identified four prognostic factors at baseline: ≥3 metastatic sites [hazard ratio (HR) 1.90, 95% CI 1.21-2.97], performance status by Eastern Cooperative Oncology Group ≥1 (HR 2.02, 95% CI 1.28-3.18), lymphopenia (HR 2.85, 95% CI 1.54-5.27) or increased lactate dehydrogenase (HR 2.08, 95% CI 1.19-3.63). The MELimmune score grouped patients into three risk categories: favourable prognosis (no risk factors; = 34), intermediate prognosis (one risk factor; = 65) and poor prognosis (two or more risk factors; = 48). The mOS was 43.4 (95% CI 32.1-54.7), 14.4 (95% CI 6.8-22.0) and 6.5 (95% CI 3.6-9.4) months for favourable, intermediate and poor prognosis groups, respectively ( < 0.001). The area under the ROC curve was 0.74 (95% CI 0.66-0.82).
Using easily accessible variables from daily practice, the MELimmune prognostic score for patients with advanced melanoma treated with anti-PD-1 monotherapy holds potential to be used in clinical practice and prospectively validated in clinical trials.
免疫疗法彻底改变了晚期黑色素瘤的治疗方式。已经研究了多种预后因素来预测这种情况下的生存率。我们旨在制定一个预后评分。
进行了一项多中心回顾性队列研究，纳入2016年1月至2019年10月期间开始接受抗程序性细胞死亡蛋白1（PD-1）单药治疗且既往治疗线数≤2的晚期黑色素瘤患者。研究终点为总生存期（OS）。单因素和多因素Cox回归确定独立预后因素，并给出95%置信区间（CI）。通过受试者工作特征（ROC）曲线模型评估模型的预测准确性。
我们纳入了147例患者，中位随访时间为28.9个月（95%CI 22.5-33.5个月）。整个队列的中位OS（mOS）为14.8个月（95%CI 10.8-18.7个月）。总体而言，分别有43例和l04例患者接受了纳武利尤单抗和帕博利尤单抗治疗。我们在基线时确定了四个预后因素：≥3个转移部位[风险比（HR）1.90，95%CI 1.21-2.97]、东部肿瘤协作组体能状态≥1（HR 2.02，95%CI 1.28-3.18）、淋巴细胞减少（HR 2.85，95%CI 1.54-5.27）或乳酸脱氢酶升高（HR 2.08，95%CI 1.1-3.63）。MELimmune评分将患者分为三个风险类别：预后良好（无风险因素；n=34）、预后中等（一个风险因素；n=65）和预后不良（两个或更多风险因素；n=48）。预后良好、中等和不良组的mOS分别为43.4（95%CI 32.1-54.7）、14.4（95%CI 6.8-22.0）和6.5（95%CI 3.6-9.4）个月（P<0.001）。ROC曲线下面积为0.74（95%CI 0.66-0.82）。
利用日常实践中易于获取的变量，用于接受抗PD-1单药治疗的晚期黑色素瘤患者的MELimmune预后评分有潜力应用于临床实践，并在临床试验中进行前瞻性验证。
