Adjuvant Sunitinib in High-Risk Patients with Uveal Melanoma Comparison with Institutional Controls
Adjuvant Sunitinib in High-Risk Patients with Uveal Melanoma Comparison with Institutional Controls
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DOI：
10.1016/j.ophtha.2017.08.017
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发表时间：
2018-02-01
期刊：
影响因子：
13.7
通讯作者：
Sato, Takami
中科院分区：
文献类型：
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作者：
Valsecchi, Matias E.;Orloff, Marlana;Sato, Takami
目的：比较接受舒尼替尼辅助治疗的原发性葡萄膜黑色素瘤高危患者与机构对照患者的总生存率。设计：回顾性队列。参与者：选择标准为(1)3号单体和8q细胞遗传学扩增或decisionx - um 2级扩增；(2)3号单体和大肿瘤大小（美国癌症分类联合委员会T3-4）。排除标准为诊断日期2007年以前或2013年以后，年龄< 18岁。方法：一组拟接受辅助舒尼替尼治疗6个月的患者与具有相同危险因素的机构历史对照进行比较。采用kaplan - meier和Cox比例风险模型对结果进行分析。倾向评分用于调整非随机分配给舒尼替尼。主要观察指标：总生存期。结果：从威尔斯眼科医院肿瘤服务部葡萄膜黑色素瘤细胞遗传学数据库（N = 1172）中，128例患者符合选择和排除标准。中位随访时间为52.7个月（范围0.26 ~ 108个月）。共有54名患者接受舒尼替尼治疗。他们的中位年龄为56岁（范围29-81岁），48%为男性。共确定了74个具有相同风险类别的历史对照。他们的中位年龄为62岁（21-80岁），48%为男性。舒尼替尼组患者的细胞遗传学或分子特征更差（单体3和8q扩增或2类87%对57%，P < 0.001），肿瘤大小更小（T3-4 56%对83%，P = 0.001），年龄更小。51例死亡，舒尼替尼组14例（26%），对照组37例（50%）。在单因素分析中，舒尼替尼组的总生存期更长（风险比0.53；95%可信区间0.29-0.99;P - 0.041）。在多变量Cox回归分析中，舒尼替尼使用与年龄作为二分变量的交互作用非常显著（P = 0.003）。以下变量与总生存率的预测有统计学相关性：细胞遗传学/分子状态（P = 0.015）、t大小类别（P - 0.022）、性别（P - 0.040）和年龄< 60岁患者的辅助舒尼替尼（P - 0.004）。结果经倾向评分分析证实。结论：在这项回顾性研究中，在辅助治疗中使用舒尼替尼与更好的总生存率相关。(C) 2017年由美国眼科学会发布
Purpose: To compare overall survival in high-risk patients with primary uveal melanoma who received adjuvant sunitinib with institutional controls.Design: Retrospective cohort.Participants: Selection criteria were (1) monosomy 3 and 8q amplification by cytogenetic or DecisionDx-UM Class 2 and (2) monosomy 3 and large tumor size (T3-4 by American Joint Committee on Cancer classification). Exclusion criteria were date of diagnosis before 2007 or after 2013 and age < 18 years.Methods: A cohort of patients who intended to receive adjuvant sunitinib for 6 months was compared with institutional historical controls with the same risk factors. Kaplane-Meier and Cox proportional hazards models were used to analyze the outcome. Propensity score was used to adjust for nonrandom assignment to sunitinib.Main Outcome Measures: Overall survival.Results: From the Wills Eye Hospital Oncology Service Uveal Melanoma Cytogenetic Database (N = 1172), 128 patients fulfilled the selection and exclusion criteria. Median follow-up was 52.7 months (range, 0.26e108 months). A total of 54 patients received sunitinib. Their median age was 56 years (range, 29-81 years), and 48% were men. A total of 74 historical controls in the same risk category were identified. Their median age was 62 years (21-80 years), and 48% were men. Patients in the sunitinib group had worse cytogenetic or molecular features (monosomy 3 and 8q amplification or class 2 87% vs. 57%; P < 0.001), had smaller tumor sizes (T3-4 56% vs. 83%; P = 0.001), and were younger. There were 51 deaths, 14 (26%) in the sunitinib group and 37 (50%) in the control group. In the univariate analysis, the sunitinib group had longer overall survival (hazard ratio, 0.53; 95% confidence interval, 0.29-0.99; P - 0.041). In multivariate Cox regression analysis, interaction between use of sunitinib and age as a dichotomous variable was highly significant (P = 0.003). The following variables were statistically associated with prediction of overall survival: cytogenetic/ molecular status (P = 0.015), T-size category (P - 0.022), gender (P - 0.040), and adjuvant sunitinib in patients aged < 60 years (P - 0.004). Results were confirmed by propensity score analysis.Conclusions: In this retrospective study, the use of sunitinib in the adjuvant setting was associated with better overall survival. (C) 2017 by the American Academy of Ophthalmology