Adjuvant Sunitinib in High-Risk Patients with Uveal Melanoma: Comparison with Institutional Controls

Abstract

To compare overall survival in high-risk patients with primary uveal melanoma who received adjuvant sunitinib with institutional controls. Retrospective cohort. 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. A cohort of patients who intended to receive adjuvant sunitinib for 6 months was compared with institutional historical controls with the same risk factors. Kaplan-Meier and Cox proportional hazards models were used to analyze the outcome. Propensity score was used to adjust for nonrandom assignment to sunitinib. Overall survival. 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, 0.26-108 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. In this retrospective study, the use of sunitinib in the adjuvant setting was associated with better overall survival.