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Abstract
Background Immune checkpoint inhibitors (ICI) have changed the paradigm of advanced malignant melanoma (MM). Several prognostic factors, mostly linked to inflammation, have been under scope to better select patients for such therapies. We aimed to build and apply a prognostic score in this setting.
Methods Baseline characteristics and outcomes on 147 patients with advanced MM treated with an anti-PD1 (nivolumab or pembrolizumab) in monotherapy, between Jan-2016 and Oct-2019, in the 1st, 2nd or 3rd line setting were collected from two centres in Portugal. Data cut-off for follow-up was May-2020. Cox proportional hazards regression was used to identify independent prognostic factors for OS.
Results With a median FU of 28.93 months (95% CI [22.52–33.54]), mOS for the whole cohort was 14.75 months (95% CI, [10.80–18.71]). Overall, 43 and 104 patients were treated with nivolumab and pembrolizumab, respectively. We identified four adverse prognostic factors that were independent predictors of bad prognosis: number of metastatic sites >2 (p<0.001), baseline PS-ECOG =1 (p<0.001), presence of baseline lymphopenia (over lower limit of normal) (p=0.002) or very high baseline LDH (>2x upper limit of normal) (p<0.001).Patients were separated into three risk categories according to the number of risk factors present: favourable prognosis (no risk factors; n=34), intermediate prognosis (one risk factor; n=65) and poor prognosis (two or more risk factors; n=48). mOS was 43.41 (95% CI [32.13–54.69], 14.39 (95% CI [6.78–22.01]) and 6.53 months (95% CI [3.61–9.44]), for favourable, intermediate, and poor prognosis group, respectively (p<0.001; figure 1). AUC of ROC curve for OS was 0.737 (95% CI [0.654–0.819], p<0.001).
Time to death - Kaplan-Meier survival plot
Conclusions Using easily accessible parameters from our daily practice, we propose the MELImmune prognostic score for advanced MM patients treated with anti-PD1 in monotherapy that could be incorporated to the daily clinical practice and clinical trials. We further aim to validate this score in an independent larger sample.
Ethics Approval The study was approved by both institutions’ Ethics Committee.
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