Abstract
Abstract Background: Although immune-related adverse effects (irAEs) are commonly seen in anti-PD-1 monotherapy-treated patients, their predictive biomarkers are still lacking. Methods: In this retrospective analysis, clinical data were collected from 141 advanced melanoma patients treated with anti-PD-1 monotherapy at Massachusetts General Hospital from Sept. 2009 to Dec. 2017. Demographic characteristics, baseline, and early-on-treatment (median 3 weeks after anti-PD-1 monotherapy initiation) routine laboratory variables were collected and correlated with occurrence of irAEs in both univariate and multivariate analyses. Results: 80/141 (56.7%) patients developed irAEs after anti-PD-1 monotherapy initiation. Significant independent predictive variables (P < 0.05) in favor of the occurrence of irAEs included the following: with no distant metastasis (Stage M0) before treatment initiation, high baseline neutrophils, and high early-on-treatment neutrophil-to-lymphocyte ratio (NLR). High baseline monocytes, high baseline basophils, and high early-on-treatment WBCs were of borderline significance (P < 0.1) in multivariate analyses. An irAE risk scoring model (total scale: 0-6) comprising these 6 factors (all as dichotomous variables) was established (HR 1.781, 95% CI 1.450 – 2.187, P < 0.001). Risks of developing at least one irAE within 12 weeks after anti-PD-1 monotherapy initiation were 0%, 21%, 21%, 39%, 30%, and 63%; within 48 weeks were 0%, 41%, 57%, 68%, 77%, and 100%, for patients with scores of 0 to 5 (no patient scored 6 within this cohort), respectively. Conclusions: Scoring system based on simple, easily accessible, and routinely tested biomarkers could be used to help predict the risk of irAEs occurrence in anti-PD-1 monotherapy-treated advanced melanoma patients. Citation Format: Xue Bai, Michelle S. Kim, Gyulnara Kasumova, Justine Cohen, Donald Lawrence, Christine Freedman, Riley Fadden, Krista Rubin, Tatyana Sharova, Keith Flaherty, Ryan Sullivan, Genevieve Boland. Demographic characteristics and peripheral blood clinical laboratory variables predict irAE occurrence in patients with advanced melanoma receiving anti-PD-1 monotherapy [abstract]. In: Proceedings of the AACR Special Conference on Melanoma: From Biology to Target; 2019 Jan 15-18; Houston, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(19 Suppl):Abstract nr B25.
Published Version
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