Abstract 1688P
Background
Although melanoma is not associated with a high incidence of venous thromboembolic disease (VTE) and arterial thrombosis (AT), it is unknown whether immune checkpoint inhibitors (ICI) increase the risk of VTE/AT.
Methods
Retrospective and multicenter study (10 hospitals). Patients with melanoma who started ICI between 01/01/2015–31/12/2019 were recruited. A descriptive study and analysis of overall survival (OS) was performed using the Kaplan-Meier method.
Results
291 patients were recruited, with a median age of 62 years, 52.6% being men, 3.4% had a history of VTE/AT prior to cancer diagnosis. At diagnosis, 21.4% had stage IV and 41.1% had stage III. 29.55% had BRAF mutation and 98.8% of these were V600E. PD-L1 status was determined in 8.93% and, of them, 84.6% was <1%. 95.5% had ECOG 0-1. ICIs were used mainly in first line (62.5%), followed by second line (17.5%) and adjuvant treatment (15.5%). The most used regimen was nivolumab (40.2%), followed by pembrolizumab (36.1%). Between the diagnosis of cancer and the beginning of ICI, 1.4% presented VTE/AT. The incidence of VTE/AT associated with ICI in the study period was 5.8%. Within this subgroup, 82.35% had stage IV, with a worse functional status (58.8% ECOG 0-1 and 35.3% ECOG 2). In the reassessed patients (76.47%), 46.15% had disease progression. At the diagnosis of VTE/AT, 0.3% and 0.3% received prophylactic/therapeutic anticoagulation. The most frequent type of VTE was pulmonary embolism (47.06%), with 5.9% myocardial infarction and 5.9% stroke as events of AT. 58.8% of the events occurred during the first 6 months after the start of ICI and 58.8% were symptomatic. 58.8% were admitted to the hospital. 88.2% received low molecular weight heparin. After starting anticoagulation, 11.8% presented re-thrombosis and 11.8% hemorrhages. In the multivariate analysis, LDH ≥198 U/L and the neutrophil/lymphocyte ratio ≥3.01 are statistically significantly correlated with an increased risk of VTE/AT. Median OS in the group with thrombosis was 10 months (95% CI 0 - 20.27) versus 28 months (95% CI 19.58 - 36.42) in the group without thrombosis (p = 0.045).
Conclusions
The incidence of VTE/AT in patients with ICI was 5.8%, with a statistically significant impact on OS.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
D. Fernandez Garay: Financial Interests, Personal, Invited Speaker: Leo Pharma; Financial Interests, Personal, Invited Speaker: Angelini Pharma; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: KyowaKirin. L. Ortega Morán: Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Leo Pharma; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: Merck. M. Lobo de Mena: Financial Interests, Personal, Advisory Board: Fresenius; Financial Interests, Personal, Invited Speaker: Leo Pharma; Financial Interests, Personal, Advisory Board: Leo Pharma; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Vifor Pharma. T. Quintanar Verduguez: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Nestle; Financial Interests, Personal, Advisory Role: Lilly. B. Obispo Portero: Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Fresenius; Financial Interests, Personal, Invited Speaker: Angelini; Financial Interests, Personal, Invited Speaker: Rovi; Financial Interests, Personal, Invited Speaker: Leo Pharma. A. Muñoz Martín: Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Leo Pharma; Financial Interests, Personal, Invited Speaker: BMS, Pfizer; Financial Interests, Personal, Invited Speaker: Rovi; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: Daiichi-Sanko; Financial Interests, Institutional, Funding: Leo Pharma; Financial Interests, Institutional, Funding: Rovi. M. Sánchez Cánovas: Financial Interests, Personal, Invited Speaker: Leo Pharma; Financial Interests, Personal, Invited Speaker: Angelini Pharma; Financial Interests, Personal, Invited Speaker: Kyowakirin; Financial Interests, Institutional, Funding: Leo Pharma. All other authors have declared no conflicts of interest.