Background. In ambulatory patients with advanced or metastatic stage of lung adenocarcinoma (LA) the risk of VTE increases during chemotherapy. but individual risk factors cannot identify patients at risk. The available RAM are not applicable in patients already on chemotherapy.
Aim. The prospective longitudinal non interventional study ROADMAP was designed to elaborate a RAM for VTE specific for ambulatory patients with LA on chemotherapy.
Methods. Patients with LA on chemotherapy were included and followed up at 3, 6 and 12 months. Documented symptomatic VTE was the end-point of the study. Blood samples were collected at inclusion and assessed for thrombin generation (TG) and procoagulant phospholipids (PPL-ct). Assays and reagents were from Diagnostic Stago (France). Multivariate analysis was performed and the RAM was developed using the logistic regression. Sensitivity, specificity and the predictive value of the RAM were calculated. The ROC Curve was plotted.
Results. The study included 150 patients (mean age 65 years, 73% male). The LA diagnosis was done within 6 months before inclusion in 70% of them and 90% had advanced or metastatic disease at inclusion. In 85% of patients the ECOG performance status was <3. In one year follow up 12 symptomatic VTE episodes occured (8%), 75% of which occurred within the 3 months from inclusion. The RAM includes the following variables: Recent hospitalisation, Time since diagnosis of the cancer, Mean Rate Index of TG and PPL-ct. The ROC analysis gave a AUC value of 0.84. The sensitivity of the RAM was 89% and the specificiy was 70%. The postive predictive value is 16% and the negative predictive value is 98%
Conclusions. The new RAM for VTE is specific for ambulatory patients with LA on chemotherapy and can relibly predict VTE using simple clinical variables and biomarkers of hypercoagulability. This RAM can be used by physitians for the identification of ambulatory lung cancer patients eligible for thromboprophylaxis.