Cancer Associated Thrombosis:how many lung cancer patients seen in clinical practice would be eligible to a DOAC randomized controlled trial?

Background: Based on the results of randomized clinical trials (RCT) assessing direct oral anticoagulants (DOACs) for the treatment of patients with cancer-associated thrombosis, DOACs have been proposed as alternative to low molecular weight heparin by several international guidelines. However, the proportion of patients with VTE associated with lung cancer who would not have been eligible for such trials is currently unknownMethods: In a multicenter, observational study, all patients consecutively admitted from 01/2017 to 12/2019 for an acute VTE event were retrospectively analyzed. Patients were classified according to the presence or absence of non-inclusion criteria from the CARAVAGGIO study. Death, VTE recurrence and major bleeding during a 6-month follow-up were analyzed as secondary endpointsAims: The primary aim of this study was to assess the proportion of patients with lung cancer seen in clinical practice for acute VTE but ineligible for a RCT Secondary aims were to describe patients outcomes according to eligibility statusResults: Among the 302 patients included, 59 (19.5%) had lung cancer, in whom 39 (66.1%: 95%CI [54.02, 78.18]) were ineligible for the CARAVAGGIO study. Main exclusion criteria were: brain metastases (n=18, 46%), unusual deep vein thrombosis (n=10, 25.6%), ECOG PS>2 (n=10, 25.6%), risk of bleeding (n=8, 20.5%). At 6 months, the event-free survival rate was similar among groupsConclusion: Among patients with VTE associated with lung cancer, more than a half would have not been able to participate in a trial as CARAVAGGIO. Evaluation of DOACs safety and efficacy in these specific setting needs further researc