PB0974 - Safety of direct oral anticoagulant (DOAC) in adult patients with venous thromboembolism or non-valvular atrial fibrillation in the context of urogenital and gynecological cancer: systematic review

Background: Direct oral anticoagulants (DOACs) are considered one of the main treatment options used for management of venous thrombosis and non-valvular atrial fibrillation, with or without an underlying cancer. However, cancer patients are generally more prone to bleeding complications with 2-3-fold increased risk compared to non-cancer patients taking anticoagulant therapy. Bleeding rates vary among different cancer types, but bleeding rates for urogenital and gynecological cancers are poorly defined.

Aims: To characterize the bleeding risk of DOAC use in urogenital (GU) and gynecological cancer patients.

Methods: We conducted a systematic review of RCTs and prospective cohort studies to address safety of DOACs for venous thromboembolism (VTE) and atrial fibrillation (AF) when used in the context of urogenital and gynecological malignancy. MEDLINE, EMBASE and COCHRANE central registry of controlled trials were searched up to and including (Oct 28, 2022), the protocol was published in PROSPERO (CRD42022370981). Studies were independently assessed for inclusion and extracted for data by the authors.

Results: Seven studies met our inclusion criteria (Figure 1) of which 2 were RCTs while 5 were prospective cohorts. A total of 907 patients were included, 859 (94.7%) had VTE, while 48 (5.3%) had AF. All AF patients were on DOACs, while 628 (73.1%) of VTE patients were on DOACs, 135(15.7%) on low molecular weight heparin(LMWH), and 96 (11.1%) on Vitamin K antagonist(VKA). In VTE cases, pooled major bleeding rate was 2.1%, 95%CI(0.9% to 3.3%) with DOACs, 2.2% for LMWH and 8.3% for warfarin for included studies. In AF patients the major bleeding rate was 3.3% (-2.4%-9.1%) for DOAC treated patients (Figure 2).

Conclusion(s): Major bleeding rates in GU and gynecological cancer patients treated with DOACs are similar to that of the general cancer population and this group does not seem to be at a higher risk of bleeding with DOACs.