Efficacy and safety of direct oral anticoagulants (DOACs) compared to low-molecular weight heparin (LMWH) in digestive system cancers: individual patient data metanalysis from randomized controlled trial

Digestive system cancers, which include colorectal cancer, anal cancer, gastric cancer, esophageal cancer, liver cancer, bile duct cancers, pancreatic cancer, and certain neuroendocrine tumors, are the most common type of cancer worldwide. Neuroendocrine tumors are cancers that begin in specialized cells called neuroendocrine cells, which are cells similar to nerve cells and hormone-producing cells. Neuroendocrine tumors are rare and can occur anywhere in the body, since neudoendocrine cells are widespread throughout the body. Digestive system cancers account for about 30% of all cancer cases and lead to nearly 35% of all cancer-related deaths. A common complication associated with these cancers is venous thromboembolism (VTE), a condition where blood clots form in the veins. VTE is the second leading cause of death among cancer patients, just after the cancer itself.

Traditionally, treatments including low-molecular weight heparin (LMWH) have been the primary treatment for VTE. LMWH is a type of blood thinner, derived from unfractionated heparin, that helps prevent blood clots or treat it once it occurred in some vessels. Over the last ten years, direct oral anticoagulants (DOACs), which are taken by mouth, have become available. However, their use in patients with digestive system cancers remains limited. Clinical studies have shown a higher risk of bleeding complications with DOACs in these patients, which is a significant concern.

Our project aims to evaluate the safety and effectiveness of DOACs for treating blood clots in patients with digestive system cancers. We will focus on determining how often bleeding occurs, the types of bleeding, and the severity of these incidents among this patient population. To conduct this research, we will perform a meta-analysis using individual patient data from randomized controlled trials (RCTs). This approach allows us to combine data from different studies to create a larger, uniform group of patients with similar characteristics. We will then analyze this data statistically to compare the bleeding risks associated with DOACs versus LMWH.

The findings from our study will be crucial for improving patient care and guiding doctors in treatment decisions. If our research shows that DOACs are safe and effective for this group of patients, it could expand the use of these medications, potentially benefiting many individuals who currently do not have access to them.