Global Medical Manager LEO Pharma 92210, Saint-Cloud, Ile-de-France, France
Background: Gastro-intestinal (GI) disorders/toxicities are important to consider for the management of anticoagulation in cancer-associated-thrombosis (CAT) patients. Some of these toxicities could be adverse events (AE) induced by anticancer drugs. However, little is known about the potential GI toxicities of anticancer drugs in CAT patients.
Aims: The aim of this work was to check all the anticancer drug SmPCs (Summary of Product Characteristics) for the risk GI AE.
Methods: All SmPCs of anticancer drugs indicated for lung cancer were checked on the EMA website. All adverse events regarding GI disorders/toxicities were collected. The frequency of adverse events used was the following: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare ( < 1/10,000) (section 4.8). Bleeding AE did not use the ISTH definitions. Severity and outcomes were rarely recorded.
Results: Thirty-nine anticancer drugs were identified for lung cancer with a mix of traditional chemotherapies (platinum salts…), tyrosine kinase inhibitors (nib) and monoclonal antibodies (mab). Among these 39 anticancer drugs, nausea&vomiting (92.3% and diarrhoea (97.4%) were obviously very frequent (Table1). Other GI AE such as Stomatitis (71.8%) and colitis (25.6%) were also very frequent. GI Bleeding AE was reported in 25.6% of all the SmPCs but only 2.6% were very common. GI Perforation (30.8%) was not very common (0.0%). Finally, 30.8% of the SmPCs reported a potential risk of ulcer AE.
Conclusion(s): This review of SmPCs reported that GI AE are frequent in anticancer drug SmPCs. it seems reasonable to consider some these potential GI toxicities, before starting and during a CAT treatment when managing thrombosis with an anticoagulant.