Posology adjustments of oral antineoplastic agents for special populations: patients with renal impairment, hepatic impairment and hematologic toxicities

ABSTRACTBackground: Oral antineoplastic agents (OAA) have reached 30–50% of all antineoplastic treatments. Although they seem safer than parenteral therapy, many severe problems can occur if the dose is not adequately adjusted in special situations. Our objective is to create a comprehensive guide with dosage adjustment recommendations for OAA in cases of renal and hepatic impairment and hematologic toxicities.Research design and methods: We analyzed all OAA approved by EMA in July 2017. We assessed data related to dose adjusted from the FDA’s and EMA’s summary of product characteristics.Results: 53 OAA were analyzed. We identified 44 (83%) OAA requiring dosage adjustments in special situations: 20 (37.7%) in renal impairment, 37 (69.8%) in hepatic impairment, and 22 (41.5%) in patients with hematologic toxicity. The dose adjustment recommendations varied in 31 (58.5%) OAA between the FDA and EMA. Detailed recommendations for each OAA were collated into comprehensive tables.Conclusions: Most OAA have to b...