Evaluation of nausea induced by trifluridine/tipiracil in metastatic colorectal cancer treatment

Trifluridine/tipiracil (FTD/TPI) frequently induces chemotherapy-induced nausea and vomiting (CINV). As evidence of factors associated with CINV in oral chemotherapeutic agents is limited, we aimed to assess factors for nausea development in a real-world FTD/TPI-containing treatment for metastatic colorectal cancer (mCRC). Patients with mCRC receiving FTD/TPI with or without bevacizumab (<i>n</i> = 104) were retrospectively evaluated. Nausea occurred in 40.4% of the patients, and the severity was grade 1 for 23.1%, grade 2 for 15.4%, and grade 3 for 1.9%. Multivariable logistic regression analysis suggested that female sex (adjusted odds ratio 2.74, 95% confidence interval 1.02-7.33, <i>p</i> = 0.045) and concomitant bevacizumab (2.68, 1.13-6.37, <i>p</i> = 0.03) were independent risk factors for all-grade nausea during the first cycle as a primary endpoint. Particularly, among patients with FTD/TPI monotherapy, females significantly exhibited nausea compared to males. Our study revealed that concomitant bevacizumab and female sex are independent risk factors for nausea in FTD/TPI-containing treatment for mCRC.