Incidence and risk factors for nausea during oral lenvatinib treatment: a single-institution nested case-control study
Year: 2026
Type: preprint
Abstract: Background Lenvatinib is an oral anticancer agent with moderate-to-high emetogenic risk and causes nausea; however, evidence for the associated symptoms and risk factors is limited. This study aimed to investigate the nausea onset characteristics in lenvatinib-treated patients and identify the risk factors for nausea. Methods A single-institution, nested case-control study was conducted in 161 lenvatinib-treated patients at Mie University Hospital between March 10, 2014, and March 31, 2024. The primary outcome was nausea development during lenvatinib administration; it was graded per the Common Terminology Criteria for Adverse Events, version 5.0. To evaluate the association between concomitant opioid analgesic use and the occurrence of nausea, 1:1 propensity score matching was performed, and the proportions of patients receiving concomitant opioid analgesics were compared between the case and control groups. Multivariable logistic regression analysis was performed as a sensitivity analysis in the propensity score-matched cohort. Results Prophylactic antiemetics were prescribed to 13 subjects (8.07%); 12 received dopamine D 2 antagonists and one received dexamethasone. Nausea was observed in 41 (25.5%) patients, and its severity was classified as grade 2 in 31 and as grade 3 in 10. The median time to onset was 32 days. In the case group, significant differences were observed in sex ( p = 0.0109), height ( p = 0.00230), body weight ( p = 0.0104), body surface area ( p = 0.00330), and concomitant opioid analgesic use ( p = 0.0304) before propensity score matching. Even after 1:1 propensity score matching, the rate of concomitant opioid analgesic use in the case group was significantly higher (case group: 8/38, 21.1% vs control group: 2/38, 5.26%; p = 0.0417). Multivariate logistic regression analysis identified concomitant opioid analgesic use as an independent risk factor for nausea (adjusted odds ratio = 4.56, p = 0.0461). Conclusions Emetogenic risk appears to be higher in patients receiving concomitant opioid analgesics, thereby highlighting the importance of close monitoring. These findings suggest that the intensification of antiemetic therapy may be warranted in high-risk patients receiving opioid analgesics. However, further investigations are needed to confirm these findings and validate this treatment strategy.
Source: Research Square
Institution: Mie University Hospital
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7225770454