LAUSR

Abstract Background Ramucirumab is a fully human monoclonal antibody (IgG1) developed for the treatment of solid tumors. To reduce the risk of an infusion-related reaction (IRR) with ramucirumab, H1-antihistamines are recommended as premedication. However, IRR is hardly observed in clinical practice in the ramucirumab regimen. The H1-antihistamines have several side effects, such as drowsiness and dizziness, and the use of H1-antihistamines might be restricted for the patients who need to drive a car or for elderly patients. The aim of this study was to investigate the safety of ramucirumab without H1-antihistamines as a premedication in patients with solid cancer. Methods We retrospectively reviewed the solid tumour patients who received ramucirumab, including regimen without H1-antihistamines at our institution between 2017 and 2019. The patients who received antiemetic steroid for cytotoxic chemotherapy was also included. The primary endpoint was the incidence of IRR during the infusion in the first cycle. The secondary endpoints were the incidence of IRR at any time and other ramucirumab related adverse events. Results Of the 51 patients enrolled (median age, 69.5 years; range 41 - 83), 28 (55%) were male. The origins of cancer were gastric cancer (n = 22), lung cancer (n = 26), and colon cancer (n = 3), respectively. Forty-two patients (82%) received ramucirumab in combination with antiemetic steroid for cytotoxic chemotherapy, and nine patients (18%) received ramucirumab monotherapy without steroid. No IRR was observed in this study (IRR rate, 0%; 95% CI 0 - 0.69). Among the overall 272 infusions, there were no events of IRRs or other ramucirumab related adverse events. Conclusions There was no IRRs without H1-antihistamines in our retrospective study. Ramucirumab without H1-antihistamines as premedication would be a favourable option for the patients who had trouble with the side effects of H1 antihistamine. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.