Safety of Ramucirumab Regimen Without H1-antihistamine Premedication in Patients With Solid Cancers

Abstract

Background/Aim: To prevent infusion-related reactions (IRRs), H1-antihistamines (H 1 AT) are recommended as a premedication for monoclonal antibodies, such as Ramucirumab (RAM), even though there are H 1 AT-related side effects, such as drowsiness and dizziness. Here, we investigated the safety of H 1 AT-free RAM regimens in patients with solid cancer. Patients and Methods: We retrospectively reviewed the patients with solid cancer receiving RAM without H 1 AT at Osaka Medical College Hospital between 2015 and 2019. Results: Among the 123 registered patients, 58 were identified as eligible. The total number of RAM infusions was 291, and the median number of RAM administration was 4 cycles (range=1-23 cycles). IRRs were not observed in any patient. Conclusion: Although our data are preliminary and limited, H 1 AT-free RAM regimens may be a treatment option for cancer patients having a significant risk of developing H 1 AT-related side effects. Further studies are needed to confirm the safety of H 1 AT-free RAM regimens.Monoclonal antibodies (mAbs) have been widely used for the treatment of various malignancies (1-3). As most mAbs show lower toxicity than conventional anticancer agents, they are generally better tolerated (2-4). However, like other infused 3489 This article is freely accessible online.

Preventive effect of dexamethasone premedication on the development of infusion‐related reaction in breast cancer patients receiving trastuzumab

“…Most IRRs occurred during the first dose (53 of 58 patients, 91.4%). The incidence of IRRs was higher with the first course and the first dose of 8 mg/kg, which is consistent with previous reports 3 . Previous studies have reported a relatively high incidence of IRRs caused by trastuzumab, from 3.4% 24 to 5.9% 25 to up to 40% 2 .…”

“…In general, monoclonal antibodies are less toxic and better tolerated than conventional cytotoxic chemotherapeutic agents. However, as with other injected anticancer agents, monoclonal antibodies can cause infusion‐related reactions (IRRs) 1–3 . Most IRRs are mild and include chills, fever, nausea, skin rash and pruritus.…”

Preventive effects of dexamethasone premedication on the development of infusion-related reactions in breast cancer patients receiving trastuzumab

“…The incidence of IRRs was higher with the first course and the first dose of 8 mg/kg, which is consistent with previous reports. 3 Previous studies have reported a relatively high incidence of IRRs with trastuzumab (40%, 2 3.4%, 24 or 5.9%). 25 Although the incidence of IRR in our study was on the low side, the wide range in IRR incidence between different reports seems to result from differences in comorbidities or premedication use.…”

“…However, as with other injected anticancer agents, monoclonal antibodies can cause infusion-related reactions (IRRs). [1][2][3] Most IRRs are mild and include chills, fever, nausea, skin rash, and pruritus. Severe side effects are less frequent but can include low blood pressure, tracheal spasm, and angioedema and can be fatal without proper care.…”

“…32 Larger tumor loads are known to promote more severe cytokine release. 33,34 Although IRRs occur almost exclusively with the first infusion, [1][2][3][35][36][37] IgE-mediated hypersensitivity requires prior sensitization and is not expected to occur with the first infusion of monoclonal antibodies. Cytokine-dependent mechanisms in IRRs have been proposed, 2 since cytokines can cause a variety of symptoms characteristic of IRRs and cytokine-dependent mechanisms are independent of prior sensitization.…”