Abstract 1851P
Background
Ranitidine, a histamine 2-blocker, is standard of care premedication to prevent hypersensitivity reactions (HSRs) caused by paclitaxel infusion. However, the added value of ranitidine in this premedication regimen is controversial. Therefore, we compared the incidence of clinically relevant HSRs during paclitaxel treatment of a standard premedication regimen including ranitidine with a premedication regimen without ranitidine.
Methods
This prospective, pre-post interventional, non-inferiority study was conducted between October 2018 and December 2019 at the Erasmus MC Cancer Institute, Rotterdam, the Netherlands. The standard premedication regimen (N = 183) with dexamethasone, clemastine and ranitidine was compared with a premedication regimen without ranitidine (N = 183). The primary outcome was the incidence of HSR grade ≥3. Non-inferiority was determined by checking whether the upper bound of the two-sided 90% confidence interval (CI) for the difference in HSR rates excluded the +6% non-inferiority margin.
Results
In both the pre-intervention and post-intervention period 183 patients were included. The incidence of HSR grade ≥3 was 4.4% (N = 8) in the pre-intervention group and 1.6% (N = 3) in the post-intervention group: difference -2.7% (90% CI: -6.2% - 0.1%).
Conclusions
A premedication regimen without ranitidine is non-inferior to a premedication regimen with ranitidine. This study provides evidence that ranitidine has no added value in preventing paclitaxel-induced HSRs and can safely and permanently be removed from all paclitaxel premedication regimens. Only in the Netherlands, the annual costs savings are estimated to be already over $1,000,000 when ranitidine is omitted from the paclitaxel premedication regimens.
Clinical trial identification
Trial NL8173.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Mitialto.
Disclosure
R.H. Mathijssen: Speaker Bureau/Expert testimony, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Servier; Research grant/Funding (institution), Patent pending: Pamgene; Pfizer; Roche; Bayer; Astellas; Boehringer-Ingelheim; Cristal Therapeutics. R.W.F. van Leeuwen: Honoraria (institution): Roche; Boehringer; Bayer; Honoraria (institution), Advisory/Consultancy: Astallas; Sanofi. All other authors have declared no conflicts of interest.