The added value of H2 antagonists in premedication regimens during paclitaxel treatment

Juul M. Cox, Leni van Doorn, Ruben Malmberg, Esther Oomen-de Hoop, Tessa M. Bosch, Patricia M.L.A. van den Bemt, Ingrid A. Boere, Agnes Jager, Ron H.J. Mathijssen, Roelof W.F. van Leeuwen*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

6 Citations (Scopus)
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Abstract

Background: Ranitidine, a histamine 2 blocker, is the standard of care 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 HSRs during paclitaxel treatment between a standard regimen including ranitidine and a regimen without ranitidine. Methods: This prospective, pre–post interventional, non-inferiority study compared the standard premedication regimen (N = 183) with dexamethasone, clemastine and ranitidine 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 (with ranitidine) and post-intervention (without ranitidine) group 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 to 0.1). Conclusions: As the upper boundary of the 90% CI does not exceed the predefined non-inferiority margin of +6%, it can be concluded that a premedication regimen without ranitidine is non-inferior to a premedication regimen with ranitidine. Clinical Trial Registration: www.trialregister.nl; NL8173.

Original languageEnglish
Pages (from-to)1647-1652
Number of pages6
JournalBritish Journal of Cancer
Volume124
Issue number10
Early online date24 Mar 2021
DOIs
Publication statusPublished - 11 May 2021

Bibliographical note

Funding Information:
Competing interests R.H.J.M. reports research grants from Astellas, Bayer, Boehringer-Ingelheim, Cristal Therapeutics, Pfizer, Prostakan, Roche and Pamgene. Personal fees from Novartis and Servier; all outside the submitted work. R.W.F.v.L. reports research grants from Astellas, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Servier and Roche. Personal fees from Roche, Pfizer and Sanofi; all outside the submitted work. All other authors declare no potential competing interests.

Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Cancer Research UK.

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