Br J Cancer. 2021 May;124(10):1647-1652. doi: 10.1038/s41416-021-01313-0. Epub 2021 Mar 24.

The added value of H.

British journal of cancer

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

PMID: 33762718 PMCID: PMC8110571 DOI: 10.1038/s41416-021-01313-0

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.

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Publication Types

• Journal Article
• Research Support, Non-U.S. Gov't