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Clinical Study

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

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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Fig. 1: Distribution of patients.

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Acknowledgements

We thank all the nurses from the Department of Medical Oncology from the Erasmus MC Cancer Institute for contributing to the RANISTOP study. This work was earlier presented as a poster on the ESMO Virtual Congress 2020 (1851p).

Author information

Affiliations

Authors

Contributions

R.W.F.v.L. conceived the study. J.M.C., L.v.D., E.O.-d.H., P.M.L.A.v.d.B., R.H.J.M. and R.W.F.v.L. contributed to study design. J.M.C., L.v.D. and E.O.-d.H. had a role in data analysis. J.M.C. and L.v.D. wrote the first draft of the manuscript and contributed to data collection. All authors had a role in the interpretation of the results and critically reviewed the manuscript. J.M.C., L.v.D. and E.O.-d.H. contributed to data preparation and analysis. All authors agreed with the decision to submit for publication.

Corresponding author

Correspondence to Roelof W. F. van Leeuwen.

Ethics declarations

Ethics approval and consent to participate

This study was approved by the medical ethical board of the Erasmus MC, reference number MEC-2018-1499. All included patients gave informed consent. This study was performed in accordance with the Declaration of Helsinki.

Data availability

All data supporting the findings of this study are available within the article and its information files and from the corresponding author upon reasonable request.

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.

Funding information

This study was funded by the Foundation Mitialto in the Netherlands. Foundation Mitialto had no role in any aspect of this study.

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Cox, J.M., van Doorn, L., Malmberg, R. et al. The added value of H2 antagonists in premedication regimens during paclitaxel treatment. Br J Cancer 124, 1647–1652 (2021). https://doi.org/10.1038/s41416-021-01313-0

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