Skip to main content

Advertisement

SpringerLink
Log in

Impact of histamine-2 antagonist shortage on the incidence of hypersensitivity reactions to paclitaxel: a reconsideration of premedication protocols in France (PACLIREACT Study)

  • Research
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

An international shortage of ranitidine led to adjustments in premedication regimens for paclitaxel-based chemotherapy in early October 2019. In this study, we implemented and evaluated an anti-allergic protocol without histamine-2 antagonists (H2As) and aimed to assess the risk of hypersensitivity reactions (HSRs) to the different premedication regimens used.

Methods

We conducted a single-center observational retrospective study of paclitaxel administrations (7173 administrations in 831 patients). Between January 2019 and December 2020, all allergies reported were recorded. A mixed logistic regression model was implemented to predict the risk of allergy at each injection and to account for repeated administration per patient.

Results

A total of 27 HSRs occurred in 24 patients. No protective effect was observed for H2A when comparing paclitaxel injections with H2A premedication versus without H2A (OR = 1.12, p = 0.84). There was also no significant difference in risk of HSR for famotidine versus ranitidine (OR = 0.79, p = 0.78). However, the risk of HSRs was significantly lower for paclitaxel injections with corticosteroids than for those without (OR = 0.08, p = 0.03). In addition, the risk of HSR was significantly higher for the first, second, or third paclitaxel injections than for the subsequent injections (OR = 10.1, p < 0.001).

Conclusion

We did not find substantial evidence of an increased risk of HSR due to the absence of H2A in the premedication protocols for paclitaxel. Thus, in contrary to the existing literature on paclitaxel, our findings support the use of a premedication protocol without H2A.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

Data availability

The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.

References

  1. Picard M (2017) Management of hypersensitivity reactions to taxanes. Immunol Allergy Clin North Am 37:679–693. https://doi.org/10.1016/j.iac.2017.07.004

    Article  PubMed  Google Scholar 

  2. Pellegrino B, Boggiani D, Tommasi C, Palli D, Musolino A (2017) Nab-paclitaxel after docetaxel hypersensitivity reaction: case report and literature review. Acta Biomed 88:329–333. https://doi.org/10.23750/abm.v88i3.6138

  3. Kundranda MN, Niu J (2015) Albumin-bound paclitaxel in solid tumors: clinical development and future directions. Drug Des Devel Ther 9:3767–3777. https://doi.org/10.2147/DDDT.S88023

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. de Lemos ML, Waignein S, de Haan M (2016) Evidence-based practice in times of drug shortage. J Oncol Pharm Pract 22:566–570. https://doi.org/10.1177/1078155215589980

    Article  PubMed  Google Scholar 

  5. de Santi F, Beltrame FL, Hinton BT, Cerri PS, Sasso-Cerri E (2018) Reduced levels of stromal sex hormone-binding globulin and androgen receptor dysfunction in the sperm storage region of the rat epididymis. Reproduction 155:467–479. https://doi.org/10.1530/REP-18-0014

    Article  PubMed  Google Scholar 

  6. Banerji A, Lax T, Guyer A et al (2014) Management of hypersensitivity reactions to carboplatin and paclitaxel in an outpatient oncology infusion center: a 5-year review. J Allergy Clin Immunol Pract 2:428–433. https://doi.org/10.1016/j.jaip.2014.04.010

    Article  PubMed  Google Scholar 

  7. Rezáč A, Jílek P, Rezáčová V, Škapinec P, Sedláková I, Tošner J, Špaček J (2013) Hypersensitivity reactions to carboplatin and paclitaxel – our five-years experiences. Ceska Gynekol 78:514–521

    PubMed  Google Scholar 

  8. Pan EY, Merl MY, Lin K (2020) The impact of corticosteroid use during anti-PD1 treatment. J Oncol Pharm Pract 26:814–822. https://doi.org/10.1177/1078155219872786

    Article  CAS  PubMed  Google Scholar 

  9. Goromaru T, Morita N, Hase Y, Ochi Y, Shinohara Y, Takahashi K, Eto S (2011) Comparison of hypersensitivity to branded and generic paclitaxel injections in rats. Gan To Kagaku Ryoho 38:615–619

    PubMed  Google Scholar 

  10. ANSM (2019) Rappel des médicaments à base de ranitidine en comprimé (Azantac et génériques): informations pour les patients et les professionnels de santé. https://ansm.sante.fr/actualites/rappel-des-medicaments-a-base-de-ranitidine-en-comprime-azantac-et-generiques-informations-pour-les-patients-et-les-professionnels-de-sante. Accessed 3 Dec 2022

  11. ANSM (2018) Rappel de certains médicaments à base de valsartan: l’ANSM met à disposition des patients un numéro vert et un document d’information. https://ansm.sante.fr/actualites/rappel-de-certains-medicaments-a-base-de-valsartan-lansm-met-a-disposition-des-patients-un-numero-vert-et-un-document-dinformation. Accessed 3 Dec 2022

  12. (2021) Risk of the presence of mutagenic azido impurities in losartan active substance. https://www.edqm.eu/en/news/risk-presence-mutagenic-azido-impurities-losartan-active-substance. Accessed 5 Dec 2021. Council of Europe, EDQM – European Directorate for the Quality of Medicines.

  13. ANSM (2019) L’ANSM publie son rapport d’activité 2018. https://ansm.sante.fr/actualites/lansm-publie-son-rapport-dactivite-2018. Accessed 3 Dec 2022

  14. LEEM (2019) Ruptures des stocks des médicaments: les 10 classes thérapeutiques les plus touchées. https://www.leem.org/media/ruptures-des-stocks-des-medicaments-les-10-classes-therapeutiques-les-plus-touchees. Accessed 3 Dec 2022

  15. Decool JP (2018) Pénuries de médicaments et de vaccins: renforcer l’éthique de santé publique dans la chaîne du médicament. http://www.senat.fr/rap/r17-737/r17-737.html

  16. French League against cancer (2020) Shortages of medicines: increased risks for patients everywhere: focus on cancer. https://www.ligue-cancer.net/sites/default/files/docs/infographies_essentielles_en_anglais-.pdf

  17. Auffret M, Tyvaert L, Laroche ML, Godet B, Peyron R, Guy C, Géniaux H, Pécriaux C, Baldin B, Béné J, Gautier S (2015) Drug shortage may have serious outcome: the French exemple of phenytoine. Ther Recreat J 70:377–380. https://doi.org/10.2515/therapie/2015018

    Article  Google Scholar 

  18. Fox ER, Sweet BV, Jensen V (2014) Drug shortages: a complex health care crisis. Mayo Clin Proc 89:361–373. https://doi.org/10.1016/j.mayocp.2013.11.014

    Article  PubMed  Google Scholar 

  19. Official national Legifrance database (2016). LOI n° 2016–41 du 26 janvier 2016 de modernisation de notre système de santé - Article 151. https://www.legifrance.gouv.fr/loda/id/JORFTEXT000031912641/. Accessed 7 Feb 2022

  20. Académie Nationale de Pharmacie (2018) Indisponibilité des médicaments. https://www.acadpharm.org/dos_public/2018_06_20_AnP_RAPPORT_INDISPONIBILITE_MED_VF1.pdf

  21. Bourneau-Martin D, Babin M, Grandvuillemin A, Mullet C, Salvo F, Singier A, Cellier M, Fresse A, de Canecaude C, Pietri T, Drablier G, Geniaux H, Lagarce L, Laroche ML, Briet M, Network F, of Regional Pharmacovigilance Centres, (2022) Adverse drug reaction related to drug shortage: A retrospective study on the French National pharmacovigilance Database. Br J Clin Pharmacol:n/a. https://doi.org/10.1111/bcp.15550

    Article  Google Scholar 

  22. de Leon MCB, Bolla S, Greene B, Hutchinson L, Del Priore G (2013) Successful treatment with nab-paclitaxel after hypersensitivity reaction to paclitaxel and docetaxel. Gynecol Oncol Case Rep 5:70–71. https://doi.org/10.1016/j.gynor.2013.05.003

    Article  PubMed  PubMed Central  Google Scholar 

  23. Picard M, Pur L, Caiado J, Giavina-Bianchi P, Galvão VR, Berlin ST, Campos SM, Matulonis UA, Castells MC (2016) Risk stratification and skin testing to guide re-exposure in taxane-induced hypersensitivity reactions. J Allergy Clin Immunol 137:1154-1164.e12. https://doi.org/10.1016/j.jaci.2015.10.039

    Article  CAS  PubMed  Google Scholar 

  24. Slimano F, Coliat P, Perotin JM, Vella-Boucaud J, Mongaret C, Bouché O (2016) Is antihistaminergic H2 really useful in prevention of hypersensitivity induced by paclitaxel? Support Care Cancer 24:4475–4477. https://doi.org/10.1007/s00520-016-3366-0

    Article  PubMed  Google Scholar 

  25. Berger MJ, Vargo C, Vincent M, Shaver K, Phillips G, Layman R, Macrae E, Mrozek E, Ramaswamy B, Wesolowski R, Shapiro CL, Lustberg MB (2015) Stopping paclitaxel premedication after two doses in patients not experiencing a previous infusion hypersensitivity reaction. Support Care Cancer 23:2019–2024. https://doi.org/10.1007/s00520-014-2556-x

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

We would like to thank the French cancer centers that participated in the benchmarking and all the teams in our institution that worked to resolve the shortage in the interest of the patient.

Author information

Authors and Affiliations

  1. Pole produits de santé, Service de pharmacie, Centre Oscar Lambret, 3, rue Frédéric Combemale, 59020, Cedex BP307, Lille, France

    Geoffrey Strobbe, Marie Abelé, Alexandre Villain, Frédéric Feutry, Ilyes Sakji & Guillaume Marliot

  2. Centre Régional de Pharmacovigilance, Service de pharmacologie, CHU, Lille, France

    Louise Gaboriau

  3. Pole d’oncologie médicale, Centre Oscar Lambret, Lille, France

    Capucine Aelbrecht-Meurisse & Aurélien Carnot

  4. Unité de Biostatistiques, Centre Oscar Lambret, Lille, France

    Marie-Cécile Le Deley & Clémence Léguillette

Authors
  1. Geoffrey Strobbe
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Louise Gaboriau
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Marie Abelé
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Alexandre Villain
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Capucine Aelbrecht-Meurisse
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Aurélien Carnot
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Marie-Cécile Le Deley
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Clémence Léguillette
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Frédéric Feutry
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Ilyes Sakji
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Guillaume Marliot
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

All authors contributed to the conception and design of the study. Material preparation, data collection, and analysis were performed by Geoffrey Strobbe, Clémence Léguillette, Alexandre Villain, Ilyes Sakji, Marie Abelé, and Marie Cécile Le Deley. The first draft of the manuscript was written by Geoffrey Strobbe and Louise Gaboriau, and all the authors commented on the previous versions of the manuscript. All the authors have read and approved the final manuscript.

Corresponding author

Correspondence to Geoffrey Strobbe.

Ethics declarations

Ethical approval

This is an observational study. The Institutional Review Board of the Oscar Lambret Center has confirmed that no ethical approval is required (number CEC-2021–005). The study complies with the “reference methodology” MR004 adopted by the French Data Protection Authority (CNIL). Inform consent was waived and we checked that patients did not object to the use of their clinical data for the research purpose.

Consent to participate

Consent for participation was obtained in compliance with the French Regulation for retrospective studies.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Strobbe, G., Gaboriau, L., Abelé, M. et al. Impact of histamine-2 antagonist shortage on the incidence of hypersensitivity reactions to paclitaxel: a reconsideration of premedication protocols in France (PACLIREACT Study). Eur J Clin Pharmacol 79, 1229–1238 (2023). https://doi.org/10.1007/s00228-023-03536-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00228-023-03536-x

Keywords

Search

Navigation