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Étude de phase IV de pharmacovigilance portant sur la toxicité cardiaque du trastuzumab en néoadjuvant et adjuvant dans le cancer du sein. Analyse conduite par l’Observatoire des Médicaments et des Innovations Thérapeutiques de Bretagne et des Pays de la Loire (OMIT B PL)

Cardiac toxicity of trastuzumab in adjuvant and neoadjuvant breast cancer analysis. Phase IV pharmacovigilance study led by the “Observatoire des Médicaments et Innovations Thérapeutiques” (OMIT B PL)

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Oncologie

Abstract

The “Observatoire des Médicaments et Innovations Thérapeutiques OMIT” directed by ARH Bretagne et Pays de la Loire, has been created in 2002. He’s specialized in oncology, monitoring a few drugs every year and brings together public and private hospitals of both two regions on commun objectives. The prescriptions of trastuzumab (Herceptin®) were the object of an analysis in all the establishments listed by OMIT in 2003/2004. Further to the positive results of the trials HERA, NSABP B31 and NCCTG N9831 presented in plenary session to the Congress of the ASCO (Americal Society of Clinical Oncology) in May 2005, and published since, the medical oncologists and the pharmacists of the scientific steering Committee decided to bring together all the data of the patients treated in these situations to know the therapeutic plans used, the incidence of cardiac dysfunction in practice current and their risk factors.

Résumé

L’Observatoire des médicaments et des innovations thérapeutiques (OMIT) Bretagne et Pays de la Loire a été créé en 2003 par lesAgences régionales de l’hospitalisation (ARH) respectives. Il est spécialisé en cancérologie, assure le suivi qualitatif de médicaments en continu et fédère les établissements publics et privés des deux régions sur des objectifs communs. Les prescriptions de trastuzumab (Herceptin®) ont fait l’objet d’une analyse dans tous les établissements recensés par l’OMIT. Suite aux résultats positifs des essais HERA, NSABP B31 et NCCTG N9831 présentés en séance plénière au Congrès de l’ASCO (American Society of Clinical Oncology) en mai 2005, et publiés depuis, les praticiens du comité de pilotage OMIT ont décidé de colliger toutes les données des patientes traitées dans ces situations afin de connaître les schémas thérapeutiques employés, l’incidence des dysfonctionnements cardiaques en pratique courante ainsi que leurs facteurs de risque.

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Authors and Affiliations

  1. Coordination OMIT B PL, siège médical, CRLCC Paul-Papin, 2, rue Moll, F-49933, Angers, France

    F. Grudé

  2. Service d’oncologie médicale, CRLCC René-Gauducheau, boulevard Jacques-Monod, F-44805, Nantes, France

    M. Campone

  3. Service d’oncologie médicale, centre Catherine-de-Sienne, 2, rue Éric-Tabarly, F-44202, Nantes, France

    A. Lortholary

  4. Service d’oncologie médicale, CRLCC Paul-Papin, 2, rue Moll, F-49933, Angers, France

    R. Delva, P. Soulie & E. Gamelin

  5. Service d’oncologie médicale, CRLCC Eugène-Marquis, rue de la Bataille Flandre-Dunkerque, F-35042, Rennes, France

    P. Kerbrat

  6. Service d’oncologie médicale, centre Jean-Bernard, 9, rue Beauverger, F-72000, Le Mans, France

    G. Ganem & H. Bourgeois

  7. Service d’oncologie médicale, centre hospitalier de Quimper, 14, avenue Yves-Thépot, F-29107, Quimper, France

    S. Van Hulst

  8. Service d’oncologie médicale, Clinique Océane, 11, rue du Docteur-Joseph-Audic, F-56000, Vannes, France

    E. Vuillemin

  9. Service d’oncologie médicale, Clinique Armoricaine de Radiologie, 21, rue du Vieux-Séminaire, F-22000, Saint-Brieuc, France

    A.-C. Hardy-Bessard

  10. Service d’oncologie médicale, centre hospitalier de Lorient, 27, rue Du Docteur-Lettry, F-56100, Lorient, France

    M.-J. Goudier

  11. Service d’oncologie médicale, CHU de Brest, 2, avenue du Maréchal Foch, F-29200, Brest, France

    H. Simon & B. Lucas

  12. Service d’oncologie médicale, centre hospitalier de La Roche-sur-Yon, F-85000, Roche-sur-Yon, France

    F. Priou

  13. Service de pharmacologie, CHU de Brest, avenue du Maréchal Foch, F-29200, Brest, France

    C. Riché

Authors
  1. F. Grudé
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  2. M. Campone
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  3. A. Lortholary
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  4. R. Delva
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  5. P. Soulie
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  6. P. Kerbrat
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  7. G. Ganem
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  8. H. Bourgeois
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  9. S. Van Hulst
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  10. E. Vuillemin
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  11. A.-C. Hardy-Bessard
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  12. M.-J. Goudier
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  13. H. Simon
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  14. B. Lucas
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  15. F. Priou
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  16. C. Riché
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  17. E. Gamelin
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Corresponding author

Correspondence to F. Grudé.

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Grudé, F., Campone, M., Lortholary, A. et al. Étude de phase IV de pharmacovigilance portant sur la toxicité cardiaque du trastuzumab en néoadjuvant et adjuvant dans le cancer du sein. Analyse conduite par l’Observatoire des Médicaments et des Innovations Thérapeutiques de Bretagne et des Pays de la Loire (OMIT B PL). Oncologie 12, 362–368 (2010). https://doi.org/10.1007/s10269-010-1888-5

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  • DOI: https://doi.org/10.1007/s10269-010-1888-5

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