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 Pay

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• 作者：F. Grudé (1)
  M. Campone (2)
  A. Lortholary (3)
  R. Delva (4)
  P. Soulie (4)
  P. Kerbrat (5)
  G. Ganem (6)
  H. Bourgeois (6)
  S. Van Hulst (7)
  E. Vuillemin (8)
  A.-C. Hardy-Bessard (9)
  M.-J. Goudier (10)
  H. Simon (11)
  B. Lucas (11)
  F. Priou (12)
  C. Riché (13)
  E. Gamelin (4)
  
• 关键词：Trastuzumab ; Cancer ; Cardiac toxicity ; Trastuzumab ; Cancer ; Toxicité cardiaque
• 刊名：Oncologie
• 出版年：2010
• 出版时间：June 2010
• 年：2010
• 卷：12
• 期：5-6
• 页码：362-368
• 全文大小：405KB
• 参考文献：1. Cobleigh MA, Vogel CL, Tripathy D et al. (1999) Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 17(9): 2639-8
  2. Cook-Bruns N (2001) Retrospective analysis of the safety of Herceptin immunotherapy in metastatic breast cancer. Oncology 61(Suppl 2): 58-6 class="external" href="http://dx.doi.org/10.1159/000055403">CrossRef
  3. Guarneri V, Lenihan DJ, Valero V, et al. (2006) Long-term cardiac tolerability of trastuzumab in metastatic breast cancer: the M.D. Anderson Cancer Center experience. J Clin Oncol 24(25): 1- class="external" href="http://dx.doi.org/10.1200/JCO.2005.04.9551">CrossRef
  4. Joensuu H, Kellokumpu-Lehtinen P, Bono P, et al. (2006) Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 354(8): 809-0 class="external" href="http://dx.doi.org/10.1056/NEJMoa053028">CrossRef
  5. Marty M, Baselga J, Gatzemeier U, et al. (2003) Pooled analysis of six trials of trastuzumab (Herceptin): exploratory analysis of changes in left ventricular ejection fraction (LVEF) as a surrogate for clinical cardiac events [abstract 218]. Breast Cancer Res Treat 82: S48
  6. Marty M, Cognetti F, Maraninchi D, et al. (2005) Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol 23(19): 4265-4 class="external" href="http://dx.doi.org/10.1200/JCO.2005.04.173">CrossRef
  7. Perez EA, Koehler M, Byrne J, et al. (2008) Cardiac safety of lapatinib: pooled analysis of 3689 patients enrolled in clinical trials. Mayo Clin Proc 83(6): 679-6 class="external" href="http://dx.doi.org/10.4065/83.6.679">CrossRef
  8. Perez EA, Suman VJ, Davidson NE, et al. (2008) Cardiac safety analysis of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in the North Central Cancer Treatment Group N9831 adjuvant breast cancer trial. J Clin Oncol 26(8): 1231- class="external" href="http://dx.doi.org/10.1200/JCO.2007.13.5467">CrossRef
  9. Piccart-Gehhart MJ, Procter M, Leyland-Jones B, et al. (2005) Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 353(16): 1659-2 class="external" href="http://dx.doi.org/10.1056/NEJMoa052306">CrossRef
  10. Rastogi P (2007) Five year update of cardiac dysfunction on NSABP B-31, a randomized trial of sequential doxorubicin/cyclophosphamide (AC)→paclitaxel (T) vs. AC→T with trastuzumab(H). Proc Annu Meet Am Soc Clin Oncol LBA513. Oral presentation
  11. Roché H, Fumoleau P, Spielmann M, e al. (2004) Essai PACS 01 6 cycles of FEC100 vs 3 cycles of FEC 100 followed by 3 cycles of docetaxel for the adjuvant treatment of node positive breast cancer: analysis at 5 years of the PACS 01 trial. 27th Annual San Antonio Breast Cancer Symposium (27)
  12. Romond E, Perez E, Bryant J, et al. (2005) Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 353(16): 1673-4 class="external" href="http://dx.doi.org/10.1056/NEJMoa052122">CrossRef
  13. Seidman A, Hudis C, Pierri MK, et al. (2002) Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 20(5): 1215-1 class="external" href="http://dx.doi.org/10.1200/JCO.20.5.1215">CrossRef
  14. Shepard HM, Lewis GD, Sarup JC, et al. (1991) Monoclonal antibody therapy of human cancer: taking the HER-2 protooncogene to the clinic. J Clin Immunol 11: 117-7 class="external" href="http://dx.doi.org/10.1007/BF00918679">CrossRef
  15. Slamon D, Eiermann W, Robert N, et al. (2006) BCIRG 006: 2nd interim analysis phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC→T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC→TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2neu positive early breast cancer patients. Proc SABCS Abs 52
  16. Slamon DJ, Leyland-Jones B, Shak S, et al. (2001) Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344(11): 783-2 class="external" href="http://dx.doi.org/10.1056/NEJM200103153441101">CrossRef
  17. Suter TM, Procter M, Van Veldhuisen D, et al (2007) Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. J Clin Oncol 25(25): 3859-5. Epub 2007 class="external" href="http://dx.doi.org/10.1200/JCO.2006.09.1611">CrossRef
  18. Tsoutsou PG, Koukourakis MI, Azria D, Belkacémi Y (2009) Optimal timing for adjuvant radiation therapy in breast cancer: a comprehensive review and perspectives. Crit Rev Oncol Hematol 71(2): 102-6 class="external" href="http://dx.doi.org/10.1016/j.critrevonc.2008.09.002">CrossRef
  
• 作者单位：F. Grudé (1)
  M. Campone (2)
  A. Lortholary (3)
  R. Delva (4)
  P. Soulie (4)
  P. Kerbrat (5)
  G. Ganem (6)
  H. Bourgeois (6)
  S. Van Hulst (7)
  E. Vuillemin (8)
  A.-C. Hardy-Bessard (9)
  M.-J. Goudier (10)
  H. Simon (11)
  B. Lucas (11)
  F. Priou (12)
  C. Riché (13)
  E. Gamelin (4)
  
  1. Coordination OMIT B PL, siège médical, CRLCC Paul-Papin, 2, rue Moll, F-49933, Angers, France
  2. Service d’oncologie médicale, CRLCC René-Gauducheau, boulevard Jacques-Monod, F-44805, Nantes, France
  3. Service d’oncologie médicale, centre Catherine-de-Sienne, 2, rue éric-Tabarly, F-44202, Nantes, France
  4. Service d’oncologie médicale, CRLCC Paul-Papin, 2, rue Moll, F-49933, Angers, France
  5. Service d’oncologie médicale, CRLCC Eugène-Marquis, rue de la Bataille Flandre-Dunkerque, F-35042, Rennes, France
  6. Service d’oncologie médicale, centre Jean-Bernard, 9, rue Beauverger, F-72000, Le Mans, France
  7. Service d’oncologie médicale, centre hospitalier de Quimper, 14, avenue Yves-Thépot, F-29107, Quimper, France
  8. Service d’oncologie médicale, Clinique Océane, 11, rue du Docteur-Joseph-Audic, F-56000, Vannes, France
  9. Service d’oncologie médicale, Clinique Armoricaine de Radiologie, 21, rue du Vieux-Séminaire, F-22000, Saint-Brieuc, France
  10. Service d’oncologie médicale, centre hospitalier de Lorient, 27, rue Du Docteur-Lettry, F-56100, Lorient, France
  11. Service d’oncologie médicale, CHU de Brest, 2, avenue du Maréchal Foch, F-29200, Brest, France
  12. Service d’oncologie médicale, centre hospitalier de La Roche-sur-Yon, F-85000, Roche-sur-Yon, France
  13. Service de pharmacologie, CHU de Brest, avenue du Maréchal Foch, F-29200, Brest, France
  

文摘

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.