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Critères d’efficacité des traitements de première ligne métastatique du cancer du sein

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Cancer du sein en situation métastatique
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Résumé

Le critère d’efficacité dans un essai clinique permet de mettre en évidence l’effet du traitement évalué en comparant les deux groupes de l’essai thérapeutique (le groupe traité et le groupe contrôle), par exemple la réponse tumorale ou le temps jusqu’à la progression tumorale. L’effet du traitement testé sera mis en évidence en comparant les groupes randomisés au moyen d’un test statistique (test du χ2 pour la réponse tumorale ou test du logrank pour le temps jusqu’à la progression tumorale). Si l’essai montre une différence entre les groupes, on s’intéressera à savoir, d’une part, si cet effet est statistiquement significatif (p < 0,5) et, d’autre part, s’il est cliniquement pertinent.

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Références

  1. Burzykowski T, Molenberghs G, Buyse M (2005) The Evaluation of Surrogate Endpoints. Springer, New York

    Book  Google Scholar 

  2. Buyse M, Burzykowski T, Carroll K et al. (2007) Progression-free survival is a surrogate for survival in advanced colorectal cancer. J Clin Oncol 25: 5218–5224

    Article  PubMed  CAS  Google Scholar 

  3. Sargent D, Wieand S, Haller DG et al. (2005) Disease-free Survival (DFS) vs. Overall Survival (OS) as a Primary Endpoint for Adjuvant Colon Cancer Studies: Individual patient data from 20,898 patients on 18 Randomized Trials. J Clin Oncol 23: 8664–8670

    Article  PubMed  Google Scholar 

  4. Burzykowski T, Buyse M, Piccart-Gebhart MJ et al. (2008) Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate endpoints in metastatic breast cancer. J Clin Oncol 26: 1987–1992

    Article  PubMed  CAS  Google Scholar 

  5. Michiels S, Le Maître A, Buyse M et al. (2009) Surrogate endpoints for overall survival in locally advanced head and neck cancer: meta-analyses of individual patient data. Lancet Oncol 10: 341–350

    Article  PubMed  Google Scholar 

  6. Broglio KR, Berry DA (2009) Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 101: 1642–1649

    Article  PubMed  Google Scholar 

  7. Saad ED, Katz A, Buyse M (2010) Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials. J Clin Oncol 28: 1958–1962

    Article  PubMed  Google Scholar 

  8. Fleming TR, Rothmann MD, Lu HL (2009) Issues in using progression-free survival when evaluating oncology products. J Clin Oncol 27: 2874–2880

    Article  PubMed  Google Scholar 

  9. Schilsky RL (2002) Endpoints in cancer clinical trials and the drug approval process. Clin Cancer Res 8: 935–938

    PubMed  Google Scholar 

  10. DiLeo A, Bleiberg H, Buyse M (2003) Overall survival is not a realistic endpoint for clinical trials in advanced solid tumors: a critical assessment based on recently reported phase III trials in colorectal and breast cancer. J Clin Oncol 21: 2045–2047

    Article  Google Scholar 

  11. Sargent DJ, Hayes DF (2008) Assessing the measure of a new drug: is survival the only thing that matters? J Clin Oncol 26: 1922–1923

    Article  PubMed  Google Scholar 

  12. Therasse P, Arbuck SG, Eisenhauer EA et al. (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92: 205–216

    Article  PubMed  CAS  Google Scholar 

  13. Eisenhauer EA, Therasse P, Bogaerts J et al. (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) Eur J Cancer 45: 228–247

    Article  PubMed  CAS  Google Scholar 

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Buyse, M., Cucherat, M. (2010). Critères d’efficacité des traitements de première ligne métastatique du cancer du sein. In: Cancer du sein en situation métastatique. Springer, Paris. https://doi.org/10.1007/978-2-8178-0076-9_35

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  • DOI: https://doi.org/10.1007/978-2-8178-0076-9_35

  • Publisher Name: Springer, Paris

  • Print ISBN: 978-2-8178-0075-2

  • Online ISBN: 978-2-8178-0076-9

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