European Journal of Cancer
Volume 41, Issue 11 , Pages 1528-1532 , July 2005

Assessment of the value of confirming responses in clinical trials in oncology

  • Jose Luis Perez-Gracia

      Affiliations

    • Medical Oncology Department, Clínica Universitaria de Navarra, Avenida de Pío XII 36, 31008 Pamplona, Spain
    • Corresponding Author InformationCorresponding author. Tel.: +34 658 92 02 12; fax: +34 948 255 500.
    • ,
  • Maria Muñoz

      Affiliations

    • Clinical Research Department, Eli Lilly and Company, Madrid, Spain
    • ,
  • Grant Williams

      Affiliations

    • US Food and Drug Administration, USA
    • ,
  • Jun Wu

      Affiliations

    • Clinical Research Department, Eli Lilly and Company Indianapolis, USA
    • ,
  • Eva Carrasco

      Affiliations

    • Clinical Research Department, Eli Lilly and Company, Madrid, Spain
    • ,
  • Ignacio Garcia-Ribas

      Affiliations

    • Clinical Research Department, Eli Lilly and Company, Madrid, Spain
    • ,
  • Ana Peiro

      Affiliations

    • Clinical Research Department, Eli Lilly and Company, Madrid, Spain
    • ,
  • Jose Maria Lopez-Picazo

      Affiliations

    • Medical Oncology Department, Clínica Universitaria de Navarra, Avenida de Pío XII 36, 31008 Pamplona, Spain
    • ,
  • Alfonso Gurpide

      Affiliations

    • Medical Oncology Department, Clínica Universitaria de Navarra, Avenida de Pío XII 36, 31008 Pamplona, Spain
    • ,
  • Ana Chopitea

      Affiliations

    • Medical Oncology Department, Clínica Universitaria de Navarra, Avenida de Pío XII 36, 31008 Pamplona, Spain
    • ,
  • Salvador Martín-Algarra

      Affiliations

    • Medical Oncology Department, Clínica Universitaria de Navarra, Avenida de Pío XII 36, 31008 Pamplona, Spain
    • ,
  • Jesus García-Foncillas

      Affiliations

    • Medical Oncology Department, Clínica Universitaria de Navarra, Avenida de Pío XII 36, 31008 Pamplona, Spain
    • ,
  • Johannes Blatter

      Affiliations

    • Clinical Research Department, Eli Lilly and Company, Frankfort, Germany

Received 6 December 2004 ,Revised 20 January 2005 ,Accepted 27 January 2005.

References 

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  2. Hayward JL, Rubens RD, Carbone PP, et al. Assessment of response to therapy in advanced breast cancer. A project of the programme on clinical oncology of the International Union against Cancer, Geneva, Switzerland. Eur J Cancer. 1978;14:1291–1292
  3. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer. 1981;47:207–214
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  5. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205–216
  6. Leemis LM, Trivedi KS. A comparison of approximate interval estimators for the Bernoulli parameter. The American Statistician. 1996;50:63–68
  7. Cohen J. A coefficient of agreement for nominal scales. Educational and Psychological Measurement. 1960;20:37–46
  8. Landis J, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159–174
  9. RECIST Working Party. How to combine the results of two subsequent evaluations to define the best overall response. June 2000. Available from URL: http://www.eortc.bc/.
  10. Thiesse P, Ollivier L, Di Stefano-Louineau D, et al. Response rate accuracy in oncology trials: reasons for interobserver variability, Groupe Francais d’Immunotherapie of the Federation Nationale des Centres de Lutte Contre le Cancer. J Clin Oncol. 1997;15:3507–3514
  11. Biganzoli L, Lohrisch C, Paridacns R, et al. Analysis of two EORTC trials in metastatic breast cancer support the recommendation for external response review in trials with response rate as primary endpoint. Eur J Cancer. 2000;36(suppl 5):S90;(abstract 227)
  12. Gwyther SJ, Aapro MS, Hatty SR, et al. Results of an independent oncology review board of pivotal clinical trials of gemcitabine in non-small cell lung cancer. Anticancer Drugs. 1999;10:693–698

PII: S0959-8049(05)00210-8

doi: 10.1016/j.ejca.2005.01.023

European Journal of Cancer
Volume 41, Issue 11 , Pages 1528-1532 , July 2005

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