Adjuvant therapy of breast cancer: compliance and data validity in a multicenter trial |
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| Authors: | S Ryden T M?ller L Hafstr?m J Ranstam C Westrup O Wiklander |
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| Affiliation: | 1. Departments of Surgery (S.R.), Oncology (T.M.), and the Regional Tumour Registry (T (T.M.; J.R.; C.W.) University Hospital, Lund, Sweden;2. Department of Surgery I (L.H.), Sahlgren Hospital, Göteborg, Sweden;3. Department of Surgery (O.W.), Helsingborg Hospital, Helsingborg, Sweden;1. SOLTI Breast Cancer Research Group, Barcelona;2. Statistics Unit, Vall d’Hebron Institute of Oncology, Barcelona;3. Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona;4. Medical Oncology Department, Hospital Clínic, Barcelona;5. Reveal Genomics, Barcelona;6. International Breast Cancer Center, Pangaea Oncology, Quirónsalud Group, Barcelona;7. Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid;8. Medical Oncology Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañon (IiSGM), CIBERONC, Geicam, Universidad Complutense, Madrid, Spain;9. San Camillo Hospital, IRCCS, Venezia Lido, Italy;10. Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill;11. Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, USA;12. Breast Center, Ludwig Maximilians University-Grosshadern, Munich, Germany;13. Cancer Genomics Group, VHIO, Barcelona, Spain;14. Early Drug Development for Innovative Therapies Division, Istituto Europeo di Oncologia, IRCCS, Milan;15. Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy;16. Medical Oncology, Dana-Farber Cancer Institute, Boston;17. Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston;18. Harvard Medical School, Boston, USA;1. Department of Medical Oncology, Institut de Cancérologie Strasbourg Europe, Strasbourg;2. Department of Medical Oncology, Gustave Roussy Cancer Campus, Paris;3. Department of Medical Oncology, Centre Hospitalier Universitaire de Tours, Tours;4. Department of Urology, Centre Hospitalier Universitaire d’Angers, Angers;5. Department of Medical Oncology and Hematology, Centre Hospitalier de Saint-Quentin, Saint-Quentin;6. Department of Medical Oncology, Centre Hospitalier Universitaire de Poitiers, Poitiers;7. Department of Medical Oncology, Centre Hospitalier Universitaire de Besançon, Besançon;8. Department of Medical Oncology, Institut Jean Godinot, Reims CEDEX;9. Department of Medical Oncology, Centre Hospitalier Intercommunal Quimper, Quimper;10. Department of Thoracic Oncology, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand;11. Department of Medical Oncology, Clinique Tivoli-Ducos, Bordeaux;12. Department of Medical Oncology and Radiotherapy, Hôpital privé Toulon Hyères—Sainte Marguerite, Hyères;13. Department of Medical Oncology, Hôpital Nord, Marseille;14. Department of Medical Oncology, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux;15. Department of Medical Oncology, Polyclinique de Gentilly, Nancy;16. Department of Medical Affairs, Bristol Myers Squibb, Paris;17. Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP Centre—Université de Paris, Paris, France;1. Department of Urology, Vall d’Hebron Hospital, Barcelona, Spain;2. Department of Surgery, Universitat Autònoma de Barcelona, Bellaterra, Spain;3. Clínica Creu Blanca, Barcelona, Spain;4. Department of Urology, Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Spain;5. Department of Urology, Hospital Universitari Parc Taulí, Sabadell, Spain;6. Department of Urology, Hospital Universitari Joan XXIII, Tarragona, Spain;7. Department of Urology, Hospital Universitari Arnau de Vilanova, Lleida, Spain;8. Department of Urology, Hospital Universitari Josep Trueta, Girona, Spain;9. Department of Urology, Parc de Salut Mar, Barcelona, Spain;10. Department of Medical Sciences, Universitat Pompeu Fabra, Barcelona, Spain;11. Department of Urology, Hospital Germans Trias i Pujol, Badalona, Spain |
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| Abstract: | ![]()
Multicenter clinical trials are often large and complex, involving many institutions and investigators. The organizational structure is of vital importance in conducting and coordinating such trials. The present article describes the organization of a multicenter trial of adjuvant therapy of breast cancer. The trial is conducted since 1978 and involves all 15 hospitals in the Southern Swedish Health Care Region. The paper also describes methods of determining patient accrual rate, compliance with entrance criteria, diagnostic procedures, treatment, and follow-up. Comparison of data obtained from a population-based regional tumor registry revealed an accrual rate of more than 80%. Compliance with entrance criteria varied between the treatment groups from 85% to 97%. No patients were lost to follow-up. Compliance with diagnostic procedures and treatment was generally good. Reporting of recurrences was in accordance with data from patients' records in 98% of patients. One hundred thirteen patients died during the first 5 years of study. Twenty-one of these deaths were not reported to the secretariat. This strongly illustrates the necessity of matching to a population register before presenting data of such trials. |
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