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Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project†
A. Kramar, S. Negrier, R. Sylvester, S. Joniau, P. Mulders, T. Powles, A. Bex, F. Bonnetain, A. Bossi, S. Bracarda, R. Bukowski, J. Catto, TK. Choueiri, S. Crabb, T. Eisen, M. El Demery, J. Fitzpatrick, V. Flamand, PJ. Goebell, G. Gravis, N....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, práce podpořená grantem, přehledy
PubMed
26371288
DOI
10.1093/annonc/mdv380
Knihovny.cz E-zdroje
- MeSH
- delfská metoda MeSH
- dodržování směrnic normy MeSH
- karcinom z renálních buněk mortalita terapie MeSH
- lidé MeSH
- lokální recidiva nádoru mortalita terapie MeSH
- nádory ledvin mortalita terapie MeSH
- přežití bez známek nemoci MeSH
- randomizované kontrolované studie jako téma metody normy MeSH
- stanovení cílového parametru metody normy MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- přehledy MeSH
BACKGROUND: In clinical trials, the use of intermediate time-to-event end points (TEEs) is increasingly common, yet their choice and definitions are not standardized. This limits the usefulness for comparing treatment effects between studies. The aim of the DATECAN Kidney project is to clarify and recommend definitions of TEE in renal cell cancer (RCC) through a formal consensus method for end point definitions. MATERIALS AND METHODS: A formal modified Delphi method was used for establishing consensus. From a 2006-2009 literature review, the Steering Committee (SC) selected 9 TEE and 15 events in the nonmetastatic (NM) and metastatic/advanced (MA) RCC disease settings. Events were scored on the range of 1 (totally disagree to include) to 9 (totally agree to include) in the definition of each end point. Rating Committee (RC) experts were contacted for the scoring rounds. From these results, final recommendations were established for selecting pertinent end points and the associated events. RESULTS: Thirty-four experts scored 121 events for 9 end points. Consensus was reached for 31%, 43% and 85% events during the first, second and third rounds, respectively. The expert recommend the use of three and two endpoints in NM and MA setting, respectively. In the NM setting: disease-free survival (contralateral RCC, appearance of metastases, local or regional recurrence, death from RCC or protocol treatment), metastasis-free survival (appearance of metastases, regional recurrence, death from RCC); and local-regional-free survival (local or regional recurrence, death from RCC). In the MA setting: kidney cancer-specific survival (death from RCC or protocol treatment) and progression-free survival (death from RCC, local, regional, or metastatic progression). CONCLUSIONS: The consensus method revealed that intermediate end points have not been well defined, because all of the selected end points had at least one event definition for which no consensus was obtained. These clarified definitions of TEE should become standard practice in all RCC clinical trials, thus facilitating reporting and increasing precision in between trial comparisons.
Academic Urology Unit University of Sheffield Sheffield UK
Cancer Sciences Unit University of Southampton Faculty of Medicine Southampton
Department of Academic Radiation Oncology Centre Oscar Lambret and SIRIC ONCO LILLE Lille France
Department of Biostatistics EORTC Headquarters Brussels
Department of Immunology Cleveland Clinic Taussig Cancer Center Cleveland USA
Department of Medical Oncology Centre Eugène Marquis Rennes France
Department of Medical Oncology CHU Caremeau Nîmes
Department of Medical Oncology Fondazione IRCCS Policlinico San Matteo Pavia Italy
Department of Medical Oncology Hôpital Saint André Bordeaux
Department of Medical Oncology Hôpital Saint Louis APHP Paris France
Department of Medical Oncology Institut de cancérologie de l'Ouest René Gauducheau Nantes France
Department of Medical Oncology Institut Paoli Calmettes Marseille
Department of Medical Oncology Institut Régional du Cancer Val d'Aurelle Montpellier
Department of Medical Oncology Mount Vernon Cancer Centre Northwood Middlesex UK
Department of Medical Oncology University Hospital of Nîmes Nimes France
Department of Medical Oncology University of Lyon 1 Centre Léon Bérard Lyon France
Department of Oncology Cambridge University Health Partners Cambridge UK
Department of Oncology Ospedale San Donato Arezzo Italy
Department of Radiation Oncology Institut Gustave Roussy Villejuif France
Department of Urology CHRU Strasbourg France
Department of Urology CHU Toulouse France
Department of Urology Cliniques Universitaires Saint Luc Brussels Belgium
Department of Urology Friedrich Alexander University Erlangen Nueremberg Erlangen Germany
Department of Urology Radboud University Medical Centre Nijmegan The Netherlands
Department of Urology University Hospitals Leuven Leuven Belgium
Department of Urology University Lille2 Nord de France Lille France
Division of Oncology USC Norris Comprehensive Cancer Center and Hospital Los Angeles USA
Division of Surgery Mater Misericordiae Hospital and University College Dublin Dublin Ireland
Division of Urology University of Eastern Piedmont Maggiore della Carità Hospital Novara Italy
Methodology and Biostatistics Unit Centre Oscar Lambret and SIRIC ONCO LILLE Lille
Methodology and Quality of Life in Oncology Unit University Hospital of Besançon Besançon
MRC Clinical Trials Unit University College London London UK
Citace poskytuje Crossref.org
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