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

Barts Experimental Cancer Medicine Centre Barts Cancer Institute Queen Mary University of London London 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 General Medical Oncology University Hospitals Leuven Leuven Cancer Institute Leuven Belgium

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 Claudius Regaud Institut Universitaire du Cancer Oncopole Toulouse 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 Medicine 1 Clinical Division of Oncology and Comprehensive Cancer Center Medical University of Vienna Vienna Austria

Department of Oncology Cambridge University Health Partners Cambridge UK

Department of Oncology Ospedale San Donato Arezzo Italy

Department of Oncology Palacký University Medical School and Teaching Hospital Olomouc Czech Republic

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 The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis Amsterdam 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

Kidney Cancer Center The Lank Center for Genitourinary Oncology Dana Farber Cancer Institute Boston USA

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

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