Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project+

Kramar A, Negrier S, Sylvester R, Joniau S, Mulders P, Powles T, Bex A, Bonnetain F, Bossi A, Bracarda S, Bukowski R, Catto J, Choueiri TK, Crabb S, Eisen T, El Demery M, Fitzpatrick J, Flamand V, Goebell P, Gravis G, Houede N, Jacqmin D, Kaplan R, Malavaud B, Massard C, Melichar B, Mourey L, Nathan P, Pasquier D, Porta C, Pouessel D, Quinn D, Ravaud A, Rolland F, Schmidinger M, Tombal B, Tosi D, Vauleon E, Volpe A, Wolter P, Escudier B, Filleron T (2015)

Publication Type: Journal article

Publication year: 2015

Journal

Book Volume: 26

Pages Range: 2392-8

Journal Issue: 12

DOI: 10.1093/annonc/mdv380

Abstract

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.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.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).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.

Authors with CRIS profile

Involved external institutions

Centre Hospitalier Universitaire Carémeau France (FR) Hôpitaux universitaires de Strasbourg (HUS) / University Hospital Strasbourg France (FR) University College London (UCL) United Kingdom (GB) Centre Hospitalier Universitaire (CHU) de Toulouse France (FR) Institut Gustave-Roussy France (FR) Palacky University Olomouc / Univerzita Palackého v Olomouci Czech Republic (CZ) Institut Claudius-Regaud (ICR) UNICANCER France (FR) Mount Vernon Cancer Centre United Kingdom (GB) Centre Oscar Lambret (UNICANCER) France (FR) Policlinico San Matteo Pavia Fondazione IRCCS Italy (IT) Assistance Publique-Hôpitaux de Paris (AP-HP) France (FR) University of Southern California (USC) United States (USA) (US) Centre Hospitalier Universitaire de Bordeaux / CHU Bordeaux France (FR) Institut de Cancérologie de l'Ouest France (FR) Medizinische Universität Wien Austria (AT) Cliniques universitaires Saint-Luc (CHU St-Luc) Belgium (BE) Institut régional du Cancer de Montpellier (ICM) France (FR) Centre Eugène Marquis France (FR) University of Eastern Piedmont / Università degli Studi del Piemonte Orientale "Amedeo Avogadro" Italy (IT) University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven Belgium (BE) Université Claude Bernard Lyon 1 (UCB) France (FR) European Organisation for Research and Treatment of Cancer (EORTC) Belgium (BE) Radboud University Nijmegen Netherlands (NL) Queen Mary, University of London United Kingdom (GB) Netherlands Cancer Institute (NKI) Netherlands (NL) Centre hospitalier régional et universitaire de Besançon (CHRU Besancon) France (FR) Gruppo Ospedaliero San Donato Italy (IT) Cleveland Clinic United States (USA) (US) University of Sheffield United Kingdom (GB) Dana–Farber Cancer Institute United States (USA) (US) University of Southampton United Kingdom (GB) Cambridge University Hospital United Kingdom (GB) Mater Misericordiae University Hospital (MMUH) / Ospidéal an Mater Misercordiae Ireland (IE) Université de Lille (ULille) / University of Lille Nord de France / Université Lille Nord de France / Université Lille II France (FR) Institute Paoli-Calmettes France (FR)

How to cite

APA:

Kramar, A., Negrier, S., Sylvester, R., Joniau, S., Mulders, P., Powles, T.,... Filleron, T. (2015). Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project+. Annals of Oncology, 26(12), 2392-8. https://doi.org/10.1093/annonc/mdv380

MLA:

Kramar, A., et al. "Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project+." Annals of Oncology 26.12 (2015): 2392-8.

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