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| Annals of oncology : official journal of the European Society for Medical Oncology / ESMO. 2015 Sep 14. pii: mdv380. doi: 10.1093/annonc/mdv380 |
| Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project†. |
| Kramar A1, Negrier S2, Sylvester R3, Joniau S4, Mulders P5, Powles T6, Bex A7, Bonnetain F8, Bossi A9, Bracarda S10, Bukowski R11, Catto J12, Choueiri TK13, Crabb S14, Eisen T15, El Demery M16, Fitzpatrick J17, Flamand V18, Goebell PJ19, Gravis G20, Houédé N21, Jacqmin D22, Kaplan R23, Malavaud B24, Massard C25, Melichar B26, Mourey L27, Nathan P28, Pasquier D29, Porta C30, Pouessel D31, Quinn D32, Ravaud A33, Rolland F34, Schmidinger M35, Tombal B36, Tosi D37, Vauleon E38, Volpe A39, Wolter P40, Escudier B41, Filleron T42 |
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Abstract 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. |
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© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. |
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KEYWORDS: DATECAN, clinical trials, recommendations, renal cell cancer, time-to-event end points |
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Publikations ID: 26371288 Quelle: öffnen |
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