Rational selection of a control arm for randomised trials in metastatic renal cell carcinoma

European Urology
G H J Mickisch

Abstract

Immunotherapy, and only immunotherapy, has reproducible, albeit limited efficacy in metastatic renal cell cancer (MRCC). Further improvement is warranted and progress will have to be investigated in randomised clinical trials, because the variable natural history of this disease precludes firm conclusions outside the context of controlled clinical studies. Currently, there is no general accepted standard arm to compare for those randomised clinical protocols. This needs to be established, which is the goal of this project. Interferon-alpha (IFN-alpha) or interleukin-2 (Il-2) are registered for the use in MRCC. Taking this regulatory affair into consideration, a systematic literature research using Medline Sources was carried out to identify large controlled clinical studies in MRCC, in which one or both of the registered drugs were involved. Scientific value of the trials was weighed, and the applicability, efficacy, and safety of the control arm was analysed. 13 large controlled studies qualified for this purpose, and a total of 3065 patients were included. IFN-alpha monotherapy, the combination of IFN-alpha and Il-2, and the combination of IFN-alpha, Il-2 and 5-fluorouracil (5-FU) were used as a standard treatment in decreasi...Continue Reading

Citations

Dec 23, 2003·Pathology Oncology Research : POR·Attila SzendrôiZsolt Kelemen
Mar 26, 2005·World Journal of Urology·Gerald H Mickisch, Roland H Mattes
Mar 1, 2008·Biologics : Targets & Therapy·Chris Coppin
Feb 24, 2009·Cancer Treatment Reviews·Manuela Schmidinger, Christoph C Zielinski
Nov 13, 2009·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Sergio BracardaJan Samuelsson
Dec 7, 2017·International Braz J Urol : Official Journal of the Brazilian Society of Urology·Chao WeiZhiqiang Chen
Apr 22, 2008·The Cochrane Database of Systematic Reviews·C CoppinT Wilt
Jun 7, 2008·Expert Review of Anticancer Therapy·Chris Coppin
Oct 16, 2020·The Cochrane Database of Systematic Reviews·Fabian HofmannBörje Ljungberg

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