Temsirolimus in daily use: results of a prospective multicentre noninterventional study of patients with metastatic kidney cancer
Schrader AJ, Seseke S, Keil C, Herrmann E, Goebell P, Weikert S, Steffens S, Bergmann L, Roigas J, Steiner T (2014)
Publication Type: Journal article
Publication year: 2014
Journal
Publisher: Elsevier
Book Volume: 66
Pages Range: 275-81
Journal Issue: 2
DOI: 10.1016/j.eururo.2013.08.055
Abstract
Temsirolimus (TEMSR) was approved for treating advanced renal cell carcinoma (RCC) in 2007. Based on the data from a single phase 3 trial, it is recommended explicitly as first-line therapy for patients with a poor clinical prognosis.The aim of this prospective multicentre trial (STARTOR) was to examine the effectiveness of TEMSR in daily clinical practice with a broader indication in the treatment of metastatic RCC.Metastatic RCC patients treated with 25mg of TEMSR weekly were submitted to a prospective systematic evaluation and follow-up in 87 German centres between January 2008 and October 2011 using standardised procedures.All data were centrally analysed by an independent clinical research organisation.This interim analysis of the STARTOR study included 386 patients. The observed toxicity was tolerable, the median dose intensity was 91% (interquartile range: 79-100%), and the median treatment duration was 20.1 wk (95% confidence interval [CI], 17.0-23.3 wk). Clinical benefit was seen in 157 patients (40.7%); the median progression-free and overall survival were 4.9 mo (95% CI, 4.2-5.6) and 11.6 mo (95% CI, 9.3-13.9), respectively. The effectiveness of TEMSR did not differ significantly in relation to the patient's age, histologic RCC subtype, or line of treatment. The major limitations were the noninterventional study design, limited information about Memorial Sloan-Kettering Cancer Center risk factors and detailed toxicity, and the lack of central radiologic review.TEMSR is an effective and largely well-tolerated treatment alternative for metastatic RCC patients in daily clinical practice, irrespective of the patient's age, histologic RCC subtype, or line of treatment.
Authors with CRIS profile
Involved external institutions
Universität Ulm
Germany (DE)
Philipps-Universität Marburg
Germany (DE)
Westfälische Wilhelms-Universität (WWU) Münster
Germany (DE)
Charité - Universitätsmedizin Berlin
Germany (DE)
Medizinische Hochschule Hannover (MHH) / Hannover Medical School
Germany (DE)
Goethe-Universität Frankfurt am Main
Germany (DE)
Vivantes - Netzwerk für Gesundheit GmbH
Germany (DE)
HELIOS Kliniken
Germany (DE)
Germany (DE)
Philipps-Universität Marburg
Germany (DE)
Westfälische Wilhelms-Universität (WWU) Münster
Germany (DE)
Charité - Universitätsmedizin Berlin
Germany (DE)
Medizinische Hochschule Hannover (MHH) / Hannover Medical School
Germany (DE)
Goethe-Universität Frankfurt am Main
Germany (DE)
Vivantes - Netzwerk für Gesundheit GmbH
Germany (DE)
HELIOS Kliniken
Germany (DE)
How to cite
APA:
Schrader, A.J., Seseke, S., Keil, C., Herrmann, E., Goebell, P., Weikert, S.,... Steiner, T. (2014). Temsirolimus in daily use: results of a prospective multicentre noninterventional study of patients with metastatic kidney cancer. European Urology, 66(2), 275-81. https://doi.org/10.1016/j.eururo.2013.08.055
MLA:
Schrader, Andres Jan, et al. "Temsirolimus in daily use: results of a prospective multicentre noninterventional study of patients with metastatic kidney cancer." European Urology 66.2 (2014): 275-81.
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