Andres Jan Schrader1, Sandra Seseke2, Christian Keil3, Edwin Herrmann4, Peter J Goebell5, Steffen Weikert6, Sandra Steffens7, Lothar Bergmann8, Jan Roigas9, Thomas Steiner10. 1. Department of Urology, Ulm University Medical Centre, Ulm, Germany. Electronic address: ajschrader@gmx.de. 2. Department of Urology, Diakonissenkrankenhaus, Dessau, Germany. 3. Department of Urology, Philipps-University, Marburg, Germany. 4. Department of Urology, Muenster University Medical Centre (UKM), Muenster, Germany. 5. Department of Urology, Erlangen University, Erlangen, Germany. 6. Department of Urology, University Hospital Charité, Berlin, Germany. 7. Department of Urology, MH Hannover, Hannover, Germany. 8. Department of Haematology and Oncology, J.W. Goethe University, Frankfurt, Germany. 9. Department of Urology, Vivantes Hospital im Friedrichshain, Berlin, Germany. 10. Department of Urology, Helios Hospital, Erfurt, Germany.
Abstract
BACKGROUND: 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. OBJECTIVE: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: All data were centrally analysed by an independent clinical research organisation. RESULTS AND LIMITATIONS: 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. CONCLUSIONS: 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.
BACKGROUND: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. OBJECTIVE: 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. DESIGN, SETTING, AND PARTICIPANTS: Metastatic RCCpatients 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. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: All data were centrally analysed by an independent clinical research organisation. RESULTS AND LIMITATIONS: 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. CONCLUSIONS: TEMSR is an effective and largely well-tolerated treatment alternative for metastatic RCCpatients in daily clinical practice, irrespective of the patient's age, histologic RCC subtype, or line of treatment.
Authors: Lauren C Harshman; Nils Kroeger; Sun Young Rha; Frede Donskov; Lori Wood; Srinivas K Tantravahi; Ulka Vaishampayan; Brian I Rini; Jennifer Knox; Scott North; Scott Ernst; Takeshi Yuasa; Sandy Srinivas; Sumanta Pal; Daniel Y Heng; Toni K Choueiri Journal: Clin Genitourin Cancer Date: 2014-03-15 Impact factor: 2.872