title: Temsirolimus in daily use: results of a prospective multicentre noninterventional study of patients with metastatic kidney cancer.
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.
  
  
  METHODS
  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.
  
  
  METHODS
  All data were centrally analysed by an independent clinical research organisation.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Urology, Ulm University Medical Centre, Ulm, Germany. Electronic address: ajschrader@gmx.de.
authors.forename: Andres Jan
authors.initials: AJ
authors.lastname: Schrader
authors.affiliation: Department of Urology, Diakonissenkrankenhaus, Dessau, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Seseke
authors.affiliation: Department of Urology, Philipps-University, Marburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Keil
authors.affiliation: Department of Urology, Muenster University Medical Centre (UKM), Muenster, Germany.
authors.forename: Edwin
authors.initials: E
authors.lastname: Herrmann
authors.affiliation: Department of Urology, Erlangen University, Erlangen, Germany.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Goebell
authors.affiliation: Department of Urology, University Hospital Charité, Berlin, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Weikert
authors.affiliation: Department of Urology, MH Hannover, Hannover, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Steffens
authors.affiliation: Department of Haematology and Oncology, J.W. Goethe University, Frankfurt, Germany.
authors.forename: Lothar
authors.initials: L
authors.lastname: Bergmann
authors.affiliation: Department of Urology, Vivantes Hospital im Friedrichshain, Berlin, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Roigas
authors.affiliation: Department of Urology, Helios Hospital, Erfurt, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Steiner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; C401859:temsirolimus; D020123:Sirolimus
keywords: Prognosis; Prospective clinical trial; Renal cell carcinoma; Study; TEMSR; Temsirolimus; Toxicity; mTOR inhibitor