Abstract
e15127 Background: Temsirolimus (TEMS), an i.v. mTOR inhibitor, was approved in the EU for the first-line treatment of patients with aRCC who have at least 3 of 6 prognostic risk factors in Nov 2007. A pivotal study had demonstrated significantly increased overall survival with TEMS in poor risk aRCC compared to the former standard Interferon (10.9 mo vs 7.3 mo). To better identify the safety profile and efficacy of TEMS during clinical routine, collection of data on pharmacovigilance in the post-approval period is essential. Hence a non-interventional trial appears to be adequate. Methods: To prospectively evaluate TEMS in the usual health care setting a registry for TEMS-treated patients with aRCC was started in Germany in Jan 2008 (NCT00700258). Primary objective is the evaluation of TEMS's safety profile. Secondary objectives include the tolerability and activity of TEMS as well as the profile, comorbidity and characteristics of patients and sequence of systemic therapies in aRCC. Inclusion criteria are a histologically confirmed aRCC treated with TEMS and written informed consent by the patient. Results: 84 active centers recruited 278 pts from February 2008 to November 2009. Preliminary data are available on 220 pts (70% male, 30% female): median age 67.9 yrs (40.4 – 87.0), median Karnofsky index 80% (40 - 100%), clear cell carcinomas predominant (76.8%). 143 pts experienced 622 AEs, including 63 pts with 147 SAEs (47 of them considered related by the treating physician). Median PFS is 141 days. The subgroup of pts ≥ 65 yrs is equivalent to total study population regarding to number of AEs, SAEs, and median PFS. Conclusions: Patient population in the registry represents the expected pattern in aRCC regarding distribution of age, sex and histology. Safety profile and efficacy of TEMS are comparable to phase-III data. For patients ≥ 65 yrs safety and efficacy are similar to those of the overall study population. In August 2009 additional EU-approval for patients with recurrent and/or refractory MCL was granted for TEMS. Hence, by protocol amendment the registry is now open for MCL as well. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Wyeth Wyeth Wyeth Wyeth
Published Version
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