Evaluation of safety, tolerability, and activity: A registry for temsirolimus-treated patients with advanced or metastatic renal cell carcinoma (aRCC) in the usual health care setting

• Published in: Journal of clinical oncology Vol. 27; no. 15_suppl; p. e16127
• Main Authors: Pelz, H. F., Krekeler, G., Bergmann, L., Roigas, J., Steiner, T., Loeschmann, P. A., Kosch, M.
• Format: Journal Article
• Language: English
• Published: 20.05.2009
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/jco.2009.27.15_suppl.e16127

Abstract only e16127 Background: In November 2007, temsirolimus (TEMS) was approved in the EU for the first-line treatment of patients with aRCC who have at least 3 of 6 prognostic risk factors. 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). A pre-registration compassionate use program (CUP) for patients with aRCC confirmed the known safety profile of TEMS. However, the low incidence of reported serious adverse events (SAE) even in the CUP (8 SAE during about 2,200 applications) reflects the low level of spontaneous SAE reporting in oncology. To better identify the true safety profile of newly approved drugs, collection of data on pharmacovigilance in the post-approval period is essential. Hence, a noninterventional trial appears to be adequate. Methods: To prospectively evaluate TEMS in the usual health care setting we started a registry for TEMS-treated patients with aRCC. 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: histologically confirmed aRCC treated with TEMS, written informed consent by the patient. Results: With regulatory and ethic committee's notification the registry started in Germany in January 2008. The registry is set up and managed by Wyeth´s medical department in collaboration with a scientific advisory board. Up to the December 15, 2008, 124 centers have recruited 130 patients. Preliminary documentation is available for 68 patients (57 male, 11 female), median age 65.8 yrs (43.2 –86.7), median Karnofsky index 75%. 32 pts experienced 90 AE, including 15 pts with 40 SAE (16 of them considered related, 24 not related by the treating physician). Conclusions: To further evaluate the safety, tolerability and efficacy of TEMS in the post-approval period and also due to the low level of spontaneously reported SAE in oncology Wyeth started a registry for TEMS-treated patients in aRCC. Updated results will be presented. [Table: see text]