839P - Efficacy and Safety of Temsirolimus in Patients with Metastatic Renal Cell Carcinoma: Results from the Spanish Experience

Abstract

ABSTRACT Disclosure E. Esteban: Compensated advisory/consultant role for Pfizer. A. Lopez: CRA at TFS working for Pfizer. A. Viqueira: Pfizer Employee. P. Maroto: Compensated advisory/consultant role for Pfizer. All other authors have declared no conflicts of interest. Temsirolimus (TEM) is an mTOR inhibitor approved for first-line treatment of patients with poor-prognosis metastatic renal cell carcinoma (RCC). In a phase III trial TEM showed a statistically significant benefit in overall survival when compared to interferon-α. Recently, several authors have described that TEM also appears to be effective in second or further lines of treatment. Here we report the Spanish experience with TEM both in first and subsequent lines of treatment. A retrospective, observational and multicenter study of TEM used following routine clinical practice in patients with RCC was carried out. Patients treated with TEM between 2007 and 2012 were included. The objective of the study was to analyze the efficacy and safety of TEM. A total of 101 patients were included, 70% were male and the median age was 62. According to Motzer Criteria, 13% patients had a favorable prognosis, 44% an intermediate prognosis and 43% a poor prognosis. Of the 101 patients, 53% were treated with TEM in 1st line, 18% in 2nd line, 23% in 3rd line and 4% in 4th or further lines; 23% were patients with non-clear cell RCC and 28% were non-nephrectomized. Median PFS for all patients was 3 months. The clinical benefit rate was 59% with an ORR of 17% (all partial responses) and 42% of disease stabilization. In patients treated in 1st line, median PFS was 3 months, in patients treated in subsequent lines median PFS were 5, 4 and 1 months in 2nd, 3rd and 4th line respectively. In non-nephrectomized patients and patients with non-clear RCC median PFS was 3 months for both subgroups. In terms of tolerability, 79% of the patients developed at least one adverse event (AE). Most common AE (all grades) were anemia (39%), asthenia (22%), stomatitis (20%) and rash (15%). TEM appears to have a modest efficacy and an acceptable toxicity profile in patients with RCC, both in first and subsequent lines of treatment. TEM seems to achieve similar efficacy in patient subgroups such as non-nephrectomized patients and patients with non-clear histologies. Efficacy seems to be consistent with previous reports in second and third lines of treatment, but seems to be somewhat lower in first line, probably due to the poor-risk profile of the patients.