Safety and efficacy of temsirolimus in heavily pretreated patients with metastatic renal cell carcinoma.

Background. First line treatment with temsirolimus is considered standard of care in poor risk patients with metastatic renal cell carcinoma. The role of temsirolimus in pretreated patients with any risk profile is unclear. The aim of this retrospective analysis was to investigate the impact of temsirolimus in patients who had progressed on various treatment lines. Material and methods. From April 2007 to July 2009, all patients who had progressed on receptor-tyrosine kinase-inhibitors,VEGF-antibodies and other agents were treated with temsirolimus (25 mg weekly). Physical examination, white blood cell count and chemistry were obtained weekly and tumor response was assessed every 12 weeks. Results. Thirty patients with a median age of 68 years range (44-81) received treatment with temsirolimus. Most patients were categorized intermediate risk (60%) and the majority had three or more metastatic sites (56.7%).Temsirolimus was median the fourth (range 2-5) systemic treatment line. Grade 3 and 4 toxicities were rare and consisted of anemia, thrombocytopenia and hyperglycemia. Objective remission and stable disease were achieved in 13.3% and 60% of the patients, respectively. The median progression free survival was 4.9 months (2.93-6.81 95% CI). Conclusion. Temsirolimus appears feasible, safe and active in heavily pretreated patients. [ABSTRACT FROM AUTHOR]