Temsirolimus for advanced renal cell carcinoma (RCC): Compassionate versus commercial use

Abstract

16139 Background: Temsirolimus, a specific inhibitor of the mammalian target of rapamycin kinase, has been approved on May 31st, 2007 for treatment of metastatic renal carcinoma based on a study which showed improved survival compared to interferon among patients with metastatic renal cell carcinoma and poor risk features. Methods: In this single institution study, we have treated 15 patients (8 patients on compassionate use and 7 patients on commercial use). All patients had prior nephrectomy and received prior systemic immunotherapy and (or) chemotherapeutic agents (sutent, sorafenib, avastin, gemzar, HDIL2, interferon, AG 013736, Adriamycin). 93% of the patients had at least 3 of the 6 predictors of poor prognosis for RCC. Temsirolimus was administered as 25 mg I.V infusion weekly. The primary end point was overall survival. Results: Patients in commercial group of temsirolimus use had a better performance status and had received less number of prior systemic treatments and received more doses of temsirolimus and had a median survival of 4+ months still continuing (range 2 to 6+ months) compared to compassionate group with a median survival of 2.5 months (range 30 days to 8 months). 1 patient from each group had to discontinue the study due to the rapid progression of the disease. 1 patient from each group had stable disease for 18+ weeks still continuing. No lethal toxicities observed in these patients. Conclusion: Patients who received less number of prior systemic treatments received more doses of temsirolimus and had a prolonged survival. Baseline patient characteristics Patient Characteristics (M- Median, R- Range) Compassionate group (8) Commercial group (7) M/F 5/3 3/4 Age M 60 56 R 39-78 39-81 Time from Dx to Rx M 5 yrs 4 yrs R 3-24 yrs 2-16 yrs # Prior Rx # Cycles M 20 15 R 3–23 1-29 # Agents M 4 2 R 1-9 1-7 Performance status M 3 2 R 1-4 1-3 Median survival M 2.5 months 4+ months R 1-8 months 2-6+ months Time from last Rx to temsirolimus M 75 days 15 days R 15 days-2 yrs 10 days-1.5 yrs No. of temsirolimus doses M 7 8+ R 2-25 5-15+ Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bayer, Genentech™ BioOncology, Novartis, Onyx, Pfizer Oncology, Wyeth Bayer, Novartis, Onyx, Pfizer Oncology, Wyeth Bayer, Genentech™ BioOncology, Novartis, Onyx, Pfizer Oncology, Wyeth