Sunitinib treatment for longer than 2 years for renal cell carcinoma.

Abstract

e15099 Background: Sunitinib has transformed the management of advanced renal cell carcinoma (RCC). Progression-free survival in the pivotal randomized study was 11 months but few data are reported regarding patients treated with sunitinib for longer periods. Methods: Patients with advanced RCC treated with sunitinib for over 2 years were identified from our institutional database and their characteristics and outcomes summarized. Results: Twenty eight patients were treated with sunitinib for over 2 years out of 109 treated in total between 2005 and September 2007. All 28 had undergone nephrectomy, median age was 56 (range 27-68) and 79% were male. Median number of lines of prior therapy was 1 (range 0-3), Motzer scores were 0 (n=6), 1 (n=7), 2 (n=7), 3 (n=6), 4 (n=1) and not known (n=1). Median ECOG PS was 1 (range 0-2). A median of 2 sites of metastatic disease were present at baseline (range 1-4). Sunitinib was started a median of 22 (range 1-83) months after diagnosis of advanced disease. Median duration of therapy as of September 2009 was 36 (range 24- 47+) months. All patients started sunitinib at 50mg daily on the 4/2 week schedule; toxicity was manageable although 75% (21/28) underwent dose modification. Reduction to 37.5mg on the 4/2 schedule occurred in 16 (57%) and to 25mg (4/2 or continuous) in 8 patients (29%). Eight patients underwent dose re-escalation after dose reduction. Best response was partial response (PR) in 13 (46%) and stable disease (SD) in 15 patients (54%). Median duration of therapy was 40 months (range 27-45+) in the PR group and 31 months (range 24-47+) in the SD group. Median overall survival was 45 (95% CI 39-51) months. Twenty two patients (79%) had progressed as of September 2009; 10 (45%) progressed initially in bone alone; all 10 were treated with surgery and/or radiotherapy and subsequently received sunitinib for a median of 19.5 (range 1-37) months. Conclusions: A quarter of patients treated with sunitinib for RCC received therapy for 2 years or longer. Toxicity was manageable with appropriate dose modification; subsequent dose re-escalation was feasible in a significant number of patients. There may be a group of patients in whom sunitinib therapy can be continued with clinical benefit after local therapy to progressive disease in bone. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer Pfizer Pfizer Pfizer Pfizer