Multicenter prospective phase II study of sunitinib in non-clear cell type renal cell carcinoma.

Abstract

325 Background: Sunitinib has been shown to produce a high response rate (RR), and improved progression-free survival (PFS) in patients (pts) with clear cell RCC. Retrospective data suggest sunitinib may be effective in papillary and chromophobe RCC. We conducted a multicenter phase II trial of sunitinib in non-clear cell RCC (nccRCC). Methods: Eligibility criteria included PS 0-1, measurable disease, and adequate organ function. Pts with brain metastases were not excluded if controlled without steroid dependence. Response assessment was performed every 6 weeks. Primary endpoint was RR. Secondary endpoints were TTP, safety and OS. Results: Between 6/2008 and 7/2010, 29 pts with nccRCC were enrolled (total accrual 35: P0=5%, P1=20%, alpha=0.05, beta=0.2, drop-out rate 15%). Median age was 52 (18–76). Twenty-four pts (84%) had prior nephrectomy. Seven pts (24%) had poor risk and 13 (45%) had intermediate risk disease by MSKCC criteria. Twenty-one pts had papillary RCC (type II in 11 and type not- specified in 10), and 4 patients had chromophobe RCC. Two pts discontinued protocol treatment due to toxicity prior to completion of cycle 1 (one pt had cardiogenic shock 27 days after start of therapy and the other refused further treatment 5 days after therapy). Eleven pts out of 29 had partial response with a RR of 38% (95% CI, 20.2%–55.6%) and additional 15 patients (52%) had SD with a disease control rate of 90%. Response rates were not significantly different according to the histologic type (43% in papillary type and 25% in chromophobe type). Median duration of response was 12.7 months (95% CI, 2.3∼23.1) and median TTP was 6.4 months (95% CI, 4.5∼8.3). With a median FU duration of 16 months (95% CI, 8.6∼23.4), 10 pts have been dead resulting in an estimated median OS of 17.9 months. Toxicity profiles were commensurate with prior reports on Korean patients (Yoo, et al. Jpn J Clin Oncol 2010). However, there was one treatment-related death caused by acute heart failure in patient without relevant risk factors for heart disease. Conclusions: Although our study is ongoing, the primary endpoint has been met and these data suggest that suntinib has promising activity in patients with nccRCC. No significant financial relationships to disclose.