Safety and efficacy of sunitinib for advanced non-clear cell renal cell carcinoma.

Abstract

This study evaluated the safety and efficacy of sunitinib in the treatment of advanced non-clear cell renal cell carcinoma. Thirty-seven Chinese patients with advanced non-clear cell renal cell carcinoma were enrolled from October 2008 to October 2013. Sunitinib monotherapy was administered in repeated 6-week cycles of daily oral administration of 50 mg for 4 weeks, followed by 2 weeks off. Computed tomography scan was used to evaluate the efficacy every two cycles. All 37 patients received sunitinib treatment according to the schedule and were evaluated for response and toxicity. Thirty (81.1%) patients underwent nephrectomy before sunitinib treatment and seven (18.9%) patients had kidney biopsy. Twenty-five patients were diagnosed with papillary renal cell carcinoma, two with spindle cell-type renal cell carcinoma, two with chromophobe renal cell carcinoma and eight with unclassified cell types. The disease control rate was 73.0%, with partial response in 5 (13.5%), stable disease in 22 (59.5%) and progression disease in 10 (27.0%), the best tumor response. The median progression-free survival (PFS) was 6 months and the median overall survival (OS) was 9 months. In patients with papillary renal cell carcinoma, the median PFS was 6 months and the median OS was 10 months. The most common adverse events were hand-foot syndrome, fatigue, leukopenia, anemia, thrombocytopenia, mucositis, edema and hypertension. All adverse events were ameliorated by supportive treatment, dose reduction or treatment interruption. Sunitinib was efficacious in the treatment of advanced non-clear cell renal cell carcinoma. Most adverse events were tolerable.