Clinical and prognosis analysis in 78 patients with advanced renal cell carcinoma treated with sunitinib: a report from single center

Abstract

Objective To discuss and evaluate the clinical efficacy and safety of sunitinib for patients with advanced renal cell carcinoma and further to analyze the associated prognostic factors. Methods A retrospective analysis was performed in 78 cases with advanced renal cell carcinoma, receiving sunitinib therapy from April 2009 to December 2014. Patients consisted of 53 males and 25 females, with median age of 54 years old, ranged from 25-85 years old. Therapeutic regimen was described as following: 52 cases receiving sunitinib 50.0 mg/d 4 weeks on and 2 weeks off (4/2 regimen), 26 cases receiving 50.0 mg/d 2 weeks on and 1 weeks off (2/1 regimen). The dosage and regimen were adjusted according to the severity of side effects. Efficacy evaluation and drug-related toxicity were based on RECIST version 1.1 and CTCAE version 3.0. Progression-free survival (PFS) and overall survival (OS) were evaluated using the Kaplan-Meier method. Univariate and multivariate Cox proportional hazards model were used to assess the risk factors of PFS and OS. Results Nineteen cases switched from 4/2 to 2/1 regimen. Attenuated dosage was allowed in 49 cases to ameliorate drug-related toxicities. The most common drug-related toxicities were hand-foot syndrome (HFS) in 63 cases (80.8%), diarrhea in 59 cases (75.6%), fatigue in 59 cases (75.6%) and thrombocytopenia in 6 cases (71.8%). The most common grade Ⅲ-Ⅳ toxicities were HFS in 9 cases (11.5%), thrombocytopenia in 6 cases (7.7%) and hypertension in 5 cases (6.4%). In RECIST evaluation, complete response (CR) was not recorded. 8 cases (10.3%) achieved partial response (PR) , 59 cases (75.6%) kept stable disease (SD) and 11 cases (14.1%) suffered progressive disease (PD). The objective response rate (ORR) was 10.3% and the disease control rate (DCR) was 85.9%. The median PFS was 11.0 months and median OS was 21.8 months. Multivariate Cox proportional hazards model showed two independent risk factors for PFS, including number of metastasis organs≥2 and a high ECOG score. One independent risk factor for OS was number of metastasis organs≥2. Conclusions Sunitinib shows encouraging efficacy and safety for patients with advanced renal cell carcinoma. Patients with multiple metastatic organs and poor performance status seems to be high risky of poor prognosis. Key words: Tyrosine kinase inhibitor; Sunitinib; Advanced renal cell carcinoma; Efficacy; Adverse reactions