中华医学杂志（英文版）2011，Vol.124Issue(18)：2920-2924,5.DOI:10.3760/cma.j.issn.0366-6999.2011.18.023
Efficacy and safety of sunitinib in the treatment of metastatic renal cell carcinoma
Efficacy and safety of sunitinib in the treatment of metastatic renal cell carcinoma
LI Xue-song 1ZHANG Zheng 1ZHANG Qian 1WANG Gang 1HE Zhi-song 1ZHOU Li-quan 1JIN Jie 1WU Xiang 1ZHAO Peng-ju 2HUANG Li-hua 1SONG Yi 1GONG Kan 1SHEN Cheng YU Wei 1SONG Gang 1ZHAO Zheng1
作者信息
- 1. Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Center,Beijing 100034, China
- 2. Department of Urology, Fujian Provincial Hospital, Fuzhou, Fujian350001, China
- 折叠
摘要
Abstract
Background The tyrosine kinase inhibitors (TKIs) sunitinib, the first targeted agent for the first line treatment of metastatic renal cell carcinoma (RCC), targets the vascular endothelial growth factor (VEGF) pathway. The objective of this study was to investigate the efficacy and safety of sunitinib in treating metastatic clear-cell RCC and to confirm if hypertension is an effective predictive factor.Methods A total of 36 patients with metastatic RCC were enrolled between June 2008 and December 2010. Among them 29 cases were first line therapy and 7 cases were in progression on first-line cytokine or sorafinib therapy. The pathology of all patients was confirmed predominant in clear cell type. Sunitinib mono-therapy was administered in repeated 6-week cycles of daily oral therapy for 4 weeks, followed by 2 weeks off in 34 patients; and 3 patients were administered with 37.5 mg/d continuously until disease progression or unacceptable toxicities occurred. Overall response rate and safety were evaluated. We divided patients into Group A and Group B according to the blood pressure level.Results The median follow-up was 15 months (10 cycles, range 1.5-30.0 months (1-20 cycles)). Ten patients (29.4％)achieved partial responses (PR); 23 patients (67.6％) demonstrated stable disease (SD) lasting ＞2 cycles. Seventeen patients (50％) developed progressive disease (PD) during follow-up. The median progression-free survival (PFS) was 15 months (range 3.0-28.5) months. A total of 9 patients died; the overall survival has not been reached; the median survival time of the deceased patients was 13 months (range 7-24) months. The most common adverse events were hand-foot syndrome (77.8％), thrombocytopenia (75.0％), hypertension (61.1％) and diarrhea (46.0％). Most adverse events were reversible by treatment interruption. Twenty-two patients (61.1％) developed hypertension; and hypertension was associated with a long time to disease progression and long overall survival (P=0.004, 0.000, respectively).Conclusions The results of this study demonstrate the efficacy and manageable adverse event profile of sunitinib as a single agent in first- or second-line therapy for patients with metastatic clear cell RCC. Further, sunitinib-associated hypertension may be a strong predictive marker for treatment efficacy in metastatic RCC.关键词
sunitinib/carcinoma, renal cell/neoplasm metastasis/hypertension/predictive factorKey words
sunitinib/carcinoma, renal cell/neoplasm metastasis/hypertension/predictive factor引用本文复制引用
LI Xue-song,ZHANG Zheng ,ZHANG Qian,WANG Gang,HE Zhi-song,ZHOU Li-quan,JIN Jie,WU Xiang,ZHAO Peng-ju,HUANG Li-hua,SONG Yi,GONG Kan,SHEN Cheng YU Wei,SONG Gang ,ZHAO Zheng..Efficacy and safety of sunitinib in the treatment of metastatic renal cell carcinoma[J].中华医学杂志（英文版）,2011,124(18):2920-2924,5.
