Efficacy and safety of sunitinib in treating metastatic renal cell carcinoma: a single center 37 cases report
10.3760/cma.j.issn.1000-6702.2011.04.018
- VernacularTitle:舒尼替尼治疗转移性肾癌的疗效和安全性分析:单中心37例总结
- Author:
Xiang WU
;
Xuesong LI
;
Lihua HUANG
;
Yi SONG
;
Kan GONG
;
Cheng SHEN
;
Wei YU
;
Gang SONG
;
Zheng ZHAO
;
Zheng ZHANG
;
Qian ZHANG
;
Gang WANG
;
Zhisong HE
;
Liqun ZHOU
;
Jie JIN
- Publication Type:Journal Article
- Keywords:
Carcinoma,renal cell;
Neoplasm metastasis;
Sunitinib;
Treatment outcome;
Survival rate
- From:
Chinese Journal of Urology
2011;32(4):278-281
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of sunitinib in the treatment of metastatic renal cell carcinoma (RCC). Methods A total of 37 patients with metastatic RCC were treated with between June 2008 and April 2010, including 28 males and 9 females. The median age was 52 (17-74) years. All patients received a pathologic diagnosis of RCC, which consisted of 1 papillary cell carcinoma and 36 clear cell carcinomas, 4 of which accompanied with partial sarcoma differentiation. Thirty cases were treated with first line therapy and 7 cases showed progression on first-line cytokine or sorafinib therapy. Sunitinib monotherapy was administered in repeated 6-week cycles of daily oral therapy for 4 weeks, followed by 2 weeks off in 34 patients, while another 3 patients received 37. 5 mg Qd continuously until disease progression or unacceptable toxicities occurred. Overall response rate and safety were evaluated. Results The median follow up was 12 months (8 cycles),range 1.5-19. 5 months (1-13 cycles). 26.5% (9/34) patients achieved partial responses, 70.6%(24/34) patients demonstrated stable disease over≥3 months and 1 (2. 9%) patient developed progressive disease. The objective response rate was 26.5%, and the disease control rate was 97. 1%.The 12 months' overall survival rate was 95.8% (23/24), and 12 months' progression-free survival rate was 62.5 % (15/24). The most common treatment-related adverse events were thrombocytopenia (30 cases, 81.1%), thyroid dysfunction (18/22, 81.8%) ,hand-foot syndrome (27 cases, 73.0%),neutropenia (23 cases, 62.2%) and hypertension (18 cases, 48.6%). The major grade 3 adverse events included thrombocytopenia (8 cases, 21.6%), hand-foot syndrome (4 cases, 10.8%) and diarrhea (2 cases, 5. 4%). Most adverse events were ameliorated by treatment interruption. Ten (27.0%) patients had dose decrement or drug discontinuation and 1 patient quit the treatment for intolerable fatigue. Conclusion The efficacy and manageable adverse event profile of sunitinib as a single agent in first- or second-line therapy for patients with metastatic RCC.