A pilot study of sunitinib as first-line therapy for metastatic renal cell carcinoma on a 2weeks on/1 week off intermittent dosing schedule
10.3760/cma.j.issn.0253-3766.2015.05.013
- VernacularTitle:舒尼替尼服药2周停药1周方案一线治疗转移性肾细胞癌患者的探索性研究
- Author:
Chuanliang CUI
1
;
Siming LI
;
Zhihong CHI
;
Lu SI
;
Xinan SHENG
;
Lili MAO
;
Bin LIAN
;
Xuan WANG
;
Bixia TANG
;
Jun GUO
Author Information
1. 100142北京大学肿瘤医院暨北京市肿瘤防治研究所恶性肿瘤发病机制及转化研究教育部重点实验室,肾癌黑色素瘤科
- Keywords:
Kidney neoplasms;
Antineoplastic protocols;
Sunitinib;
Treatment outcome
- From:
Chinese Journal of Oncology
2015;(5):375-378
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the efficacy and safety of sunitinib as first-line therapy for metastatic renal cell carcinoma ( mRCC) on a 2 weeks on/1 week off intermittent dosing schedule.Methods A total of 11 mRCC patients were enrolled to receive sunitinib 50 mg/day in 2 weeks on/1 week off schedule per 6 weeks till disease progression or intolerable toxicity occurred.The primary end point was progression free survival ( PFS) , the secondary end points were overall survival ( OS) , incidence of adverse effects and objective response.Results The objective response rate in the 11 cases was 45.5%and disease control rate 72.7%( partial response n=5, stable disease n=3) .Till the last follow up on Dec 2013, the median PFS was 17.0 months (95%CI 7.3 to 26.7 months), and median OS 26.0 months (95%CI 2.2 to 49.8 months). The common adverse events included leucopenia, thrombocytopenia, diarrhea, mucositis and hand-foot skin reaction.Dose reduction to 37.5 mg was seen only in 2 patients without discontinuation. Conclusions Sunitinib on an intermittent dosing schedule 2 weeks on /1 week off as first-line therapy for mRCC patients shows a good efficacy and tolerance, with less grade 3-4 drug-related toxicities and a tendency of prolonged PFS in mRCC patients.
