Efficacy and tolerability of two weeks on and one week off schedule of sunitinib versus standard four weeks on and two weeks off schedule for metastatic renal cell carcinoma
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摘要: 目的:对比分析舒尼替尼2/1方案与4/2方案治疗转移性肾癌的疗效及其对不良反应的耐受性。方法:2009年1月~2013年1月采用舒尼替尼2/1方案(每天50 mg,服用2周,停用1周)和4/2方案(每天50 mg,服用4周,停用2周)治疗转移性肾癌患者56例,其中接受2/1方案治疗者18例,4/2方案治疗者38例。第1个疗程每周随访1次,此后每3周随访1次,并进行有效性及安全性评价,随访时间至少1年,统计分析比较两组患者疗效及其对不良反应的耐受性。结果:采用舒尼替尼治疗转移性肾癌患者12个月的效果评价,两种方案差异无统计学意义;但在部分药物不良反应中,如手足综合征、乏力、白细胞减少、腹泻中,2/1方案明显优于4/2方案(手足综合征:P=0.004;乏力:P=0.015;白细胞减少:P=0.013;腹泻:P=0.022)。结论:舒尼替尼2/1方案治疗转移性肾癌与4/2方案相比疗效相似,但不良反应发生率低。
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关键词:
- 肾肿瘤 /
- 肾部分切除术 /
- R.E.N.A.L.评分 /
- PADUA评分 /
- 预后
Abstract: Objective:To compare the efficacy and tolerability between 2/1 sunitinib schedule and standard 4/2 schedule in patients with metastatic renal cell carcinoma.Method:A retrospective analysis of patients with metastatic renal cell carcinoma treated with sunitinib was carried out from January 2009 to January 2013 in our hospital. Dosing schedules of sunitinib included schedule 2/1 (50 mg/day, two weeks on and one week off) and schedule 4/2 (50 mg/day, four weeks on and two weeks off). Schedule 2/1 was performed in 18 patients, and schedule 4/2 was carried out in 38 patients. We evaluated and compared the efficacy and safety between two schedules. The follow-up data were collected once a week at the first course and then every three weeks in the following courses, and the duration of follow-up of each patient was more than one year. Statistical analysis was carried out to compare the efficacy and tolerability between two groups.Result:No statistical significance was found in the results of 12-month therapeutic evaluation of patients with metastatic renal cell carcinoma between two schedules. The rate of adverse events of hand-foot syndrome, fatigue, leukocytopenia and diarrhoea in patients treated with sunitinib was significantly lower in the schedule 2/1 group than in the schedule 4/2 group (hand-foot syndrome: P=0.004; fatigue: P=0.015; leukocytopenia: P=0.013; diarrhoea: P=0.022). However, there was no statistical difference in other adverse events caused by sunitinib between two schedules.Conclusion:Schedule 2/1 of sunitinib in patients with metastatic renal cell carcinoma was associated with lower adverse event rate and similar efficacy compared with schedule 4/2.-
Key words:
- metastatic renal cell carcinoma /
- sunitinib /
- schedule 2/1 /
- schedule 4/2 /
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