舒尼替尼个体化治疗转移性肾细胞癌的疗效评价

Efficacy evaluation of sunitinib in the individualized treatment of metastatic renal cell carcinoma

目的 评价舒尼替尼个体化治疗转移性肾透明细胞及乳头状肾细胞癌的有效性和安全性.方法 回顾性分析四川大学华西医院2008年4月至2012年9月采用舒尼替尼治疗的转移性肾透明细胞癌和转移性乳头状肾细胞癌（2型）病例资料.共纳入44例患者,包括33例转移性肾透明细胞癌和11例转移性乳头状肾细胞癌.采用SPSS 17.0统计软件进行秩和检验、x2检验及单因素/多因素生存分析评价舒尼替尼治疗的疗效及不良反应,分析影响该药物疗效的危险因素.结果 舒尼替尼的中位治疗周期为19.1个周期,中位随访时间为30个月,其中18例接受舒尼替尼标准方案治疗,26例接受剂量调整方案治疗.44例患者总体肿瘤缓解率为34％ （15/44）,疾病控制率达71％ （31/44）,中位无疾病进展生存时间14.0个月,中位总生存时间达37.0个月.生存分析显示,肿瘤病理类型及药物个体化治疗方案并不是影响疗效的危险因素.多因素分析显示,单纯肺或淋巴结转移是影响舒尼替尼治疗转移性肾细胞癌疗效的唯一独立预后因素.治疗期间,高血压、手足综合征、口腔黏膜炎等不良反应发生率较高,但均可控可逆.剂量调整组因严重不良反应需行药物暂停或减量的比例明显低于标准剂量组（35％和67％,P=0.034）.结论 舒尼替尼对转移性肾透明细胞癌和乳头状肾细胞癌均具有良好疗效,剂量调整的个体化药物治疗方案使患者的疗效及安全性最大化.

Objective To evaluate the efficacy and safety of sunitinib in the individualized treatment of metastatic clear cell and papillary renal cell carcinoma.Methods The data of 44 patients （33 cases of metastatic renal clear cell carcinoma （mRCC） and 11 cases of metastatic papillary renal cell carcinoma） were analyzed retrospectively in West China Hospital from Apr.2008 to Sept.2012.Progression free survival （PFS）,overall survival （OS） and adverse events were compared,and SPSS17.0 software was used to evaluate the effect,adverse events and the risk factors.Results The median sunitinib therapeutic cycle was 19.1 and the median follow-up time was 30 months.Among the 44 patients,18 patients were treated with standard therapeutic schedule,while 26 patients were treated with adjusted alternative schedule.The median PFS,OS,tumor objective response rate and disease control rate for the entire cohort were 14 months,37 months,34％ （15/44） and 71％ （31/44）,respectively.Survival analysis demonstrated that neither histological types nor individual therapeutic regimen was associated with efficacy of sunitinib.Multivariate analysis demonstrated that solitary lung or lymph node metastasis was the only independent factor predicting the effectiveness of sunitinib in the treatment of mRCC.Although incidence of hypertension,hand-foot syndrome and oral mucositis was relatively high,all adverse events were tolerable and reversible.Compared to patients with standard schedule,the proptrtion of dose reduction or interruption was much lower in patients with alternative schedule （35％ vs.67％,P=0.034）.Conclusion Sunitinib may have similar effect on metastatic renal clear cell carcinoma and papillary renal cell carcinoma,and the individualized therapeutic schedules of sunitinib maximize the efficacy and safety of sunitinib.