索拉非尼治疗转移性肾癌的疗效与安全性观察

目的:评估63例转移性肾细胞癌（metastatic renal cell carcinoma，mRCC）患者服用索拉非尼的疗效及安全性。方法:前瞻性观察2010年6月至2018年6月就诊于西安交通大学第一附属医院肿瘤内科及中华慈善总会索拉非尼援助赠药项目mRCC患者共计71例，其中63例可评价疗效及安全性。使用SPSS 18.0 软件进行K-M单因素生存分析，所得阳性因素导入COX回归模型进行多因素分析，明确影响索拉非尼治疗mRCC疗效的因素。结果:63例可评价mRCC患者中，无CR患者，PR 18例，SD 22例，PD 23例，ORR为28.57%（18/63），DCR为63.49%（40/63）；中位PFS为14月（3~51月），中位OS为29月（6~69月）；所有不良反应均可控或随剂量减少而降低。索拉非尼作为mRCC一线治疗者39例，二线及以上治疗者24例。一线和二线及以上治疗的ORR及DCR均无统计学差异，且中位PFS分别为24月（4~51月）和13月（3~42月）（P=0.021）。COX回归分析示，索拉菲尼是否为一线治疗是影响PFS的独立危险因素（P=0.030）。结论:索拉非尼治疗mRCC疗效确切，不良反应较少，并且是否为一线治疗是影响患者中位PFS的独立预测因素。

Efficacy and safety of sorafenib in patients with metastatic renal cell carcinoma

Objective:To evaluate the efficacy and safety of sorafenib in 63 patients with metastatic renal cell carcinoma (mRCC).Methods:From June 2010 to June 2018,a total of 71 patients were prospectively observed in the department of oncology of the First Affiliated Hospital of Xi'an Jiaotong University and the mRCC program of sorafenib assistance and drug donation of China Charity Federation,among which 63 patients could be evaluated for efficacy and safety.K-M single factor survival analysis was performed using SPSS 18.0 software,and the positive factors were introduced into the COX regression model for multivariate analysis to determine the factors affecting the efficacy of sorafenib in the treatment of mRCC.Results:In 63 patients,there was no CR patient,but 18 cases of PR,22 cases of SD,23 cases of PD.ORR was 28.57% (18/63),DCR was 63.49% (40/63).Median progression free survival (PFS) was 14 (3~51) months and median overall survival (OS) was 29 (6~69) months.All adverse reactions were controlled or decreased with dose reduction.Sorafenib was used as a first-line treatment for mRCC in 39 patients,and 24 patients in second-line and above.There was no significant difference in ORR and DCR between first-line and second-line and above treatment.The median PFS for first-line and second-line and above treatment were 24 (4~51) months and 13 (3~42) months (P=0.021).COX regression analysis showed that the first-line treatment of sorafenib was an independent risk factor for PFS (P=0.030).Conclusion:The efficacy of sorafenib in the treatment of mRCC is definite,with few adverse events,and the choice of first-line treatment is an independent predictor of the median PFS in patients.