摘要
目的：探讨索拉非尼治疗晚期肾癌相关的手足皮肤反应（HFSR）与疗效的关系。方法：回顾性分析两个中心2007年5月-2014年10月共148例接受索拉非尼治疗的晚期肾癌患者的临床资料,男109例,女39例,年龄22-78岁,平均53.4岁。初始给药方案均为索拉非尼400mg,bid口服。比较治疗后有无HFSR两组患者的疾病控制率（DCR）、中位无疾病进展生存期（mPFS）及中位生存期（mOS）的差异。结果：两组总体疾病控制率为89.9%,其中缓解30例（20.3%）,稳定103例（69.6%）,进展15例（10.1%）。主要不良反应包括腹泻74例（50.0%）,高血压41例（27.7%）,HFSR 64例（43.2%）,乏力71例（48.0%）。共64例出现HFSR,其中Ⅰ-Ⅱ级47例,Ⅲ-Ⅳ级17例。两组疾病控制率分别为88.1%和92.2%（P=0.552）;两组mPFS分别为24.291个月（95%CI：18.177-30.406）和21.795个月（95%CI：17.268-26.322）,差异均无统计学意义（P=0.578）;两组mOS分别为32.027个月（95%CI：23.417-40.638）和43.626个月（95%CI：33.198-54.053）,差异有统计学意义（P=0.032）。结论：治疗后HFSR的出现可作为索拉非尼治疗晚期肾癌临床疗效的预示指标,但是疗效是否随HFSR严重程度的递增而增加尚待论证。
Objective：To investigate the relationship between sorafenib-associated hand-foot skin reaction（HFSR）and efficacy in treatment of metastatic renal cell carcinoma（mRCC）.Method：We performed a retrospective study in two Chinese centers of 148 patients with mRCC who were treated with sorafenib from May 2007 to Oct.2014.Patients were divided into HFSR cases（group A）and non-HFSR cases（group B）.We retrospectively analyzed the incidence of HFSR,compared tumor disease control rate（DCR）,median progression free survival（mPFS）and median overall survival（mOS）between two groups.Result：In this study 109 male and 39 female mRCC patients were treated with sorafenib.The average age was 53.4（range,22-78）years old.The total DCR was 89.9%including partial response（PR）in 30cases（20.3%）and stable disease（SD）in 103cases（69.6%）.The main adverse events included diarrhea（50.0%）,hypertension（27.7%）,HFSR（43.2%）and fatigue（48.0%）.Totally 64 cases developed all grades of HFSR.Grade 1-2HFSR was found in 47 cases,and grade 3-4HFSR was found in 17 cases.The DCR of group A and B were 88.1% and 92.2% respectively（P =0.552）.The mPFS of group A and B were 24.291months（95%CI：18.177-30.406）and 21.795months（95%CI：17.268-26.322）respectively P =0.578.The mOS of group A and B were 32.027months（95%CI：23.417-40.638）and43.626months（95%CI：33.198-54.053）respectively P =0.032,which showed statistically significant difference between the two groups.Conclusion：HFSR induced by sorafenib may be a predictor of sorafenib treatment outcome in advanced mRCC.But it has yet to be demonstrated whether the efficacy increases with the severity of HFSR or not.
出处
《临床泌尿外科杂志》
2015年第10期893-896,共4页
Journal of Clinical Urology
关键词
肾癌
索拉非尼
手足皮肤反应
疗效
renal cell carcinoma
sorafenib
hand-foot skin reaction
outcome
