索拉非尼治疗晚期肾癌所致手足皮肤反应与疗效的相关性研究

郭刚; 李学松; 张帆; 张旭

doi:10.13201/j.issn.1001-1420.2015.10.008

索拉非尼治疗晚期肾癌所致手足皮肤反应与疗效的相关性研究

- 1. 解放军总医院泌尿外科(北京, 100853);
- 2. 北京大学第一医院泌尿外科

详细信息

通讯作者: 张旭,E-mail:xzhang@foxmail.com

中图分类号: R737.11

收稿日期: 2015-02-08

Relationship between sorafenib-associated hand-foot skin reaction and efficacy in treatment of metastatic renal cell carcinoma

- 1. Department of Urology, PLA General Hospital, Beijing, 100853, China;
- 2. Department of Urology, Peking University First Hospital

More Information

Corresponding author: ZHANG Xu, E-mail: xzhang@foxmail.com

Received Date: 08 February 2015

摘要

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400 mg,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。
- 肾癌 /
- 索拉非尼 /
- 手足皮肤反应 /
- 疗效
Abstract: 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 30 cases (20.3%) and stable disease (SD) in 103 cases (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 1-2 HFSR was found in 47 cases, and grade 3-4 HFSR 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 24.291 months (95%CI:18.177-30.406) and 21.795 months(95%CI:17.268-26.322) respectively P=0.578. The mOS of group A and B were 32.027 months (95%CI:23.417-40.638) and 43.626 months (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.
- renal cell carcinoma /
- sorafenib /
- hand-foot skin reaction /
- outcome

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