索拉非尼治疗晚期肾癌五年临床观察  

Five-year therapeutic experience of sorafenib for patients with advanced renal cell carcinoma

作　　者：周昌东[1] 张奇夫 刘一[1] 金刚[1] 田玉新[1] 王英迪[1] 孙凯[1] 杨新平[1] 

机构地区：[1]吉林省肿瘤医院泌尿外科,长春130012

出　　处：《中华医学杂志》2014年第46期3658-3660,共3页National Medical Journal of China

摘　　要：目的探讨索拉非尼治疗晚期肾癌患者的疗效、耐受性与安全性。方法对2008年6月至2013年2月间在吉林省肿瘤医院住院的晚期肾癌患者63例进行随访观察，男45例，女18例，中位年龄57岁（15-82岁）。48例行患肾切除术后复发或转移，其中36例在复发及转移前曾行细胞因子治疗；手术后发现复发或转移的间期〈1年者11例，≥1年者37例；肾原发病灶不能手术切除的患者15例，均行肾肿瘤穿刺活检。手术后及肾穿刺活检病理类型有49例为透明细胞癌，14例为乳头状癌。用药前患者体能状态按KPS（Karnofsky，卡氏功能状态评分标准）标准评分均在70分以上。均以索拉非尼作为一线药物，单一用药，口服索拉非尼400mg，2次／d，持续使用至疾病进展或出现不可耐受的不良反应。结果随访截止2013年2月，中位随访时间20（6-42）个月，死亡患者24例。63例患者中完全缓解（CR）2例、部分缓解（PR）8例、疾病稳定（SD）30例、疾病进展（PD）23例，客观反应率15．9％（10／63），疾病控制率为63．5％（40／63）。手足综合征发生率70．0％、脱发62．5％、皮疹52．5％、腹泻37．5％、食欲减退32．5％、疲劳乏力27．5％，不良反应多于服药2-4周内出现，持续时间不等，经对症治疗后，均可缓解，未影响服药。结论索拉非尼用于晚期肾癌患者，具有较高的疾病控制率，所产生的不良反应类型与文献报道相似，程度一般较轻，具有良好的耐受性与安全性。Objective To explore the tolerability and safety of sorafenib for patients with advanced renal cell carcinoma. Methods Among 63 cases of advanced renal cell carcinoma, there were 45 males and 18 females with a median age of 57 years. And 48 patients had recurrence or metastasis after nephrectomy. And cytokine therapy was offered for 36 of them before recurrence or metastasis. Postoperative recurrence or metastasis occurred 〈 1 year （ n = 11 ） and≥1 year （ n = 37）. And 15 cases of primary non-resectable renal lesions received biopsy. The pathological types were clear cell carcinoma （n = 49 ） and papillary carcinoma （ n = 14）. The pre-dosing Karnofsky performance scores were all ≥ 70 points. Sorafenib was used as a first- line single drug at 400 mg twice daily until disease progression or an onset of intolerable adverse reactions. Results Follow-ups ended in February 2013. The median follow-up period was 20 （6 -42 ） months. Twenty-four patients died. The outcomes were complete remission （ n = 2 ）, partial remission （ n = 8 ）, stable disease （n = 30 ） and disease progression （n = 23 ）. The overall objective response rate was 15.9% （10/63） and disease control rate 63.5% （40/63）. Hand-foot skin reaction （70. 0% ）, alopecia （62. 5% ）, rash （52. 5% ） , diarrhea （37.5%） , loss of appetite （32. 5% ） and fatigue （27.5%） were noted. Most adverse reactions occurred at 2 -4 weeks and subsided after symptomatic measures. And medication was not disrupted. Conclusion Sorafenib has a high disease control rate for advanced renal cell carcinoma. And its adverse reactions are generally mild and similar to those reported in the literature. It has excellent profiles of tolerability and safety.

关 键 词：肾肿瘤 索拉非尼 治疗结果 

分 类 号：R737.11[医药卫生—肿瘤]