舒尼替尼一线治疗转移性肾癌38例临床分析  

A clinical study of sunitinib as the first line treatment in 38 patients with metastatic renal cell carcinoma

作　　者：宋继文[1] 米振国[1] 王斌[1] 张超[1] 张建斌[1] 庞东梓[1] 崔嵛[1] 王振国[1] 

机构地区：[1]山西省肿瘤医院泌尿外科,山西太原030013

出　　处：《现代泌尿外科杂志》2016年第8期597-600,共4页Journal of Modern Urology

摘　　要：目的 评价舒尼替尼一线治疗转移性肾癌的疗效、安全性,并探讨其对不同转移灶的疗效。方法 2008年12月至2011年7月经病理确诊为转移性肾透明细胞癌的38例患者接受舒尼替尼治疗,男25例,女13例,中位年龄57（32~74）岁。曾行原发肿瘤姑息性切除术35例,行彩超引导下肿瘤穿刺活检术3例,组织学类型均为肾透明细胞癌。治疗方案为舒尼替尼50mg/d,4/2方案34例,37.5mg/d,持续口服方案4例。结果 中位随访时间13（3~34）月。36例患者治疗2周期以上,可进行疗效评估。根据标准进行疗效评价显示部分缓解（PR）6例（16.7%）,疾病稳定（SD）28例（77.8%）,疾病进展（PD）2例（5.6%）,其中死亡1例。全组客观反应率16.7%（6/36）,疾病控制率94.4%（34/36）。主要不良反应包括乏力11例（30.6%）、脱发3例（8.3%）、血小板减少21例（58.3%）、甲状腺功能异常26例（72.2%）、白细胞减少20例（55.6%）、高血压16例（44.4%）、手足反应10例（27.8%）、腹泻4例（11.1%）等。大多数不良反应为1~2级,3级以上不良反应包括血小板降低2例（5.6%）和水肿1例（2.8%）等。13例（36.1%）患者在治疗过程中减量或停药,停药时间均小于2周。通过对症支持,减量或停药,不良反应可控制并耐受。缓解病例多为局部复发及肺转移病灶,进展病例为骨、肝、脑转移病灶。结论 舒尼替尼一线治疗晚期转移性肾透明细胞癌可取得较高的疾病控制率,不良反应可控、可逆,并且其对不同器官组织转移灶的疗效可能存在一定的差异。Objective To evaluate the efficacy and safety of sunitinib as the first line treatment for metastatic renal cell carcinoma （mRCC）. Methods A total of 38 cases of pathologically confirmed mRCC were treated during Dec. 2008 arid Jul. 2011, including 25 males and 13 females. The median age was 57（32--74）years. Of all cases, 35 received palliative resection of tumors, 3 underwent needle biopsy under the guidance of color Doppler ultrasound. All cases were confirmed to be renal clear cell carcinoma. Sunitinib monotherapy was administered in repeated 6-week cycles of daily oral therapy of 50 mg/d for 4 weeks, followed by 2 weeks off in 34 patients, while another 4 patients continuously received 37.5 mg daily until disease pro- gression or unacceptable toxicities occurred. The overall response rate and safety were evaluated. Results The median fol- low-up was 13 months, ranging 3--34 months. Thirty six patients received 2 cycles of treatment and the efficacy was evaluated. According to the RECIST criteria, the disease was relieved in 16.7% （6/36） patients, remained unchanged in 77.8% （28/36） patients, progressed in 2 （5.6%） patients, one of whom dead. The overall objective response rate was 16. 7%, and the control rate was 94.4%. The most common side effects included fatigue in 11 cases （30.6%）, alopecia in 3 cases （8.3%）, thrombocy- topenia in 21 cases （58.3%） ,thyroid dysfunction in 26 cases （72.2%）, neutropenia in 20 cases （55.6%）, hypertension inl6 ca- ses （44.4%）, hand-foot syndrome in 10 cases （27.8%） and diarrhea in 4 cases （11.1%）. Most adverse events were grade 1-- 2. The major grade 3 adverse events included thrombocytopenia （2 cases, 5.6%） and edema 1 case （2.8%）. Thirteen patients reduced dosage or stop medication for less than 2 weeks during treatment, and the adverse events were then tolerable. Remis- sion was achieved in patients with local recurrence or pulmonary metastasis. Progress occurred in patients with bone, liver or brain metastasis.

关 键 词：癌 肾细胞 肿瘤转移 舒尼替尼 

分 类 号：R737[医药卫生—肿瘤]