CAJ | 학술논문

目的评价舒尼替尼治疗转移性肾细胞癌的疗效及安全性,并分析疗效与不良反应的相关性. 方法 2008年6月至2013年3月91例转移性肾细胞癌患者接受舒尼替尼治疗.其中男73例,女18例.年龄17～77岁,中位年龄58岁.行根治性肾切除术83例,肾穿刺活检或转移灶穿刺活检8例.肾透明细胞癌86例,肾乳头状细胞癌4例,未分类肾癌1例.一线治疗77例,细胞因子治疗失败者8例,索拉非尼治疗进展后二线治疗6例.81例口服舒尼替尼50 mg/d 4周,停药2周,6周为1个周期;10例口服舒尼替尼37.5 mg/d,持续用药.治疗期间根据不良反应的严重程度调整用药,直至出现疾病进展或出现不可耐受的不良反应. 结果中位随访时间19.0个月.完全缓解2例(2.2％),部分缓解23例(25.3％),疾病稳定57例(62.6％),疾病进展9例(9.9％).客观缓解率为27.5％,疾病控制率为90.1％.获得疾病控制患者达到最佳疗效的中位时间为5.5个月(2.0～27.0个月).中位无疾病进展时间15.5个月.主要不良反应包括血小板减少71例(78.0％),甲状腺功能异常43例(76.8％,43/56),手足皮肤反应68例(74.7％),白细胞减少57例(62.6％),高血压44例(48.4％),乏力43例(47.3％).3～4级不良反应38例,主要包括血小板减少14例、中性粒细胞减少8例、手足皮肤反应7例及甲状腺功能异常6例.31例(34.1％)患者因不良反应需要调整药物剂量或短暂停药,多数患者经对症支持后可继续治疗,2例患者分别因严重乏力和心肌梗死中断治疗.出现1～2级不良反应与出现3～4级不良反应患者的中位无疾病进展生存期分别为11.5个月和18.0个月(p=0.04). 结论舒尼替尼用于治疗转移性肾细胞癌患者具有较好的疗效和安全性,可获得较长的无进展生存期.多数不良反应可以耐受,出现3～4级不良反应可能是治疗有效的预测因子.
목적 평개서니체니치료전이성신세포암적료효급안전성,병분석료효여불량반응적상관성. 방법 2008년6월지2013년3월91례전이성신세포암환자접수서니체니치료.기중남73례,녀18례.년령17～77세,중위년령58세.행근치성신절제술83례,신천자활검혹전이조천자활검8례.신투명세포암86례,신유두상세포암4례,미분류신암1례.일선치료77례,세포인자치료실패자8례,색랍비니치료진전후이선치료6례.81례구복서니체니50 mg/d 4주,정약2주,6주위1개주기;10례구복서니체니37.5 mg/d,지속용약.치료기간근거불량반응적엄중정도조정용약,직지출현질병진전혹출현불가내수적불량반응. 결과 중위수방시간19.0개월.완전완해2례(2.2％),부분완해23례(25.3％),질병은정57례(62.6％),질병진전9례(9.9％).객관완해솔위27.5％,질병공제솔위90.1％.획득질병공제환자체도최가료효적중위시간위5.5개월(2.0～27.0개월).중위무질병진전시간15.5개월.주요불량반응포괄혈소판감소71례(78.0％),갑상선공능이상43례(76.8％,43/56),수족피부반응68례(74.7％),백세포감소57례(62.6％),고혈압44례(48.4％),핍력43례(47.3％).3～4급불량반응38례,주요포괄혈소판감소14례、중성립세포감소8례、수족피부반응7례급갑상선공능이상6례.31례(34.1％)환자인불량반응수요조정약물제량혹단잠정약,다수환자경대증지지후가계속치료,2례환자분별인엄중핍력화심기경사중단치료.출현1～2급불량반응여출현3～4급불량반응환자적중위무질병진전생존기분별위11.5개월화18.0개월(p=0.04). 결론 서니체니용우치료전이성신세포암환자구유교호적료효화안전성,가획득교장적무진전생존기.다수불량반응가이내수,출현3～4급불량반응가능시치료유효적예측인자.
Objective To evaluate the efficacy,safety and their correlation of sunitinib in the treatment of metastatic renal cell carcinoma (mRCC).Methods Ninety-one cases with mRCC were treated with sunitinib between June 2008 and March 2013,including 73 males and 18 females.The median age was 58 (17-77) years.All patients were diagnosed as RCC,which consisted of 86 clear cell carcinomas,4 papillary cell carcinomas and 1 unclassified RCC.Seventy-seven cases were treated with first line therapy and 14 cases showed progression on first-line cytokine or sorafinib therapy.Daily oral sunitinib monotherapy was administered for 4 weeks,followed by 2 weeks off by repeated 6-week cycles in 81 patients,while another 10 patients received 37.5 mg Qd continuously until disease progression or unacceptable toxicities occurred.Results The median follow-up was 19.0 months.Two (2.2％) patients achieved complete responses,23 (25.3％) patients achieved partial responses,57 (62.6％) patients demonstrated stable disease for ≥ 3 months and 9 (9.9％) patients developed progressive disease.The objective response rate was 27.5％,and the disease control rate was 90.1％.The median progression-free survival (PFS) was 15.5 months.The most common treatment-related adverse events were thrombocytopenia (71 cases,78.0％),thyroid dysfunction (43/56,76.8％),hand-foot syndrome(68 cases,74.7％),leucopenia (57 cases,62.6％),hypertension (44 cases,48.4％),fatigue (43 cases,47.3％).The grade 3-4 major adverse events (38 cases) included thrombocytopenia (14 cases),neutropenia(8 cases),hand-foot syndrome (7 cases) and thyroid dysfunction (6 cases).Thirty-one (34.1％) patients had dose decrement or drug discontinuation.Two patients withdrew fiom treatment for intolerable fatigue and cardiac infarction.The median PFS was significantly improved in patients with grade 3-4 adverse events compared with those with only grade 1-2 adverse events(18.0 versus 11.5 months,P=0.04).Conclusions The efficacy of sunitinib in patients with mRCC is encouraging.At the same time,the tolerability is good.Sunitinib-associated severe adverse events may be a predictive marker for treatment efficacy in mRCC.