背景与目的:舒尼替尼治疗转移性肾癌的有效性已经被Ⅱ期和Ⅲ期临床实验验证,在多个临床指南中推荐为晚期肾癌的一线治疗方案.本研究观察舒尼替尼治疗晚期肾细胞癌的疗效和安全性.方法:中国医学科学院肿瘤医院于2008年8月—2011年12月收治晚期肾细胞癌患者52例,男性43例,女性9例.年龄29~76岁,中位年龄54.5岁.原发肾脏病灶手术切除45例,穿刺病理证实7例.肾透明细胞癌48例,肾乳头状细胞癌4例.治疗方案:舒尼替尼50 mg,每天1次,治疗4周停2周为1个周期;每2个周期行影像学检查评价疗效.结果:随访1~36个月,3例因患者经济情况停药,49例可评价疗效.完全缓解(complete remission,CR)2例(4.1%),部分缓解(partial remission,PR)10例(20.4%),疾病稳定(stable disease,SD)31例(63.3%),疾病进展(progression of disease,PD)6例(12.2%),疾病控制率(CR+PR+SD)为87.8%.1年疾病控制率为61%,1年生存率为85%.中位疾病无进展期(progression free survival,PFS)为15个月,中位总生存时间(overall survival,OS)为23个月.根据病理类型、转移部位和体力状况评分等将患者分为亚组进一步统计.肾透明细胞癌组中位PFS为12个月,中位OS为23个月.中位PFS在单脏器转移组为18个月,多脏器转移组为9个月,在术后病理确诊组为18个月,在穿刺病理确诊组为8个月;在美国东部肿瘤协作组(Eastern Cooperative Oncology Group,ECOG)评分分组中,0分组为15个月,1分组为12个月.中位生存时间在单脏器转移组未达到,多脏器转移组为12个月;在术后病理确诊组为23个月,在穿刺病理确诊组为9个月;在ECOG为0分组未达到,在ECOG为1分组为23个月.常见不良反应包括手足皮肤反应、乏力、白细胞降低、血小板降低、口腔黏膜炎及高血压等,发生的Ⅲ级不良反应包括手足皮肤反应、白细胞降低、血小板降低、贫血、腹泻、口腔黏膜炎、甲状腺功能减低、呕吐和浮肿.通过对症支持及减量,不良反应可以控制并耐受.结论:舒尼替尼治疗晚期肾细胞癌疗效显著,常见不良反应患者可耐受,严重不良反应需要医疗干预.
揹景與目的:舒尼替尼治療轉移性腎癌的有效性已經被Ⅱ期和Ⅲ期臨床實驗驗證,在多箇臨床指南中推薦為晚期腎癌的一線治療方案.本研究觀察舒尼替尼治療晚期腎細胞癌的療效和安全性.方法:中國醫學科學院腫瘤醫院于2008年8月—2011年12月收治晚期腎細胞癌患者52例,男性43例,女性9例.年齡29~76歲,中位年齡54.5歲.原髮腎髒病竈手術切除45例,穿刺病理證實7例.腎透明細胞癌48例,腎乳頭狀細胞癌4例.治療方案:舒尼替尼50 mg,每天1次,治療4週停2週為1箇週期;每2箇週期行影像學檢查評價療效.結果:隨訪1~36箇月,3例因患者經濟情況停藥,49例可評價療效.完全緩解(complete remission,CR)2例(4.1%),部分緩解(partial remission,PR)10例(20.4%),疾病穩定(stable disease,SD)31例(63.3%),疾病進展(progression of disease,PD)6例(12.2%),疾病控製率(CR+PR+SD)為87.8%.1年疾病控製率為61%,1年生存率為85%.中位疾病無進展期(progression free survival,PFS)為15箇月,中位總生存時間(overall survival,OS)為23箇月.根據病理類型、轉移部位和體力狀況評分等將患者分為亞組進一步統計.腎透明細胞癌組中位PFS為12箇月,中位OS為23箇月.中位PFS在單髒器轉移組為18箇月,多髒器轉移組為9箇月,在術後病理確診組為18箇月,在穿刺病理確診組為8箇月;在美國東部腫瘤協作組(Eastern Cooperative Oncology Group,ECOG)評分分組中,0分組為15箇月,1分組為12箇月.中位生存時間在單髒器轉移組未達到,多髒器轉移組為12箇月;在術後病理確診組為23箇月,在穿刺病理確診組為9箇月;在ECOG為0分組未達到,在ECOG為1分組為23箇月.常見不良反應包括手足皮膚反應、乏力、白細胞降低、血小闆降低、口腔黏膜炎及高血壓等,髮生的Ⅲ級不良反應包括手足皮膚反應、白細胞降低、血小闆降低、貧血、腹瀉、口腔黏膜炎、甲狀腺功能減低、嘔吐和浮腫.通過對癥支持及減量,不良反應可以控製併耐受.結論:舒尼替尼治療晚期腎細胞癌療效顯著,常見不良反應患者可耐受,嚴重不良反應需要醫療榦預.
배경여목적:서니체니치료전이성신암적유효성이경피Ⅱ기화Ⅲ기림상실험험증,재다개림상지남중추천위만기신암적일선치료방안.본연구관찰서니체니치료만기신세포암적료효화안전성.방법:중국의학과학원종류의원우2008년8월—2011년12월수치만기신세포암환자52례,남성43례,녀성9례.년령29~76세,중위년령54.5세.원발신장병조수술절제45례,천자병리증실7례.신투명세포암48례,신유두상세포암4례.치료방안:서니체니50 mg,매천1차,치료4주정2주위1개주기;매2개주기행영상학검사평개료효.결과:수방1~36개월,3례인환자경제정황정약,49례가평개료효.완전완해(complete remission,CR)2례(4.1%),부분완해(partial remission,PR)10례(20.4%),질병은정(stable disease,SD)31례(63.3%),질병진전(progression of disease,PD)6례(12.2%),질병공제솔(CR+PR+SD)위87.8%.1년질병공제솔위61%,1년생존솔위85%.중위질병무진전기(progression free survival,PFS)위15개월,중위총생존시간(overall survival,OS)위23개월.근거병리류형、전이부위화체력상황평분등장환자분위아조진일보통계.신투명세포암조중위PFS위12개월,중위OS위23개월.중위PFS재단장기전이조위18개월,다장기전이조위9개월,재술후병리학진조위18개월,재천자병리학진조위8개월;재미국동부종류협작조(Eastern Cooperative Oncology Group,ECOG)평분분조중,0분조위15개월,1분조위12개월.중위생존시간재단장기전이조미체도,다장기전이조위12개월;재술후병리학진조위23개월,재천자병리학진조위9개월;재ECOG위0분조미체도,재ECOG위1분조위23개월.상견불량반응포괄수족피부반응、핍력、백세포강저、혈소판강저、구강점막염급고혈압등,발생적Ⅲ급불량반응포괄수족피부반응、백세포강저、혈소판강저、빈혈、복사、구강점막염、갑상선공능감저、구토화부종.통과대증지지급감량,불량반응가이공제병내수.결론:서니체니치료만기신세포암료효현저,상견불량반응환자가내수,엄중불량반응수요의료간예.
@@@@Background and purpose:The effectiveness of sunitinib in the treatment of metastatic renal cell carcinoma has been verified by phaseⅡandⅢclinical trails. Sunitinib is approved multinationally for the first-line treatment of advanced renal cell carcinoma. Our study was designed to evaluate the safety and efficacy of sunitinib in the treatment of advanced renal cell carcinoma. Methods:A total number of 52 patients with advanced renal cell carcinoma were enrolled from Aug. 2008 to Dec. 2011, during which, 43 were male, 9 were female, the median age was 54.5 years (ranged from 29 to 76 years). Forty-five patients received prior radical nephrectomy, 7 patients received biopsy. Forty-eight patients were diagnosed as renal clear cell carcinoma, 4 patients were diagnosed as renal papillary cell carcinoma. Sunitinib monotherapy was administered in repeated 6-week cycles of daily oral 50 mg for 4 weeks, followed by 2 weeks off. CT or MRI scan was used to evaluate the efficacy every 2 cycles. Results:Follow ups were raging from 1 to 36 months. Forty-nine patients could be evaluated the efficacy, 3 patients discontinued for lacking of financial support. The disease control rate was 87.8%, 2 (4.1%) patients with complete response (CR), 10 (20.4%) patients with partial response (PR), 31 (63.3%) patients with stable disease (SD), and 6 (12.2%) patients with progression disease (PD) as the best tumor response. The 1-year control rate was 61%, and the 1-year survival rate was 85%. Median progression-free survival (PFS) was 15 months, and median overall survival (OS) was 23 months. According to the pathological types, metastatic sites, and ECOG status, the patients were divided into subgroups. In patients with clear cell renal cell carcinoma, median PFS was 12 months, and median OS was 23 months. Median PFS was longer in patients with single-organ metastasis compared with multi-organ metastases subgroup (18 vs 9 month), surgery compared with biopsy subgroup (18 vs 8 month), and ECOG 0 score compared with ECOG 1 score subgroup (15 vs 12 month). Median OS has not been reached in single-organ metastasis compared with 12 months in multi-organ metastasis subgroup, was 23 months in surgery compared with 9 months in biopsy subgroup, and has not been reached in ECOG 0 score compared with 23 months in ECOG 1 score subgroup. The most common adverse events were hand-foot syndrome, fatigue, leucopenia, thrombocytopenia, mucositis, and hypertension. Grade 3 adverse events included hand-foot syndrome, leucopenia, thrombocytopenia, anemia, diarrhea, mucositis, hypothyroidism, vomiting, and facial edema. All adverse events were ameliorated by supportive treatment or dose reduction. Conclusion:Sunitinib was efficacious in the treatment of advanced renal cell carcinoma. Most adverse events were tolerable, and grade 3 adverse events need medical treatment.
