舒尼替尼治疗转移性肾癌的初步评价

目的 评价舒尼替尼治疗转移性肾癌的疗效和安全性. 方法转移性肾癌患者31例.男23例,女8例.中位年龄55(25～75)岁.31例中行原发肿瘤切除30例,仅行活检术1例,病理证实为肾细胞癌,并至少有1处可测量的转移病灶.初始患者均口服舒尼替尼50 mg/d,用药4周、间歇2周为1个周期,每2个周期行CT扫描以评价疗效. 结果全组可评价疗效24例,无完全缓解病例,部分缓解5例、疾病稳定15例、疾病进展4例,其中死亡1例.中断治疗4例,其中因高龄、全身情况差、不能耐受服药1例,因经济困难停药2例,因肝功能损害停药1例.3例因治疗时间短而未评价.全组客观反应率21%(5/24),疾病控制率83%(20/24),中位无疾病进展生存时间11个月,1年无进展生存率80%.常见不良反应是手足皮肤反应、腹泻、食欲差、口腔炎、出血倾向和血液学毒性,分别通过外敷、口服药物和补液治疗得到及制. 结论舒尼替尼对转移性肾癌的病情控制有显著效果,也存在一定不良反应,通过及时干预和处理,患者大多可以耐受其不良反应.     

舒尼替尼治疗转移性肾癌的近期疗效及耐受性

目的 探讨舒尼替尼治疗转移性肾癌两种方案的疗效、不良反应特点及其相应处理方法.方法 舒尼替尼治疗晚期转移性肾癌病例45例,男25例,女20例,年龄36～78岁,平均48岁.随机分为2组,第1组:25例,舒尼替尼50 mg/d口服,用药4周、间歇2周为1个周期.第2组:20例,舒尼替尼口服,37.5 mg/d,连续服用.观察评估治疗中出现的不良反应及相应的处理方法.结果 全组可评估疗效40例,完全缓解1例,部分缓解3例,稳定28例,进展8例(死亡4例).全组疾病控制率为80%(32/40).2级以上的不良反应发生率:2组高血压分别有32%(8/25)与10%(2/20),P=0.02;肝功能损害分别为32%(8/25)与20%(4/20),P=0.011;手足皮肤反应分别为68%(17/25)与60%(12/20),血液学毒性分别为68%(17/25)与50%(10/20),口腔黏膜、反流性食管炎及胃炎分别为56%(14/25)与50%(10/20),疲劳乏力分别为64%(16/25)与40%(8/20).不良反应出现时间不同,但大多在服药3个月内出现.结论 舒尼替尼治疗转移性肾癌所产生的绝大多数常见不良反应发生率与国外报道略有不同,但通过严格随访,积极预防及对症处理,服药后安全性良好.舒尼替尼37.5 mg/d,连续服用在肝功能损伤、高血压等方面优于间歇服用的方案.

Abstract：

Objective To evaluate the clinical efficacy and side effects of sunitinib in the treatment of advanced renal cell carcinoma. Methods Forty-five patients with advanced renal cell carcinoma and an average age of 48.6 yrs were treated with sunitinib. Among the study group, 25 were male and 20 were female. In group one, patients received sunitinib treatment in repeated six week cycles consisting of four weeks of sunitinib 50 mg daily followed by two weeks off treatment (schedule 4/2). In group two, a single daily dose of sunitinib 37.5 mg was administrated to 20 patients without off treatment. A CT scan was used to evaluate the treatment efficacy after each cycle and the side effects were recorded accordingly. Results Clinical efficacy could be evaluated in 40 patients. Of these, two achieved complete response, eight achieved partial response, 27 were stable and the remaining eight experienced disease progression with four patients dying during the study period. The side effects of sunitinib in group one and in group two included hypertension 32% (8/25) and 10% (2/20), P=0.02; liver function impairment 32% (8/25) and 20% (4/20), P=0.011; hand-foot skin reaction 68% (17/25) and 60% (12/20), respectively. The incidence of major side effects of sunitinib were different in Chinese patients than from what had been previously reported in studies conducted in US and Europe. Generally, most of the sunitinib side effects were easy to manage. Conclusions There weredifferences between the two groups of Chinese patients treated with different sunitinib protocols. The protocol of sunitinib 37.5mg daily without off-treatment was better than the protocol of sunitinib 50mg daily (schedule 4/2) in regard to liver function impairment and hypertension.     

舒尼替尼治疗转移性肾癌的疗效及安全性评价

目的 评价舒尼替尼治疗转移性肾癌的疗效及安全性. 方法转移性肾癌患者15例.男10例,女5例.中位年龄56(37～73)岁.曾行原发肿瘤切除术13例,行CT引导下肿瘤穿刺活检术2例.组织学类型为透明细胞癌14例,乳头状细胞癌1例.舒尼替尼50 mg/d连续给药4周,停药2周方案4例;37.5 mg/d持续口服方案11例.评价肿瘤治疗疗效、患者无疾病进展生存时间及总体生存时间,同时观察治疗相关不良反应. 结果中位随访时间13(2～24)个月,15例均可评价疗效,其中部分缓解8例、疾病稳定5例、疾病进展2例.总客观缓解率53%(8/15),疾病控制率87%(13/15).由于随访时间短,尚不能报告中位无进展生存时间和总生存时间.常见不良反应包括手足皮肤反应11例(73%),头发颜色改变10例(67%),口腔溃疡、脱发各9例(60%),腹泻、中性粒细胞减少各8例(53%).多数不良反应为1～2级,且所有不良反应均可逆. 结论舒尼替尼治疗晚期转移性肾癌疗效显著,具有较高的肿瘤客观缓解率,大多数不良反应较轻且可逆,患者多可耐受,安全性较好,但长期疗效及安全性需进一步随访.     

舒尼替尼治疗转移性肾细胞癌9例报告

目的评价舒尼替尼治疗转移性肾细胞癌的疗效和安全性。方法转移性肾细胞癌患者9例,均为男性。年龄27～79岁（中位年龄56岁）。接受根治性肾切除术者7例,原发灶无法切除者2例。6例曾接受免疫治疗。透明细胞癌8例,乳头状癌1例。转移灶部位：肺转移3例,肝转移4例,淋巴结转移4例,肾上腺转移1例,骨转移1例,脑转移1例,其中4例患者为多发转移。每例患者至少有1处可测量病灶,即目标病灶。治疗时间3～15个月。治疗方案：舒尼替尼50 mg/d,连续服用4周后停药2周,6周为一个周期,直至肿瘤进展或出现不可耐受的不良反应。结果9例均可评价疗效。其中完全缓解1例,部分缓解3例,疾病稳定5例。总缓解率为44.4%（4/9）,疾病控制率为100%（9/9）。中位无进展生存时间42周（16～62周）。常见不良反应有腹泻、乏力、手足综合征、白细胞减少、高血压。结论舒尼替尼治疗转移性肾细胞癌疗效显著,不良反应多为轻中度1～2级。     

舒尼替尼治疗转移性非透明细胞肾癌的疗效观察

目的 初步探讨舒尼替尼治疗转移性非透明细胞肾癌的疗效.方法 非透明细胞肾癌22例.男14例,女8例.年龄29～76岁,中位年龄46岁.根治性肾切除术后出现转移14例,初诊时诊断为肾癌伴转移行减瘤性肾切除术8例.病理证实乳头状癌12例,嫌色细胞癌1例,集合管癌3例,未分类癌6例.转移部位包括肺、淋巴结、肾上腺,骨和肝脏.舒尼替尼50mg/d,口服,每天1次,治疗4周休息2周.治疗时间4.5 ～24.0个月,中位时间11个月.随访4.5 ～25.0个月,中位时间14个月.结果 22例疾病控制率为73％ (16/22).部分缓解4例(18％),其中乳头状癌3例,嫌色细胞癌1例,转移灶位于肺或肺加腹膜后淋巴结,或腹膜后淋巴结.疾病稳定＞3个月12例(55％),用药3个疗程内疾病进展6例(27％).结论 舒尼替尼治疗转移性肾乳头状癌、嫌色细胞癌、集合管癌、未分类癌有效,对淋巴结转移及肺转移者的疗效相对较好.     

舒尼替尼治疗转移性肾脏透明细胞癌的临床研究

目的 评价舒尼替尼治疗转移性肾脏透明细胞癌的疗效和安全性.方法 2008年6月至2009年6月共有23例转移性肾透明细胞癌患者接受舒尼替尼治疗,男性16例,女性7例,中位年龄52岁.其中一线治疗20例,索拉非尼治疗进展后二线治疗3例.患者病理检查均为肾脏透明细胞癌.治疗方案:舒尼替尼50 mg,每天1次,4/2方案,治疗4周停2周为1周期.直至疾病进展或者出现不可耐受的不良反应.结果 中位随访时间7.5个月(5个周期).根据RECIST标准进行疗效评价显示部分缓解(PR)4例(17.4%);疾病稳定(SD)18例(78.3%),疾病进展(PD)1例(4.3%).17例患者治疗超过6个月(4个周期),6个月的生存率为100%,6个月的无进展生存率为88.2%(15/17).不良反应多为Ⅰ～Ⅱ级,Ⅲ级不良反应为手足反应3例(13.0%)、血小板降低2例(8.7%)、腹泻1例(4.3%)和乏力1例(4.3%),Ⅳ级不良反应1例(4.3%).通过对症支持和减量治疗,不良反应大多可以控制并耐受.结论 舒尼替尼一线及二线治疗晚期转移性肾脏透明细胞癌可取得较高的客观控制率,不良反应可控制,严重不良反应少见.     

老年肾癌服用苹果酸舒尼替尼的护理体会

目的探讨老年肾癌患者服用苹果酸舒尼替尼过程中不良反应与护理特点,为临床安全合理用药提供参考。方法回顾分析应用苹果酸舒尼替尼治疗的36例老年晚期肾癌患者的临床资料,了解不良反应特点,对老年肾癌患者进行干预护理。结果本组不良反应发生率为手足综合征14(38.9%)、高血压19(52.8%)、腹泻21例(58.3%)、乏力22(61.1%)、口腔炎9(25%)、恶心呕吐7(19.5%)、甲状腺功能异常7(19.4%)、血液学毒性14(38.9%)等,其中手足综合征,高血压,腹泻和乏力发生率稍高于文献。护理干预后症状可减轻。结论老年患者服用苹果酸舒尼替尼安全有效,积极护理干预有助于提高老年患者耐受性。     

舒尼替尼治疗转移性肾癌的疗效和安全性分析:单中心37例总结

目的 评价舒尼替尼治疗转移性肾细胞癌的疗效和安全性.方法 2008年6月至2010年4月37例转移性肾细胞癌患者接受舒尼替尼治疗.其中男28例,女9例.年龄17～74岁,中位年龄52岁.行根治性肾切除手术33例,肾穿刺活检3例,腋窝转移淋巴结穿刺活检1例.vonHippel-Lindau综合征患者2例.肾透明细胞癌36例,其中伴颗粒细胞成分1例、伴肉瘤样分化4例,肾乳头状细胞癌1例.一线治疗30例,细胞因子或索拉非尼治疗进展后二线治疗7例.其中34例采用4/2方案,即口服舒尼替尼50.0 mg/d 4周,停用2周,6周为1个周期;3例予口服37.5 mg/d持续治疗,直至疾病进展或者出现不可耐受的不良反应.结果 中位随访时间12个月(8个周期).34例患者治疗2周期以上,可进行疗效评估.根据RECIST标准评价最佳疗效,部分缓解9例(26.5%),疾病稳定24例(70.6%),疾病进展1例(2.9%).客观反应率26.5%,疾病控制率97.1%.1年生存率95.8%(23/24),1年无进展生存率62.5%(15/24).主要不良反应包括血小板减少30例(81.1%)、甲状腺功能异常18/22例(81.8%)、手足反应27例(73.0%),白细胞减少23例(62.2%)、高血压18例(48.6%)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8例(21.6%)、甲状腺功能异常4/22例(18.2%)、手足反应4例(10.8%)、血磷降低4例(10.8%)和腹泻2例(5.4%)等.10例(27.0%)在治疗过程中减量或停药,1例因严重乏力不能耐受终止治疗.通过对症支持,减量或停药,不良反应可控制并耐受.结论 舒尼替尼一线及二线治疗晚期转移性肾细胞癌可取得较高的疾病控制率,不良反应发生率多数轻而易耐受,严重不良反应较少且可控.

Abstract：

Objective To evaluate the efficacy and safety of sunitinib in the treatment of metastatic renal cell carcinoma (RCC). Methods A total of 37 patients with metastatic RCC were treated with between June 2008 and April 2010, including 28 males and 9 females. The median age was 52 (17-74) years. All patients received a pathologic diagnosis of RCC, which consisted of 1 papillary cell carcinoma and 36 clear cell carcinomas, 4 of which accompanied with partial sarcoma differentiation. Thirty cases were treated with first line therapy and 7 cases showed progression on first-line cytokine or sorafinib therapy. Sunitinib monotherapy was administered in repeated 6-week cycles of daily oral therapy for 4 weeks, followed by 2 weeks off in 34 patients, while another 3 patients received 37. 5 mg Qd continuously until disease progression or unacceptable toxicities occurred. Overall response rate and safety were evaluated. Results The median follow up was 12 months (8 cycles),range 1.5-19. 5 months (1-13 cycles). 26.5% (9/34) patients achieved partial responses, 70.6%(24/34) patients demonstrated stable disease over≥3 months and 1 (2. 9%) patient developed progressive disease. The objective response rate was 26.5%, and the disease control rate was 97. 1%.The 12 months' overall survival rate was 95.8% (23/24), and 12 months' progression-free survival rate was 62.5 % (15/24). The most common treatment-related adverse events were thrombocytopenia (30 cases, 81.1%), thyroid dysfunction (18/22, 81.8%) ,hand-foot syndrome (27 cases, 73.0%),neutropenia (23 cases, 62.2%) and hypertension (18 cases, 48.6%). The major grade 3 adverse events included thrombocytopenia (8 cases, 21.6%), hand-foot syndrome (4 cases, 10.8%) and diarrhea (2 cases, 5. 4%). Most adverse events were ameliorated by treatment interruption. Ten (27.0%) patients had dose decrement or drug discontinuation and 1 patient quit the treatment for intolerable fatigue. Conclusion The efficacy and manageable adverse event profile of sunitinib as a single agent in first- or second-line therapy for patients with metastatic RCC.     

舒尼替尼治疗转移性肾癌的疗效和安全性分析:单中心37例总结

Objective To evaluate the efficacy and safety of sunitinib in the treatment of metastatic renal cell carcinoma (RCC). Methods A total of 37 patients with metastatic RCC were treated with between June 2008 and April 2010, including 28 males and 9 females. The median age was 52 (17-74) years. All patients received a pathologic diagnosis of RCC, which consisted of 1 papillary cell carcinoma and 36 clear cell carcinomas, 4 of which accompanied with partial sarcoma differentiation. Thirty cases were treated with first line therapy and 7 cases showed progression on first-line cytokine or sorafinib therapy. Sunitinib monotherapy was administered in repeated 6-week cycles of daily oral therapy for 4 weeks, followed by 2 weeks off in 34 patients, while another 3 patients received 37. 5 mg Qd continuously until disease progression or unacceptable toxicities occurred. Overall response rate and safety were evaluated. Results The median follow up was 12 months (8 cycles),range 1.5-19. 5 months (1-13 cycles). 26.5% (9/34) patients achieved partial responses, 70.6%(24/34) patients demonstrated stable disease over≥3 months and 1 (2. 9%) patient developed progressive disease. The objective response rate was 26.5%, and the disease control rate was 97. 1%.The 12 months' overall survival rate was 95.8% (23/24), and 12 months' progression-free survival rate was 62.5 % (15/24). The most common treatment-related adverse events were thrombocytopenia (30 cases, 81.1%), thyroid dysfunction (18/22, 81.8%) ,hand-foot syndrome (27 cases, 73.0%),neutropenia (23 cases, 62.2%) and hypertension (18 cases, 48.6%). The major grade 3 adverse events included thrombocytopenia (8 cases, 21.6%), hand-foot syndrome (4 cases, 10.8%) and diarrhea (2 cases, 5. 4%). Most adverse events were ameliorated by treatment interruption. Ten (27.0%) patients had dose decrement or drug discontinuation and 1 patient quit the treatment for intolerable fatigue. Conclusion The efficacy and manageable adverse event profile of sunitinib as a single agent in first- or second-line therapy for patients with metastatic RCC.     

舒尼替尼治疗转移性肾癌的疗效和安全性分析:单中心37例总结

Objective To evaluate the efficacy and safety of sunitinib in the treatment of metastatic renal cell carcinoma (RCC). Methods A total of 37 patients with metastatic RCC were treated with between June 2008 and April 2010, including 28 males and 9 females. The median age was 52 (17-74) years. All patients received a pathologic diagnosis of RCC, which consisted of 1 papillary cell carcinoma and 36 clear cell carcinomas, 4 of which accompanied with partial sarcoma differentiation. Thirty cases were treated with first line therapy and 7 cases showed progression on first-line cytokine or sorafinib therapy. Sunitinib monotherapy was administered in repeated 6-week cycles of daily oral therapy for 4 weeks, followed by 2 weeks off in 34 patients, while another 3 patients received 37. 5 mg Qd continuously until disease progression or unacceptable toxicities occurred. Overall response rate and safety were evaluated. Results The median follow up was 12 months (8 cycles),range 1.5-19. 5 months (1-13 cycles). 26.5% (9/34) patients achieved partial responses, 70.6%(24/34) patients demonstrated stable disease over≥3 months and 1 (2. 9%) patient developed progressive disease. The objective response rate was 26.5%, and the disease control rate was 97. 1%.The 12 months' overall survival rate was 95.8% (23/24), and 12 months' progression-free survival rate was 62.5 % (15/24). The most common treatment-related adverse events were thrombocytopenia (30 cases, 81.1%), thyroid dysfunction (18/22, 81.8%) ,hand-foot syndrome (27 cases, 73.0%),neutropenia (23 cases, 62.2%) and hypertension (18 cases, 48.6%). The major grade 3 adverse events included thrombocytopenia (8 cases, 21.6%), hand-foot syndrome (4 cases, 10.8%) and diarrhea (2 cases, 5. 4%). Most adverse events were ameliorated by treatment interruption. Ten (27.0%) patients had dose decrement or drug discontinuation and 1 patient quit the treatment for intolerable fatigue. Conclusion The efficacy and manageable adverse event profile of sunitinib as a single agent in first- or second-line therapy for patients with metastatic RCC.     

舒尼替尼治疗肾透明细胞癌的临床研究

目的 探讨舒尼替尼治疗肾透明细胞癌的疗效和安全性. 方法 我院2008年4月至2009年10月采用舒尼替尼治疗的肾透明细胞癌患者15例,男11例,女4例.年龄26 ～ 74岁,平均55岁.T3～T4期13例,其中8例曾行肾癌根治术,5例行肾活检术,病理诊断均为肾透明细胞癌.另2例为孤立肾肾癌T1a期合并肾功能不全,活检病理诊断为肾透明细胞癌.1例既往有高血压病史,单药控制血压＜140/90 mm Hg(1 mm Hg=0.133 kPa).肿瘤最大径(9.5 ±3.3)cm,可评估转移灶包括腹膜后淋巴结(6例)、纵隔淋巴结(3例)、脑(2例)、肺(6例)、骨(2例)及肝脏(2例).采用舒尼替尼50 mg,每天1次,用药4周、停药2周的方案.每个治疗周期开始前采用RECIST疗效评价标准对本组患者进行临床评估.观察并记录肿瘤变化情况、不良反应以及生存期等数据. 结果 本组用药时间1.5 ～15.0个月(中位时间6.0个月),最短为1个周期,最长10个周期.其中部分缓解7例,疾病稳定7例,疾病进展1例.治疗的客观反应率为46.7％ (7/15),疾病控制率为93.3％(14/15).6个月无进展生存率为93.3％(14/15),中位无进展生存时间12个月,治疗后肾肿瘤最大径(8.7±4.0)cm.1例既往有高血压病史者,第二周期血压＞ 160/105 mm Hg,降压药加量并调整为两联后血压控制良好;1例治疗前无高血压病史者,第三周期出现血压＞ 150/100 mm Hg,使用降压药后血压控制良好.此2例治疗后肿瘤最大径分别从4.2 cm和3.2 cm减小至2.0 cm和1.3 cm.本组1/2级不良反应:皮肤发黄及黄色汗液12例(80％),乏力12例(80％),甲状腺功能低下4例(26.7％),胆红素升高和三酰甘油升高各有7例(46.7％);3/4级不良反应4例,其中因突发血小板减少,出现消化道出血1例;严重乏力、恶心、呕吐合并严重手足皮肤反应3例. 结论 舒尼替尼治疗肾透明细胞癌效果良好,患者耐受性较好,安全性高.     

高危肾细胞癌术后舒尼替尼辅助治疗的效果观察

目的 评价高危肾细胞癌术后舒尼替尼辅助治疗的疗效与安全性. 方法 接受根治性肾切除术的肾癌患者60例,均经病理检查确诊为肾透明细胞癌.术后1个月开始口服舒尼替尼50 mg(用4周停2周方案)或37.5 mg每日连续给药的方案治疗,共3个周期. 结果 60例患者均可耐受舒尼替尼治疗,无因不良反应而中止治疗者.不良反应多为1～2度.其中中性粒细胞减少56.7％,其次为血小板减少53.3％、白细胞减少48.3％、手足综合征46.7％和高血压36.7％.3 ～4度不良反应血小板减少发生率为25.0％,其次为中性粒细胞减少(15.0％)、手足综合征(11.7％)、白细胞减少(8.3％).大多数不良反应于治疗后1～2个周期内发生,并于治疗停止后1个月左右减轻,无不可逆的不良反应发生.截至2012年4月5日,除1例死于与疾病无关的脑血管意外外,余59例未出现复发,6个月和9个月的无疾病复发生存率100％. 结论 高危肾癌患者术后舒尼替尼辅助治疗的骨髓抑制发生率少于晚期肾癌患者,但仍需较长期的进一步数据来证实.     

索拉非尼增量治疗转移性肾癌的初步报告

目的 评价索拉非尼增量治疗转移性肾癌的疗效及安全性. 方法 16例复治的转移性肾透明细胞癌患者,中位年龄53(37～71)岁.男女比例3:1.既往均接受过肾癌根治术和至少1个方案的全身治疗,存在至少1个单径可测病灶,均服用索拉非尼,从800 mg/d逐渐增量至1200或1600 mg/d,直至不能耐受或病情进展,评价近期疗效、不良反应和无进展生存期. 结果 16例患者中位随访时间11(9～16)个月.客观有效(完全缓解加部分缓解)7例,临床受益(完全缓解加部分缓解加病灶稳定)13例.严重不良反应(≥3级)主要表现为手足皮肤反应25%(4/16)、黏膜炎19%(3/16)、腹泻19%(3/16)、高血压12%(2/16)和骨髓抑制12%(2/16),经剂量调整和一般对症治疗后短期内症状可消失或减轻到1～2级. 结论 索拉非尼增量治疗晚期肾癌可获较高的客观反应率,不良反应可控制,能延长高危患者的无进展生存期.     

舒尼替尼在晚期肾细胞癌二线序贯治疗中的临床应用研究

目的:探讨舒尼替尼在晚期肾细胞癌(renal cell carcinoma,RCC)患者二线序贯治疗中的临床效果与安全性。方法:对11例曾接受其他靶向药物治疗的晚期RCC患者在我院行二线舒尼替尼治疗,观察其客观缓解率(ORR)、疾病控制率(DCR)、中位无进展生存期(PFS)及总生存期(OS)等疗效指标及不良反应发生情况。结果:11例患者中2例因不良反应进行药物减量,1例终止治疗。平均接受舒尼替尼治疗时间10.2个月,9例死亡,2例仍存活。DCR 90.9%,中位PFS为7.4个月,中位OS为22.6个月。主要不良反应包括血小板减少症、白细胞减少症、手足皮肤反应、甲状腺功能低下、高血压等。结论:舒尼替尼序贯治疗对于接受过其他靶向药物治疗后进展的晚期RCC患者仍具有良好的疗效和安全性。     

Presurgical sunitinib reduces tumor size and may facilitate partial nephrectomy in patients with renal cell carcinoma

ObjectiveTo determine whether presurgical sunitinib reduces primary renal cell carcinoma (RCC) size and facilitates partial nephrectomy (PN).MethodsData from potential candidates for PN treated with sunitinib with primary RCC in situ were reviewed retrospectively. Primary outcome was reduction in tumor bidirectional area.ResultsIncluded were 72 potential candidates for PN who received sunitinib before definitive renal surgery on 78 kidneys. Median primary tumor size was 7.2 cm (interquartile range [IQR]: 5.3–8.7 cm) before and 5.3 cm (IQR: 4.1–7.5 cm) after sunitinib treatment (P<0.0001), resulting in 32% reduction in tumor bidirectional area (IQR: 14%–46%). Downsizing occurred in 65 tumors (83%), with 15 partial responses (19%). Tumor complexity per R.E.N.A.L. score was reduced in 59%, with median posttreatment score of 9 (IQR: 8–10). Predictors of lesser tumor downsizing included clinical evidence of lymph node metastases (P<0.0001), non–clear cell histology (P = 0.0017), and higher nuclear grade (P = 0.023). Surgery was performed for 68 tumors (87%) and was not delayed in any patient owing to sunitinib toxicity. Grade≥3 surgical complications occurred in 5 patients (7%). PN was performed for 49 kidneys (63%) after sunitinib, including 76% of patients without and 41% with metastatic disease (P = 0.0026). PN was completed in 100%, 86%, 65%, and 60% of localized cT1a, cT1b, cT2, and cT3 tumors, respectively.ConclusionPresurgical sunitinib leads to modest tumor reduction in most primary RCC, and many patients can be subsequently treated with PN with acceptable morbidity and preserved renal function. A randomized trial is required to definitively determine whether presurgical therapy enhances feasibility of PN.     

舒尼替尼治疗晚期肾癌的临床疗效及安全性分析

目的 初步探究舒尼替尼治疗晚期肾癌的疗效及安全性.方法 回顾性分析我科38例接受舒尼替尼治疗的晚期肾癌患者的临床资料.38例中男27例,女11例;行肾癌根治术34例,行保留肾单位手术1例,3例未行手术治疗.病理类型:透明细胞癌31例、乳头状癌3例、嫌色细胞癌1例、混合细胞癌3例.转移部位:肺21例、淋巴结9例、肝2例、骨5例、肾上腺2例、腔静脉10例、附件1例、腹膜后7例,其中单发转移20例(52.6%),多发转移18例(47.4%).舒尼替尼治疗采用标准的4/2方案:50 mg/d,口服,服4周停2周.结果 38例患者的疗效评价:完全缓解2例(5.4%)、部分缓解5例(13.1%)、疾病稳定26例(68.4%)、疾病进展5例(13.1%);客观缓解率18.5%,疾病控制率86.9%.中位无进展生存期为15个月,中位总生存期为22个月.常见不良反应有中性粒细胞降低、手足反应、口腔黏膜溃疡、皮肤黄染、毛发变白、腹泻、乏力和高血压.结论 舒尼替尼治疗晚期肾癌具有良好的效果,患者临床获益明显.虽然不良反应较多,但多为Ⅰ或Ⅱ级,在患者耐受范围之内.     

Hilar fat infiltration: A new prognostic factor in metastatic clear cell renal cell carcinoma with first-line sunitinib treatment

Introduction

The selection of patients with metastatic clear cell renal cell carcinoma (ccRCC) who may benefit from targeted tyrosine kinase inhibitors has been a challenge, even more so now with the advent of new therapies. Hilar fat infiltration (HFI) is a validated prognostic factor in nonmetastatic ccRCC (TNM 2009 staging system) but has never been studied in metastatic patients. We aimed to assess its phenotype and prognostic effect in patients with metastatic ccRCC treated with first-line sunitinib.