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.     

索拉非尼治疗具有肉瘤样分化的转移性肾癌的疗效观察

目的 分析索拉非尼治疗具有肉瘤样分化的转移性肾癌的疗效.方法 已行肾脏原发肿瘤切除的转移性肾细胞癌患者14例,病理证实原发肿瘤中含有肉瘤样分化成分.平均年龄61(45～77)岁.肾透明细胞癌伴肉瘤样分化8例,乳头状癌伴肉瘤样分化2例,单纯肉瘤样癌4例,肾原发病灶中肉瘤样成分比例为20%～100%.肿瘤转移部位分别为肺、淋巴结、肾上腺、肝或骨.采用索拉非尼400 mg或600 mg,2次/d治疗.采用Kendall相关检验和Pearson相关检验分别检测肉瘤样成分比例与治疗客观反应及中位无疾病进展时间(PFS)的相关性.中位治疗时间8(3～19)个月.结果 部分缓解(PR)2例,其转移病灶均位于腹膜后及纵隔淋巴结,肉瘤样成分比例分别为100%和20%;疾病稳定(SD)7例,转移部位包括肺、淋巴结、肾上腺、骨和肝;疾病进展(PD)5例,总疾病控制率为64%.随访至2009年7月,出现PD 9例,PFS 6(0～19)个月.肉瘤样成分比例与治疗的客观反应及PFS均无相关性(P=0.247,P=0.554).结论 索拉非尼常规剂量治疗具有肉瘤样分化的转移性肾细胞癌有一定疗效,但客观有效率及PFS与肉瘤样成分的比例无明显相关性.     

肾嫌色细胞癌21例临床分析及文献复习

目的 提高肾嫌色细胞癌的诊治水平和对此类型肾癌的认识.方法 回顾性分析21例肾嫌色细胞癌的临床资料.男11例,女10例.年龄27 ～ 85岁,平均52岁.11例行腹腔镜下肾癌根治术,8例行腹腔镜下肾部分切除术,2例行开放肾癌根治术.结果 术后病理证实为肾嫌色细胞癌.病理分期:pT1N0M0 13例,pT2N0M0 5例,pT3aN1 M0 2例,pT4N0M0 1例.Fuhrman病理分级:G1 6例,G2 14例,G31例.术后随访19例,时间3～36个月,平均17个月,1例死于心脏病,1例术后6个月局部复发,给予索拉非尼治疗2个月后肺部感染死亡,1例术后12个月后出现肺转移,给予索拉非尼治疗1个月后死亡,16例无瘤生存.结论 肾嫌色细胞癌是一种具有特殊形态的少见肾癌类型.肾根治性切除术是治疗肾嫌色细胞癌的首选方法.与同期、同级的其他类型肾癌相比,肾嫌色细胞癌预后较好.     

索拉非尼治疗转移性肾透明细胞癌21例临床分析

目的 初步评价索拉非尼治疗转移性肾透明细胞癌的疗效和安全性.方法 应用索拉非尼治疗转移性肾透明细胞癌21例.中位年龄60(38～82)岁.18例曾接受免疫治疗和(或)化疗,3例应用索拉非尼为一线治疗.单一脏器转移14例,多脏器转移7例.至少具有1处可测量病灶.发现肾癌同时伴转移者10例,术后发现转移者11例,其中术后≤1年发现者4例,＞1年者7例.治疗方法:索拉非尼400 mg,口服,2次/d,直至肿瘤进展或出现不可耐受的不良反应.采用实体肿瘤疗效评价标准评价疗效,每8周评定1次.中位随访时间29(11～61)周.结果 部分缓解(PR)4例(19%),疾病稳定(SD)17例(81%),无死亡和出组病例.PR 4例中肺部转移灶缓解3例.最常见不良反应为手足皮肤反应18例(86%)、脱发2例(10%),口腔溃疡2例(10%)、高血压2例(10%)、发热1例(5%)和腹泻1例(5%).仅出现3级不良反应1例,未见4级不良反应.结论 索拉非尼治疗晚期肾透明细胞癌的有效率和疾病控制率均较高,不良反应多较轻.     

增加索拉非尼剂量治疗常规剂量无效的晚期肾癌的临床评价

目的 观察索拉非尼常规剂量治疗晚期肾癌失败后,增加药物剂量继续治疗的疗效和不良反应.方法 索拉非尼常规剂量(400 mg 2次/d)治疗4～22个月后出现进展的晚期肾癌患者24例,中位年龄52(27～72)岁.索拉非尼增加剂量至600 mg,2次/d 10例;增加剂量至800 mg,2次/d 14例.计算治疗的客观反应率,疾病控制率,中位无疾病进展生存时间(PFS).统计不同剂量药物相关不良反应.结果 在进行索拉非尼增量治疗1个月后,疾病进展(PD)4例,终止治疗.继续治疗20例,其中1例肾透明细胞癌术后肺转移者增量治疗后肿瘤最大径较增最前缩小42.5%,疗效评价为部分缓解(PR);疾病稳定(SD)19例,其中2例转移灶分别位于脑、肺和腹膜后淋巴结的患者增量治疗后肿瘤最大径之和分别缩小24.3%和11.6%.10例患者于增量治疗3～14个月后出现疾病进展,PFS为7个月.本组24例索拉非尼增量治疗后PR 1例(4.2%),SD 19例(79.2%),总体疾病控制率83.3%(20/24).中位PFS为5(0～14)个月.索拉非尼增量后常见不良反应与常规剂量相似,但增量后不良反应发生率较常规剂量有所增加,如手足皮肤反应分别为21例和13例、腹泻分别为14例和4例、乏力分别为15例和7例、中性粒细胞下降分别为3例和0例,本组未出现4级不良反应.结论 索拉非尼常规剂量治疗失败后可增加索拉非尼剂量进一步治疗,仍有较高的疾病控制率,且不良反应增加并不显著,多数患者可耐受.     

肾癌不同病理亚型的MRI特点

目的探讨肾癌不同病理亚型的MRI表现。方法回顾性分析了2009年1月至2013年6月本中心收治的47例肾癌病例,所有病例均经MRI检查,术后病理确诊为肾细胞癌。以正常肾皮质信号强度为标准,采用目测法比较总结各病例的MRI特点。用SPSS 13.0统计软件,以P=0.05为标准进行卡方分析。结果肾透明细胞癌T1WI增强序列强化幅度明显高于其他两个亚型,且具有明显的"快进快出"的特点,有统计学意义(P0.05)。而肾乳头状细胞癌与肾嫌色细胞癌的T1WI增强序列图像无明显差异(P0.05)。肾透明细胞癌及肾乳头状细胞癌的化学位移图像中反相位图像部分区域较同相位图像有所降低,而肾嫌色细胞癌无此特点,有统计学意义(P0.05)。三种肿瘤均在DWI及ADC图像上呈略高信号,无明显差异(P0.05)。结论 MRI对鉴别肾透明细胞癌、乳头状肾细胞癌、肾嫌色细胞癌均有一定的参考价值,其中增强序列是鉴别肾透明细胞癌和乳头状肾细胞癌及肾嫌色细胞癌的重要参数。而通过化学位移成像能较好地鉴别肾嫌色细胞癌与肾透明细胞癌及肾乳头状细胞癌。     

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.     

上海仁济医院肾癌数据库资料分析

目的 探讨肾癌临床、病理、分期、分级与预后特征. 方法 分析2003年至2005年上海仁济医院泌尿科肾癌数据库435例患者临床和病理资料.采用WHO 1997年肾实质上皮性肿瘤组织学分类标准、2002年ATCC的TNM分期和临床分期、1982年Fuhrman病理分级.采用Kaplan-Meier法和Logrank检验对57例获随访的晚期患者行生存分析和预后因素判断. 结果 435例患者中,遗传性VHL病肾癌10例(2.4%)、散发性肾透明细胞癌372例(85.5%)、乳头状癌13例(3.0%)、嫌色细胞癌18例(4.1%)、集合管癌4例(0.9%)、嗜酸性细胞腺瘤4例(0.9 %)、未分类肾癌.14例(3.2%).行根治性肾切除术335例(77.0%),保留肾单位手术74例(17.0%),姑息性肾切除等手术26例(6.0%).遗传性VHL病肾癌均为双肾癌伴多发囊肿,临床分期Ⅰ期7例、Ⅱ期3例,病理分级Ⅰ级6例、Ⅱ级4例,基因测序均存在VHL基因突变,平均随访28.6个月,患者无肿瘤局部进展或转移,但4例患者出现同侧或双侧肿瘤再发.嫌色细胞癌临床分期均为Ⅰ期,病理分级Ⅰ级5例,Ⅱ级13例,平均随访19.8个月均存活,无肿瘤转移或复发.集合管癌临床分期均为Ⅰ期,病理分级均为Ⅲ级,平均生存时间11.3个月.肾透明细胞癌和乳头状癌临床分期Ⅰ期260例(67.6%)、Ⅱ期64例(16.6%)、Ⅲ期32例(8.3%)、Ⅳ期29例(7.5%),其中T1a 147例(38.2%)、T1b 113例(29.4 %);病理分级Ⅰ级124例(32.2%)、Ⅱ级219例(56.9%)、Ⅲ级40例(10.4%)、Ⅳ级2例(0.5%).57例晚期肾癌患者中位生存时间(16.0±1.3)个月,1年生存率55.0%,2年生存率31.0%.预后因素分析显示,临床分期、肿瘤大小、淋巴结转移、远处转移和病理分级是晚期肾癌解剖水平和组织学水平的预后影响因素. 结论 不同组织学亚型的肾癌生物学特征存在较大差异,遗传性VHL病肾癌存在基因突变,常为双侧、多中心、低Fuhrman分级透明细胞癌,易再发不易转移.肾嫌色细胞癌预后较好,而集合管癌预后差.在解剖水平和组织学水平,TNM分期、肿瘤大小、淋巴结转移、远处转移和肾癌病理分级是晚期肾癌的预后影响因素.     

索拉非尼一线治疗晚期转移性肾癌的Ⅱ期临床研究

目的 评价索拉非尼一线治疗晚期转移性肾癌的疗效及安全性. 方法 转移性肾透明细胞癌患者12例,其中根治性肾切除术后出现复发或转移者11例,肿瘤侵及临近器官,原发灶无法手术切除者1例.均为初次治疗.12例均经病理检查证实为肾透明细胞癌.治疗方案:索拉非尼400 mg,每日2次,持续使用至疾病进展或出现不可耐受的不良反应. 结果 12例患者均可评价疗效.部分缓解3例,疾病稳定7例,疾病进展2例.客观反应率25%(3/12),疾病控制率83%(10/12).中位无进展生存期12(1～24)个月,中位生存期16(3～24)个月,6个月无进展生存率83%(10/12),1年生存率为50%(6/12).不良反应:食欲下降7例、脱发5例、乏力5例、腹泻5例、皮疹5例、手足皮肤反应4例、高血压4例、心悸3例、黏膜出血3例、声嘶1例、肾功能损害1例.通过对症治疗,不良反应基本可以控制并耐受. 结论 索拉非尼一线治疗转移性肾癌可取得较高的疾病控制率,无进展生存、总生存期均明显延长,不良反应可控制.     

经后腹腔途径治疗合并肾静脉癌栓型中晚期肾癌的初步临床观察

目的:研究经后腹腔途径治疗合并肾静脉癌栓型肾癌的临床疗效,初步探讨其手术安全性及肾周淋巴结转移对此类患者生存预后的影响。方法:回顾性分析2011年7月~2015年2月我院收治的37例肾肿瘤伴肾静脉癌栓的临床资料,其中男25例、女12例,平均年龄(53±9.6)岁。21例患者因血尿就诊时查泌尿系彩超时发现肾肿瘤合并肾静脉癌栓,16例因腰部酸胀不适主诉就诊。肿瘤位于左肾14例,右肾23例。所有患者术前均行CT、MRI检查证实肾脏肿瘤合并肾静脉癌栓形成,同时均未发现远处转移病例。所有患者完善术前检查、排除手术禁忌后于全麻行后腹腔镜下肾癌根治术联合肾静脉癌栓取出术。结果:37例患者均手术成功,无中转开放,手术平均用时(178.0±37.5)min。术中平均出血量(289.0±78.6)ml,4例患者术中给予术中输血治疗。术后1周内无继发出血、感染等手术并发症发生。术后病理结果显示肾透明细胞癌28例;乳头状肾细胞癌5例;嫌色细胞癌3例;未分类癌1例。按照TNM肾癌分期标准均属于Ⅲ期肾癌。其中12例提示癌组织侵及肾周淋巴结。术后平均随访(19.3±4.8)个月,5例患者术后因癌组织肝转移死亡,2例发生肺部转移。结论:后腹腔镜治疗合并静脉癌栓的中晚期肾癌是安全、有效的,同期存在肾门部淋巴结转移较单独肾静脉癌栓患者生存时间明显较短。     

Effect of papillary and chromophobe cell type on disease-free survival after nephrectomy for renal cell carcinoma

Background The clinical staging of renal cortical tumors traditionally has not evaluated the potential effect of histological subtypes on survival. Evidence suggests that conventional clear cell renal cell carcinoma (RCC) and nonconventional clear cell RCC (chromophobe and papillary) have different metastatic potential. Using a large renal tumor database, we examined the effect of tumor histology on the pattern of metastasis and patient survival. Methods All patients with nonmetastatic renal cortical tumors undergoing partial or radical nephrectomy were identified from a renal tumor database between July 1989 and July 2002. Kaplan-Meier and Cox regression tests were used for statistical analysis. Results Analysis revealed 1057 patients: 794 with conventional clear cell RCC, 157 with papillary RCC, and 106 with chromophobe RCC. Metastasis occurred in 95 conventional clear cell RCC, 9 papillary RCC, and 6 chromophobe RCC. Metastasis occurred in 95 conventional clear cell RCC, 9 papillary RCC, and 6 chromophobe RCC with a median follow-up of 34.6, 43.0, and 33.2 months, respectively. Using log-rank analysis, chromophobe and papillary RCC were associated with an improved disease-free survival at 5 years (P=.009 and .015, respectively). Multivariate analysis revealed tumor size, stage, and chromophobe histology as significant variables for disease progression. Conclusions Renal cortical tumors have distinct histological subtypes with varying degrees of metastatic potential. Conventional clear cell RCC, which comprises two thirds of renal cortical tumors presenting with localized disease, has a less favorable outcome when compared with papillary and chromophobe RCC. Controlling for size and stage, chromophobe, and not papillary, RCC was a significant variable for disease progression compared with conventional clear cell RCC. Knowledge of renal cortical tumor histological subtype is critical for projecting prognosis, tailoring follow-up strategies, and designing clinical trials. Presented at the 56th Annual Cancer Symposium, Society of Surgical Oncology, San Diego, CA, March 5–9, 2003.     

Cyst-associated renal cell carcinoma: Clinicopathologic characteristics and evaluation of prognosis in 27 cases

BACKGROUND: No consistent clinicopathologic characteristics of cyst-associated renal cell carcinoma (CRCC) have previously been determined. METHODS: In total, 768 patients with renal cell carcinoma (RCC) underwent radical or partial nephrectomy. Renal cell carcinoma was classified as CRCC in 27 of these patients (3.5%, subdivided into RCC originating in a cyst and cystic RCC), clear-cell RCC in 662 patients (86.2%), chromophobe cell renal carcinoma in 36 patients (4.7%) and papillary RCC in 43 patients (5.6%) according to the criteria of the World Health Organization. RESULTS: The pathologic stage and nuclear grade were usually lower in those with CRCC (low stage/low grade; 89%/96%) or chromophobe cell renal carcinoma (low stage/low grade; 89%/80%) than in those with clear-cell RCC (low stage/low grade; 59%/65%) or papillary RCC (low stage/low grade; 53%/69%). Of the 27 CRCC patients, only 19 (70%) could be diagnosed through preoperative imaging studies. Patients with CRCC showed a favorable prognosis (survival rate: 95% at 1 year, 89.7% at 3 years and 84.4% thereafter) and, especially among the patients with RCC originating in a cyst, no cancer-related death was observed. Comparing the survival among four types of RCC, a favorable outcome was observed in cases of CRCC or chromophobe cell renal carcinoma compared with clear-cell RCC or papillary RCC (clear vs chromophobe: P = 0.002; chromophobe vs papillary: P = 0.019; clear vs cyst-associated: P = 0.001; papillary vs cyst-associated: P = 0.00079). CONCLUSIONS: In cases of CRCC, the disease was usually detected at lower stages and grades and therefore the prognosis was better than in cases of other types of RCC. Preoperative diagnosis of this disease was very difficult, especially in cases of RCC originating in a cyst.     

Human kidney injury molecule-1 (hKIM-1): a useful immunohistochemical marker for diagnosing renal cell carcinoma and ovarian clear cell carcinoma

Human kidney injury molecule-1 (hKIM-1), a type I transmembrane glycoprotein expressed in injured renal proximal tubules, was also found in renal cell carcinoma (RCC). The current study attempts to evaluate the diagnostic utility of hKIM-1 in a large series of 480 neoplasms including defined subtypes of renal cell tumors, metastatic RCCs, and nonrenal tumors. Tissue microarray (TMA) sections containing 179 renal cell tumors (73 clear cell RCC, 30 papillary RCC, 16 chromophobe RCC, 15 oncocytoma, and 45 metastatic RCC) were included in this study. In addition, 80 cases of renal cell neoplasm and 221 nonrenal tumors in routine tissue sections were also included. Both TMA and routine sections were incubated with anti-hKIM-1 monoclonal antibody using an EnVision-HRP kit. The results demonstrated that a membranous/cytoplasmic staining pattern for hKIM-1 was observed in 54 of 73 (74%) clear cell RCCs and 28 of 30 (93%) papillary RCCs on TMA sections. Zero of 54 chromophobe RCCs and 4 of 41 (9.75%) oncocytomas were positive for hKIM-1 when combining TMA and routine sections. Similar staining results were observed in 35 of 45 (78%) metastatic RCCs. Data from cDNA microarray expression and Western blot demonstrated similar findings. Fifteen of 16 cases (93.8%) of clear cell carcinoma of the ovary demonstrated positive reactivity for hKIM-1. These data indicate that hKIM-1: (1) is a relatively sensitive and specific marker for papillary, clear cell, and metastatic RCCs, (2) can be used to distinguish clear cell from chromophobe RCC, and (3) may serve as a diagnostic marker for clear cell carcinoma of the ovary.     

Prognostic significance of the Heidelberg classification of renal cell carcinoma

OBJECTIVE: The specific genetic alterations characterising renal cell carcinoma (RCC) have lead to the recognition of distinctive types of tumours. In a large material of patients, the prognostic and clinical information of these different tumour types were evaluated. METHODS: Tumours from 186 patients were evaluated retrospectively according to the guidelines given by the Heidelberg Classification Conference. All patients were primarily nephrectomised and TNM staged, and the follow-up times for alive patients varied between 44 and 174 months. RESULTS: The material consisted of 145 conventional (non-papillary), 25 papillary, 12 chromophobe and 4 unclassified RCCs. There was no difference in tumour size between the different RCC types. Among patients with conventional RCC, 37% had distant metastases at the time of diagnosis, significantly more frequently than 16% in patients with papillary and 8% in chromophobe RCC (p = 0.044 and 0.048, respectively). Conventional RCC more frequently had vein invasion compared with papillary RCC (p = 0.009). Patients with chromophobe and papillary RCC survived significantly longer than patients with conventional RCC (p = 0.017 and 0.031, respectively). CONCLUSIONS: A significant difference in clinical behaviour between the different RCC types was found. Patients with conventional RCC had a higher incidence of metastases, vein invasion and had adverse survival compared with papillary and chromophobe RCCs. Thus, the RCC types recognised by specific genetic alterations seem to represent different malignant phenotypes.     

肾细胞癌不同病理组织亚型与预后的关系

目的:探讨肾癌术后病理组织分型对预后的影响。方法:回顾性分析华西医院2002年7月至2014年6月行手术治疗的1 346例肾癌患者的临床病理资料,男839例,女507例;术时年龄(55.1±13.4)岁;美国东部肿瘤协作组(ECOG)评分0分911例,≥1分435例;透明细胞癌1 120例,乳头状细胞癌62例,嫌色细胞...     

索拉非尼治疗晚期肾癌33例临床分析

目的 初步评价索拉非尼治疗晚期肾癌的疗效和不良反应.方法 2007年5月至2009年6月应用索拉非尼治疗转移性肾癌33例.男23例,女10例.年龄21～81岁,中位年龄54岁.其中透明细胞癌29例,乳头状细胞癌2例,嫌色细胞癌和透明混合嫌色细胞癌各1例.单一脏器转移18例,多脏器转移15例,至少具有1处可测量病灶.其中发现肾癌同时伴有转移4例,术后发现转移29例,术后1年以内发现转移15例,＞1年14例.曾接受免疫治疗和(或)化疗13例,索拉非尼一线治疗20例.口服索拉非尼400～600 mg 2次/d,直至肿瘤进展或出现不可耐受的不良反应.采用实体瘤疗效评价标准每8周评定1次.随访11～106周,中位随访时间29周.结果 全组无完全缓解患者,部分缓解 4例(12%),疾病稳定27例(82%),疾病进展2例(6%),无死亡病例.最常见的不良反应是手足皮肤反应28例(85%)、腹泻15例(46%)、皮疹14例(42%)、脱发12例(36%)、口腔炎及溃疡6例(18%)、高血压2例(9%),3级腹泻1例(3%),未见4级毒副反应.结论索拉非尼治疗晚期肾癌有效率12%,疾病控制率94%.不良反应较轻,大多数患者可以耐受.

Abstract：

Objective To investigate the efficacy and toxicity of sorafenib in the treatment of advanced renal cell carcinoma. Methods From May 2007 to JUN 2009, 33 patients with advanced renal cell carcinoma were given oral sorafenib 400-600 mg twice daily. There were 23 males and 10 females in the study group. The pathological diagnosis of the primary tumors was clear cell carcinoma in 29 patients, papillary renal cell carcinoma in 2 patients, chromophobe renal cell carcinoma in 1 patient and chromophobe renal cell carcinoma mixed with clear renal cell carcinoma in 1 patient. Fifteen patients had multiple organ metastases and 18 patients had single organ metastasis. The median follow-up time was 29 weeks. Results Four (12%) patients achieved partial remission, 2 (6%) patients achieved progression disease, the remaining 27 (82%) patients achieved stable disease. Complete remission was not observed in the group. Two of the partial remission patients benefited on bone metastases. Common toxicities were skin reaction (85%), diarrhea (46%), erythra (42%), alopecia (36%), oral ulcer (18%) and hypertension (9%). Conclusions Sorafenib could be effective in controlling tumor growth. The overall effectiveness was 12%, the disease control proportion was 94% in this group and its toxicity was relatively minor and well tolerated.     

Treatment outcomes of sorafenib for first line or cytokinerefractory advanced renal cell carcinoma in Japanese patients

The objective of the present study was to document the treatment efficacy and safety of sorafenib in Japanese patients with advanced renal cell carcinoma (RCC). A retrospective analysis of 50 consecutive patients with metastatic RCC between January 2005 and December 2009 was carried out. Patients received sorafenib after failed cytokine therapy or first‐line sorafenib treatment. All received 400 mg of sorafenib orally twice daily. Five of 14 patients with bone metastases were also given bisphosphonates. Tumor response was evaluated every 1–2 months according to the Response Evaluation Criteria in Solid Tumors. Adverse events (AE) were evaluated at each visit during and after treatment, and were recorded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 3.0. Dose modification of sorafenib was permitted if grade 3 or 4 AE occurred. Treatment continued until disease progression or treatment intolerance occurred. Partial response, and stable disease as best objective responses were observed in 11 (22%) and 23 (46%) patients, respectively. Median progression‐free survival was 7.3 months and median overall survival was 11.9 months. All patients experienced AE and one or more grade 3/4 AE occurred in 43 of 50 (86%) patients. Although it requires close monitoring, sorafenib treatment seemed to be effective in the present study population.