renal cell

肾细胞
  • 文章类型: Journal Article
    目的:利用一个大型国家队列比较根治性(RN)和部分肾切除术(PN)治疗肉瘤样肾细胞癌(sRCC)的结果。由于RN是具有临床侵袭性特征的局部RCC的参考标准,很少对sRCC中的PN进行研究。
    方法:我们对2004年至2019年的国家癌症数据库进行了回顾性队列分析,分析了接受PN和RN的sRCC患者(T1-T3N0-N1M0)。我们进行了多变量分析(MVA)来确定与PN和全因死亡率(ACM)相关的因素,和Kaplan-Meier分析(KMA)在Charlson0例接受PN与RN根据临床分期。
    结果:该队列包括5,265名患者[RN4,582(87.0%)/PN683(13.0%)]。接受PN的几率增加与乳头状RCC相关(OR=1.69,p=0.015);与年龄增长相反(OR=0.99,p=0.004),cT2-cT3(OR=0.23,p<0.001),和cN1(OR=0.2,p<0.001)。恶化的ACM与阳性边缘相关(HR=1.59,p<0.001),男性(HR=1.1,p=0.044),Charlson[公式:见正文]2(HR=1.47,p<0.001),cT2-cT3(HR1.17-1.39,p<0.001-0.035),和cN1(HR=1.59,p<0.001)。改善的ACM与PN(HR=0.64,p<0.001),增加家庭收入(HR=0.77-0.79,p<0.001),和私人保险(HR=0.80,p=0.018)。KMA显示,与cT1的RN相比,PN的5年OS有所改善(86.5%与63.2%,p<0.001),和cT3(61.0%与44.0%p<0.001),但不是cT2(p=0.67)。
    结论:在部分患者中,负边距的PN可能不会损害结果,并且在指示时可能会带来好处。拥有私人保险和最高收入的患者的生存率有所提高,这表明护理存在差异。
    OBJECTIVE: To compare outcomes of radical (RN) and partial nephrectomy (PN) in Sarcomatoid Renal Cell Carcinoma (sRCC) utilizing a large national cohort. As RN is the reference standard for localized RCC with clinically aggressive features, PN in sRCC has been seldom studied.
    METHODS: We performed a retrospective cohort analysis of the National Cancer Database from 2004 to 2019 for patients who underwent PN and RN for sRCC (T1-T3N0-N1M0). We performed multivariable analyses (MVA) to determine factors associated with PN and all-cause mortality (ACM), and Kaplan-Meier Analysis (KMA) for overall survival (OS) in Charlson 0 patients who underwent PN vs. RN according to clinical stage.
    RESULTS: The cohort consisted of 5,265 patients [RN 4,582 (87.0%)/PN 683 (13.0%)]. Increased odds of receiving PN was associated with papillary RCC (OR = 1.69, p = 0.015); inversely with increasing age (OR = 0.99, p = 0.004), cT2-cT3 (OR = 0.23, p < 0.001), and cN1 (OR = 0.2, p < 0.001). Worsened ACM was associated with positive margins (HR = 1.59, p < 0.001), male (HR = 1.1, p = 0.044), Charlson [Formula: see text]2 (HR = 1.47, p < 0.001), cT2-cT3 (HR 1.17-1.39, p < 0.001-0.035), and cN1 (HR = 1.59, p < 0.001). Improved ACM was noted with PN (HR = 0.64, p < 0.001), increasing household income (HR = 0.77-0.79, p < 0.001), and private insurance (HR = 0.80, p = 0.018). KMA showed PN had improved 5-year OS compared to RN in cT1 (86.5% vs. 63.2%, p < 0.001), and cT3 (61.0% vs. 44.0% p < 0.001), but not cT2 (p = 0.67).
    CONCLUSIONS: In select patients, PN with negative margins may not compromise outcomes and may provide benefit when indicated. Patients with private insurance and highest income experienced improved survival suggesting disparity in care.
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  • 文章类型: Journal Article
    背景:本研究旨在比较机器人辅助肾部分切除术治疗完全内生肾肿瘤的疗效与传统腹腔镜肾部分切除术的疗效,并探讨机器人辅助肾部分切除术后肾功能的转变。
    方法:我们进行了前瞻性,多中心,单臂,在日本的17个学术中心进行开放标签试验。纳入分为cT1,cN0,cM0的内生肾肿瘤患者,并接受机器人辅助的部分肾切除术。我们定义了两个主要结果来评估手术的功能和肿瘤方面,以热缺血时间和阳性手术切缘为代表,分别。使用先前在腹腔镜部分肾切除术研究中报道的对照值进行比较。在历史对照组中,热缺血时间为25.2,阳性手术切缘为13%。
    结果:我们的符合方案分析包括98名参与者。平均热缺血时间为20.3分钟(99%置信区间18.3-22.3;p<0.0001vs.25.2).98名参与者均无阳性手术切缘(99%置信区间0-5.3%;p<0.0001vs.13.0%)。方案治疗前后eGFR的肾功能比率乘以分裂为0.70(95%置信区间:0.66-0.75)。术前eGFR等因素,切除重量,和热缺血时间影响机器人辅助肾部分切除术后部分肾切除的肾功能丧失。
    结论:与传统腹腔镜肾部分切除术相比,机器人辅助的完全内生肾肿瘤部分切除术提供了更短的热缺血时间和相当的阳性切缘率。
    BACKGROUND: This study aimed to compare the efficacy of robot-assisted partial nephrectomy for completely endophytic renal tumors with the reported outcomes of conventional laparoscopic partial nephrectomy and investigate the transition of renal function after robot-assisted partial nephrectomy.
    METHODS: We conducted a prospective, multicenter, single-arm, open-label trial across 17 academic centers in Japan. Patients with endophytic renal tumors classified as cT1, cN0, cM0 were included and underwent robot-assisted partial nephrectomy. We defined two primary outcomes to assess functional and oncological aspects of the procedure, which were represented by the warm ischemic time and positive surgical margin, respectively. Comparisons were made using control values previously reported in laparoscopic partial nephrectomy studies. In the historical control group, the warm ischemia time was 25.2, and the positive surgical margin was 13%.
    RESULTS: Our per-protocol analysis included 98 participants. The mean warm ischemic time was 20.3 min (99% confidence interval 18.3-22.3; p < 0.0001 vs. 25.2). None of the 98 participants had a positive surgical margin (99% confidence interval 0-5.3%; p < 0.0001 vs. 13.0%). The renal function ratio of eGFR before and after protocol treatment multiplied by splits was 0.70 (95% confidence interval: 0.66-0.75). Factors such as preoperative eGFR, resected weight, and warm ischemic time influenced the functional loss of the partially nephrectomized kidney after robot-assisted partial nephrectomy.
    CONCLUSIONS: Robot-assisted partial nephrectomy for completely endophytic renal tumors offers a shorter warm ischemia time and comparable positive surgical margin rate compared with conventional laparoscopic partial nephrectomy.
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  • 文章类型: Case Reports
    我们报告了一例38岁的男子,患有两个vonHippel-Lindau疾病相关的T1a肾细胞癌(RCC)(直径<2cm),发展为2.5cm的孤立性diaphragm肌转移瘤。在使用经皮活检诊断后,行腹腔镜切除和经皮冷冻消融术治疗膈肌转移和两种RCC,分别。治疗一年后,患者存活,无局部复发或远处转移.本报告描述了VHL疾病中罕见的RCC转移病例及其治疗。
    We report the case of a 38-year-old man with two von Hippel-Lindau disease-associated T1a renal cell carcinomas (RCCs) (<2 cm in diameter) which developed into a 2.5-cm solitary diaphragmatic metastatic tumor. After diagnosis using percutaneous biopsy, the diaphragmatic metastasis and two RCCs were treated by laparoscopic resection and percutaneous cryoablation, respectively. One year after treatment, the patient survived without local recurrence or distant metastasis. This report describes a rare case of RCC metastasis in VHL disease and its treatment.
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    文章类型: Case Reports
    肾移植受者(KTR)的恶性肿瘤患病率高于普通人群。尽管据报道,KTR后肾细胞癌(RCC)的发病率为0.6%,死亡率高达13.9%,除了欧洲最佳实践指南(EBPG)外,没有一个指南建议基于成本效益和缺乏确凿的证据进行RCC筛查。EBPG建议每1-3年通过超声检查(USG)对天然肾脏(不是同种异体移植)进行RCC筛查。
    一名55岁的男性患者,14年前从活体捐献者那里进行了肾脏移植,出现突然发作的不受控制的高血压(180/110mmHg)和移植物功能迅速恶化(血清肌酐升高至基线的两倍)。评估显示同种异体移植物中的RCC。腹痛,血尿,发烧,减肥,流感样综合征,复发性尿路感染,弱点,高血压,据报道,同种异体移植功能障碍是KTR患者RCC的主要主诉和体征。我们的患者的发现是高血压和同种异体移植功能障碍。
    对于KTR,必须遵循EBPG,而不要忘记每年的USG在天然肾脏和同种异体移植物中筛查RCC。HIPPOKRATIA2023,27(2):69-71.
    UNASSIGNED: The prevalence of malignancies is higher among kidney transplant recipients (KTR) than general population. Although the incidence of renal cell cancer (RCC) after KTR was reported as 0.6 % with a high mortality rate of 13.9 %, none of the guidelines except the European Best Practice Guideline (EBPG) recommends RCC screening based on cost-effectiveness and lack of solid evidence. The EBPG recommends RCC screening in native kidneys (not the allograft) by ultrasonography (USG) every 1-3 years.
    UNASSIGNED: A 55-year-old male patient who had a kidney transplant from a living donor 14 years before, presented with sudden onset uncontrolled hypertension (180/110 mmHg) and rapid deterioration in graft functions (increase in serum creatinine to two-times baseline). Evaluations revealed RCC in the allograft. Abdominal pain, hematuria, fever, weight loss, flu-like syndrome, recurrent urinary tract infections, weakness, hypertension, and allograft dysfunction are reported as the main complaints and signs of RCC in KTR patients. Our patient\'s findings were hypertension and allograft dysfunction.
    UNASSIGNED: It is essential to follow EBPG for KTR and not to forget the annual USG for screening of RCC both in native kidneys and allograft. HIPPOKRATIA 2023, 27 (2):69-71.
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  • 文章类型: Journal Article
    目的:晚期肾透明细胞癌(ccRCC)严重影响患者的生命健康,但是这种疾病的有效治疗在临床上仍然缺乏。本研究探讨了纳武单抗联合卡博替尼与舒尼替尼治疗老年晚期ccRCC的疗效。
    方法:回顾性分析我院2020年1月至2022年1月216例老年晚期ccRCC患者的临床资料。根据不同的治疗方案,患者被分为卡博替尼组(n=111,接受纳武单抗和卡博替尼)和舒尼替尼组(n=105,接受纳武单抗和舒尼替尼).总生存时间,疾病控制率,健康状况,比较两组患者的不良事件发生率和预后风险.
    结果:卡博替尼组的总生存时间更长,癌症治疗功能评估-肾脏症状指数和EuroQol-五维度-三级问卷的疾病控制率和评分高于舒尼替尼组。卡博替尼组的不良事件发生率低于舒尼替尼组(p<0.001)。然而,两组间对预后风险的判断差异无统计学意义(p>0.05)。
    结论:纳武单抗联合卡博替尼治疗老年晚期ccRCC的效果优于纳武单抗联合舒尼替尼,不良反应少,安全性高。然而,研究结果需要进一步的临床研究来证实和推广。
    OBJECTIVE: Advanced clear cell renal cell carcinoma (ccRCC) seriously affects the life and health of patients, but effective treatment for this disease is still lacking in clinic. This study investigated the efficacy of nivolumab plus cabozantinib versus sunitinib in the treatment of elderly patients with advanced ccRCC.
    METHODS: The clinical data of 216 elderly patients with advanced ccRCC in our hospital from January 2020 to January 2022 were retrospectively analysed. On the basis of different treatment regimens, patients were divided into the cabozantinib group (n = 111, receiving nivolumab and cabozantinib) and the sunitinib group (n = 105, receiving nivolumab and sunitinib). The overall survival time, disease control rates, health status, incidence of adverse events and identification of prognostic risk were compared between the two groups.
    RESULTS: The cabozantinib group had higher overall survival time, disease control rate and scores in the Functional Assessment of Cancer Therapy-Kidney Symptom Index and EuroQol-Five Dimensions-Three Levels Questionnaire than the sunitinib group. The incidence of adverse events in the cabozantinib group was lower than that in the sunitinib group (p < 0.001). However, no difference existed in the identification of prognostic risk between the two groups (p > 0.05).
    CONCLUSIONS: The effect of nivolumab plus cabozantinib on the treatment of elderly patients with advanced ccRCC is better than that of nivolumab plus sunitinib, with fewer adverse reactions and higher safety. However, the research results require further clinical studies to confirm and promote.
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  • 文章类型: Journal Article
    目的调查FLCN的患病率,BAP1,SDH,和肿瘤队列中的MET突变,并确定患病率,临床特征,与这些突变相关的肾细胞癌(RCC)的影像学特征。其次,以确定所遇到的良性肾脏病变的患病率。材料和方法从2015年至2021年,来自25220名癌症患者,他们前瞻性地接受了一组70多个癌症易感基因的种系分析,BAP1,SDH,或对MET突变进行回顾性鉴定.对患者年龄的临床记录进行了审查,性别,种族/民族,和肾癌诊断。如果存在RCC,基线CT和MRI检查由两名放射科医师独立评估。摘要统计用于通过突变总结连续变量和分类变量。结果25220例患者中79例(0.31%)存在种系突变:FLCN,25220中的17个(0.07%);BAP1,25220中的22个(0.09%);SDH,25220中的39个(0.15%);和MET,25220之一(0.004%)。在这79名患者中,18例(23%)被诊断为RCC(FLCN,17个中的四个[24%];BAP1,22个中的四个[18%];SDH,39人中有9人[23%];MET,一个[100%])。大多数遗传性RCC表现出不明确的边缘,中央非强化区(囊性或坏死),异质增强,以及各种其他CT和MR放射学特征,与非遗传性RCC的放射学外观重叠。患者中其他良性实性肾脏病变(复杂囊肿除外)的患病率高达11%。结论FLCN,BAP1,SDH,在该肿瘤队列中,MET突变的发生率不到1%.在研究样本量限制内,遗传性肾细胞癌的影像学表现与非遗传性肾细胞癌的影像学表现重叠,其他相关良性实性肾脏病变(复杂囊肿除外)的患病率高达11%。关键词:家族性肾细胞癌,Birt-Hogg-Dubé综合征,癌,肾细胞,副神经节瘤,尿路,肾脏©RSNA,2024.
    Purpose To investigate the prevalence of FLCN, BAP1, SDH, and MET mutations in an oncologic cohort and determine the prevalence, clinical features, and imaging features of renal cell carcinoma (RCC) associated with these mutations. Secondarily, to determine the prevalence of encountered benign renal lesions. Materials and Methods From 25 220 patients with cancer who prospectively underwent germline analysis with a panel of more than 70 cancer-predisposing genes from 2015 to 2021, patients with FLCN, BAP1, SDH, or MET mutations were retrospectively identified. Clinical records were reviewed for patient age, sex, race/ethnicity, and renal cancer diagnosis. If RCC was present, baseline CT and MRI examinations were independently assessed by two radiologists. Summary statistics were used to summarize continuous and categorical variables by mutation. Results A total of 79 of 25 220 (0.31%) patients had a germline mutation: FLCN, 17 of 25 220 (0.07%); BAP1, 22 of 25 220 (0.09%); SDH, 39 of 25 220 (0.15%); and MET, one of 25 220 (0.004%). Of these 79 patients, 18 (23%) were diagnosed with RCC (FLCN, four of 17 [24%]; BAP1, four of 22 [18%]; SDH, nine of 39 [23%]; MET, one of one [100%]). Most hereditary RCCs demonstrated ill-defined margins, central nonenhancing area (cystic or necrotic), heterogeneous enhancement, and various other CT and MR radiologic features, overlapping with the radiologic appearance of nonhereditary RCCs. The prevalence of other benign solid renal lesions (other than complex cysts) in patients was up to 11%. Conclusion FLCN, BAP1, SDH, and MET mutations were present in less than 1% of this oncologic cohort. Within the study sample size limits, imaging findings for hereditary RCC overlapped with those of nonhereditary RCC, and the prevalence of other associated benign solid renal lesions (other than complex cysts) was up to 11%. Keywords: Familial Renal Cell Carcinoma, Birt-Hogg-Dubé Syndrome, Carcinoma, Renal Cell, Paragangliomas, Urinary, Kidney © RSNA, 2024.
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  • 文章类型: Case Reports
    对于终末期肾病和血液透析患者,免疫检查点和酪氨酸激酶抑制剂的联合治疗需要仔细考虑,因为很少有病例报告提供合适的管理决定。
    一名70岁的男子,因肾硬化而接受了6年的血液透析。Avelumab联合阿西替尼联合治疗反复肺转移,并且达到了完全的反应,没有重大的副作用。
    在接受透析的患者中,Ave加Axi联合治疗透明细胞肾细胞癌后获得了完全缓解。这表明Ave加Axi联合治疗对透析患者可能是安全有效的。
    UNASSIGNED: Combination therapies of immune checkpoint and tyrosine kinase inhibitors for end-stage kidney disease and patients on hemodialysis need careful consideration as few case reports provide suitable management decisions.
    UNASSIGNED: A 70-year-old man who had undergone hemodialysis for 6 years due to nephrosclerosis. Avelumab plus axitinib combination therapy was performed for repeated lung metastasis, and a complete response was achieved without major side effects.
    UNASSIGNED: A complete response was achieved after Ave plus Axi combination therapy for clear cell renal cell carcinoma in a patient undergoing dialysis. This suggests that Ave plus Axi combination therapy may be safe and effective for dialysis patients.
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  • 文章类型: Case Reports
    患有遗传性平滑肌瘤和肾细胞癌(HLRCC)综合征的患者患子宫和皮肤平滑肌瘤和肾细胞癌(RCC)的风险很高,这是由富马酸水合酶(FH)基因的种系突变引起的。RCC病变多为高级别肿瘤,预后较差。
    一名37岁男子曾接受过左肾细胞癌治疗,被转诊至我院,诊断为右肾细胞癌。进行了机器人辅助的肾部分切除术,病理诊断为富马酸水合酶(FH)缺陷型RCC。左侧碾压混凝土,最初被诊断为粘液性管状和梭形细胞癌,进行审查并诊断为FH缺陷型RCC。病人的父亲和叔叔都死于肾癌,父亲的肿瘤也被免疫组织化学证实为FH缺陷型RCC。
    HLRCC相关性RCC在有RCC家族史的年轻患者的鉴别诊断中应考虑。
    UNASSIGNED: Patients with hereditary leiomyomatosis and renal cell cancer (HLRCC) syndrome have high risks of uterine and cutaneous leiomyomas and renal cell carcinoma (RCC), which are caused by germline mutation of the fumarate hydratase (FH) gene. RCC lesions are mostly high-grade tumors with a poor prognosis.
    UNASSIGNED: A 37-year-old man who had previously undergone treatment for a left RCC was referred to our hospital with a diagnosis of right RCC. Robot-assisted partial nephrectomy was performed, and the pathological diagnosis revealed fumarate hydratase (FH)-deficient RCC. The left RCC, which was originally diagnosed as mucinous tubular and spindle cell carcinoma, was reviewed and diagnosed as FH-deficient RCC. The patient\'s father and uncle both died of RCC, and the father\'s tumor was also immunohistochemically proven to be FH-deficient RCC.
    UNASSIGNED: HLRCC-related RCC should be considered in a differential diagnosis of young patients with a family history of RCC.
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  • 文章类型: Journal Article
    目的:目前指南中缺乏严格的适应症,导致肾脏小肿块的治疗模式发生显著变化。泌尿科医生对肾脏小肿块患者的管理方法的影响尚未得到探讨。
    方法:使用链接监视,流行病学,和最终结果-医疗保险数据库,我们对2004年1月1日至2013年12月31日诊断为肾脏小肿块的年龄≥66岁患者进行了鉴定,并将其分配至主要泌尿科医师.混合效应逻辑模型用于评估与不同管理方法相关的因素,估计每种方法的泌尿科医生级别的概率,评估管理差异,并确定泌尿科医生对方法选择的影响。
    结果:共有12,402名患者和2,794名相应的原发性泌尿科医师纳入研究。在个人泌尿科医生层面,不同方法的估计病例调整概率差异显著:非手术管理(平均值,12.8%;范围,4.9%-36.1%);热消融(平均值,10.8%;范围,2.4%-66.3%);肾部分切除术(平均,30.1%;范围,10.1%-66.6%);和根治性肾切除术(平均,40.4%;范围,17.7%-71.6%)。与患者和肿瘤特征相比,主要泌尿科医生是一个更有影响力的测量因素,占13.6%(vs.12.9%),33.8%(与2.1%),15.1%(与8.4%),和13.5%(与4.0%)非手术管理的管理选择变化,热消融,肾部分切除术,和根治性肾切除术,分别。
    结论:肾脏小肿块的处理存在显著差异,似乎主要由泌尿科医生的偏好和实践模式驱动。我们的发现强调需要对这些群众的管理进行统一指导,以减少不必要的护理变化。
    Lack of strict indications in current guidelines have led to significant variation in management patterns of small renal masses. The impact of the urologist on the management approach for patients with small renal masses has not been explored previously.
    Using the linked Surveillance, Epidemiology, and End Results-Medicare database, patients aged ≥66 years diagnosed with small renal masses from January 1, 2004 to December 31, 2013 were identified and assigned to primary urologists. Mixed-effects logistic models were used to evaluate factors associated with different management approaches, estimate urologist-level probabilities of each approach, assess management variation, and determine urologist impact on choice of approach.
    A total of 12,402 patients with 2,794 corresponding primary urologists were included in the study. At the individual urologist level, the estimated case-adjusted probability of different approaches varied markedly: nonsurgical management (mean, 12.8%; range, 4.9%-36.1%); thermal ablation (mean, 10.8%; range, 2.4%-66.3%); partial nephrectomy (mean, 30.1%; range, 10.1%-66.6%); and radical nephrectomy (mean, 40.4%; range, 17.7%-71.6%). Compared to patient and tumor characteristics, the primary urologist was a more influential measured factor, accounting for 13.6% (vs. 12.9%), 33.8% (vs. 2.1%), 15.1% (vs. 8.4%), and 13.5% (vs. 4.0%) of the variation in management choice for nonsurgical management, thermal ablation, partial nephrectomy, and radical nephrectomy, respectively.
    Significant variation exists in the management of small renal masses and appears to be driven primarily by urologist preference and practice patterns. Our findings emphasize the need for unified guidance regarding management of these masses to reduce unwarranted variation in care.
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  • 文章类型: Journal Article
    背景:Tivozanib是一种口服血管内皮生长因子受体(VEGFR)酪氨酸激酶抑制剂(TKI),对晚期肾细胞癌(RCC)有效。报告了来自TIVO-3试验的复发/难治性(R/R)RCC的长期探索性分析,包括先前接受过免疫肿瘤学(IO)治疗的患者(26%)。
    方法:R/R晚期RCC患者在2或3次全身治疗(≥1个VEGFRTKI)后,被随机分配给替科扎尼1.5mgQD或索拉非尼400mgBID,根据IMDC风险和以前的治疗进行分层。安全,研究者评估的长期无进展生存期(LT-PFS),和系列总生存期(OS)进行评估。
    结果:替沃扎尼的平均治疗时间为11.0个月(n=175),索拉非尼的平均治疗时间为6.3个月(n=175)。与索拉非尼(55%)相比,替沃扎尼(46%)发生的≥3级治疗相关不良事件较少。在不同年龄/先前IO亚组中,使用tivozanib的剂量调整率低于索拉非尼;先前IO治疗不影响任一臂的剂量减少或停药。具有里程碑意义的LT-PFS率高于替沃扎尼(3年:12.3%vs2.4%;4年:7.6%vs0%)。平均随访22.8个月后,OSHR为0.89(95%CI,0.70-1.14);以12个月具有里程碑意义的PFS为条件时,与索拉非尼相比,托沃扎尼显示出显着的OS改善(HR,0.45;95%CI,0.22-0.91;双侧P=0.0221)。
    结论:Tivozanib在12个月时存活且无进展的R/R晚期RCC患者中表现出一致的安全性和长期生存获益。这些对LT-PFS和有条件OS的事后探索性分析支持在该晚期RCC人群中使用替沃扎尼与索拉非尼的临床意义改善。
    BACKGROUND: Tivozanib is an oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) with efficacy in advanced renal cell carcinoma (RCC). Long-term exploratory analyses from the TIVO-3 trial in relapsed/refractory (R/R) RCC including patients (26%) with prior immuno-oncology (IO) therapy are reported.
    METHODS: Patients with R/R advanced RCC that progressed with 2 or 3 prior systemic therapies (≥1 VEGFR TKI) were randomized to tivozanib 1.5 mg QD or sorafenib 400 mg BID, stratified by IMDC risk and previous therapy. Safety, investigator-assessed long-term progression-free survival (LT-PFS), and serial overall survival (OS) were assessed.
    RESULTS: Mean time on treatment was 11.0 months with tivozanib (n = 175) and 6.3 months with sorafenib (n = 175). Fewer grade ≥3 treatment-related adverse events occurred with tivozanib (46%) than sorafenib (55%). Dose modification rates were lower with tivozanib than sorafenib across age/prior IO subgroups; prior IO therapy did not impact dose reductions or discontinuations in either arm. Landmark LT-PFS rates were higher with tivozanib (3 years: 12.3% vs 2.4%; 4 years: 7.6% vs 0%). After 22.8 months mean follow-up, the OS HR was 0.89 (95% CI, 0.70-1.14); when conditioned on 12-month landmark PFS, tivozanib showed significant OS improvement over sorafenib (HR, 0.45; 95% CI, 0.22-0.91; 2-sided P = .0221).
    CONCLUSIONS: Tivozanib demonstrated a consistent safety profile and long-term survival benefit in patients with R/R advanced RCC who were alive and progression free at 12 months. These post hoc exploratory analyses of LT-PFS and conditional OS support a clinically meaningful improvement with tivozanib versus sorafenib in this advanced RCC population.
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