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Influences of Age and Comorbidities on Indication for Partial Nephrectomy: A Systematic Review 年龄和合并症对部分肾切除适应证的影响:系统评价
IF 1.2 Q4 ONCOLOGY Pub Date : 2023-05-19 DOI: 10.3233/kca-230001
D. Cignoli, G. Fallara, C. Re, F. Cei, G. Musso, G. Basile, G. Rosiello, A. Salonia, A. Larcher, F. Montorsi, U. Capitanio
BACKGROUND: The influence of age and comorbidities during decision-making for patients with renal cell carcinoma remains controversial. OBJECTIVE: To comprehensively review the available evidence regarding the impacts of age and comorbidities on the decision to perform partial nephrectomy (PN). EVIDENCE ACQUISITION: A systematic review was conducted in accordance with PRISMA and registered with PROSPERO (CRD42022344759). Only randomized control trials, prospective cohort studies, registry-based studies, or single/multi-institutional retrospective cohort studies comparing PN to other therapeutic options for cT1N0M0 renal masses were considered. The primary outcome was to assess differences in patients’ baseline characteristics between different treatments in order to investigate how those aspects have influenced clinical decision-making. Finally, perioperative outcomes were compared across the different options. EVIDENCE SYNTHESIS: Overall, patients who underwent PN were 3 to 11 years younger than those who underwent other treatments. Baseline renal function was slightly better in patients who underwent PN than in those who underwent radical nephrectomy (RN), active surveillance (AS), or tumor ablation. Patients undergoing PN had an average pre-treatment eGFR 4 to 6 points (mL/min/1.73 m2) higher than patients undergoing RN or tumor ablation. Likewise, the proportion of baseline chronic kidney disease (CKD) before treatment was higher in patients undergoing other treatments, with a rate of CKD between 6% and 56% higher compared with that for PN. A slightly higher proportion of baseline diabetes mellitus (DM) and cardiovascular comorbidities (CVD) were found in patients who underwent PN than in those who underwent RN (20% vs. 21% for DM and 37% vs. 41% for CVD). On average, patients who underwent AS and tumor ablation had more comorbidities, in terms of Charlson comorbidity index (CCI), DM, and CVD (50% vs. 38% for CCI ≥2; 25% vs. 20% for DM; and 43% vs. 37% for CVD). In terms of Eastern Cooperative Oncology Group (ECOG) Performance Status and American Society of Anesthesiologists (ASA) classification, no major differences were found between PN and other treatments, but a trend emerged whereby more fit patients underwent PN compared with RN (16% of ECOG >1 for PN vs. 18% for RN and 15% of ASA grade ≥3 for PN vs. 26% for RN). Again, tumor ablation was preferred for less fit patients (31% of ASA grade ≥3). No study included in our systematic review reported the baseline frailty status of patients treated for cT1 renal masses. The rates of perioperative complications and length of hospital stay (LOS) were similar between different techniques. CONCLUSIONS: Patients who underwent PN tended to be younger and fitter than those who underwent other available treatments for cT1 renal masses. Since this technique aims at reducing renal function impairment after surgery, a greater effort should be made to optimize patient selection to include more comorbid pat
背景:年龄和合并症对肾细胞癌患者决策的影响仍有争议。目的:全面回顾有关年龄和合并症对决定进行部分肾切除术(PN)的影响的现有证据。证据获取:根据PRISMA进行了系统评价,并在PROSPERO注册(CRD42022344759)。仅考虑随机对照试验、前瞻性队列研究、基于登记的研究或单/多机构回顾性队列研究,比较PN与cT1N0M0肾肿块的其他治疗方案。主要结果是评估不同治疗之间患者基线特征的差异,以调查这些方面如何影响临床决策。最后,比较不同方案的围手术期结果。证据综合:总体而言,接受PN治疗的患者比接受其他治疗的患者年轻3 - 11岁。接受肾切除术的患者的基线肾功能略好于接受根治性肾切除术(RN)、主动监测(AS)或肿瘤消融的患者。接受PN的患者治疗前eGFR平均比接受RN或肿瘤消融的患者高4 ~ 6个点(mL/min/1.73 m2)。同样,在接受其他治疗的患者中,治疗前基线慢性肾脏疾病(CKD)的比例更高,CKD的发生率比接受PN治疗的患者高6%至56%。在接受PN的患者中发现基线糖尿病(DM)和心血管合并症(CVD)的比例略高于接受RN的患者(20% vs 21% DM和37% vs 41% CVD)。平均而言,接受AS和肿瘤消融的患者在Charlson合并症指数(CCI)、DM和CVD方面有更多的合并症(CCI≥2的50% vs 38%;DM组25% vs 20%;43% vs. CVD 37%)。在东部肿瘤合作组(ECOG)的表现状况和美国麻醉医师协会(ASA)的分类方面,在PN和其他治疗之间没有发现重大差异,但出现了一种趋势,即与RN相比,更多适合的患者接受了PN(16%的ECOG患者接受了PN, 18%的患者接受了RN, 15%的患者接受了PN, ASA分级≥3的患者接受了PN, 26%的患者接受了RN)。同样,不太适合的患者首选肿瘤消融(31%的ASA分级≥3)。在我们的系统综述中,没有研究报告cT1肾肿块治疗患者的基线虚弱状态。不同技术的围手术期并发症发生率和住院时间(LOS)相似。结论:接受PN治疗的患者比接受其他治疗的cT1肾肿块的患者更年轻,更健康。由于这项技术的目的是减少术后肾功能损害,因此应该做出更大的努力来优化患者选择,以包括更多可能对PN有用的合并症患者。
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引用次数: 0
Efficacy of Therapy vs Surveillance in Patients with Resected Early-Stage Intermediate to High-Risk Renal Cell Carcinoma 早期中高危肾细胞癌切除术后治疗与监测的疗效比较
IF 1.2 Q4 ONCOLOGY Pub Date : 2023-05-16 DOI: 10.3233/kca-220018
C. Major, Carlos I. Rodriguez, N. Haas
BACKGROUND: The historical standard of care for locally advanced renal cell carcinoma (RCC) is nephrectomy + active surveillance. Despite a high recurrence rate ( 40% ), adjuvant therapy was previously not included in the standard of care. This review of adjuvant pharmacotherapy reflects conflicting results from multiple trials. OBJECTIVE: The objective of this review is to summarize the efficacy of therapy vs surveillance in resected early-stage intermediate to high-risk renal cell carcinoma. METHODS: We performed a systematic literature search using PubMed, EMBASE, and SCOPUS. Keywords such as “renal cell carcinoma”, “adjuvant therapy” and “nephrectomy” were used. In the literature search, 2,711 studies were identified and screened. RESULTS: We included a total of 21 publications. The most common histology seen in trials was clear cell carcinoma. A variety of interventions were reviewed including immunotherapy, medroxyprogesterone acetate, interferon alfa, and tyrosine kinase inhibitors. Most trials did not demonstrate a benefit in relapse-free survival (RPS) or overall survival (OS). Pembrolizumab demonstrated a significant difference in disease recurrence in the KEYNOTE-564 trial although median data was not reached. Blinded independent reviewers identified a benefit in disease-free survival (DFS) with Sunitinib in the S-TRAC trial. CONCLUSION: There was not a clear benefit in using adjuvant therapy broadly for resected locoregional RCC; however, further investigation should be done in the highest-risk group to elucidate potential benefit.
背景:局部晚期肾细胞癌(RCC)的历史护理标准是肾切除术+积极监测。尽管复发率很高(40%),但辅助治疗以前不包括在护理标准中。这篇关于辅助药物治疗的综述反映了来自多个试验的相互矛盾的结果。目的:本综述的目的是总结治疗与监测在早期中高危肾细胞癌切除中的疗效。方法:我们使用PubMed、EMBASE和SCOPUS进行了系统的文献检索。使用“肾细胞癌”、“辅助治疗”和“肾切除术”等关键词。在文献检索中,确定并筛选了2711项研究。结果:我们总共收录了21篇出版物。试验中最常见的组织学表现为透明细胞癌。综述了多种干预措施,包括免疫疗法、醋酸甲羟孕酮、干扰素α和酪氨酸激酶抑制剂。大多数试验没有证明对无复发生存期(RPS)或总生存期(OS)有益处。在KEYNOTE-564试验中,Pembrolizumab在疾病复发方面表现出显著差异,尽管未达到中位数数据。在S-TRAC试验中,失明的独立评审员发现舒尼替尼对无病生存率(DFS)有益处。结论:广泛应用辅助治疗局部肾细胞癌没有明显的疗效;然而,应该对风险最高的人群进行进一步的调查,以阐明潜在的益处。
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引用次数: 0
Clinical Trials Corner: Raising the SABR to Renal Cell Carcinoma 临床试验角:提高肾细胞癌的SABR
IF 1.2 Q4 ONCOLOGY Pub Date : 2023-03-10 DOI: 10.3233/kca-239001
M. Parikh
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引用次数: 0
Erratum to: SETD2 Regulates the Methylation of Translation Elongation Factor eEF1A1 in Clear Cell Renal Cell Carcinoma SETD2调节透明细胞肾细胞癌中翻译延伸因子eEF1A1的甲基化
IF 1.2 Q4 ONCOLOGY Pub Date : 2023-02-14 DOI: 10.3233/kca-229010
R. Hapke, L. Venton, K. Rose, Q. Sheng, Anupama Reddy, Rebecca A. Prather, Angela Jones, W. Rathmell, Scott M. Haak
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引用次数: 0
Adjuvant Therapy in Renal Cell Carcinoma: Are we ready for prime time? 肾细胞癌的辅助治疗:我们准备好了吗?
IF 1.2 Q4 ONCOLOGY Pub Date : 2022-12-29 DOI: 10.3233/kca-220014
Luke Wang, A. Saidian, Elizabeth Pan, Justine Panian, I. Derweesh, R. McKay
The standard of care for localized renal cell carcinoma (RCC) is radical or partial nephrectomy. Despite complete resection, a subset of patients will develop locoregional recurrence or metastatic disease. Adjuvant immunotherapy has been studied since the 1980 s as the primary method to mitigate tumor recurrence after definitive surgery. We herein discuss published and ongoing clinical trials investigating adjuvant therapy in localized or locoregional RCC.
局限性肾细胞癌(RCC)的治疗标准是根治性或部分切除。尽管完全切除,仍有一部分患者会出现局部复发或转移性疾病。佐剂免疫疗法自1980年以来一直在研究 s是减轻肿瘤最终手术后复发的主要方法。我们在此讨论已发表和正在进行的研究局部或局部RCC辅助治疗的临床试验。
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引用次数: 1
Clinical Trials Corner: Another Approach to Treatment of Advanced Papillary Renal Cell Carcinoma 临床试验专区:晚期乳头状肾细胞癌的另一种治疗方法
IF 1.2 Q4 ONCOLOGY Pub Date : 2022-12-19 DOI: 10.3233/kca-229006
M. Parikh
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引用次数: 0
Activity of Immunotherapy Regimens on Primary Renal Tumours: A Systematic Review 免疫治疗方案对原发性肾肿瘤的活性:一项系统综述
IF 1.2 Q4 ONCOLOGY Pub Date : 2022-11-29 DOI: 10.3233/kca-220012
James O. Jones, Will Ince, S. Welsh, G. Stewart
BACKGROUND: Immune checkpoint inhibitors (ICPIs) are widely used in treating metastatic renal cell carcinoma (RCC). Cytoreductive nephrectomy (CN) forms part of multimodality treatment in advanced disease, however there is no prospective evidence for its use in the ICPI era. Trials of neoadjuvant ICPIs in RCC are underway; understanding the anticipated effect of ICPIs on the primary tumour may help clinical decision making in both localised and advanced settings. METHODS: A systematic search (PubMed, Web of Science, clinicaltrials.gov) of English literature from 2012 to 2022 was performed according to PRISMA guidelines. 2,398 records were identified, 54 were included in the analysis. RESULTS: In the metastatic setting, response in the primary tumour (≥30% reduction in size) is seen in 33–56% of patients treated with dual ICPI or ICPI + VEGFR-TKI. Pathological complete response rates were 14% for patients undergoing CN after a period of ICPI therapy. In the neoadjuvant setting there is a single published trial of VEGFR-TKI + ICPI, 30% of patients had a≥30% reduction in size of the primary. This appears superior to single agent ICPI. Grade 3 adverse event rates are comparable to the metastatic setting. CONCLUSIONS: A period of ICPI combination therapy followed by nephrectomy may be considered for selected patients as a strategy to manage metastatic disease. In the neoadjuvant setting, it is not clear whether ICPI + VEGFR-TKI is superior to VEGFR-TKI alone. There is minimal data on whether either CN after ICPI in metastatic patients, or neoadjuvant ICPI therapy for localised disease, improves long term survival.
背景:免疫检查点抑制剂(ICPI)广泛应用于治疗转移性肾细胞癌(RCC)。细胞减少性肾切除术(CN)是晚期疾病多模式治疗的一部分,但在ICPI时代没有使用它的前瞻性证据。新佐剂ICPI在RCC中的试验正在进行中;了解ICPI对原发性肿瘤的预期影响可能有助于在局部和晚期环境中做出临床决策。方法:根据PRISMA指南,对2012年至2022年的英语文献进行系统检索(PubMed,Web of Science,clinicaltrials.gov)。确定了2398份记录,其中54份被纳入分析。结果:在转移性环境中,33–56%接受双重ICPI或ICPI+VEGFR-TKI治疗的患者对原发性肿瘤有反应(大小缩小≥30%)。在ICPI治疗一段时间后,接受CN的患者的病理完全缓解率为14%。在新佐剂环境中,有一项VEGFR-TKI+ICPI的单一已发表试验,30%的患者原发性肿瘤大小缩小≥30%。这似乎优于单剂ICPI。3级不良事件发生率与转移情况相当。结论:对于选定的患者,可以考虑在肾切除后进行一段时间的ICPI联合治疗,作为治疗转移性疾病的策略。在新佐剂设置中,尚不清楚ICPI+VEGFR-TKI是否优于单独的VEGFR-TKI。关于转移性患者ICPI后的CN,或局部疾病的新辅助ICPI治疗是否能提高长期生存率,目前的数据很少。
{"title":"Activity of Immunotherapy Regimens on Primary Renal Tumours: A Systematic Review","authors":"James O. Jones, Will Ince, S. Welsh, G. Stewart","doi":"10.3233/kca-220012","DOIUrl":"https://doi.org/10.3233/kca-220012","url":null,"abstract":"BACKGROUND: Immune checkpoint inhibitors (ICPIs) are widely used in treating metastatic renal cell carcinoma (RCC). Cytoreductive nephrectomy (CN) forms part of multimodality treatment in advanced disease, however there is no prospective evidence for its use in the ICPI era. Trials of neoadjuvant ICPIs in RCC are underway; understanding the anticipated effect of ICPIs on the primary tumour may help clinical decision making in both localised and advanced settings. METHODS: A systematic search (PubMed, Web of Science, clinicaltrials.gov) of English literature from 2012 to 2022 was performed according to PRISMA guidelines. 2,398 records were identified, 54 were included in the analysis. RESULTS: In the metastatic setting, response in the primary tumour (≥30% reduction in size) is seen in 33–56% of patients treated with dual ICPI or ICPI + VEGFR-TKI. Pathological complete response rates were 14% for patients undergoing CN after a period of ICPI therapy. In the neoadjuvant setting there is a single published trial of VEGFR-TKI + ICPI, 30% of patients had a≥30% reduction in size of the primary. This appears superior to single agent ICPI. Grade 3 adverse event rates are comparable to the metastatic setting. CONCLUSIONS: A period of ICPI combination therapy followed by nephrectomy may be considered for selected patients as a strategy to manage metastatic disease. In the neoadjuvant setting, it is not clear whether ICPI + VEGFR-TKI is superior to VEGFR-TKI alone. There is minimal data on whether either CN after ICPI in metastatic patients, or neoadjuvant ICPI therapy for localised disease, improves long term survival.","PeriodicalId":17823,"journal":{"name":"Kidney Cancer","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2022-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43019107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Systematic Review of Comparative Studies of 3D Models for Preoperative Planning in Minimally Invasive Partial Nephrectomy 微创部分肾切除术前计划三维模型比较研究的系统评价
IF 1.2 Q4 ONCOLOGY Pub Date : 2022-11-29 DOI: 10.3233/kca-220008
F. Piramide, Dorival M Duarte, D. Amparore, A. Piana, S. De Cillis, G. Volpi, J. Meziere, C. Fiori, F. Porpiglia, E. Checcucci
Background: The employment of 3-dimensional (3D) virtual models of the organs and tumors, obtained from conventional 2-dimensional (2D) imaging (i.e. computed tomography scan and magnetic resonance imaging) have already demonstrated an outstanding potential in urology, especially in renal surgery. Objectives: The aim of this systematic review is to provide an updated focus on the results obtained from the preoperative employment of 3D virtual imaging reconstructions in nephron sparing oncological surgery. Methods: A systematic literature search was conducted in April 2022 using Medline (via PubMed), Embase (via Ovid), Scopus, and Web of Science. The search strategy used PICO criteria and article selection was conducted in accordance with the PRISMA guidelines. The risk of bias and the quality of the articles included were assessed. A dedicated data extraction form was used to collect the data of interest. Results: The initial electronic search identified 471 papers, of which 13 ultimately met the inclusion criteria and were included in the review. 11 studies reported outcomes of virtual models, 2 studies focused on printed 3D models. In these studies, the application of 3D models for preoperative planning has been reported to increase the selective clamping rate and reducing the opening of collecting system, blood loss and loss of renal function. Conclusions: 3D virtual models seem to provide some surgical benefits for preoperative planning especially for complex renal masses. In the next future the continuous evolution of this technology may further increase its field of application and its potential clinical benefit.
背景:从传统的二维(2D)成像(即计算机断层扫描和磁共振成像)中获得的器官和肿瘤的三维(3D)虚拟模型的应用已经在泌尿外科,特别是肾脏外科中显示出突出的潜力。目的:本系统综述的目的是对保留肾单位肿瘤手术中术前使用3D虚拟成像重建获得的结果进行最新的关注。方法:2022年4月,使用Medline(通过PubMed)、Embase(通过Ovid)、Scopus和Web of Science进行系统的文献检索。搜索策略使用PICO标准,文章选择根据PRISMA指南进行。评估了偏倚的风险和文章的质量。使用了专门的数据提取表格来收集感兴趣的数据。结果:最初的电子搜索确定了471篇论文,其中13篇最终符合入选标准并被纳入审查。11项研究报告了虚拟模型的结果,2项研究侧重于打印的3D模型。在这些研究中,据报道,3D模型在术前计划中的应用可以提高选择性夹紧率,减少采集系统的开放、失血和肾功能丧失。结论:三维虚拟模型似乎为术前计划提供了一些手术益处,尤其是对于复杂的肾脏肿块。在未来,这项技术的不断发展可能会进一步扩大其应用领域和潜在的临床效益。
{"title":"Systematic Review of Comparative Studies of 3D Models for Preoperative Planning in Minimally Invasive Partial Nephrectomy","authors":"F. Piramide, Dorival M Duarte, D. Amparore, A. Piana, S. De Cillis, G. Volpi, J. Meziere, C. Fiori, F. Porpiglia, E. Checcucci","doi":"10.3233/kca-220008","DOIUrl":"https://doi.org/10.3233/kca-220008","url":null,"abstract":"Background: The employment of 3-dimensional (3D) virtual models of the organs and tumors, obtained from conventional 2-dimensional (2D) imaging (i.e. computed tomography scan and magnetic resonance imaging) have already demonstrated an outstanding potential in urology, especially in renal surgery. Objectives: The aim of this systematic review is to provide an updated focus on the results obtained from the preoperative employment of 3D virtual imaging reconstructions in nephron sparing oncological surgery. Methods: A systematic literature search was conducted in April 2022 using Medline (via PubMed), Embase (via Ovid), Scopus, and Web of Science. The search strategy used PICO criteria and article selection was conducted in accordance with the PRISMA guidelines. The risk of bias and the quality of the articles included were assessed. A dedicated data extraction form was used to collect the data of interest. Results: The initial electronic search identified 471 papers, of which 13 ultimately met the inclusion criteria and were included in the review. 11 studies reported outcomes of virtual models, 2 studies focused on printed 3D models. In these studies, the application of 3D models for preoperative planning has been reported to increase the selective clamping rate and reducing the opening of collecting system, blood loss and loss of renal function. Conclusions: 3D virtual models seem to provide some surgical benefits for preoperative planning especially for complex renal masses. In the next future the continuous evolution of this technology may further increase its field of application and its potential clinical benefit.","PeriodicalId":17823,"journal":{"name":"Kidney Cancer","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2022-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49406466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
In Memoriam: Nicholas J. Vogelzang MD 纪念:Nicholas J.Vogelzang医学博士
IF 1.2 Q4 ONCOLOGY Pub Date : 2022-11-02 DOI: 10.3233/kca-229005
P. Lara, Peter Mulders
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引用次数: 0
Clinical Trials Corner: Optimizing Papillary Renal Cell Carcinoma Care 临床试验专区:优化乳头状肾细胞癌护理
IF 1.2 Q4 ONCOLOGY Pub Date : 2022-10-14 DOI: 10.3233/kca-229004
M. Parikh
The Clinical Trials Corner of Kidney Cancer highlights planned or ongoing high-impact studies in renal cell 8 carcinoma (RCC). In this issue, we highlight the PAPMET-2 study, an important Phase II study evaluating the 9 treatment of patients with advanced papillary renal cell carcinoma (pRCC). 10 In future, if you feel that you would like to draw attention to a specific trial, A Phase II Randomized Trial of Cabozantinib (NSC#761968) With or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma Study Design: This study enrolls patients with metastatic histologically confirmed pRCC (either Type 1 or Type 34 2) with radiographically measurable disease who are ICI- and cabozantinib-na¨ıve and who have been treated 35 with one or fewer targeted therapies for pRCC. Following enrollment, patients are randomized to receive either 36 60 mg of cabozantinib orally or 60 mg of cabozantinib orally plus atezolizumab 1200 mg intravenously every 3 37 weeks, until the time of disease progression or unacceptable toxicity. 38 Endpoints: The primary endpoint of this trial is progression-free survival (PFS). Key secondary outcomes include 39 overall survival (OS), objective response rate (ORR), and quantitative & qualitative adverse events observed in 40 each treatment arm. 41 as trials combining nivolumab with cabozantinib have treated patients with 40 mg of cabozantinib daily; in this study, the dose will be 60 mg in both arms. Thus, tolerance of this dose level in combination with ICI will be an important observation. The strength of this study is its uniformity in enrolling patients with pRCC, which is important as retrospective studies have reflected heterogeneity in outcomes based on histologic subtypes undoubtedly in part due to differences in responses to currently available therapies.
癌症临床试验角强调了计划或正在进行的肾8细胞癌(RCC)高影响研究。在本期中,我们重点介绍了PAPMET-2研究,这是一项重要的II期研究,评估了晚期乳头状肾细胞癌(pRCC)患者的9种治疗方法。10将来,如果你觉得你想引起人们对特定试验的关注,卡博扎替尼(NSC#761968)在晚期乳头状肾细胞癌患者中使用或不使用阿替唑珠单抗的II期随机试验研究设计:该研究纳入了患有转移性组织学证实的pRCC(1型或34 2型)的患者,这些患者具有ICI和卡博扎替尼阴性,并接受了35次一种或更少靶向药物治疗pRCC的治疗。入组后,患者随机接受36 60 mg卡博替尼口服或60 mg卡博替尼口服加atezolizumab 1200 mg静脉注射,每3 37周一次,直到疾病进展或出现不可接受的毒性。38终点:本试验的主要终点是无进展生存期(PFS)。关键的次要结果包括39例总生存率(OS)、客观反应率(ORR)以及在每个治疗组40例中观察到的定量和定性不良事件。41因为将尼沃单抗与卡博扎替尼联合的试验每天用40毫克卡博扎替尼治疗患者;在这项研究中,双臂的剂量为60mg。因此,这种剂量水平与ICI结合的耐受性将是一个重要的观察结果。这项研究的优势在于其在招募pRCC患者方面的一致性,这一点很重要,因为回顾性研究反映了基于组织学亚型的结果的异质性,毫无疑问,部分原因是对当前可用治疗的反应存在差异。
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引用次数: 0
期刊
Kidney Cancer
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