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[[原创地带]] EAU 2008 - Renal Cancer Highlights第23届欧洲泌尿科学年2008-3-(26-29)会议文献翻

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发表于 2008-4-27 15:30:52 | 显示全部楼层 |阅读模式
最近从老师接到一任务翻译些东东,当时满口就答应了,回来才看到有这么多,本人也就六级水平,而且过了之后,就没看过英语书了,本来想下过全文翻译软件搞定,没想到搞出来的效果这么差,没办法只有硬着头皮上了,第一次搞这东东希望大家多多拍砖!

不断更新中!!!!

如果谁有翻译好的现成的酬谢200论坛币.


EAU 2008 - - Advances in Targeted Therapy and Tissue Engineering in Urology: Targeted Therapy
EAU2008-靶向治疗和组织工程在泌尿科学的进展:靶向治疗
When a patient comes to the pharmacist in the future he may state: “Here is my sequence”. This could be a consequence of the development of targeted therapies as presented by Chris Evans. He pointed out that molecular profile of a patient will have an increasing impact on the selection patients for a diagnostic procedure or even a specific therapy. For instance it was recently shown that 5 common single-nucleotide polymorphisms (SNPs) are associated with a 46% chance to develop prostate cancer. Also, in prostate cancer: more than 80 targets (e.g. neuropeptides) have been shown to be altered following antihormonal therapy. LnCap-GRP tumors in castrated SCID mice were successfully treated with the inhibitor of src kinases AZD0530 from AstraZeneca. In bone metastases many different molecules are involved and bone metastases from prostate cancer may serve as a tool for biomarkers as well as target for therapy. Injection of AZD0530 into bone of mice resulted in disappearance of cancer cells. The drug is now in a phase-II trial for the treatment of prostate cancer.
在将来当一位病人来找药剂师他可能说:“这里是我序列”。 这可能是克里斯埃文斯所介绍的靶向治疗发展的结果。他指出病人分子的特点将对将选择病人的诊断程序甚至具体的治疗方法产生起来越多的影响. 例如最近5个普通的单一核苷酸多形性(snps)被显示与46%机会发展为前列腺癌有关. 另外,在前列腺癌:超过80靶物质(例如神经肽)已经证明改变下面的抗激素治疗 有LnCap-GRP肿瘤的去势的SCID 小鼠被src kinases AZD0530的抑制剂成功治疗.骨转移许可能跟很多不同分子有关,来自前列腺癌的骨转移灶可能成为靶向治疗的生物标记工具. 注射ZD0530进入小鼠的骨头结果导致癌细胞的消失。这种药物现在正在进行针对前列腺癌的二期实验。
In bladder cancer biomarkers such as p53, Rb, EGFR, angiogenesis markers and promoter hypermethylation are associated with a change of prognosis in terms of progression-free survival and cancer-specific survival. In kidney cancer: different enzymes are associated with histologic subtypes and an upregulation of certain molecules such as von-Hippel Lindau gene (VHL gene), hypoxia inducible factor (HIF), vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF) and others justify the treatment with Sorafenib and Sunitinib.

依据无进展生存和癌症特定存活,膀胱癌生物标志物比如p53, Rb, EGFR, 血管生成标志和基因启动子过甲基化与预后的变化有关. 在肾癌症:不同的酶与组织学亚型和向上调节的确定的分子有关比如von-Hippel Lindau gene (VHL基因),缺氧诱导因子 ,血管内皮细胞生长因子(VEGF),血小板衍生生长因子(PDGF)及其他调整治疗随着Sorafenib和Sunitinib.

EAU 2008 - Research Shows Elevated Serum Amyloid Alpha (SAA-1) Levels in Renal Cell Cacinoma
EAU2008-研究显示在肾细胞癌血清淀粉状蛋白α((SAA-1))水平升高.
Serum amyloid alpha 1 (SAA-1) was measured in serum of 62 patients with renal cell carcinoma (RCC) and compared to healthy volunteers as well as patients with prostate cancer or bladder cancer (n=54).Patients with RCC demonstrated higher SAA-1 levels compared to controls, and also the clear-cell subtype was associated with two times higher levels compared to non-clear-cell subtype. Additionally, metastatic disease was associated with higher levels than non-metastatic disease and patients with response following immunotherapy showed a decrease of SAA-1 serum levels.
在肾细胞癌血清淀粉样蛋白α-1(SAA-1)被测量在62个肾细胞癌病人的血清中并且和健康志愿者以及前列腺癌和膀胱癌的病人进行比较.(n=54) 有RCC的病人显示更高的SAA-1水平和控制者比较,以及透明细胞亚型比起非透明细胞亚型高两倍. 另外,代谢性疾病比非代谢性疾病水平更高.
The authors noted that SAA-1 is a valuable biomarker for prognostic evaluation and monitoring of patients with RCC. However, SAA-1 also became elevated after surgery. This may underline its property as an acute phase protein rather than a RCC-specific biomarker.
作者认为对于肾细胞癌SAA-1是一个有价值的生物标志物做为预测,评估和监测病人.但是SAA-1在外科手术后也会升高. 这可能更强调他是一个急性期反应蛋白,而非肾癌的的特殊生物标志物
Presented by: K. Junker, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Presented by:被 K. Junker, MD 等在第23届欧洲泌尿科学年会发表2008-3-(26-29)意大

Advances in Targeted Therapy and Tissue Engineering in Urology
利米兰靶向治疗和组织工程在泌尿科学的进展
Dr. Evans (Sacramento) presented a lecture on targeted therapies. Most drugs have a mechanistic “target”, such as the enzymes 5-α reductase in the treatment of BPH or 5-phosphodiesterase in the treatment of erectile dysfunction. However, in the current presentation, “targeted therapy” is defined as molecular targeting.
医生埃文斯(萨克拉门托)介绍了有关靶向治疗的一个讲痤. 大多数药物有一个机械的目标,比如5-α还原酶在前列腺的治疗或者5-磷酸二酯在勃起功能障碍的治疗.但是,在现在介绍中,靶向治疗上档是分子.
Historically, the selection of systemic therapies for most cancer patients has been largely empiric. However, recent advances in cancer molecular biology suggest that defining biomarkers predictive of response and survival are achievable goals. The Human Genome Project, the International HapMap and progress in high-throughput assays have made genetic testing and individualized therapy a tangible reality. Using pharmacogenomic approaches to cancer therapeutics, one translational approach is to exploit the underlying molecular profile of the tumor (DNA, RNA, protein) or the host (patient genomic DNA) to improve treatment outcomes. To do this researchers must take into account both inter-individual differences (between individual patients) and population-related differences (ethnic/racial differences).
从前对癌症病人的治疗方案的选择主要靠经验.但是,最近在在肿瘤分子生物学的进展表明限定的生物标志物对预测治疗反应以及存活都是可能的. 人类基因组计划,国际HapMa和高速含量测定使基因测定和个体化治疗成为可以摸得着的事实. 利用药物基因组学的方法治疗癌症,一个相对应的方法是利用肿瘤或者宿主基因的基本分子特点改进治疗效果. 做这个研究必须考虑个体及种族之间的差异.
While patients may carry the same diagnosis and clinical features, they possibly harbor different molecular profiles. Among patients carrying the same disease diagnosis, a subset that exhibit toxicity or non-response to standard therapy may have molecular attributes that identify them for alternate therapy. The concept of prognostic biomarkers is well established, but predictive biomarkers that confirm a molecular target or reflect the impact of a therapeutic intervention are newer. For example, while HER2 status delineates poor prognosis in breast cancer, it has positive predictive value for benefit from trastuzumab. On the other hand, the epidermal growth factor receptor inhibitor gefitinib was not initially appreciated to have selectivity for lung cancer patients with mutated EGF receptor (and gene copy number by FISH) and because of this 4,000 patients in 4 major clinical trials were not optimally selected to benefit.
当病人可能有相同的诊断和临床特征时,他们可能隐藏不同的分子方面的特点. 在一些相同诊断的病人中,可能对标准治疗没有反应或者有毒性反应,这可能是由于他们的分子组成造成的,他们须要另外的治疗. 预测生物标志物的概念是被很好的建立,但是预测生物标志物确定一个分子靶点或反映介入治疗的影响是新的. 比如,当高雌激素应答者2的状态在乳腺癌表明预后差时,在曲妥珠单抗表明预后好. 在另一方面,表皮生长因子受体抑制物吉非他尼开始不被理解对肺癌有选择性随着表皮生长因子的突变并且由于在4个重要的临床试验中的4000个病人没有理想的被选择得利.
Urologists perhaps became most aware of targeted therapy with the introduction of tyrosine kinase inhibitors for renal cell carcinoma. They resulted from the discovery that most patients with conventional cell renal cancer demonstrated mutation or silencing of the VHL gene, with subsequent delineation of pathways modified by pVHL. Sorafenib and sunitinib are “multikinase” inhibitors that target several kinases to include KIT, FLT3, PDGF and VEGF receptors. But in other histologic types of kidney cancer, different molecular alterations will drive therapy; mutations in the MET proto-oncogene in hereditary papillary renal carcinoma or mutations in the fumarate hydratase gene in hereditary leiomyomatosis renal cell carcinoma for examples. As such, receptors or pathways related to these specific alterations provide different targets. In bladder and prostate cancer numerous potential targets exist, based upon oncogenes, survival genes, gene products and suppressor gene mutations. In addition to testing as monotherapy, many targeted drugs are under investigation as combination therapy, such as the targeted endothelin-1 receptor A inhibitor atrasentan and docetaxel.
随着酷氨酸激酶抑制剂对肾细胞癌治疗的介绍,泌尿外医师也许是最知道靶向治疗的. 他们从新发现中知道,大多数的有常规肾细胞癌的病人会表现出突变或VHL基因的沉默,随着后来描述的被pVHL.Sorafenib and sunitinib 修改的通路是多激酶抑制剂,他定位个别的激酶以包括KIT,FLT3,PDGF and VEGF 受体. 但是在其它的组织学类型的肾癌,不同的分子组成的变更将驱动治疗: 例如遗传性的乳突状肾癌MET原癌基因的突变或遗传性的平滑肌瘤病的肾细胞癌的延胡索酸水合酶基因的突变.同样的,受体或通道有关的这些具体的变化提供不同的靶点. 在膀胱和前列腺癌有许多潜在的靶点存在,基于致癌基因,抗凋往基因,基因产物,和抑制基因突变. 除测试象单一疗法外,许多定向的药物在联合治疗中被研究,比如定向的肉皮肽-1受体A抑制剂阿曲生坦和多西紫杉醇.

As a bench to bedside example of targeted therapy, Dr. Evans’ group has researched Src kinase, a prototypical non-receptor tyrosine kinase and the first identified oncogene. Androgen withdrawal promotes prostate cancer cells to transdifferentiate to a NE phenotype and express neuropeptides and growth factors. We identified androgen-independent activation of the androgen receptor mediated by neuropeptides, epidermal growth factor (EGF), and interleukin (IL)-8 to be mediated by Src activation. In clinical samples, Src hyperactivation correlates with aberrant androgen receptor activation of high-grade prostate cancer cells and also androgen-independent disease.
做为一个正在实验的靶向治疗的例子,医生埃文斯的团队已经在研究Src激酶,一个典型的非受体酷氨激酶和第一个被识别的致癌基因. 去雄激素促进前列腺癌细胞分化为一个NE表型并且表达神经肽和生长因子. 我们识别被神经肽,表皮生长因子和被Src活化介导的中间白细胞素-8,介导的雄激素受体的独立雄激素的活化. 在临床样本中,Src高反应性相关与高分化前列腺癌细胞和雄激素慧非依赖性的疾病的异常的雄激素受体活化.

To explore Src as a target, the investigators hypothesized that NE cells are androgen-independent and secrete neuropeptides that further support androgen sensitive cell proliferation in the absence of androgens. They developed an in vitro and in vivo model by stable overexpression of the neuropeptide gastrin-releasing peptide (GRP) in LNCaP cells (LNCaP-GRP) through transfection and selection. LNCaP-GRP cells demonstrated androgen- and anchorage-independent growth and enhanced cell motility via Src activation. LNCaP-GRP cells developed orthotopic tumors in castrated nude and SCID mice and metastasized to regional lymph nodes in the SCID mice. The tumors expressed GRP, PSA and demonstrated nuclear translocation of the androgen receptor. These xenografts were re-cultured and provided paracrine growth support and migratory stimulation to wild-type LNCaP cells under androgen-deprived conditions in vitro and in vivo. They confirmed the signaling mechanism by which neuropeptides activate the androgen receptor in the absence of androgens to be activation of a non-receptor tyrosine kinase complex of Src, FAK and Etk. Using a novel and specific Src kinase oral inhibitor AZD0530, they demonstrated inhibition of growth and metastases in vivo. These observations have resulted in a National Cancer Institute sponsored Phase II trial using AZD0530 in patients with hormone refractory prostate cancer. Biomarkers predictive of drug activity (such as activated Src in circulating mononucleocytes) or target specificity (such as tyrosine kinase activity in tumor biopsies) are central to clinical target validation.
为了探索Src做为一个靶点,研究员猜测NE细胞是雄激素非依赖性的并且分泌神经肽,神经肽长久的支持雄激素敏感细胞增殖在雄激素缺失的情况下. 他们发展了一个体外研究和体内研究模型通过稳定的神经肽,胃泌素释放肽在前列腺癌细胞系细胞中通过转染和选择. 经由Src活化前列腺癌细胞系-胃泌素释放肽细胞展示非雄激素依赖性非固定依赖性的增加并且提高细胞运动性. 前列腺癌细胞系-胃泌素释放肽细胞在去势的和严重联合免疫缺陷的老鼠发展为常规部位的肿瘤,而且在严重联合免疫缺陷鼠标转移到淋巴结. 肿瘤青表达胃泌素释放肽PSA和展示雄激素受体核转运. 这种异种移植是反复培养并且提供旁分泌生长支持并且迁徙刺激对野生型前列腺癌细胞系细胞在去雄激素下的体外体内研究. 他们证实信号肽的机制,神经肽激活雄激素受体在去雄激素以非受体酪氨酸激酶Src,FAK,Etk的复合物. 使用新的特效的口服的Src激酶抑制剂AZD0530,他们显示了在体内对增殖和转移的抑制. 这些观察导致一个国家的癌症学会赞助对激素抵抗前列腺癌使用AZD0530的二期实验. 药物活性的生物标志物的预测是主要的临床药物靶标确证批准,比如激活的Src在单核细胞的循环或特异性的靶点比如酪氨酸激酶在肿块活组织检查的活动.

Presented by: Christopher P. Evans, MD at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
被 Christopher P. Evans MD 在第23届欧洲泌尿科学年会发表2008-3-(26-29)意大利米兰.

Optical Coherence Tomography (OCT) Helps Distinguish Normal Renal Parenchyma from Renal Cancer Tissue光学相干断层扫描帮助辨别正常的肾实质从肾癌组织中.

MILAN, ITALY (UroToday.com) - Optical coherence tomography (OCT) was shown to distinguish normal renal parenchyma from tumor tissue in 20 patients undergoing partial nephrectomy. OCT provides a 10-15 μm resolution and a depth of imaging of less than 2 mm. A group from the Cleveland Clinic compared in-vivo and ex-vivo images using the Imalux NirisTM System probe and validated their results against final pathology. Ex-vivo images were superior to in-vivo images to distinguish normal renal parenchyma from renal cancer tissue. The authors, however, were not able to identify a specific subtype of renal cell carcinoma. They also noted that a larger probe with larger scanning capacity should be developed to improve the performance of OCT.
米兰,意大利-光学相干断层扫描(光学相干断层扫描)被展示辨别正常肾实质从肿块组织在经历肾部分切除术的20个病人中. 光学相干断层扫描提供一个10-15微米分辨率和一个小于2毫米的深度成像. 一群来自克利夫兰研究所比较体内和体外影像利用ImaluxNirisTM系统探针并且证实他们的结果和最后的病理相一致. 体外影像优越于体内影像对于从肾癌症组织中辨别正常肾实质。 然而作者不能辨别一个肾细胞癌具体亚型.他们也注意到一个更大的探针带来更多的扫描容量应该被发展以发送光学相干断层扫描的性能.

Presented by: P. Koenig, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
被 P. Koenig MD 等在第23届欧洲泌尿科学年会发表2008-3-(26-29)意大利米兰

The Use of Biological Markers in Clinical Practice
生物标志物在临床实践中的应用.

Dr. Bjartell (Lund) presented on the use of biological markers as they can apply to clinical practice. A useful biomarker, he said is a molecular test that provides additional information to clinical information. It can improve cancer detection, staging, predict outcome, identify subclasses of a cancer and be applied to new therapies.
Dr. Bjartell介绍可以服务于临床实践的生物标志物的利用.他说一个有用的生物标志物是一个分子测试,那可以对临床资料提供附加的信息. 它可以改进癌症的检测,分期,判定预后,识别癌症的亚型和被用于新式的治疗.

Biomarkers in prostate cancer (CaP) included nomograms and the Partin tables. These are in wide use to predict the risk of a positive prostate biopsy, adverse pathology and recurrence. The usefulness of a biomarker can be assessed by adding it to a model and assessing the receiver-operating characteristics for enhancement over the existing model. This can also be measured by the concordance index. He pointed out that many new markers do not add to existing markers.
前列腺癌的标志物包括nomograms and the Partin tables .这些广泛用于预测一个阳性前列腺活检的危险,相反的病理学和再发生. 生物标志物的有用性可以被评定通过把它放入一个模型并且评价接收器运行特性为提高现有型号. 这也可以通过一致性的指标被测量. 他指出许多新的标志物没有加入到已存在的标志物.

Biomarkers in blood are often prostate specific, but not cancer specific. Despite that, multiplexing with other forms of PSA is shown to be useful. PSAV and PSADT reflecting PSA dynamics are shown to provide improved prediction for several aspects of CaP. Other new potential markers that may be useful include TGF-beta1 and IL6-SR and PAI1. These require more validation. EPCA1, 2 are nuclear matrix proteins in clinic trial for external validation as described by Dr. Getzenberg.
生物标志物在血洗经常是前列腺特有的,但不是癌症特有的. 尽管如此,多种多样其它形式的前列腺抗原被证实是有用的. 反映前列腺特异性抗原前列腺特异性抗原动力学的PSA速率(即在一定时间内 pSA变化率)和前列腺特异性抗原倍增时间提供更好的预测对于前列腺癌的某些方面. 其它潜在可能有用的标记物包括TGF -beta 1and IL 6-6-SR and PAI 1. 这些需要更多的证据. Dr. Getzenberg曾描述EPCA 1,2在体外证实的临床实验中是核基质蛋白质.

In tissue, PSA, p63, and high molecular weight keratin can identify basal cells and AMACR can identify cancer. MSP and CRISP-3 were studied by Dr. Bjartell and reported in Clinical Cancer Research. They used tissue microarrays in over 900 patients and found that they were independent predictors of recurrence but only marginally improved the accuracy of existing nomograms. Gene fusions and PCA3 are new potential biomarkers and PCA3 can be measured in a commercially available test. A recent multiplex test using gene fusion and 2 other markers outperformed PSA in a paper published in Cancer Research last month. New biomarkers to identify indolent cancers and those likely to progress to castration-resistance are needed, he concluded. Robust assays, taken from single to multicenter trials then externally validated and applied to prospective trials will bring new tests to clinical practice.
在组织,前列腺特异性抗原,p63和高分子量角蛋白可以识别基细胞和α甲基丙烯辅酶A消旋酶可以识别癌症. MSP and CRISP -3被Dr. Dr. Bjartell 研究并且被报道在临床癌症研究。 他们对超过900个病人使用组织芯片并且发现他们能独立的预测复发,但是对改进生存列线图的准确度确很有限. 基因融合和PCA 3是新的潜在的生物标志物并且PCA 3能被市场上可买到的. 最近一个利用基因融合和2个其它标志物的多样测试的优越性超过了前列腺特异性抗原,这篇文章发表在上个月的癌症研究. 他总结新的识别隐匿性癌的生物标志物和那些可能的去势抵抗的发展是被需要的. 健康试验将来新的临床实践测试,这种健康试被从单一到多中心试验然后体外证实从应用到预测试验带来.

Presented by: A. Bjartell, MD, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
被A. Bjartell , 在第23届欧洲泌尿科学年会发表2008-3-(26-29)意大利米兰.

Technology Makes the Single-Port Laparoscopic Nephrectomy Possible
新技术让单口腹腔镜肾切除成来可能.

MILAN, ITALY (UroToday.com) - Laparoscopic nephrectomy can be performed via one port. With the R-PortTM (Advanced Surgical Concepts, Wicklow, Ireland) a group from England and India for the first time removed a kidney with this technique and also performed some other minor procedures. They worked with three 5 mm instruments (one camera and two working instruments) and had short operating times without intraoperative complications. Besides two Single Laparoscopic Port Procedures (SLIPP), 3 “scar-less” One Port Umbilical Surgery (OPUS) operations were performed. The authors claimed superior cosmetic results when compared to the classical “one port – one instrument laparoscopy” but also stated that sometimes the grade of freedom for the instruments was impaired.
MILAN, ITALY (UroToday.com) - 经由一个孔可执行腹腔镜肾切除术. 用R-PortTM (先进的手术观念,Wicklow ,爱尔兰)一群来自英国和印度的医生第一次切除一个肾脏用这种技术并且用了更少的操作. 他们用三个5毫米的仪器(一个照相机和二工作仪器)并且在没有手术并发症的情况下使用了更少的时间. 除了二个腹腔镜孔,另一个脐部的孔是用来操作的. 比起经典的一个孔一个仪器,作者主张更好美容效果,但是有时会减弱仪器的自由度.

Presented by: A. Rane, MD, et al, at the European Association of Urology - 23rd Annual EAU

Vitespen Vaccine Demonstrates Possible Benefit for a Specific Subgroup of Renal Cancer PatientsVitespen疫苗显示对某个特殊的亚群肾癌病人有益.

An autologous heat shock peptide vaccine called Vitespen demonstrated a possible benefit for a specific subgroup of patients in a randomized open phase-III trial.
一个叫做Vitespen的自体热休克肽显示对某个特定的亚群病人有益在一个随机的三期实验中.

A total of 728 patients were included in this trial. Only patients with an intermediate risk following ECOG criteria showed an improvement of recurrence-free survival post-nephrectomy when treated with the vaccine compared to observation only. There were no grade 3 or 4 adverse events. The authors now look for the secondary end point overall survival for an additional three years.
这个实验总共有782个病人.在肾切除后给以疫苗治疗的病人仅仅中间物危险在ECOG标准后的显示有改善,相对于观察组来说. 没有3或4级相反的事情.作者现在正寻找第二次的终点全面的一个额外的三年存活.

Presented by: P. Mulders, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

Molecular Detection of Lymph Node Involvement
分子检测受累的淋巴结.

MILAN, ITALY (UroToday.com) - Dr. Michael Jewett (Toronto) presented the SIU lecture on detection and mapping regional lymph nodes (LN) in genitourinary cancer. He addressed the importance of LN in staging and therapy of GU cancers. Staging is prognostic and sets the scenario for adjuvant therapy. Lymphadenectomy (LA) is therapeutic and should be performed. The first lymphangiogram was performed in Britain in 1956 and set the stage for imaging. CT scanning if less than 8mm in the round dimension or 10mm on short axis if oval are historically considered normal. However, he challenged the 8-10mm size threshold as normal, and that macrometastases can exist in this size range. Dr. Jewett felt that CT or MRI are inadequate for staging and should not replace surgical staging.
MILAN, ITALY (UroToday.com) - 医生迈克尔朱厄特介绍就探测和测绘淋巴结演讲在泌尿生殖器的癌症. 他说明了淋巴结在泌尿生殖系癌症中分期和治疗的重要性. 分期用来预测和制定治疗方案. 淋巴结切除术是治疗学的和应该执行的。 第一个淋巴管造影照片是在1956在英国被执行并且为了制定了成像的步骤. 医生朱厄特认为CT和MRI分期存在不足,不应该取代手术上的分期.

The sentinel LN can be targeted using molecular probes and has been utilized in other cancers. Quantum dots with fluorescence holds promise and has been applied to melanoma. In urology, using these techniques is less developed. Also, lymph nodes can connect to micro-vessels and these vessels can serve as a mechanism for further dissemination. Probes can be injected directly into the primary tumor and color or radiation can then be identified and surgically removed. Often, the sentinel LN can serve as an indicator for involvement of more distant nodes. A better understanding of signal noise from normal nodes needs further investigation, he said. Lymphotrophic nanoparticle enhanced MRI holds promise, but the radiologist must be dedicated to the procedure to obtain reproducible results. Dr. Jewett reviewed the work of Dr. Cabanas in using the sentinel LN in penile cancer as he reported in 1977. This has evolved into scintography that is used by some in present day. The sentinel LN concept has evolved into templates for LA in testicular cancer and the extended LA in bladder and prostate cancers.
淋巴结可以用分子探针检测并且可以用于其它的癌症. 带荧光的量子点已经做到这点,并且被用于黑色素瘤. 在泌尿科学利用这个技术发展缓慢.. 而且淋巴结可以连接显微管道并且这些管道可以做为其播散的通道. 可以将探针直接注入原发肿瘤并且标记能够被识别的颜色或放射线,最后手术切除. 常常,淋巴结可以暗示远处是否有转移. 他说来处正常结点的信号噪声的更好理解需要进一步调查. 医生Jewett 回顾医生Cabanas利用守卫淋巴结诊断阴茎癌,这被报道在1977年.这已经用到了被现代人使用的scintography. 哨兵淋巴结的概念已经成为在睾丸肿瘤的LA和在膀胱,前列腺肿瘤的扩展LA的模板.

He concluded that surgical mapping remains the standard, although newer probes may eventually have a place in clinical management.
他总结虽然新的探针可能最后在临床实践中占有一席之地,但是手术标测仍然是标准.

Presented by: Michael Jewett, MD, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Sorafenib Versus Placebo as a Second Line Therapy of Metastatic Renal Cell Carcinoma (RCC)
EAU 2008 - 索拉非尼与安慰剂比较做为转移的的肾癌的二线治疗.   

Written by Christian Doehn, MD  
Tuesday, 08 April 2008

MILAN, ITALY (UroToday.com) - The randomized phase-III TARGETs trial compared Sorafenib versus Placebo as second line therapy of metastatic renal cell carcinoma (RCC). Beside the known efficacy outcome in terms of progression-free survival and overall survival researchers have now performed an analysis of two biomarkers (expression of pERK and serum levels of VEGF) and their potential to predict outcome. In fact both biomarkers did not allow prediction of outcome. The benefit of treatment with Sorafenib was rather seen in patients with both normal and elevated expression of expression of pERK and serum levels of VEGF.
MILAN, ITALY (UroToday.com) - 随机的三期试验比较索拉非尼和安慰剂做为转移性肾癌的二线治疗药物. 除了已知的有效结果,依据无进展生存和总生存率,研究员已经分析二种生物标志物(pERK 的表达和VEGF的血清水平)和他们预测预后的潜能. 事实上两种生物标志物没有允许预测结果.有pERK 表达和VEGF的血清水平升高或正常的病人被索拉非尼治疗能获得明显的益处.

Presented by: R. Bukowski, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Nephron-Sparing Surgery Should be Systematically Considered Regardless of Tumor Size
EAU 2008 - 保留肾单位外科手术应该系统的考察不管肿块的大小.   

Written by Christian Doehn, MD  
Tuesday, 08 April 2008

MILAN, ITALY (UroToday.com) - Nephron-sparing surgery is equivalent to radical nephrectomy in terms of cancer-specific survival. This is not new for a tumor size of 4 cm or less but has now also been o shown for organ-confined tumors larger than 4 cm. In a matched comparison analysis of 546 patients with renal cell carcinoma (RCC) stage pT1b-pT2N0M0 both groups (nephron-sparing surgery and radical nephrectomy) were comparable for demographic and tumor parameters. At a mean follow-up of 54 months a total of 36/546 patients had died from cancer without statistically significant differences among both groups. In a multivariate analysis only T-stage and age at diagnosis were independent prognostic parameters.
MILAN, ITALY (UroToday.com) - 依据癌症特定存活率,保留肾单位外科手术和根治性肾切除术是等价的. 对于小于4CM或更小的肿瘤这不是什么新东西,但是现在这被显示在大于4CM的局限在器官的肿块. 对546个肾细胞癌pT1b-pT 2N0M0分期的病人进行匹配比较分析,两组(保留肾单位和根治性肾切除术)比较人和肿块的参数. 在平均54个左右36/546病人死于癌症,这没有统计学意义. 在多变量分析中只有分期和年龄是独立的预测参数.

Due to the anticipated benefit in terms if renal function, nephron-sparing surgery should be systematically considered regardless of tumor size.
由于根据肾功能可以预测的益处,保留肾单位外科手术应该被系统的考察不管肿块的大小.

Presented by: J.J. Patard, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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Perioperative Use and Surgical Complications of Sunitinib in Metastatic Renal Cell Carcinoma
EAU 2008 - 舒尼替尼在手术中的使用以及并发症在转移性肾细胞癌.   


Friday, 04 April 2008

MILAN, ITALY (UroToday.com) - These investigators evaluated their postoperative complication rate in patients having metastatic renal adenocarcinoma and treated with Sunitinib during the perioperative period. From October 2005 to June 2007, 52 patients – mean age 57 – treated with Sunitinib for metastatic renal carcinoma were followed. Among these patients, all indications taken together, 9 underwent surgery. Secondary effects and complications were registered according to NCI CTC classification.
MILAN, ITALY (UroToday.com) - 这外调查评估有转移的肾腺癌的手术并发症的发生率和有手术期间用舒尼替尼治疗. 从2005年十月到2007年六月,52个病人–平均林龄57–用舒尼替尼治疗转移的肾癌。 在这些病人中,所有的指标放在一起,9个进行手术. 副效应和并发症被登记根据NCI CTC分级.

Of 52 patients admitted to follow-up, 9 (17%) had surgery during the 90 days period preceding or following treatment initiation. A total of 11 surgical events were registered. Among those patients who had surgery, 4 presented with a grade 2 cutaneous toxicity due to Sunitinib. Sunitinib administration was interrupted for a mean of 7.8 (0-54) days prior surgery and reintroduced 19.8 (0 – 55) days afterwards. Among these 11 surgical events, 2 patients presented with surgical wound necrosis. Each of those 2 patients presented before the procedure a cutaneous toxicity (grade 3) due to Sunitinib. Thus, Sunitinib administration should be suspended 10 days prior surgery as well as 10 days after.
52个病人纳入随访,9个进行了外科手术在开始治疗90左右. 总共11个手术上的事情被登记.在那些外科手术的病人中,4个表现出由于舒尼替尼的二级皮肤毒性. 舒尼替尼被打断在外科手术7.8天之前,并且再加入手术后19.8天.在这11个手术中,2个病人表现出外科手术伤口坏死. 2个病人中的每一个表现出由于舒尼替尼的三级皮肤毒性. 因此,舒尼替尼应该被终止外科手术10天前以及10天后。

Presented by: Thibault F., Billemont B., Rixe O., at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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Zoledronic Acid is Cost-Saving and Improves Quality Adjusted Survival in the Prevention of Skeletal Related Events in Patients with Bone Metastases Secondary to Advanced Renal Cell Carcinoma (RCC)
EAU 2008 - 唑来膦酸降低成本并且改善校准成活率的质量在预防骨骼的有关事情在肾癌继发骨转移的病人。   


Friday, 04 April 2008

MILAN, ITALY (UroToday.com) - A United Kingdom (UK) Perspective

A United Kingdom (UK) Perspective

Previous analyses have shown that zoledronic acid therapy is cost effective in patients with bone metastases secondary to breast cancer, lung cancer, and other solid tumors. Zoledronic acid has recently been shown to significantly reduce the risk of new skeletal related events (SREs) in patients with bone metastases secondary to RCC. The present study assessed the cost effectiveness of zoledronic acid in this population, adopting a UK health care payer perspective. This analysis was based on a retrospective analysis of a multicenter, randomized, placebo-controlled study of zoledronic acid in 46 RCC patients with bone metastases. Patients were randomized to receive zoledronic acid (n=27) or placebo (n=19) with concomitant antineoplastic therapy every 3 weeks for up to 21 months. A patient-level model was developed to simulate the costs and quality-adjusted life-years (QALYs) of trial subjects. The costs of SREs (including fractures, radiotherapy, bone surgery, and spinal cord compression) were estimated from the published literature. Drug, drug administration, and supply costs were obtained from published sources and tariffs. Consistent with similar economic analyses, patients were assumed to experience quality of life decrements lasting 1 month for each SRE experienced. A discount rate of 3.5% per annum was applied to both costs and benefits occurring beyond the first year, which is consistent with standard practice for UK cost effectiveness analyses.
以前的分析已经证实唑来膦酸对于乳腺癌肺癌及其他肿瘤继发骨转移的病人的治疗具有更好的经济效益。 唑来膦酸最近已被证明能减少新的骨骼相关事件的危险对于住院的肾癌继发骨转移病人。 目前研究评定唑来膦酸有成本效率,已通过英国保健机构的认可。 该分析是基于一个46个有骨转移肾癌病人的多中心,随机,安慰剂对照,回顾性研究。 病从随机得到唑来膦酸和安慰剂在为期3个星期到21个月的抗肿瘤药物治疗。 一个病人水平模型被开发以模拟实验主题校准寿命的花费和质量。的花费被估计从已发表的文章,包括骨折,放射线疗法,骨科手术,和脊髓压缩。药物以及其它供应的价钱是从出版物或收费表。 符合相似的经济学分析,病人被认为生活质量递减在每一个SRES经历者的最后一个月。 每年3.5%的折扣在花费和利益方面,这与英国成本效率分析一致。

Zoledronic acid patients experienced an average of 0.66 SREs vs 1.74 for placebo patients. The discounted QALYs were 0.526 and 0.402 for zoledronic acid and placebo patients, respectively. Discounted SRE-related costs were estimated to be substantially lower for zoledronic acid patients than placebo ones (£1305 v. £4454, respectively). After considering drug therapy costs, zoledronic acid resulted in net savings of £699 and QALY gains of 0.124 per patient. Because zoledronic acid resulted in cost savings and gains in QALY compared to placebo, it is the preferred strategy. These results were confirmed in the PSA simulation. The cost effectiveness ratio of zoledronic acid was below the £30000- per-QALY-gained threshold in 92% of 1000 PSA simulations. In addition, therapy with zoledronic acid was cost saving in 71% of these PSA simulations.
服用唑来膦酸的病人平均0.66SREs 对服用安慰剂的病人的1.74。 唑来膦酸和安慰剂的病酌减的生活质量调整寿命年分别是0.526和0.402。 与骨骼相关的事情的相关成本是大大降低,分别是£1305£4454。 每个病人提高0.124。唑来膦酸能够节省费用和提高生活质量。 这个结果在前列腺特异性抗原模仿中被证实。唑来膦酸的成本效率比在3000以下,每提高1000前列腺特异性抗原模仿的92%。 另外,用唑来膦酸治疗的费用节省PSA 模仿 的71%。

The present analysis suggests that zoledronic acid is cost saving and increases quality adjusted survival compared to placebo in RCC patients with bone metastases in the UK.
现在的分析表明唑来膦酸节省费用和增加了生存质量对于肾癌骨转移病人。

Presented by: Botteman F., Kaura S., Chen M., at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Laparoscopic High-Intensity Focused Ultrasound for Energy Ablative Therapy of Small Renal Tumors
EAU 2008 - Laparoscopic 高能聚焦超声烧蚀治疗小的肾肿瘤。   


Thursday, 03 April 2008

MILAN, ITALY (UroToday.com) - A group from the Medical University of Vienna, Austria presented their data on high-intensity focused ultrasound (HIFU) for the treatment of small renal tumors. They showed data that HIFU works by a targeted homogeneous ablation of renal tissue. The objective of their clinical phase I study was to evaluate the feasibility of laparoscopic HIFU ablation of small renal masses with respect to homogeneity and extent of necrosis obtained with this technique.
MILAN, ITALY (UroToday.com) - 一群来自奥地利维也纳的医科大学的成员介绍了他们用高能聚焦超声治疗小的肾肿瘤。 他们展示了高能聚焦超声通过均一的烧蚀肾组织来工作。 他们一期临床的目标是评价用腹腔镜检查的高能聚焦超声烧蚀小肾肿块的可能性。

Between November 2006 and August 2007, 16 kidneys with solitary renal lesions were treated with a newly developed 4.0MHz laparoscopic HIFU probe. They researchers targeted renal masses under ultrasonic control with a focal ablation zone of 3.5cm. In 3 patients a defined marker lesion was placed prior to laparoscopic radical nephrectomy. In 13 patients with a mean mass size of 2.5 cm the tumor was completely ablated by curative intent, followed by laparoscopic partial nephrectomy in 12. One patient only had post HIFU biopsies and was followed-up using radiographs. Specimens were analyzed by whole mount histology.
在2006年十一月和2007年八月间,16个孤立肾病变被用这种方式治疗。 他们的研究员定位肾肿块在超声控制下焦点3.5cm内的区域。 有3个病人是被定义标志损害在腹腔镜根治性肾切除术以前。 平均大小2.5CM的肿块的13个病人肿块被完全烧蚀,12个接着进行了腹腔镜肾部分切除。 只有一个病人死于高能聚焦超声活组织检查和接下来的放疗。样本被进行组织学分析。

The mean HIFU ablation time was 22 minutes, with power levels ranging between 30-38W, with a mean targeted volume of 10.2 (9-23) cm3. By histological evaluation, marker lesions showed homogeneous thermal damage that was consistent with irreversible tissue damage. Of the 15 tumors removed after HIFU 10 showed complete, homogeneous ablation of the entire tumor. Two had a 1-3 mm rim of viable tissue immediately adjacent to where the HIFU probe was approximated to the tumor. In one patient with borderline mass size, a rim of tissue 1-2mm distal to the focal ablation zone could not be ablated. One tumor showed a central area of vital tissue made up of about 20% of its volume. There were no HIFU related complications.
高能聚焦超声烧蚀时间平均是22分钟,随着功率在30-38W之间,随着平均数指标容积10.2(9-23)厘米。 通过组织学的评估,标记的损害显示均一的热损伤,这是与单一组织损伤相一致的。 被高能聚焦超声烧蚀的15个肿块,10显示完全的,均一的烧蚀整个肿块。 2个有1-3毫米有生机的边缘组织立即靠近高能聚焦超声探针所对个那个肿块。 一个有临界大小肿块的病人,烧蚀中点的远端1-2毫米的组织不能被切除。 一个肿瘤显示了一个由20%体积组成的致命组织的中央区。没有高能聚焦超声相关的并发症。

Presented by: H.C. Klingler, MD, et al at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Laparoscopic Renal Cryoablation (LRC) of Small Renal Masses
EAU 2008 - 腹腔镜肾冷冻消融术治疗小的肾肿块.   
Thursday, 03 April 2008

MILAN, ITALY (UroToday.com) - Lessons Learned from 104 Cases in a 7-year Experience
回顾7年来104个案例.
A group from Milan, Italy prospectively analyzed the outcome of patients with kidney masses treated with laparoscopic cryoablation over a 7-year period. Beginning in September 2000, 104 patients (mean age 61.6 years; 78 male and 26 female) underwent LRC for renal masses. The mean lesion diameter was 2.2cm. The procedure was performed transperitoneally in 60 cases and in 44 patients it was done retroperitoneoscopically, based upon the tumor position or potential difficulties due to previous abdominal surgery. Fifty-six patients (54%) had concomitant comorbidities.
一群来自意大利,米兰的成员,预测性地研究在7年时间里用腹腔镜检查的冷冻消融术治疗肾脏肿块的病人. 从2000年九月开始,104个病人(平均年龄61.6,78个男性和26个女性)使用了腹腔镜肾冷冻消融术治疗肾脏肿块. 平均损伤直径2.2厘米. 60个经腹腔,由于肿块的位置或者因为以前的腹部外科手术使经腹腔存在潜在的困难,44个病人经腹膜后腹腔镜,54%的病人有其它疾病.

The intra-operative mean diameter of the ice ball was 4.93cm. All the procedures were successfully completed laparoscopically, except 3 cases that were converted to open surgery, two of them due to bleeding from the site of the cryoprobe insertion (one of them requiring radical nephrectomy). Mean surgical time was 202.6min (range 90-320 min) and mean intra-operative blood loss was 211.6 cc (range 10-3.200 cc). Pathological evaluation of the intra-operative needle biopsies documented renal cell carcinoma in 64 cases, 23 oncocytomas, 6 angiomyolipomas, 1 case of Xantogranulomatous pyelonephritis and 10 cases “undefined” disease. Post-operative stay was 4.7 days (range 2-13).
术中冰球的平均直径是4.93cm,除了三个病例转为开腹,其中两个因为冷冻刀插入面出血(其中一个需要根治性的肾切除术),所有操作均在腹腔镜下完成。平均手术事件为202.6分钟(90-320分钟),平均术中出血为211.6cc(10-3200cc)。术中针刺活检病理结果显示64例肾癌,23例嗜酸粒细胞腺瘤,6例angiomyolipomas,1例xantogranulomatous pyelonephritis,另有10例为未定义病例。术后住院时间平均为4.7天(2-13天)。
Postoperative complications were always treated conservatively and included 7 cases of transient fever, 2 cases of small peri-renal hematomas, 1 case of pulmonary edema, 9 patients with significant blood loss and 1 case of gross hematuria.
术后并发症被谨慎的处理,包括7例一过性的发热,2例小的肾周血肿,1例肺水肿,9例明显的失血,1例肉眼血尿。
Delayed complication included 1 case of UPJ obstruction requiring open pyeloplasty 8 months after surgery and open nephrectomy one year after surgery due to suspected recurrence of the disease.
延迟后并发症包括1例UPJ梗阻,在术后8个月行肾盂切开成形术,1年后怀疑复发行肾脏切除术。
Six patients died during the follow-up, 5 due to previous illness and 1 patient due to worsening cirrhosis one month after surgery. No patients died secondary to renal cancer.
6例病人接下来死亡,其中5例归于先前的疾病,1例则是因为术后1月不断恶化的硬化。无死于肾癌的病人。

MRI scans on postoperative day one revealed a mean lesion of 4.91cm. Progressive reduction in size of the ablated lesion was visible in all patients with only a renal scar visible after 24 months of follow-up. This remained constant over time with 36 patients being followed up for 5 years and 11 patients for 7. In the question period, Dr. Jewett (Toronto) pointed out that 40% of the patients with benign lesions had unnecessary treatment and perhaps the biopsies should be performed a few weeks prior to the intended procedure.
术后MRI扫描显示平均4.91cm的创面。所有病人在术后24个月里创面逐渐减小,仅剩一肾区瘢痕。且36例病人在接下5年里无变化,另有11例7年保持不变。在答疑时间里,Jewett医生指出40%良性病变的病人无需治疗,活检应该在进行进一步治疗前若干周进行。

Presented by: A. Cestari, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - The Clinical Significance of Micro-Metastatic Lymph Node Disease in Kidney and Bladder Cancer   Show Comments     PDF   
肾和膀胱癌淋巴结微量转移的临床意义.


Tuesday, 01 April 2008

MILAN, ITALY (UroToday.com) - Dr. Gschwend (Munich) presented a State-of-the-Art lecture on LN disease in renal and bladder cancers. He began with bladder cancer and that staging correlates with disease specific survival. The stage also correlates with the likelihood of positive LN. Dr. Gschwend stated that surgical LA is the standard for accuracy. MIcrometastasis can be detected in blood, bone marrow and lymph nodes. In bladder cancer, RT-PCR was used to detect LN’s that were “negative” by standard pathological staging. Cytokeratin 19 and Uroplakin II have been used as the markers to detect micrometastasis by RT-PCR. In rectal cancer, using this type of technique was an independent prognostic factor for disease-specific survival. This has been shown in bladder cancer, using molecular staging for CK 20 by RT-PCR in bone marrow specimens. In a preliminary German study using RT-PCR for CK 20 in bladder cancer resulted in a 4-fold increase in detection over surgical staging.
Gschwend医生报告关于肾和膀胱癌的淋巴结病变的技术进步。他从膀胱癌和与存活率密切相关的分级开始。同时分级又与淋巴结阳性结果密切相关。Gschwend医生指出淋巴结切除术是基本的治疗。微病灶转移可以在血液,骨髓及淋巴结中发现。在膀胱肿瘤中,RT-PCR被用于检测那些传统病理分级未发现异常的淋巴结。细胞角蛋白19及Up-2用作搜寻微转移灶的标记。在肾癌中,该项技术的使用是疾病特异性生存率的独立预测因子。对于膀胱肿瘤中,检测骨髓活检物中的CK20。德国一项通过RT-PCR检测膀胱癌CK20的研究使得外科分期四倍的增长。

Three systems are responsible for development of micrometastasis. They include chemokines, mostly mediated through G-protein coupled receptors. Ligand 12 and CXCR4 on leukocytes is important. But in addition to leukocytes, tumor cells utilize the same mechanism to be directed to LNs. Secondly, lymphangioneogenesis occurs through VEGF pathways. Extracellular matrix metalloproteinase inducer (EMMPRIN) increases invasive enzymes and enhances tumor cell migration and is a third mechanism. EMMPRIN keeps the tumor cells from adhering to one another and facilitates invasion and migration.
三个学会负责微灶转移的研究,他们包括主要由G蛋白受体介导的CK。白细胞中Ligand12和CXCR4在leukocytes是重要的.但是除白细胞之外,肿瘤细胞运用同样的机制诱导向淋巴结.第二点,淋巴管产生通过VEGF途径,细胞外基质金属蛋白诱导物增强穿透酶,增强肿瘤细胞的游走,这是第三条机制。EMMPRIN可以使得肿瘤细胞粘附一个又一个细胞,促进侵入及游走。

In renal cell cancer, the incidence of unsuspected LN positivity is 3.3%. Molecular staging for VHL mutation has not shown a significant yield. However, studies for molecular staging in renal cell cancer to date have been minimal and he encouraged research in this area.
在肾细胞癌中,遗漏的阳性淋巴结发生率为3.3。分子分级对于VHL基因突变并未显示出明确的一致性,但是,对于肾细胞癌的分子分级研究太少了,他估计在这个领域进行研究。

Presented by: J.E. Gschwend, MD, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - 根治性肾切除术没有优于保留肾单位的外科手术在pT 1b-pT 2N0M0期的肾肿瘤.   Show Comments     PDF     Print     E-mail   
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Thursday, 03 April 2008

MILAN, ITALY (UroToday.com) - 来自法国Rennes 医生Patard 匹配比较分析546病例,介绍一个大的国际群体关心2406个肾部分切除术操作来自多机构的数据,289个pT 1b-pT 2N0M0期的肾肿瘤患者被选择与匹配的根治性肾切除患者相比较.和根治性肾切除术的好处对于设置器官限制肿块测量.

2406个肾部分切除术操作来自多机构的数据,289个pT 1b-pT 2N0M0期的肾肿瘤患者被选择与匹配的根治性肾切除患者相比较. 为了这个目的,1507个被执行根治性肾切除的患者和有相同的TNM分期人,257个被选中与肾部分切除术的患者进行比较,因为其肿块大小和Fuhrman 分级.

546个肾操作被纳入这个回顾性分析研究. 在平均54个月的随访中,只有36(6.6%)的病人死于癌症. 部分肾切除组和根治性切除组病人进行比较,诊断年龄(59.3vs. 61)肿块大小(5.47对比5.5厘米)分级(T1273(94.5%)vs. 241(93.8%)和Fuhrman 分级(G1-1-G2 234(81%)vs. 204(79.4%)). 比较两组病人的生存率,生存曲线完美重叠. 关于预测参数,作者发现生存率,分级,Fuhrman级数和年龄有诊断中的重要性在单变量分析中,同时分级和年龄在多变量分析中也是独立的预测参数. 对于这些选定的低危险人群手术方法对结果完全没有影响在单或多变量分析中.

Presented by: J.J. Patard, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Surgical Management Safety and Short-Term Efficacy of Laparoscopic Cryoablation for Renal Tumors ≥ 3 cm: A Multicenter European Report   针对大于3cm的肾脏肿瘤腹腔镜冷冻消融术的安全性及短期疗效:欧洲一多中心报告。



Thursday, 03 April 2008

MILAN, ITALY (UroToday.com) - A multicenter European group reported on the short-term outcomes of laparoscopic cryoablation for renal lesions greater than 3cm in size. Laparoscopic cryoablation has previously been reported as safe and effective for renal tumors <3 cm. The authors studied a group of patients who were considered to be poor candidates for needle ablation therapy.
Milan,意大利,欧洲一多中心研究小组报告了大于3cm肾脏肿瘤行腹腔镜冷冻消融术的短期疗效。在以前的报告中冷冻消融术对于小于3cm的肾脏肿瘤是安全有效的。作者研究了一组被认为不适于行针刺消融治疗的病人。

Patients’ data at 7 European centers was prospectively recorded. Procedures were carried out laparoscopically using laparoscopic ultrasound guidance and 17g cryo-needles or Ice Rods. A total of 80 tumors at least 3cm in size (median 3.6) were treated over a 4 year period. Over 80% of the patients had significant comorbidity and were not considered good candidates for partial or radical nephrectomy. Twenty-five percent had a single functioning kidney.
欧洲七个中心的病人资料前瞻性的记录下来。在腹腔镜超声引导及17g冷冻针或冰杆下行腹腔镜下手术。80个最小3cm的肿瘤治疗超过4年。超过80%的病人有明显的并存症,被认为不适于行部分或根治性肾脏切除术。25%病人只有单肾功能。

A total of 20 peri-operative complications occurred in 18 of 80 patients (22.5%); 7 major and 13 minor. Major intra-operative complications included 1 nephrectomy and 2 partial nephrectomies for bleeding. Post-operatively, there was 1 hematoma requiring transfusion and 3 myocardial infarctions resulting in one death. Minor complications included chest infection (1), wound infection/hematoma (4), skin burn (1), fever (1), UTI (2) and ileus (4). Only 2 patients required transfusions. Overall, 4 major bleeding complications occurred in the 80 cases (5.0%) and the researchers stated that these could potentially be attributed to the large tumor size.
80例病例中有22.5%的病人在术前出现了总计20种并发症,包括7种主要并发症,13个次要并发症。术中主要并发症包括1个全肾切除,2个肾脏部分切除术病人发生出血,术后发生1例血肿需要输血,3例心梗病人死亡1例。次要并发症包括肺部感染(1),切口感染/血肿(4),皮肤烧伤(1),发热(1),UTI(2)及肠梗阻(4)。只有2例病人需要输血。80例病人中出现4例主要出血并发症,研究者认为并发症的发生与肿瘤大小相关。

The conclusion was that peri-operative complications for laparoscopic renal cryoablation are higher in patients with tumors larger than 3 cm; however, major bleeding complications remain relatively uncommon with 17g needles. The emphasis was that more care must be taken not to traumatize the ice ball during treatment, especially in exophytic tumors. Technical tips included freezing to a target of -40 to - 60C and no lower, which may prevent cracking and resultant bleeding complications.
肿瘤大于3cm的病人中,腹腔镜下肾脏冷冻消融术前并发症的发生率较高。而使用17g针发生主要出血并发症仍然相对较少。重点指出的是,尤其在外生性肿瘤中,需要注意勿损伤冰球。技术要点包括冷冻靶向至-40至-60度,而不致太低,可以防止破裂及出血等并发症。

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发表于 2008-4-27 17:56:51 | 显示全部楼层
EAU2008-靶向治疗和组织工程在泌尿科学的进展:靶向治疗

在将来当一位病人来找药剂师他可能说:“这里是我序列” 这 是我的序列。 这可能是克里斯埃文斯所介绍的靶向治疗发展的结果。他指出病人分子的特点将对将选择病人的诊断程序甚至具体的治疗方法产生起来越多的影响. 例如最近5个普通的单一核苷酸多形性(snps)被显示证明有46%的机率与发生前列腺癌有关 与46%机会发展为前列腺癌有关. 另外,在前列腺癌:超过80靶物质(例如神经肽)已经证明可以改变下面的抗激素治疗 有LnCap-GRP肿瘤的去势的SCID 小鼠被src kinases AZD0530的抑制剂成功治疗.骨转移许可能跟很多不同分子有关,来自前列腺癌的骨转移灶可能成为靶向治疗的生物标记工具. 注射ZD0530进入小鼠的骨头结果导致癌细胞的消失。这种药物现在正在进行针对前列腺癌的二期实验。

依据无进展生存和癌症特定存活,膀胱癌生物标志物比如p53, Rb, EGFR, 血管生成标志和基因启动子过甲基化与预后的变化有关. 在肾癌症:不同的酶与组织学亚型和向上调节的确定的分子有关比如von-Hippel Lindau gene (VHL基因),缺氧诱导因子 ,血管内皮细胞生长因子(VEGF),血小板衍生生长因子(PDGF)及Sorafenib和Sunitinib提出的其他调整治疗(随着Sorafenib和Sunitinib).
EAU2008-研究显示在肾细胞癌血清淀粉状蛋白α((SAA-1))水平升高.在肾细胞癌血清淀粉样蛋白α-1(SAA-1)被测量在62个肾细胞癌病人的血清中并且和健康志愿者以及前列腺癌和膀胱癌的病人进行比较.(n=54) 有RCC的病人显示更高的SAA-1水平和控制者比较,以及透明细胞亚型比起非透明细胞亚型高两倍. 另外,代谢性疾病比非代谢性疾病水平更高.

作者认为对于肾细胞癌SAA-1是一个有价值的生物标志物做为预测,评估和监测病人.
作者认为对有RCC的病人而言SAA-1是一个预测、监测的有价值生物标志物。
但是SAA-1在外科手术后也会升高. 这可能更强调他是一个急性期反应蛋白,而非仅仅是肾癌的的特殊生物标志物

Presented by:被 K. Junker, MD 等在第23届欧洲泌尿科学年会发表2008-3-(26-29)意大利米兰靶向治疗和组织工程在泌尿科学的进展
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 楼主| 发表于 2008-4-28 23:43:58 | 显示全部楼层
谢谢楼上兄弟,
呵呵,现在外文区好冷呀
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 楼主| 发表于 2008-5-6 13:23:23 | 显示全部楼层
EAU 2008 - Surgical Management - Scarless Nephrectomy by Transgastric and Transvesical Combined Approach   通过经胃和膀胱使肾切除术没有疤痕。


Thursday, 03 April 2008
MILAN, ITALY (UroToday.com) - Dr. Lima from Porto, Portugal presented the novel concept of “natural orifices translumenal endoscopic surgery” (NOTES) as applied to nephrectomy in an experimental model. Their team assessed the feasibility of a combined transgastric and transvesical approach for performing nephrectomy in a porcine model.
MILAN, ITALY (UroToday.com) - 来自葡萄牙波尔图的Lima 医生介绍了在一实验模型中经自然管壁的内镜手术执行肾切除的新概念. 他们的研究小组研究了在一猪的模型上经胃和膀胱肾切除的可能性.
In a non-survival study, a transgastric and transvesical combined approach was applied in 6 female pigs. Under ureteroscopic control, they placed a transvesical 5-mm over tube into the peritoneal cavity, and a flexible gastroscope was passed orally into the peritoneal cavity by a gastrotomy. Four right and two left nephrectomies were performed using instruments introduced by both devices. The pigs suffered no complications during creation of transvesical and transgastric access. In all animals, they visualized both kidneys, and the renal vessels and ureter were identified and ligated separately with ultrasonic scissors, which were introduced through the transvesical port. In two early cases, mild bleeding occurred after ultrasonic ligation. Complete renal release and mobilization to the stomach was achieved in all animals. During the discussion, it became apparent that none of the “resected” kidneys were removed from the porcine bodies, and this would require some sort of incision.
在一没有存活的研究中,六只雌性的猪接受了这种手术. 在输尿管镜的控制下,他们经膀胱放入了一个超个5毫米的管子进入腹腔,并且利用灵活的胃窥器从口经胃进入腹腔. 四个右边和两个左边的肾被切除利用上述介绍过的仪器. 在制造经膀胱和胃的通路时,猪没有并发症. 在所有动物中,他们设想的两个肾,和肾的血管,输尿管被识别和结扎分离被超声刀,超声刀是经膀胱孔放入的. 在早期的两个例子中,超声刀结扎后有轻微的流血.在所有动物中肾都是完全被切除并且移动到胃. 在这个讨论中,很明显没有一个切除的肾被从猪的身体移出,并且这需要更多的切割.

Presented by: E. Lima, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - A Large Open-Label, Non-Comparative, Phase III Study of the Multi-Targeted Kinase Inhibitor Sorafenib in European Patients with Advanced Renal Cell Carcinoma
EAU 2008 - 一人开放,非对照的三期研究显示,多靶点抑制剂索拉非尼在欧洲用于高级的肾癌病人.   Show Comments     PDF     Print     E-mail   
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Thursday, 03 April 2008
MILAN, ITALY (UroToday.com) - Dr. Verzoni presented a trial to collect safety and efficacy data on sorafenib from a large and broad study population reflecting clinical practice. This nonrandomized, open-label study included male and female patients, aged ≥18, with an ECOG PS 0–2 and a life expectancy >2 months. Patients had to be unsuitable for or have failed prior cytokine therapy. Controlled, asymptomatic brain metastases were allowed. Patients received continuous therapy with sorafenib 400 mg twice daily until disease progression, intolerable toxicity, or withdrawal of consent. Dose increases were not permitted. Recruitment was planned to continue until regulatory approval of sorafenib for advanced RCC. Study assessments were conducted at baseline and then monthly. Adverse events were graded according to NCI CTCAE v 3.0 criteria. Tumor assessment and radiological evaluation were conducted within 28 days prior to the start of sorafenib therapy, and then according to local standards of care, but at least every 3 months.
MILAN, ITALY (UroToday.com) - 医生Verzoni介绍了一个实验以收集索拉非尼安全有效的证据从大范围的临床实践中. 这个非随机,开放研究包括男性和女性病人,年龄≥18,随着ECOG PS 0–2和预期寿命〉2月. 病人必须没有不适和在先前的细胞因子治疗中失败. 被控制的,无症状的头部转移也可以. 病人连续的每天二次给于400毫克索拉非尼直到疾病恶化,无法耐受毒性,或要求退出. 剂量不能增加,募集反应被计划继续直到调整方法. 研究评定以每月基线为指导。 相反的事情被分级根据NCI CTCAE v3.0标准。 肿块的评定和放射性的评估在开始索拉非尼治疗前的28天内被指导,然后根据关心的地方标准,但是至少每3个月。
A total of 1155 patients were recruited in 11 European countries. Seventy-five percent of patients were male. Median age at enrollment was 62 years. At baseline, ECOG PS = 0 in 40% of patients, 1 in 45%, and 2 in 15%; 73% of patients had tumor lesions in the lungs, 41% in lymph nodes, 36% in bone, 28% in the liver and 23% in the kidneys. Eleven percent of patients had not had the primary tumor resected. Twenty-eight percent of patients had no prior therapy and were included because they were unsuitable for cytokine treatment. Tumor histology included pure clear cell (75%), papillary (10%) and chromophobe (3%) subtypes. Sarcomatoid features were noted in tumor samples from 5% of the patients. Most frequent Grade ≥3 drug-related adverse events were hand-foot-skin reaction [12%], fatigue [8%], diarrhea [5%], rash/desquamation [5%] and hypertension [4%]. The rates of Grade ≥3 drug-related adverse events were similar across sub-populations evaluated. The median progression-free survival was 6.8 months, and the median duration of treatment 6.9 months.
在11个欧洲国家总共1155个病人被纳入。 75%的病人是男性。 平均登记年龄62. 40%的病人ECOGPS 基线=0 45%=1 15%=2 73%的病人有肺肿块损害,41%在淋巴结,36%在骨,28%在肝和23%在肾。 11%的病人没有切除原发肿瘤。 百分之二十八的病人以前没有治疗,因为他们不适合细胞因子治疗。 肿块的组织学类型包括透明细胞癌(75%),乳突状(10%)和嫌色细胞癌(3%)。 肉瘤不被关注在5%的样品中。 与药物相关的最常见的分级≥3的不良反应是手脚的皮肤反应[12%],疲劳[8%],腹泻[5%],皮疹[5%]和高血压[4%]。 分级大于3的不良反应的概率和交叉亚群评价相似。 平均无进展生存率是6.8个月,平均治疗时间6.9月。
This EU-ARCCS study successfully provided treatment to a large number of patients with RCC across Europe prior to regulatory approval. EU-ARCCS confirmed the safety findings of the TARGET study in a real life setting and in clinically relevant patient sub-populations. The efficacy of sorafenib appears to be comparable with that observed in randomized controlled clinical trials.
EU -ARCCS研究成功的给许多有肾癌的病人提供了治疗方法,在调整方法以前。 EU -ARCCS 证实在现实生活中的靶点研究的安全探测和有临床相关的亚群病人。 索拉非尼的疗效显得与遵守随机控制临床实验相当。

Presented by: E. Verzoni, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - A Multicenter, Randomized, Phase 3 Trial of a Novel, Autologous, Therapeutic Vaccine (Vitespen) vs. Observation as Adjuvant Therapy in Patients at High Risk of Recurrence after Nephrectomy for Renal Cell CarcinomaEAU 2008 - 一新的自体的疫苗治疗对比佐剂治疗肾癌肾切除后高再发危险的病人的多中心,随机,三期试验。   Show Comments     PDF     Print     E-mail   
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Thursday, 03 April 2008
MILAN, ITALY (UroToday.com) - Representing an international group of researchers, Dr. Peter Mulders reported on the activity of vitespen (autologous, tumor-derived heat shock protein gp96-peptide complexes) in patients at high risk of recurrence after resection of locally advanced renal cell carcinoma (RCC) compared with no adjuvant treatment (observation). This represents the largest randomized study in RCC in the adjuvant setting.
MILAN, ITALY (UroToday.com) - 医生Peter报道了vitespen(自体肿瘤来源的热休克蛋白gp 96-缩氨酸合成物) 对局部高级肾癌切除术后高复发风险的作用,与没有辅助性治疗相比较。 这代表大量随机研究在肾癌以辅助设置。
Patients were randomized 1:1 to receive vitespen or observation following nephrectomy in an open-label trial. Stratification was by performance score, nodal status and histological grade. Vitespen was administered intra-dermally once weekly for 4 weeks, then every 2 weeks until vaccine depletion. Primary and secondary endpoints were recurrence-free survival (RFS) and overall survival (OS), respectively.
在一个开放的实验中,病人被随机的给Vitespen或观察。 根据得分,结节性质和组织学分级来分层。 Vitespen前4个星期每星期一次被打在皮下,然后每二周一次直到疫苗耗尽。最初的和辅助的的终点分别是无复发生存率和总生存率。
RFS was similar between arms in the intent-to-treat population (N = 728) and the full analysis set (FAS) population (eligible patients without baseline disease, n = 604). Predefined analyses by disease stage show RFS improvement associated with vitespen among FAS patients with earlier-stage (stage I or II; n =240) disease (P = .056). Post-hoc analysis of earlier-stage FAS patients with intermediate risk factors (per Eastern Cooperative Oncology Group: stage Ib/II high-grade, III T1/2/3a low-grade; n = 362) shows statistically significant RFS improvement associated with vitespen (P =.026), with RFS at the 25th percentile showing a 1-year improvement. Although OS data are still premature, encouraging trends tracking with RFS improvement have been observed for stage I/II FAS patients as well as for intermediate-risk FAS patients. In Western European patients (n = 183), there was RFS improvement among stage I/II FAS patients and intermediate-risk FAS patients. There were also encouraging OS trends among Western European stage I/II FAS patients and intermediate-risk FAS patients). Vitespen was well tolerated with no related grade 3-4 adverse events identified. Adverse events were as expected, representing a very good safety profile. The data show a positive trend associated with vitespen treatment in a large group of earlier stage patients with better prognostic factors. A registry protocol has been initiated to follow the remaining 500+ patients for survival for an additional 3 years. Advancement of vitespen as an adjuvant treatment for RCC patients with earlier-stage disease and better prognostic factors are warranted according to the authors.
无复发生存率与意向性治疗的人数(N=728)和全分析集人数相似(没有基础疾病的合格病人,N=604)。 经过疾病分斯的预测的分析显示无复发生存率改善使用vitespen 的分期早的病人。(stage Ior II n=240)(P==.056.056). 使用vitespen 的中间危险度的较早发期的病人在无复发生存率方面表现出明显的改善。 虽然总生存率资料是不成熟,无复发生存率改善已经被观察到对于I/II 期全分析集病人以及中间危险度的病人。 在西欧的183个这种病人以经有无复发生存率改善。 这种病人也有总生存率增加的趋势。 Vitespen没有发现3-4级副作用。 安全性很好。 用Vitespen治疗的大样本早期病人,有好疗效均势。 一个登记的包含500多个病人的草案已经开始。 Vitespen辅助治疗肾癌早期病人和较好预测因素是被认可。

Presented by: Peter Mulders, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Sorafenib in Advanced Renal Cell Carcinoma (RCC): Survival and Biomarker Results from a Phase III Trial
EAU 2008 - 索拉非尼在高级肾癌:来自三期实验的生存率和生物标志物的结果。   Show Comments     PDF     Print     E-mail   
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Wednesday, 02 April 2008
MILAN, ITALY (UroToday.com) - Dr. Porta presented this talk on behalf of the sorafenib (Sor) TARGET clinical trial group. It is a follow-up on the significant progression-free survival (PFS) benefit for sorafenib (Sor) versus placebo (P) as seen in a large multicenter Phase III trial (TARGET) in patients (pts) with advanced RCC. In May 2005, P pts were allowed to cross over to Sor. In this report the investigators provide the final OS and biomarker data.
MILAN, ITALY (UroToday.com) - 医生Porta 介绍了索拉非尼靶点的临床实验的好处。 基于高级肾癌的大样本多中心的三期实验,索拉非尼相对于安慰剂,能够带来显著的无进展生存提高。
Final OS analysis was planned at ~540 events. To minimize effect of crossover on OS, a secondary analysis was planned censoring P data on June 30, 2005. Plasma VEGF (n=712 pts) and soluble VEGFR2 (sVEGFR2) [n=717] were measured by ELISA at baseline (BL), cycle 1 day 21 (C1D21), and cycle 3 day 1 (C3D1). Phospho-ERK was assessed by immunohistochemistry.
最后的总生存率分析是计划在540个事件。 为了最小化总生存率的交叉效果,一人辅助的分析是被计划审查关于2005.六月30的P数据。 血浆VEGF 和可溶解的VEGFR 2经酶联免疫吸附测定,周期1,21天C1 D21和周期3 1天C3 D1)。Phospho -ERK 经免疫组织化学评定。
Pts (n=903) were randomized to Sor (n=451) or P (n=452). The analysis before crossover showed an estimated 39% OS improvement for Sor vs. P. An ITT analysis 6 months after crossover that included P pts (n=216) who had crossed to Sor showed a 30% improvement in OS for Sor vs. P. Pre-specified O’Brien–Fleming statistical boundaries were not reached by these OS differences. Final OS at 561 deaths showed a non-significant improvement of 13.5% for Sor vs. P (median 17.8 vs. 15.2 months). A pre-planned secondary analysis censoring P data showed the confounding effect of crossover: a significant OS benefit for Sor vs. P was seen. Following Sor treatment, plasma VEGF levels increased by 32% (n=279) at C1D21 and by 47% (n=203) at C3D1. In contrast, plasma sVEGFR2 decreased by 18% (n=282) and by 24% (n=206) at C1D21 and C3D1, respectively. Using a COX proportional hazards model examining VEGF and MSKCC score in P pts, BL VEGF was an independent prognostic factor for PFS (p=0.014). VEGF was also prognostic for OS in a model including ECOG PS, MSKCC, and treatment group as variables in P and Sor pts (p=0.001). High BL VEGF levels were significantly associated with higher ECOG PS (p<0.0001), intermediate MSKCC (compared with low, p<0.0001), BL Hb <0.0001), and adjusted calcium >10mg/dL (p=0.0004). Pts with high BL VEGF (>131 pg/ml) had a relatively poor prognosis in the P arm while a trend toward a greater PFS benefit was observed in the Sor arm (Sor vs. P, HR=0.48 vs. 0.64 for high vs. low VEGF, p=0.096). Tumor DNA sequencing of the VHL exons from 68 pts showed that improved PFS in the Sor arm was independent of VHL mutational status (Sor vs. P, HR=0.52 vs. 0.49 for mutated VHL vs. wild-type VHL).
Pts 是被随机分到索拉非尼或安慰剂。 以前的交叉分析显示估计有39%总生存率改善相对于安慰剂来说。 对561个死亡病人最后总生存率显示了一个不是很重要的13.5%的改善(平均17.8对比15.2月)。 一个计划前的分析审查安慰剂的数据显示交叉的混杂结果:一个明显的总生存率提高。 索拉非尼治疗之后,血浆VEGF水平提高32%在C1 D21和47%在...地C3 D1. 相反,血浆sVEGFR2分别减少18%(字母n=282))和24%(n=206)在...地C1 D21和C3 C3 D1。 利用一个COX成比例的危险模型验收VEGF和MSKCC得分在Ppts ,BL VEGF 是独立的预测因子对无进展生存(P=0.014)。 VEGF也预测总生存率在一包括ECOG PS ,MSKCC 的模型并且治疗组做为变量在P和Sor pts 。 高的VEGF 水平是明显的和高ECOG PS BL Hb 和校准钙有联系。 有高度BL VEGF 的Pts 有更差的预后,使用索拉非尼有提高无进展生存的倾向。 肿块DNA序列测定显示改善的无进展生存与VHL突变无关。

Presented by: C. Porta, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Sorafenib Monotherapy in Patients with Metastatic Renal Cell Cancer: A Phase II Intra-Patient Dose Escalation Study
EAU 2008 - 索拉非尼单独治疗肾癌转移的病人,一个二期的在病人体内的剂量逐步增加的研究。   Show Comments     PDF     Print     E-mail   
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Wednesday, 02 April 2008
MILAN, ITALY (UroToday.com) - Sorafenib 400 mg b.i.d. has shown anti-tumor activity and favorable tolerability in patients with metastatic renal cell carcinoma (RCC), allowing investigation of more intensive drug administration regimens. This titration study allowed individual patients to escalate to higher doses of sorafenib. Trial endpoints included response rate (RR), progression-free survival (PFS) and overall survival (OS).
MILAN, ITALY (UroToday.com) - 索拉非尼400毫克b.i.d. 已经显示抗肿瘤活性。并且对肾癌转移的病人能耐受。允许调查更大强化治疗方法。 为了提高索拉非尼的使用剂量滴定法研究被允许对个别病人。 试验终点包括反应率,无进展生存和总生存率。
Eligibility criteria: progressive measurable metastatic RCC; pathologic diagnosis of a component of clear cell disease; ≤1 prior cytokine therapy; Karnofsky performance status (KPS) ≥70%; adequate organ/marrow function; normal pancreatic/cardiac function, and no active CNS involvement. Escalation from Dose Level 1 (oral sorafenib 400 mg b.i.d.; day 1–28) could occur to Dose Level 2 (600 mg b.i.d; day 29–56) followed by Dose Level 3 (800 mg b.i.d.; day 57 onwards), dependent on adequate tolerability. Re-evaluation was performed every 8 weeks using RECIST
合格标准包括:有转移的肾癌,明确的病理诊断,≤1 先前的细胞因子治疗:卡氏评分≥70%:足够的器官骨髓功能:正常的胰腺,心脏功能,和没有放射的CNS 包括。 依赖足够的耐受性,1级剂量(索拉非尼400毫克b.i.d. day 1–28)可以提到2级剂量(600mg b.i.dday 29–56)接着3级剂量(800毫克b.i.d. ;day 向前的57)。 利用 RECIST每8周进行一次评估。
Of 46 enrolled patients, 44 were evaluable (37:7 male:female; median age 50 years, range 43–79); 39 and 5 had a KPS of 100% and 90%, respectively. Sites of disease included lung, nodal, liver, bone, adrenal, pancreas and kidney. Patients had metastases at 1, 2 or 3+ sites (n=26, 11, and 7, respectively), and 19 had received prior therapy. Twelve patients continue to receive sorafenib therapy; 1 at 400mg/day, 1 at 800mg/day, 3 at 1200mg/day, and 7 at 1600mg/day. Response was seen in 24 patients: 7 complete response (CR) and 17 partial response (PR); and a further 9 patients achieved stable disease for 6+ months. Median PFS was 8.4+ months (range 3–17.4+ months) at the time of analysis. Treatment related adverse events included hand-foot skin reactions, skin rash, diarrhea, alopecia, fatigue, hypertension, hypophosphatemia, and elevated amylase/lipase.
46个病人44个是有效的,39和5个病人分别有100%和90%的卡氏评分。 疾病的部分有肺,淋巴结,肝,骨,肾上腺,胰腺,和肾。 有1,2或者3个转移部位(n=分别26,11,and 7,)和19个人接受了先前的治疗。 12个病人一直接受索拉非尼的治疗1 at 400mg/day, 1 at 800mg/day, 3 at 1200mg/day, and 7 at 1600mg/day. 24个病人有效,7个完全有效,17个部分有效,9个病人获得了6个多月的病情稳定。 在分析的时候平均无进展生存是8。4个多月。 与治疗有关的副反应包括手,脚的皮肤反应,皮疹,腹泻,脱发,疲劳,高血压,低磷血症和淀粉酶/脂肪酶升高。
The presentation concludes that Sorafenib dose escalation to 1200mg or 1600mg/day was achieved in 93% of patients with metastatic RCC. The CR/PR rate of 55%, and the prolonged median PFS of 8.4+ months, show that dose-escalated sorafenib has promising anti-tumor activity in this patient group.
总结索拉非尼剂量提升到1200毫克或者1600毫克每天是可以的对于有肾癌转移的93%的病人。 55%的比率CR /PR 和延长的平均无进展生存时间8.4月,表明提高索拉非尼的剂量能够增加抗癌活性。

Presented by: R. Amato, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Sorafenib Plus Interferon-α2a in Metastatic Renal Cell Carcinoma: Results from RAPSODY (GOIRC Study 0681) - A Randomized Prospective Phase II Trial of Two Different Treatment Schedules
EAU 2008 - 索拉非尼加α2a 干扰素治疗肾癌骨转移:结果来自随机的前瞻性不同治疗的二期试验。   Show Comments     PDF     Print     E-mail   
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Wednesday, 02 April 2008
MILAN, ITALY (UroToday.com) - Sorafenib is an oral multi-kinase inhibitor that has demonstrated efficacy in metastatic renal cell carcinoma (MRCC). The pleiotropic molecule interferon-α2a (IFN) has anti-angiogenic activity that is thought to be dependent on an appropriate administration schedule. These investigators studied the activity and safety of sorafenib combined with IFN in two different schedules.
MILAN, ITALY (UroToday.com) - 索拉非尼是一种口服的肾癌转移的有效的多激酶抑制剂。 干扰素α2a具有抗血管生成的活性。 调查人员研究这两种物质放在一起的活性和安全性。
This single-stage study planned for a sample size of 100 patients to be enrolled over 18 months. Eligible patients had MRCC with a clear cell component ≥50%, previous nephrectomy, ECOG Performance Status 0–2, no cerebral metastases or previous treatment, and measurable disease; any Motzer score was allowed. Patients received oral sorafenib 400mg twice daily continuously plus sc IFN, 9 MU three times a week (arm A) or 3 MU five times a week (arm B). In order to increase compliance, IFN was started 7 days after sorafenib. Primary endpoints were progression-free survival (PFS) and safety. Secondary endpoints were overall response (intent to treat analysis) and overall survival.
一期研究计划有100个病人,历时18个月。 有肾癌转移的明确细胞组成的≥50%,实行了肾切除ECOG 性能0–2,没有大脑转移或治疗过,没有其它病症,任何的Motzer 得分是被允许。 病人一直被给索拉非尼400毫克每天二次,加干扰素9个单位一周三次,或者3个单位一周五次。 为了增加顺从性,干扰素在索拉非尼治疗后7天开始加。 最终目的是无进展生存率和安全性。 另一个目的是总响应和总生存率。
Patients (n=100) were enrolled from January 2006 (median age 63 years). Confirmed objective responses were achieved in 26 patients: 9 of 51 patients in arm A and 17 of 49 patients in arm B (17.6% [95% CI 7.2–28.1] vs. 34.7% [95% CI 21.4–48], p=0.05) while 24 and 22 patients (47.1% and 44.9%, respectively), achieved stable disease. The overall clinical benefit was therefore 64.7% in arm A and 79.6% in arm B (p=0.09). After a median followup of 8.5 months, the median PFS was 7.9+ months in arm A and 8.5+ months in arm B (p=0.21). The most common grade 3/4 toxicities were hypophosphatemia (15.7% in arm A and 20% in arm B), hand-foot skin reaction or skin-rash (12–14% in both arms); fatigue (19.6% in arm A and 10% in arm B, p=0.17), diarrhea (3.9% in arm A and 12% in arm B, p=0.13), leukopenia (5.9 vs. 2%) and thrombocytopenia (3.9 vs. 2%).
100个病人从2006年开始登记,平均年龄63 岁。 26个病人达到了目标响向,在A组51个病人中的9个,在B组49个病人的17个。分别有24和22个病人疾病得到控制。 全面的临床获益是64.7%in A和79.6%在B组。 平均跟综8.5个月,平均无进展生存是7.9个月在A组和8。5个月在B组。 最常见的3/4级不良反应是低磷酸血症,手脚的皮肤反应和皮疹12–14%,疲劳19.6%在A和和10%在B,腹泻3.9%in A和12%在B,白细胞减少5.9对比2%和血小板减少3.9对比2%。
The researchers conclude that Sorafenib plus low-dose IFN showed good tolerability and was active, with an overall response rate of 34.7% (30.6% partial response, 4.1% complete response) and a clinical benefit rate of approximately 80%.
研究员总结索拉非尼加低剂量的干扰素有很好的耐受性和活性,总反应率34.7%(30.6%部分响应4.1%完全有效)大约八成的临床获益。

Presented by: S. Bracarda, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Sunitinib as First-Line Treatment for Metastatic Renal Cell Carcinoma (mRCC)
EAU 2008 - 舒尼替尼做为一线药物治疗肾癌转移。   Show Comments     PDF     Print     E-mail   
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Wednesday, 02 April 2008
MILAN, ITALY (UroToday.com) - Updated results and analysis of prognostic factors from a phase III randomized trial.
MILAN, ITALY (UroToday.com) - 来自三期随机试验的更新结果和预测因素的分析。
Sunitinib malate has demonstrated statistically superior progression-free survival (PFS) and objective response rate (ORR) compared with IFN-alfa (IFN-α) in an international, randomized phase III trial of first-line therapy in patients (pts) with metastatic renal cell carcinoma (mRCC). Updated efficacy and safety results from this trial, and analysis of prognostic factors for PFS, are now available and presented from an international group of investigators.
舒尼替尼苹果酸已经显示统计学上的优越性在无进展生存和客观有效率比起α干扰素,在一个国际的随机肾癌转移病人一线药物治疗的三期试验中。 这个实验带来安全有效的结果,和无进展生存的预测因素的分析是可行的。
Treatment-naive pts with mRCC received oral sunitinib 50 mg/day for 4 weeks, followed by 2 weeks off treatment (4/2 schedule) or subcutaneous IFN-α 9 MU three times per week. The primary endpoint was PFS.
首次接受治疗的肾癌转移病人,口服舒尼替尼50毫克/天4星期,接下来的2个星期不治疗或皮下注射9个单位的α干扰素每周三次,主要的终点是无进展生存。
750 pts were randomized: 375 pts to sunitinib and 375 to IFN-α. At the time of analysis, the median duration of treatment for sunitinib and IFN-α was 11.1 mo vs. 4.1 mo, respectively. 59 pts (16%) on sunitinib had discontinued due to AEs vs. 86 pts (23%) on IFN-α. ORR, as assessed by independent central review, was 39% (95% CI: 34?44) for sunitinib vs. 8% (95% CI: 6?12) for IFN-α (P<0.000001). Median PFS was 11.0 mo for sunitinib vs. 5.1 mo for IFN-α. Sunitinib was favored across all MSKCC risk factor groups; pts with 0 risk factors had a median PFS of 14.9 mo for sunitinib vs. 8.4 mo for IFN-α; pts with 1–2 risk factors had a median PFS of 10.7 mo vs. 3.8 mo, respectively; and pts with ≥3 risk factors had a median PFS of 3.9 mo vs. 1.2 mo, respectively. Baseline features predictive of longer investigator-assessed PFS in sunitinib-treated pts were time interval from diagnosis to treatment (≥1 year vs. <1 year; P<0.001); ECOG performance status (0 vs. 1; P=0.007); and corrected calcium (≤10mg/dL vs. >10 mg/dL; P=0.0084). The most common treatment-related AEs for the sunitinib group were diarrhea, fatigue and nausea and, for IFN-α, fatigue, nausea and pyrexia. The investigators conclude that Sunitinib is significantly superior to IFN-α in the first-line treatment of mRCC and is a new reference standard in this setting. The benefits of sunitinib extend across all subgroups of mRCC pts, and previously defined MSKCC risk factors predict longer PFS with sunitinib.
750个病人被随机分组,375个用舒尼替尼,375个用干扰素。在分析时间的时候,治疗平均持续时间舒尼11.1个月,干扰素4.1个月。 由于AEs 59个病人中止了舒尼替尼的治疗,86个病人中止了干扰素的治疗。 客观有效率被独立的中心回顾评定,舒尼替尼为39%,干扰素为8%。 平均无进展生存舒尼替尼为11个月,干扰素为5.1个月,对带过MSKCC危险因子群舒尼替尼是有效的,对无危险因子的病人舒尼替尼有平均14.9个月的无进展生存,干扰素为8.4个月,有1-2个危险因子平均无进展生存分别为10.7个月对3.8个月。危险因子大于3平均无进展生存分别为3.9对1.2个月。 Baseline features predictive of longer investigator-assessed PFS in sunitinib-treated pts were time interval from diagnosis to treatment (≥1 year vs. <1 year; P<0.001); ECOG performance status (0 vs. 1; P=0.007); and corrected calcium (≤10mg/dL vs. >10 mg/dL; P=0.0084). 舒尼替尼最常见的治疗相关的并发症是腹泻,疲劳,恶心,而干扰素是疲劳,恶心和发热。 研究员总结舒尼替尼作为一线药物治疗肾癌转移优于干扰素,是一种新的参考标准。 舒尼替尼扩散到对所有肾癌转移的亚群病人有益,并且用舒尼替尼治疗从前定义的MSKCC危险度预示着更长的无进展生存。

Presented by: S. Oudard, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Elective Nephron-Sparing Surgery for Renal Masses
EAU 2008 - 对肾肿块病人选择性行肾保留手术。   Show Comments     PDF     Print     E-mail   
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Tuesday, 01 April 2008
MILAN, ITALY (UroToday.com) - Comparison of Open and Laparoscopic Approach in a Bi-Center Analysis
MILAN, ITALY (UroToday.com) - 在两个中心的分析中比较开放和腹腔镜方法。
Dr. Marszalek from Klagenfurt, Austria presented a study comparing the outcome of patients undergoing elective open vs. laparoscopic (lap) nephron-sparing surgery in two consecutive series. Open surgery was performed in Vienna, and the lap surgery in Klagenfurt. In this retrospective study the files of all patients who underwent elective nephron-sparing surgery over 10 years between 01/1996 and 05/2006 at both institutions were reviewed. Preoperative work-up included renal ultrasonography and abdominal CT. Histological findings, complications and oncological outcome were studied. Surgical technique was open retroperitoneal (Vienna) and laparoscopic retroperitoneoscopic (Klagenfurt) approach, respectively. Patients were either followed at one of the participating departments, the referring urologist or the family doctor.
来自奥地利的医生Marszalek 介绍了一个比较经历开放和腹腔镜保留肾单位的手术的结果的研究。 开放手术被执行在维也纳,腹腔镜在Klagenfurt。 在这个回顾性的研究中,所有的病人都是经历了选择性肾单位保留手术超过10年。 手术前进行了B超,腹部CT,病检,并发症和,和肿瘤学的研究。 开放手术被执行在维也纳,腹腔镜在Klagenfurt。 病人被随防被医师或家庭医师。
A total of 310 patients, 131 in the open and 179 in the lap group were analyzed (mean age: 61.7 vs. 62.6 yrs; p=0.7) at a mean follow up of 28.7 months. Mean tumor size on pathological evaluation was smaller in the lap group (open: 3.9 vs. lap: 2.3 cm; p<0.001). Arterial occlusion time was comparable in both groups (open: 25.2 vs. lap: 22.2 mins), but operative time was shorter in the lap group (open: 142 vs. lap: 84 mins, p<0.001) as was time of hospitalization (open: 8.1 vs. lap: 6.3 d, p=0.003). The rate of intra-operative complications was similar in both groups (open: 5.3% vs. lap: 7.8%) whereas postoperative complications were more common in the open group (13.7% vs. 3.9%;p=0.002). The rate of positive postoperative margins also was similar in the open and the lap group (2.2 % vs. 3.4 %). On pathological workup, benign histology was present in 32.1 % (open group) and 19.8% (lap group) respectively (p=0.014). Malignancies accounted for renal cell carcinoma in the majority of cases in both groups (open: 98.9%, lap: 98.6%). After a mean follow-up of 28.7 months (median: 25 months), two local recurrences were observed (both in the lap group), one patient developed lymph node metastases (open group) and four failed distantly (open: n=3, lap: n=1). At conclusion (1.2 vs. 1.1 mg/dl; p=0.6) as well as at the last follow up (1.2 vs. 1.2 mg/dl; p=0.7) serum creatinine levels were comparable between the open and the laparoscopic group.
总共310个病人,131个开放,179个腹腔镜,(平均林龄61.7对比62.6p=0.7)平均随防28.7个月。 平均肿块大小在腹腔镜那组小一些,(open 3.9vs. lap 2.3cm p<0.001)。 动脉阻断时间是可比较的在两组,(open 25.2vs. lap :22.2mins ),但是手术时间和住院时间(open :142vs. lap :mins ,p<0.001)(open :8.1vs. lap :6.3天)。 手术中并发症的几率是相似的(open 5.3%vs.lap :7.8%),术后并发症在开放手术中更多。(13.7%vs. 3.9% p=0.002)。 The rate of positive postoperative margins also was similar in the open and the lap group (2.2 % vs. 3.4 %). On pathological workup, benign histology was present in 32.1 % (open group) and 19.8% (lap group) respectively (p=0.014). 恶性的肾细胞癌占大多数在两个组(open 98.9%lap 98.6%)。 平均随访28.7个月后,两个局部再发,一个淋巴结转移,四个远处转移。 开始和最后的跟综中,血清肌酐水平也是可比较的在两组。
This comparative analysis demonstrates similar outcome of open and laparoscopic nephron-sparing surgery. Pros of the laparoscopic approach are the shorter operative and hospitalization time in this group, yet the trend to a slightly higher rate of positive margins may warrant a closer follow-up.
比较分析显示两组结果相似。 腹腔镜手术和住院时间更短,但切缘阳性的均势更高。

Presented by: M. Marszalek, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Safety and Efficacy of Sunitinib in an Expanded-Access Trial of Metastatic Renal Cell Carcinoma (mRCC): Updated Results and Subpopulation Analysis   
舒尼替尼在一肾癌转移的实验中安全有效,来自更新的结果和最新的亚群分析。


Wednesday, 02 April 2008

MILAN, ITALY (UroToday.com) - Sunitinib malate is an oral, multi-targeted tyrosine kinase inhibitor with direct anti-tumor and anti-angiogenic activities, internationally approved for the first-line treatment of advanced RCC.
舒尼替尼是国际上第一个被批准的高级肾细胞癌的转移药物,具有直接的抗肿瘤和抗血管生成的活性,是一种口服的,多靶点酪氨酸激酶抑制剂。
label trial was undertaken to provide sunitinib to patients (pts) with advanced RCC who might benefit from therapy, but who had no access to the drug prior to regulatory approval in their countries.
这个提供给高级肾细胞癌的病人舒尼替尼的实验被执行,但是在有些国家这种药物没有被批准。
Eligibility criteria were minimal: pts >18 yrs of age with histologically confirmed mRCC received oral sunitinib 50 mg/day for 4 weeks followed by 2 weeks off treatment (4/2 schedule).
合格者最低是pts >18 yrs的组织上确认肾细胞癌转移,口服舒尼动人替尼50mg/天持续4个星期接下来的2个星期不治疗。
4,217 pts had received treatment. Data are currently available on 3,997 pts (median age, 59).
4,217 pts 接受治疗。可用数据3,997 pts(平均年龄59)
Baseline demographics included 522 pts (13%) with ECOG performance status (PS) ≥2; 542 pts (14%) with non-clear cell histology; 298 pts (8%) with brain metastases; and 229 pts (6%) with prior anti-angiogenic treatment.
统计数据显示522 pts (13%) with ECOG,522 pts (13%) with ECOG没有明确的细胞组织学分型,298 pts (8%)有脑转移,298 pts (8%)之前接受过抗血管生成的治疗。
Median duration of treatment was 6.5 months (mo) (0.0–23.6). Dose reductions occurred in 42.0% of pts, and discontinuations due to adverse events (AEs) in 5.6% of pts.
平均治疗时间6.5个月。42.0% of pts剂量减少,5.6% of pts因为副作用停药。
The most common treatment-related AEs were diarrhea (27.8% grade 1/2, 3.2% grade 3/4), nausea (23.8% grade 1/2, 1.6% grade 3/4) and fatigue (20.3% grade 1/2, 5.8% grade 3/4).
最常见的副作用是腹泻(27.8% grade 1/2, 3.2% grade 3/4),恶心(23.8% grade 1/2, 1.6% grade 3/4)疲劳(20.3% grade 1/2, 5.8% grade 3/4).
The incidence of grade 3/4 treatment-related diarrhea, nausea and fatigue in pts with brain metastases was 1.7%, 1.7% and 6.0%, respectively.
有脑转移的病人3/4级副作用腹泻,恶心,疲劳的发生率分别是1.7%, 1.7% and 6.0%。
The corresponding incidence in patients with PS ≥2 was 2.9%, 2.1% and 5.0%, respectively.
对应的有PS的病人分别是2.9%, 2.1% and 5.0%
In pts with prior cytokine treatment (n=2,727), the estimated median progression-free survival (PFS) was 9.6 mo. Among the group with prior cytokine therapy, PFS was longer in pts in MSKCC favorable vs. intermediate vs. poor prognostic criteria subgroups (13.5 vs. 8.4 vs. 4.8 mo).
在以前有个细胞因子治疗的PTS(n=2,727),估计的平均无进展生存率是9.6个月。在以前进行细胞因子治疗的这个组中,

ORR in pts with ECOG PS ≥2, non-clear cell histology and brain metastases was 4.6%, 6.1% and 7.4%, respectively. Median overall survival has not been reached.

The safety profile of sunitinib in this international expanded-access trial was similar to that reported in the pivotal phase II and III clinical trials. Data are now available on specific subgroups of pts such as those with brain metastases, non-clear cell histology or PS ≥2 that have been under-represented in previous trials.
在这个国际性的实验中舒尼动人替尼的安全性和已经报道的二,三期临床实验相似。数据是适用的对于具体的有脑转移的亚群,非透明细胞癌,或以前实验没被证实的PS ≥2的病人。
Presented by: S. Oudard, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy


EAU 2008 - Surgical Management - Risk Factor Analysis of Post-Operative Complications in Laparoscopic Partial Nephrectomy   外科治疗――腹腔镜下肾脏部分切除术后危险因子分析。



Tuesday, 01 April 2008

MILAN, ITALY (UroToday.com) - Dr.Turna from the group of Dr. Gill at the Cleveland Clinic presented their experience with laparoscopic partial nephrectomy (LPN) to determine risk factors for postoperative complications.
来自克里夫兰Gill医生小组的Turna医生指出依照他们腹腔镜下肾脏部分切除的经验判断术后并发症的发生风险因子。
A prospectively maintained database of 507 LPN procedures since September 1999 was retrospectively analyzed with emphasis on postoperative complications. Severity of complications was graded using a 5-tiered scale based on NCI-CTC reporting criteria. Complication rates were compared between the 1999-2002 and 2003-2006 eras. Multivariate analysis of baseline and peri-operative variables was performed to identify risk factors associated with postoperative urologic and non-urologic complications for the two eras.
自1999年9月起507例腹腔镜下肾脏部分切除术病例数据资料针对术后并发症进行回顾性分析。根据NCI-CTC标准并发症严重程度按5级分级。对比了1999-2002与2003-2006期间的并发症发生率。在两个时间区间对术后泌尿和非泌尿系并发症发生危险因子进行基准与术前因素的多变量分析。

In 507 LPN procedures, 93 patients (19.7%) had 107 postoperative complications, including 49 urologic (9.7%) and 58 non-urologic (11.4%). Of the complications, 20.6% were grade I, 45% were grade II, 30% were grade III, 4.7% were grade IV and none were grade V. On multivariate analysis, presence of a solitary kidney, warm ischemia time and increased EBL were significant predictors of overall postoperative complications for the two eras. Compared to the 1999-2002 era, the 2003-2006 era witnessed a dramatic increase in number of total LPN procedures (100% increase) and complex tumors (132% increase), yet overall, urologic and non-urologic complications decreased significantly.
在507例LPN中,93例病人(19.7%)出现了107种术后并发症,包括49种泌尿系(9.7%)和58例非泌尿系(11.4%)。在所有并发症中,20.6% 为1级,45%为2级,30%为3级,4.7%为4级 ,未出现5级。两个时间区间的多变量分析显示,孤肾,热缺血时间及幼红细胞增多是术后并发症发生的重要警示。相对于1999-2002区间段,2003-2006区间LPN数量出现明显的增加(100%)及复杂肿瘤的增加(132%)。而泌尿及非泌尿系并发症明显减少。

He summarized that prolonged warm ischemia, increased intra-operative blood loss and solitary kidney status increase the likelihood of postoperative complications after LPN. With experience, the incidence of complications has decreased significantly despite a significant increase in tumor and procedural complexity.
他总结指出热缺血时间的延长,术中失血的增加及孤肾增加了LPN术后并发症的可能。尽管肿瘤及手术操作复杂性增加单并发症的发生几率明显降低。

Presented by: B. Turna, MD, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Urological Research Society (URS) Lecture: Surgical Strategies in Advanced RCC   
泌尿学会讲座:对高级肾细胞癌的外科策略。
Written by Christian Doehn, MD  
Tuesday, 08 April 2008

MILAN, ITALY (UroToday.com) - The URS lecture covered the topic of surgical strategies in advanced renal cell carcinoma (RCC).
泌尿学会讲座含盖了对高级肾细胞癌的外科策略的题目。
Especially the questions of routine adrenalectomy, management of intravasal tumor thrombus and surgery of metastases were raised. Today, only 3% of patients with RCC present with adrenal metastases. It is still recommended that adrenalectomy is not necessary in case of normal preoperative CT scan and normal intraoperative palpation.
特别是肾上腺肿瘤切除的程序,血管内瘤栓的处理,
仅仅3%的病人有肾上腺的转移。 肾上腺切除不是必须的,如果有正常的术前CT扫描和术中触诊正常。
In case of intravasal tumor thrombus Professor Jonas pointed out that an interdisciplinary approach should be performed. In his institution 92 patients were treated over the last 15 years. 8/92 patients died related to the operation. Median survival was 67 months and on the long-term 46% of patients died due to tumor progression.
教授Jonas 指出如果有血管内瘤栓,一个科际间的方法应该被实行。 在过去的15年他机构中的92个病人是被处理。 8个病人死于手术相关事件。平均生存率是67个月和46%的病人死于疾病恶化。
Surgery of metastases is a challenging objective. Outcome of metastasectomy is related to the site, number of metastases, and the completeness of the resection. For instance a complete resection of lung metastases results in a 10-year survival of 26% compared to only 7% when an incomplete resection was performed. Metastases to the bone or liver are generally associated with a poorer outcome.
转移癌的外科手术是一个有希望的目标。 切除转移癌灶的结果与转移位置,转移数目,和完全切除有关。 比如一个肺转移灶的完全切除10年生存率是26%,对比不完全切除仅仅为7%。 转移到骨和肝有较差的预后。

Presented by: U. Jonas, MD, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Management of Advanced Renal Cell Carcinoma (Brain Metastases) with Sorafenib
EAU 2008 - 用索拉非尼治疗高级肾细胞癌(脑转移)。   

Monday, 31 March 2008

MILAN, ITALY (UroToday.com) - Results from the ARCCS expanded access program
MILAN, ITALY (UroToday.com) - 来自ARCCS 计划的结果。
Brain metastases (BM) occur in 5-10% of: renal cell carcinoma (RCC) pts and generally portend a poor prognosis. The Advanced Renal Cell Carcinoma Sorafenib (ARCCS) expanded access program allowed enrollment of patients with BM; the current analysis explores the safety and efficacy of Sorafenib in this subset of ARCCS pts.
5-10%发生脑转移:肾癌PTS和一般者有一个差的预后。 目前的分析显示索拉非尼对于ARCCS pts的脑转移病人安全有效。
This was an open-label, nonrandomized, non-comparative treatment protocol for patients with advanced RCC who were not eligible for, or who did not have access to, other clinical trials with Sorafenib in the United States and Canada; pts were Eastern Cooperative Oncology Group (ECOG) status 0-2 with waivers granted for pts with status 3-4; age ≥15 years. Major exclusion criteria included treatment <4 wks prior, life expectancy <2 months, uncontrolled hypertension and severe renal impairment requiring dialysis. Patients received Sorafenib 400 mg twice daily. Patients with BM were required to have prior local therapy for their brain lesions, whether or not successful. Patients who had surgery for BM also were eligible. The primary endpoints were safety and efficacy per investigator assessed by RECIST guidelines every 4 weeks. BM’s were excluded as target lesions unless they were the only lesions being followed.
这个一个开放的,非随机,非比较的对于高级肾癌病人的治疗,这些不适合,或不能使用其它的索拉非尼的临床试验。 pts were Eastern Cooperative Oncology Group (ECOG) status 0-2 with waivers granted for pts with status 3-4; age ≥15 years. 主要的排除标准是之前治疗少于4周,预期寿命小于2个月,不可控制的高血压,和严重的肾损害需要透析。病人每天服用索拉非尼400mg每天二次。 有脑转移的病人被要求行在当地行脑损害的治疗,不管是否成功。 因脑转移而行手术的也可以。 主要终点是安全有效被每个研究者通过RECIST方针评定每4个星期。 脑转移作为目标损害是被排除,除非他样是唯一的损害。
Of 2,504 pts assessed for safety in the ARCCS study, 70 (3%) had been treated previously for BM: 51 pts (73%) were male with a median age of 59 years. Prior anticancer therapy included 81% radiotherapy, 79% nephrectomy, 29% interferon-α, 26 % interleukin-2, and 34.0% other. Drug-related adverse events (AEs) were reported in 63% and 76% of pts with and without BM, respectively. Drug-related AEs (Grade ≥3) occurring in >2% of pts with and without BM were hand-foot skin reaction (7% and 10%), fatigue (7% and 4%), rash (3% and 5%), diarrhea (3% and 2%), and hypertension (0% and 5%), respectively. The seizure rates for patients with and without BM were 6% and 0%, respectively. Of note, there were no CNS-related bleeding events. Of the 50 patients with BM evaluable for response, partial response was reported in 2 (4%), stable disease in 34 (68%), and progressive disease in 14 (28%) of patients.
2504pts 被评定为安全,70(3%)之前接受过脑转移的治疗,51pts (73%)是平均年龄59岁的男性。 之前的抗癌治疗包括81%的放射治疗,79%的肾切除,29%的干扰素,26%的白细胞介素2和34%的其它治疗。 药物相关的不良反应在有和没有脑转移的病人分别是63%和76%,在分级大于3的不良反应中分别是手脚皮肤反应7%和10%,疲劳7%和4%,皮疹3%和5%,腹泻3%和2%,高血压0%和5%。 在两种病人中发作频率分别是6%和0%。值得注意的是,没有CNS相关的流血事件。 50个病人对药物有响应,2个部分响应,34个疾病稳定,14个疾病恶化。
Treatment with Sorafenib was well tolerated in RCC pts with BM with no reports of cerebral hemorrhage. Toxicity and efficacy of Sorafenib in the overall population and in the BM subset of patients were comparable with possible attenuated drug related AEs in certain subcategories such as hypertension. These results suggest that Sorafenib could serve as a standard treatment option for RCC with BM.
在脑转移没有脑出血的病人,索拉非尼能被很好的耐受。 索拉非尼的毒性和效力在全部有和脑转移的病人中是可比较和可能的减药相关的AEs 在某一亚群中比如高血压。 这些结果显示索拉非尼可以做为肾癌脑转移病人的标准治疗药物。

Presented by: C.A. Henderson, MD, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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EAU 2008 - Technology Makes the Single-Port Laparoscopic Nephrectomy Possible   使单工作通道腹腔镜肾切除术成为可能


Written by Christian Doehn, MD  
Tuesday, 08 April 2008

MILAN, ITALY (UroToday.com) - Laparoscopic nephrectomy can be performed via one port. With the R-PortTM (Advanced Surgical Concepts, Wicklow, Ireland) a group from England and India for the first time removed a kidney with this technique and also performed some other minor procedures. They worked with three 5 mm instruments (one camera and two working instruments) and had short operating times without intraoperative complications. Besides two Single Laparoscopic Port Procedures (SLIPP), 3 “scar-less” One Port Umbilical Surgery (OPUS) operations were performed. The authors claimed superior cosmetic results when compared to the classical “one port – one instrument laparoscopy” but also stated that sometimes the grade of freedom for the instruments was impaired.
腹腔镜肾切除术可以通过一个工作通道完成。通过使用一种名叫R-PortTM的设备,一个来自于英格兰和印度的手术小组第一次使用这种技术切除了一个肾脏,同时也完成了其他一些小型手术。他们使用三个5mm的器械(1个是摄像头,另外两个是工作器械)。手术时间短,没有术中并发症出现。作者声称,这种单通道腹腔镜较传统腹腔镜手术疤痕好,外观效果好。当然,他们也承认,有时候要牺牲操作上的便利性。

Presented by: A. Rane, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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