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Comparison of ureteoroscopy and laser stone fragmentation between Holmium: YAG laser with MOSES versus non-MOSES technology: a prospective single-center propensity score-matched analysis using similar laser settings. 采用 MOSES 和非 MOSES 技术的钬:YAG 激光与激光碎石术的比较:采用相似激光设置的前瞻性单中心倾向得分匹配分析。
IF 2.6 4区 医学 Q2 UROLOGY & NEPHROLOGY Pub Date : 2024-08-20 eCollection Date: 2024-01-01 DOI: 10.1177/17562872241272974
Victoria Jahrreiss, Francesco Ripa, Clara Cerrato, Carlotta Nedbal, Amelia Pietropaolo, Bhaskar Somani

Background: In vitro studies have shown that the holmium Modulated Optics Enhancement Systems (MOSES) technology can lead to an increase in the efficacy of lithotripsy and a reduction of retropulsion, but clinical evidence comparing it to non-MOSES technology is still scarce. We did a comparison of ureteoroscopy and laser stone fragmentation (URSL) between Holmium:YAG laser with MOSES versus non-MOSES technologies.

Methods: Patient data and outcomes were prospectively collected and analyzed regarding patient demographics, stone parameters, and clinical outcomes. Patients undergoing URSL with standard holmium laser without MOSES technology (Group 1) were compared to holmium laser with MOSES (Group 2) using the same clinical laser settings (0.4-1 J, 20-40 Hz) with dusting and pop-dusting technique. The independent t-test, Mann-Whitney U test, and Chi-squared test were used, with a p-value of < 0.05 as significant. Given the different sizes of the cohorts, we performed a propensity score 1:1 matched analysis.

Results: A total of 206 patients (1:1 matched) with a male:female ratio of 94:112 and a median age of 56 (range: 39-68) years were analyzed. Groups 1 and 2 were matched for ureteric stones (27.7% and 22.3%, p = 0.42), pre-stenting (37% and 35%, p = 0.66), the mean number of stones (1.76 ± 1.3) and (1.82 ± 1.4, p = 0.73), and ureteral access sheath use (37% and 35%, p = 0.77) respectively.While there was no significant statistical difference in clinical outcomes, the stone size was slightly larger in Group 2, 14.8 ± 10.8 mm vs 11.7 ± 8.0 mm, for a lower operative time 42.7 ± 30.6 min versus 48.5 ± 25 min, lower perioperative complication rates 3.9% versus 4.9% and a higher stone-free rate 90.3% versus 87.4%.

Conclusion: While the use of MOSES technology was slightly beneficial for the treatment of stones in terms of clinical outcomes, this was not statistically significant. As this debate continues, there is a need for high-quality randomized studies to show if there is a true difference in these outcomes.

背景:体外研究表明,钬调制光学增强系统(MOSES)技术可提高碎石疗效并减少反推,但将其与非MOSES技术进行比较的临床证据仍然很少。我们对采用 MOSES 技术的钬:YAG 激光与非 MOSES 技术的尿道镜检查和激光碎石术(URSL)进行了比较:方法:前瞻性地收集并分析了患者数据和结果,包括患者人口统计学、结石参数和临床结果。采用相同的临床激光设置(0.4-1 J,20-40 Hz)、除尘和爆破除尘技术,将使用不含 MOSES 技术的标准钬激光进行 URSL 的患者(第 1 组)与使用 MOSES 的钬激光进行 URSL 的患者(第 2 组)进行比较。采用独立 t 检验、曼-惠特尼 U 检验和卡方检验,P 值为 结果:共分析了 206 名患者(1:1 匹配),男女比例为 94:112,中位年龄为 56 岁(范围:39-68)。第 1 组和第 2 组在输尿管结石(27.7% 和 22.3%,p = 0.42)、支架植入前(37% 和 35%,p = 0.66)、结石平均数量(1.76 ± 1.3)和(1.82 ± 1.4,p = 0.73)以及输尿管通道鞘的使用(37% 和 35%,p = 0.77)方面分别匹配。虽然在临床结果上没有明显的统计学差异,但第2组的结石大小略大,为14.8±10.8毫米对11.7±8.0毫米,手术时间为42.7±30.6分钟对48.5±25分钟,围手术期并发症发生率为3.9%对4.9%,无结石率为90.3%对87.4%:虽然从临床结果来看,使用 MOSES 技术对治疗结石略有益处,但在统计学上并不显著。由于这一争论仍在继续,因此有必要进行高质量的随机研究,以显示这些结果是否存在真正的差异。
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引用次数: 0
Outcomes of ureteroscopy and laser fragmentation using a 60 W MOSES laser: a 3-year prospective study from a University Teaching Hospital. 使用 60 W MOSES 激光进行输尿管镜检查和激光碎石术的结果:一家大学教学医院进行的一项为期 3 年的前瞻性研究。
IF 2.6 4区 医学 Q2 UROLOGY & NEPHROLOGY Pub Date : 2024-08-19 eCollection Date: 2024-01-01 DOI: 10.1177/17562872241272033
Victoria Jahrreiss, Francesco Ripa, Bhaskar Somani

Introduction: Modulated optics enhancement system (MOSES) holmium lasers use "pulse modulation" to increase the efficacy of laser lithotripsy. As the clinical evidence on the efficacy of 60 W holmium laser with MOSES technology is scarce, we analyzed the outcomes of patients treated with this laser at our institution.

Methods: A total of 96 consecutive patients with urinary stones (72 renal stones and 24 ureteral stones) were treated with the 60 W MOSES laser from 2019 until 2022 and were included in our analysis. Patient data and outcomes were prospectively collected, and analysis was performed regarding patient demographics, stone parameters, as well as stone-free rate, operating time, length of stay, and perioperative and postoperative complications.

Results: With a median age of 55 (IQR: 35-69.25) years, the male:female ratio was 53:43. The median stone size was 12 mm (IQR: 7-19), with a mean number of urinary stones of 1.82 (SD ± 1.4). While 36 (35%) patients were pre-stented, a ureteral access sheath was inserted in 36 (37.5%) patients. The median operative time was 44 min (IQR: 22.5-59.5), and 63 (65.5%) patients received postoperative stenting. Perioperative complications (all Clavien ⩽ II complications) were observed in 5 (5.2%) patients (four urinary tract infections and one acute urinary retention), and after the first procedure, 90 (93.8%) patients were stone-free. The median length of hospital stay was 1 day (IQR: 1-1).

Conclusion: This study demonstrated that the 60 W MOSES laser was safe and efficient for the treatment of urinary stones with high stone-free rates and a small risk of minor complications. More studies with larger cohorts are necessary in the future to confirm our results.

导言:调制光学增强系统(MOSES)钬激光利用 "脉冲调制 "来提高激光碎石的疗效。由于采用 MOSES 技术的 60 W 钬激光器疗效的临床证据很少,我们分析了本院使用该激光器治疗患者的疗效:从2019年到2022年,共有96名连续的尿路结石患者(72名肾结石患者和24名输尿管结石患者)接受了60 W MOSES激光治疗,并纳入了我们的分析。我们前瞻性地收集了患者数据和结果,并对患者人口统计学、结石参数以及无石率、手术时间、住院时间、围术期和术后并发症进行了分析:中位年龄为 55 岁(IQR:35-69.25),男女比例为 53:43。结石大小中位数为 12 毫米(IQR:7-19),平均结石数为 1.82(SD ± 1.4)。36名患者(35%)预先植入了支架,36名患者(37.5%)插入了输尿管通道鞘。中位手术时间为 44 分钟(IQR:22.5-59.5),63 例(65.5%)患者在术后接受了支架植入术。围手术期出现并发症(均为 Clavien ⩽ II 并发症)的患者有 5 例(5.2%)(4 例尿路感染和 1 例急性尿潴留),90 例(93.8%)患者在首次手术后无结石。住院时间中位数为 1 天(IQR:1-1):这项研究表明,60 W MOSES 激光治疗泌尿系统结石安全高效,无结石率高,轻微并发症风险小。未来有必要进行更多更大规模的研究,以证实我们的结果。
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引用次数: 0
Prostatic stents: a narrative review of current evidence 前列腺支架:现有证据综述
IF 2 4区 医学 Q2 UROLOGY & NEPHROLOGY Pub Date : 2024-05-31 DOI: 10.1177/17562872241255262
Clara Cerrato, Vaki Antoniou, Shriya Napolean Fernandes, Sanjeev Madaan, Bhaskar Kumar Somani
Benign prostatic hyperplasia (BPH) is a common chronic urologic condition affecting approximately 50% of men above the age of 60. As per European Association of Urology Guidelines, BPH can be treated according to a stepwise approach starting from a conservative management, a pharmacologic approach, and finally surgery. Both medical and surgical therapies have side effects, impacting on ejaculation and sexual function and patients with multiple comorbidities might not be considered surgically suitable candidates. Prostatic stents offer a minimally invasive procedures in an out-patient setting, possibly under local anaesthesia. Utilized since the 1980s, the past stents encompassed permanent (epithelializing) or temporary (non-epithelializing) devices, like the Uro-Lume (American Medical Systems, Minnetonka, MN, USA) and the Memokath, or Memotherm (Engineers & Doctors A/S, Denmark), and the biodegradable stents made of self-reinforced poly-L-lactide or braided poly lactic-co-glycolic acid. Previous stents however showed a quite high rate of complications among which pain, incontinence, infections, stent migration or blockage, and incomplete degradation that might lead to premature removal of stent. The stents currently available on the market instead are the temporary device Allium Triangular Prostatic Urethral Stent (Allium Urological Solutions, Caesarea, Israel) and the temporary stent SPANNER (AbbeyMoor Medical, Inc., Parkers Prairie, MN, USA), which might be used in case of bladder outflow obstruction, post-operatively, or for acute urinary retention. Studies showed encouraging results, in terms of effectiveness and safety improving patients’ quality of life and International Prostate Symptom Score, but longer-term studies are needed to identify the most suitable patients who might benefit from their use. Newer stents and nitinol devices are currently investigated, and we are waiting for the results of the ongoing clinical trials.
良性前列腺增生症(BPH)是一种常见的慢性泌尿系统疾病,约有 50%的 60 岁以上男性患有此病。根据欧洲泌尿外科协会指南,良性前列腺增生症的治疗可采取循序渐进的方法,从保守治疗到药物治疗,最后再到手术治疗。药物和手术疗法都有副作用,会影响射精和性功能,而且有多种合并症的患者可能不适合手术治疗。前列腺支架可在门诊环境下进行微创手术,可能需要局部麻醉。自 20 世纪 80 年代开始使用的支架包括永久性(上皮化)或临时性(非上皮化)装置,如 Uro-Lume(美国医疗系统公司,美国明尼苏达州明尼通卡市)和 Memokath 或 Memotherm(丹麦 Engineers & Doctors A/S),以及由自增强聚左旋乳酸或编织聚乳酸-共-乙醇酸制成的可生物降解支架。然而,以前的支架显示出相当高的并发症发生率,其中包括疼痛、大小便失禁、感染、支架移位或堵塞,以及可能导致过早移除支架的不完全降解。目前市场上的支架有临时装置 Allium 三角形前列腺尿道支架(Allium Urological Solutions,以色列凯撒利亚)和临时支架 SPANNER(AbbeyMoor Medical, Inc.,美国明尼苏达州 Parkers Prairie),可用于膀胱流出道梗阻、术后或急性尿潴留。研究显示,在提高患者生活质量和国际前列腺症状评分的有效性和安全性方面取得了令人鼓舞的结果,但还需要进行更长期的研究,以确定哪些患者最适合使用这种疗法。目前正在对更新的支架和镍钛诺装置进行研究,我们正在等待正在进行的临床试验的结果。
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引用次数: 0
Mastering bladder paraganglioma for optimal treatment: a case report of robot-assisted surgery. 掌握膀胱副神经节瘤的最佳治疗方法:机器人辅助手术病例报告。
IF 2 4区 医学 Q2 UROLOGY & NEPHROLOGY Pub Date : 2024-05-21 eCollection Date: 2024-01-01 DOI: 10.1177/17562872241249603
Angelo Orsini, Simone Ferretti, Flavia Tamborino, Rossella Cicchetti, Davide Ciavarella, Barbara Seccia, Raffaella Basilico, Antonella Colasante, Michele Marchioni, Luigi Schips

Bladder paraganglioma is a rare neuroendocrine neoplasm, either functional or non-functional, arising from the urinary bladder. Functional variants present with catecholamine-related symptoms, while non-functional variants pose diagnostic challenges, mimicking urothelial carcinoma. Misdiagnosis risks underscore the importance of accurate identification for appropriate patient management. In this case, a 52-year-old man, diagnosed incidentally with hypertension and reported occasional post-micturition tachycardia, underwent abdominal ultrasound for known hepatic cyst follow-up, revealing an oval hypoechoic bladder mass. Initial consideration of bladder urothelial carcinoma prompted further investigation with contrast-enhanced CT scan and cystoscopy that confirmed extrinsic mass nature, and subsequent robotic-assisted partial cystectomy was performed. Histologically, the removed mass exhibited characteristic features of bladder paraganglioma. Postoperative recovery was uneventful, with resolution of post-micturition tachycardia at 1 month. Follow-up includes endocrinological evaluation and a 6-month CT scan. In conclusion, bladder paraganglioma should be considered in para-vesical mass differentials. This case highlights the importance of meticulous history collection, even in asymptomatic patients, the need for a multidisciplinary approach for accurate diagnosis and management of this rare condition, and the robotic approach as a viable option.

膀胱副神经节瘤是一种罕见的神经内分泌肿瘤,可发生于膀胱的功能性或非功能性肿瘤。功能性变异表现为儿茶酚胺相关症状,而非功能性变异则会模仿尿路上皮癌,给诊断带来挑战。误诊风险凸显了准确识别对患者进行适当治疗的重要性。在本病例中,一名 52 岁的男性偶然被诊断出患有高血压,并报告偶尔出现排尿后心动过速,因已知肝囊肿而接受腹部超声波检查,发现一个椭圆形低回声膀胱肿块。初步考虑为膀胱尿路上皮癌,因此进一步进行了造影剂增强 CT 扫描和膀胱镜检查,证实了肿块的外在性质,随后进行了机器人辅助膀胱部分切除术。组织学检查显示,切除的肿块具有膀胱副神经节瘤的特征。术后恢复顺利,1 个月时排尿后心动过速症状消失。随访包括内分泌评估和 6 个月的 CT 扫描。总之,在膀胱旁肿块鉴别中应考虑膀胱副神经节瘤。本病例强调了仔细收集病史的重要性,即使是无症状的患者也不例外;强调了采用多学科方法准确诊断和治疗这种罕见疾病的必要性;强调了机器人手术是一种可行的选择。
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引用次数: 0
Systematic review of recent advancements in antibody-drug and bicycle toxin conjugates for the treatment of urothelial cancer. 系统回顾治疗尿道癌的抗体药物和自行车毒素共轭物的最新进展。
IF 2 4区 医学 Q2 UROLOGY & NEPHROLOGY Pub Date : 2024-05-20 eCollection Date: 2024-01-01 DOI: 10.1177/17562872241249073
Chaim Domb, Jorge A Garcia, Pedro C Barata, Prateek Mendiratta, Santosh Rao, Jason R Brown

Antibody-drug conjugates and bicycle toxin conjugates represent a tremendous advance in drug delivery technology and have shown great promise in the treatment of urothelial cancer. Previously approved systemic therapies, including chemotherapy and immunotherapy, are often impractical due to comorbidities, and outcomes for patients with advanced disease remain poor, even when receiving systemic therapy. In this setting, antibody-drug and bicycle toxin conjugates have emerged as novel treatments, dramatically altering the therapeutic landscape. These drugs harness unique designs consisting of antibody or bicycle peptide, linker, and cytotoxic payload with more targeted delivery than conventional chemotherapy, thus eliminating malignant cells while reducing systemic toxicities. Potential targets investigated in urothelial cancer include Nectin-4, TROP2, HER2, and EphA2. Initial clinical trials demonstrated efficacy in treatment of refractory advanced urothelial cancer, as well as improvement in quality of life. These initial studies led to FDA approval of two antibody-drug conjugates, enfortumab vedotin and sacituzumab govitecan. Moreover, antibody-drug and bicycle toxin conjugates are being studied in ongoing clinical trials in frontline treatment of advanced disease as well as for localized cancer. These studies highlight the potential for additional future therapies with novel targets, novel antibodies, cytotoxic and immunomodulatory payloads, and unique structural designs enhancing efficacy and safety. There is increasing evidence that combinations with other cancer therapies, especially immunotherapy, improve treatment outcomes. The combination of enfortumab vedotin and pembrolizumab was recently approved for first-line treatment of advanced urothelial carcinoma. Despite the great promise of these novel drugs, robust predictive biomarkers are needed to determine the patients who would maximally benefit. This review surveys the rationale and current state of the evidence for these new drugs and describes future directions actively being explored.

抗体-药物共轭物和自行车毒素共轭物代表了给药技术的巨大进步,在治疗尿路癌方面显示出巨大的前景。以前批准的全身疗法,包括化疗和免疫疗法,往往因合并症而不切实际,即使接受全身疗法,晚期患者的疗效仍然不佳。在这种情况下,抗体-药物和自行车毒素共轭物作为新型疗法应运而生,极大地改变了治疗格局。这些药物采用独特的设计,由抗体或单车肽、连接体和细胞毒性有效载荷组成,比传统化疗更具靶向性,从而在消除恶性细胞的同时减少全身毒性。在尿道癌中研究的潜在靶点包括 Nectin-4、TROP2、HER2 和 EphA2。最初的临床试验表明,该药在治疗难治性晚期尿路癌方面具有疗效,并能改善患者的生活质量。这些初步研究促使美国食品及药物管理局批准了两种抗体药物共轭物,即恩福单抗维多汀(enfortumab vedotin)和萨希珠单抗戈维替康(sacituzumab govitecan)。此外,在晚期疾病的一线治疗和局部癌症的临床试验中,正在对抗体药物和自行车毒素共轭物进行研究。这些研究凸显了未来利用新靶点、新抗体、细胞毒性和免疫调节有效载荷以及提高疗效和安全性的独特结构设计开发更多疗法的潜力。越来越多的证据表明,与其他癌症疗法,尤其是免疫疗法联合使用可提高治疗效果。enfortumab vedotin 和 pembrolizumab 的组合最近被批准用于晚期尿路上皮癌的一线治疗。尽管这些新型药物大有可为,但仍需要强有力的预测性生物标志物来确定哪些患者能最大程度地获益。这篇综述探讨了这些新药的原理和目前的证据状况,并介绍了正在积极探索的未来方向。
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引用次数: 0
Long-term impact of commonly performed operations in pediatric urology on reproductive and sexual health. 小儿泌尿外科常用手术对生殖健康和性健康的长期影响。
IF 2 4区 医学 Q2 UROLOGY & NEPHROLOGY Pub Date : 2024-05-09 eCollection Date: 2024-01-01 DOI: 10.1177/17562872241249083
Alexandra Geada, Dhaval Jivanji, Daniel M Tennenbaum, Armin Ghomeshi, Raghuram Reddy, Michael Sencaj, Jamie Thomas, Daniel E Nassau, Ranjith Ramasamy

Introduction: Sexual dysfunction is highly prevalent among men of reproductive age. Clinical practice guidelines have been established to assist providers in identification and education of patients who are at increased risk for infertility and sexual dysfunction with certain congenital and acquired urogenital disorders. The authors sought to review the reproductive and sexual health implications of treating common childhood urological conditions with commonly performed surgical procedures.

Methods: To ensure the inclusion of influential and highly regarded research, we prioritized citations from the most-frequently cited articles on our respective review topics. Our inclusion criteria considered studies with substantial sample sizes and rigorously designed methodologies. Several topics were reviewed, including penile chordee, hypospadias, posterior urethral valves, varicoceles, undescended testicles, and testicular torsion.

Results: For chordee, surgical plication or corporal grafting may be employed. Erectile function remains unaltered post-surgery, while penile length may decrease after repair, which may be avoided using dermal grafts. Hypospadias repair hinges on severity and availability of the urethral plate. Those who underwent hypospadias repair report decreased penile length, but sexual satisfaction, libido, and semen quality are comparable to controls. Posterior urethral valves are usually treated with valve ablation. While valve ablation and bladder neck incision have not been found to affect ejaculatory function, high degree of concurrent renal dysfunction related to nephrogenic and bladder dysfunction may impact semen parameters and erectile function. Regarding varicocele, earlier management has been associated with better long-term fertility outcomes, and surgical intervention is advisable if there is observable testicular atrophy. Earlier repair of undescended testicle with orchiopexy has been found to improve fertility rates as well as decrease malignancy rates. Unilateral orchiectomy for testicular torsion without the ability for salvage has been shown to have decreased semen parameters but unaffected fertility rates.

Conclusion: Infertility and sexual dysfunction are multivariable entities, with etiologies both congenital and acquired. At the same time, many common pediatric urology surgeries are performed to correct anatomic pathology that may lead to reproductive dysfunction in adulthood. This review highlights the need for diagnosis and management of pediatric urologic conditions as these conditions may impact long-term sexual function post-operatively.

简介性功能障碍在育龄男性中非常普遍。目前已制定了临床实践指南,以帮助医疗工作者识别和教育因某些先天性和后天性泌尿生殖系统疾病而增加不育和性功能障碍风险的患者。作者试图回顾用常用外科手术治疗常见儿童泌尿系统疾病对生殖健康和性健康的影响:为了确保纳入有影响力和备受推崇的研究,我们优先引用了与我们各自的综述主题相关的最常被引用的文章。我们的纳入标准考虑了样本量大、方法设计严谨的研究。我们对多个主题进行了综述,包括阴茎硬结症、尿道下裂、后尿道瓣膜、精索静脉曲张、睾丸下降不全和睾丸扭转:结果:对于阴茎硬结症,可采用手术切除或体外移植的方法。勃起功能在术后保持不变,而阴茎长度在修复后可能会缩短,使用真皮移植可避免这种情况。尿道下裂修复取决于严重程度和尿道板的可用性。接受尿道下裂修补术的患者报告阴茎长度减少,但性生活满意度、性欲和精液质量与对照组相当。后尿道瓣膜通常采用瓣膜消融术进行治疗。虽然尚未发现瓣膜消融术和膀胱颈切开术会影响射精功能,但与肾功能障碍和膀胱功能障碍相关的高度并发肾功能障碍可能会影响精液参数和勃起功能。关于精索静脉曲张,早期治疗与更好的长期生育结果相关,如果出现明显的睾丸萎缩,建议进行手术干预。研究发现,尽早通过睾丸环切术修复未降睾丸可提高生育率并降低恶性肿瘤发生率。对睾丸扭转进行单侧睾丸切除术而无法挽救的结果表明,精液参数会下降,但生育率不受影响:结论:不育症和性功能障碍是多变量实体,病因既有先天性的,也有后天性的。同时,许多常见的小儿泌尿外科手术都是为了纠正可能导致成年后生殖功能障碍的解剖病理。本综述强调了诊断和管理小儿泌尿科疾病的必要性,因为这些疾病可能会影响术后的长期性功能。
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引用次数: 0
Assessing the effectiveness and safety of lenvatinib and everolimus in advanced renal cell carcinoma: insights from the RELIEVE study’s analysis of heavily pretreated patients 评估来伐替尼和依维莫司治疗晚期肾细胞癌的有效性和安全性:从RELIEVE研究对重度预处理患者的分析中获得的启示
IF 2 4区 医学 Q2 UROLOGY & NEPHROLOGY Pub Date : 2024-04-17 DOI: 10.1177/17562872241244574
Sebastiano Buti, Alessandro Olivari, Cristina Masini, Davide Bimbatti, Donata Sartori, Paola Ermacora, Carlo Cattrini, Maria Giuseppa Vitale, Ernesto Rossi, Claudia Mucciarini, Mimma Rizzo, Michele Sisani, Matteo Santoni, Giandomenico Roviello, Veronica Mollica, Vincenza Conteduca, Francesco Grillone, Marika Cinausero, Giuseppe Prati, Francesco Atzori, Marco Stellato, Francesco Massari, Melissa Bersanelli
Background:The treatment of heavily pretreated patients with metastatic renal cell carcinoma (mRCC) represents an unmet medical need and is still challenging.Objectives:The primary objective was to assess the effectiveness of the lenvatinib plus everolimus combination and the secondary objective was the toxicity profile of this combination.Design:We conducted a longitudinal retrospective study examining mRCC patients pre-treated with one or more lines of therapy among different cancer centers in Italy.Methods:The study included patients who received the combination of lenvatinib plus everolimus as either a second-line treatment or beyond. We assessed progression-free survival (PFS), time to treatment failure (TTF), overall survival (OS), response rate (RR), and toxicity profile. In addition, we explored the potential relationship between treatment effectiveness and clinical and laboratory parameters.Results:In all, 33 patients were assessed, the median age was 60 years, 57% had an Eastern Cooperative Oncology Group performance status of 1–2 and. 63% received ⩾ 3 prior lines of therapy. 62% were ‘intermediate risk’ according to the International Metastatic Renal Cell Carcinoma Database Consortium and 30% were ‘poor risk’. The RR was 42% (no complete response), 18% stable disease. Median OS was 11.2 months (95% CI 6.8–19.9), median PFS was 6.7 months (95% CI 0.6–30.8), and median TTF was 6.7 months (95% CI 4.8–16.6). A shorter OS was significantly associated with lymph node metastases ( p = 0.043, 95% CI), neutrophils/ lymphocytes ratio (NLR) ⩾ 3 ( p = 0.007), hemoglobin/red cell distribution width ratio cutoff value <0.7 was significant ( p = 0.03) while a shorter PFS was associated with lung ( p = 0.048) and brain metastases ( p = 0.023). The most frequent G1 toxicity was diarrhea (24%), G2 was fatigue (30%), and hypertension and skin toxicity (6%) for G3.Conclusion:Our findings suggest a clinically relevant effectiveness of lenvatinib plus everolimus combination with an acceptable toxicity profile for heavily pretreated patients with mRCC.
背景:对接受过大量预处理的转移性肾细胞癌(mRCC)患者的治疗是一项尚未满足的医疗需求,目前仍面临挑战。目标:首要目标是评估来伐替尼联合依维莫司的疗效,次要目标是评估这种联合疗法的毒性概况。设计:我们进行了一项纵向回顾性研究,考察了意大利不同癌症中心接受过一线或多线治疗的mRCC患者。方法:研究纳入了接受来伐替尼联合依维莫司二线治疗或二线以上治疗的患者。我们评估了无进展生存期(PFS)、治疗失败时间(TTF)、总生存期(OS)、反应率(RR)和毒性概况。此外,我们还探讨了治疗效果与临床和实验室参数之间的潜在关系。结果:总共有 33 名患者接受了评估,中位年龄为 60 岁,57% 的患者在东部合作肿瘤学组的表现状态为 1-2 级,63% 的患者接受了ɳSm_273↩治疗。63%的患者之前接受过⩾3种治疗。根据国际转移性肾细胞癌数据库联盟(International Metastatic Renal Cell Carcinoma Database Consortium),62%的患者属于 "中危",30%属于 "低危"。RR为42%(无完全反应),18%病情稳定。中位OS为11.2个月(95% CI 6.8-19.9),中位PFS为6.7个月(95% CI 0.6-30.8),中位TTF为6.7个月(95% CI 4.8-16.6)。较短的OS与淋巴结转移(p = 0.043,95% CI)、中性粒细胞/淋巴细胞比值(NLR)⩾ 3(p = 0.007)、血红蛋白/红细胞分布宽度比值截断值<0.7显著相关(p = 0.03),而较短的PFS与肺转移(p = 0.048)和脑转移(p = 0.023)相关。最常见的G1毒性为腹泻(24%),G2为疲劳(30%),G3为高血压和皮肤毒性(6%)。
{"title":"Assessing the effectiveness and safety of lenvatinib and everolimus in advanced renal cell carcinoma: insights from the RELIEVE study’s analysis of heavily pretreated patients","authors":"Sebastiano Buti, Alessandro Olivari, Cristina Masini, Davide Bimbatti, Donata Sartori, Paola Ermacora, Carlo Cattrini, Maria Giuseppa Vitale, Ernesto Rossi, Claudia Mucciarini, Mimma Rizzo, Michele Sisani, Matteo Santoni, Giandomenico Roviello, Veronica Mollica, Vincenza Conteduca, Francesco Grillone, Marika Cinausero, Giuseppe Prati, Francesco Atzori, Marco Stellato, Francesco Massari, Melissa Bersanelli","doi":"10.1177/17562872241244574","DOIUrl":"https://doi.org/10.1177/17562872241244574","url":null,"abstract":"Background:The treatment of heavily pretreated patients with metastatic renal cell carcinoma (mRCC) represents an unmet medical need and is still challenging.Objectives:The primary objective was to assess the effectiveness of the lenvatinib plus everolimus combination and the secondary objective was the toxicity profile of this combination.Design:We conducted a longitudinal retrospective study examining mRCC patients pre-treated with one or more lines of therapy among different cancer centers in Italy.Methods:The study included patients who received the combination of lenvatinib plus everolimus as either a second-line treatment or beyond. We assessed progression-free survival (PFS), time to treatment failure (TTF), overall survival (OS), response rate (RR), and toxicity profile. In addition, we explored the potential relationship between treatment effectiveness and clinical and laboratory parameters.Results:In all, 33 patients were assessed, the median age was 60 years, 57% had an Eastern Cooperative Oncology Group performance status of 1–2 and. 63% received ⩾ 3 prior lines of therapy. 62% were ‘intermediate risk’ according to the International Metastatic Renal Cell Carcinoma Database Consortium and 30% were ‘poor risk’. The RR was 42% (no complete response), 18% stable disease. Median OS was 11.2 months (95% CI 6.8–19.9), median PFS was 6.7 months (95% CI 0.6–30.8), and median TTF was 6.7 months (95% CI 4.8–16.6). A shorter OS was significantly associated with lymph node metastases ( p = 0.043, 95% CI), neutrophils/ lymphocytes ratio (NLR) ⩾ 3 ( p = 0.007), hemoglobin/red cell distribution width ratio cutoff value &lt;0.7 was significant ( p = 0.03) while a shorter PFS was associated with lung ( p = 0.048) and brain metastases ( p = 0.023). The most frequent G1 toxicity was diarrhea (24%), G2 was fatigue (30%), and hypertension and skin toxicity (6%) for G3.Conclusion:Our findings suggest a clinically relevant effectiveness of lenvatinib plus everolimus combination with an acceptable toxicity profile for heavily pretreated patients with mRCC.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":"179 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140616219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection 经皮肾造瘘术与逆行输尿管支架植入术治疗急性梗阻性上尿路感染的围手术期疗效和安全性的 Meta 分析
IF 2 4区 医学 Q2 UROLOGY & NEPHROLOGY Pub Date : 2024-04-12 DOI: 10.1177/17562872241241854
Xidong Wang, Gang Wu, Tianqi Wang, Shangjing Liu, Guixin Ding, Qiancheng Mao, Yongli Chu, Yuanshan Cui, Jitao Wu
Background:The debate regarding the optimal drainage method for acute obstructive upper urinary tract infection persists, focusing on the choice between percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS).Aims:This study aims to systematically examine the perioperative outcomes and safety associated with PCN and RUS in treating acute obstructive upper urinary tract infections.Methods:A comprehensive investigation was conducted using the Medline, Embase, Web of Science, and Cochrane databases up to December 2022, following the guidelines of the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. The utilized keywords included ‘PCN’, ‘RUS’, ‘acute upper obstructive uropathy’, and ‘RCT’. Inclusion criteria encompassed studies providing accurate and analyzable data, which incorporated the total subject count, perioperative outcomes, and complication rates. The assessed perioperative outcomes included fluoroscopy time, normalization of temperature, normalization of serum creatinine, normalization of white blood cell (WBC) count, and operative time. Safety outcomes encompassed failure rate, intraoperative and postoperative hematuria, postoperative fever, postoperative pain, and postoperative nephrostomy tube or stent slippage rate. The study protocol was prospectively registered at PROSPERO (CRD42022352474).Results:The meta-analysis encompassed 7 trials involving 727 patients, with 412 assigned to the PCN group and 315 to the RUS group. The outcome of the meta-analysis unveiled a reduced occurrence of postoperative hematuria in the PCN group [odds ratio (OR) = 0.54, 95% confidence interval (CI) 0.30–0.99, p = 0.04], along with a decreased frequency of insertion failure (OR = 0.42, 95% CI 0.21–0.81, p = 0.01). In addition, the RUS group exhibited a shorter fluoroscopy time than the PCN group (mean difference = 0.31, 95% CI 0.14–0.48, p = 0.0004).Conclusion:Given the significant impact of hematuria and catheterization failure on postoperative quality of life, the preference for PCN appears more advantageous than RUS.
背景:关于急性梗阻性上尿路感染的最佳引流方法的争论一直存在,主要集中在经皮肾造瘘术(PCN)和逆行输尿管支架置入术(RUS)之间的选择上。方法:根据《系统综述和元分析首选报告项目》(Preferred Reporting Items for Systematic Review and Meta-analysis,PRISMA)声明的指导原则,利用 Medline、Embase、Web of Science 和 Cochrane 数据库(截至 2022 年 12 月)进行了全面调查。使用的关键词包括 "PCN"、"RUS"、"急性上梗阻性尿路病变 "和 "RCT"。纳入标准包括提供准确和可分析数据的研究,其中包括受试者总数、围手术期结果和并发症发生率。评估的围手术期结果包括透视时间、体温正常化、血清肌酐正常化、白细胞(WBC)计数正常化和手术时间。安全性结果包括失败率、术中和术后血尿、术后发热、术后疼痛以及术后肾造瘘管或支架滑脱率。研究方案在PROSPERO(CRD42022352474)上进行了前瞻性注册。结果:荟萃分析包括7项试验,涉及727名患者,其中412人被分配到PCN组,315人被分配到RUS组。荟萃分析结果显示,PCN 组术后血尿发生率降低[几率比(OR)= 0.54,95% 置信区间(CI)0.30-0.99,P = 0.04],插入失败频率降低(OR = 0.42,95% CI 0.21-0.81,P = 0.01)。此外,RUS 组的透视时间比 PCN 组更短(平均差异 = 0.31,95% CI 0.14-0.48,p = 0.0004)。
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引用次数: 0
A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product 为期 6 个月的宽剂量范围十一酸睾酮口服产品 III 期单臂试验
IF 2 4区 医学 Q2 UROLOGY & NEPHROLOGY Pub Date : 2024-04-11 DOI: 10.1177/17562872241241864
James S. Bernstein, Om P. Dhingra
Background:Oral testosterone undecanoate (TU) formulations may provide effective, safe, and easily titratable testosterone replacement therapy.Objective:Demonstrate efficacy and safety of a novel oral TU formulation.Design:An open-label, single-arm, multi-center trial treated 155 hypogonadal men for 180 days. Treatment began at 200 mg TU twice daily with meals; doses were titrated over two 28-day cycles to between 100 and 800 mg TU daily, measuring average testosterone (T Cavg) after 90 days. Ambulatory blood pressure monitoring (ABPM) occurred at baseline, 120, and 180 days.Methods:Titrations used a randomized blood sample taken 3-, 4-, or 5-h post-morning dose. Outcomes used sodium fluoride/ethylenediaminetetraacetate plasma testosterone (T) values; serum results were also reported. Blood pressure (ABPM and in-clinic) was evaluated for change from baseline.Results:After titration, 87.8% of KYZATREX™ treated participants (worse-case scenario) and 96.1% of 90-day completers achieved eugonadal mean plasma T values. Serum T Cavg was 452 ng/dL and maximum T concentrations (T Cmax) met all FDA criteria. Participant eugonadal percentages were comparable across subgroups for age, weight, and body mass index. Diet had no effect on participant eugonadal percentages. KYZATREX was well tolerated, with no drug-related serious adverse events (SAE) and one adverse drug reaction (hypertension) observed in 2% or more of participants. Systolic ambulatory blood pressure increased 1.7 mmHg (95% confidence interval: 0.3–3.1). At baseline, 36% of 155 participants were receiving anti-hypertensive medication and 22% were diabetic. No dose increases occurred in existing anti-hypertensive medication; five participants (3.2%) started anti-hypertensive medication.Conclusion:KYZATREX provided safe and effective testosterone levels within the normal range in hypogonadal male study participants.Clinical trial registration:URL: https://clinicaltrials.gov/ unique identifier NCT04467697, conducted under NCT03198728. Post-completion, clinicaltrials.gov requested creation of the separate NCT04467697 identifier. All subjects were recruited under NCT03198728.
背景:口服十一酸睾酮(TU)制剂可提供有效、安全且易于滴定的睾酮替代疗法。目标:展示新型口服 TU 制剂的疗效和安全性。设计:一项开放标签、单臂、多中心试验,对 155 名性腺功能减退的男性进行了 180 天的治疗。治疗开始时每天两次,每次200毫克TU,餐后服用;剂量在两个28天的周期内滴定为每天100至800毫克TU,90天后测量平均睾酮(T Cavg)。在基线、120 天和 180 天时进行动态血压监测 (ABPM)。结果采用氟化钠/乙二胺四乙酸盐血浆睾酮(T)值;同时报告血清结果。结果:滴定后,87.8% 的 KYZATREX™ 治疗参与者(最差情况)和 96.1% 的 90 天完成者达到了优生优育的平均血浆睾酮值。血清 T Cavg 为 452 ng/dL,最大 T 浓度 (T Cmax) 符合 FDA 的所有标准。在不同年龄、体重和体重指数的亚组中,参与者的优生率相当。饮食对参与者的性腺百分比没有影响。KYZATREX 的耐受性良好,没有出现与药物相关的严重不良事件 (SAE),2% 或更多的参与者出现了一种药物不良反应(高血压)。收缩压上升了 1.7 mmHg(95% 置信区间:0.3-3.1)。基线时,155 名参与者中有 36% 正在服用抗高血压药物,22% 患有糖尿病。结论:KYZATREX为性腺功能低下的男性研究参与者提供了安全有效的睾酮水平,且在正常范围内。临床试验注册:网址:https://clinicaltrials.gov/ 唯一标识符NCT04467697,在NCT03198728下进行。临床试验完成后,clinicaltrials.gov要求创建单独的NCT04467697标识符。所有受试者都是在 NCT03198728 下招募的。
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引用次数: 0
Treatment modalities for paediatric functional daytime lower urinary tract disorders: an updated review 儿科功能性日间下尿路疾病的治疗方法:最新综述
IF 2 4区 医学 Q2 UROLOGY & NEPHROLOGY Pub Date : 2024-04-05 DOI: 10.1177/17562872241241848
Naveen Wijekoon, Aniruddh Deshpande
Paediatric functional bladder disorders especially those causing daytime symptoms are a common cause of significant psychosocial and/or physical morbidity and impaired quality of life. Despite the availability of many therapeutic modalities, a significant number of children appear to be refractory to treatment and continue to have symptoms. In this review, we aim to evaluate the current evidence in the use of existing and novel therapeutic options for the management of daytime lower urinary tract disorders in children. We also aim to highlight the controversies around the terminology and diagnosis of paediatric lower urinary tract dysfunction (LUTD) and specific conditions. The article will then provide a reasonable critique of the existing and emerging treatment modalities in functional daytime LUTD in children including their mode of action, efficacy, indications, and recent advances. These include standard urotherapy, specific urotherapy comprised of biofeedback, alarm therapy and electrical neural stimulation and pharmacotherapy involving selective and non-selective anticholinergics, ß3 adrenergic agonists, alpha blockers and botulinum toxin. A better understanding of this common clinical problem may help clinicians achieve better profiling of these children’s diagnoses to further enable specific, targeted treatment.
小儿功能性膀胱失调,尤其是引起日间症状的小儿功能性膀胱失调,是导致严重的社会心理和/或身体疾病以及生活质量下降的常见原因。尽管目前有许多治疗方法,但仍有相当数量的儿童似乎对治疗不耐受,症状持续存在。在这篇综述中,我们旨在评估目前使用现有和新型治疗方案治疗儿童日间下尿路疾病的证据。我们还旨在强调围绕儿科下尿路功能障碍(LUTD)和特定病症的术语和诊断所存在的争议。然后,文章将对儿童日间功能性下尿路功能障碍的现有和新兴治疗方法进行合理的评论,包括其作用方式、疗效、适应症和最新进展。这些方法包括标准尿路治疗、由生物反馈、报警治疗和神经电刺激组成的特殊尿路治疗,以及涉及选择性和非选择性抗胆碱能药、ß3 肾上腺素能激动剂、α 受体阻滞剂和肉毒杆菌毒素的药物治疗。更好地了解这一常见的临床问题,有助于临床医生更好地分析这些儿童的诊断,从而进一步进行有针对性的具体治疗。
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引用次数: 0
期刊
Therapeutic Advances in Urology
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