AUA2025上的膀胱癌展示：蓝光膀胱镜检查改善风险分层和知情决策-动脉网

Bladder Cancer presentations at AUA2025: Blue Light Cystoscopy improves risk stratification and informed decision making

CISION 等信源发布 2025-04-29 14:24

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OSLO, Norway

挪威奥斯陆

，

April 29, 2025

2025年4月29日

/PRNewswire/ --

Photocure ASA

(OSE: PHO)

（OSE：PHO）

, the Bladder Cancer Company, announces four abstract presentations at the AUA 2025, highlighting the benefits of Blue Light Cystoscopy (BLC

，膀胱癌公司，宣布在AUA 2025上进行四场摘要报告，重点展示蓝光膀胱镜检查（BLC）的好处。

), notably its impact on management of the disease, improved risk stratification and therefore the ability of the BLC procedure to help urologists and patients make well-informed decisions. The American Urological Association Annual Congress 2025 was held

），特别是其对疾病管理的影响，改善了风险分层，从而增强了BLC程序帮助泌尿科医生和患者做出明智决策的能力。美国泌尿外科协会2025年年会召开。

April 26-28

4月26日至28日

, at the Venetian Convention & Expo Center in

，在威尼斯会议展览中心

Las Vegas, NV

内华达州拉斯维加斯

, USA.

，美国。

Three abstracts were presented from Photocure's U.S. Blue Light Cystoscopy with Cysview Registry, a large multicenter bladder cancer patient registry of real-world data, established by Photocure in 2014 and projected to enroll 4,400 patients. In addition, the study protocol of a randomized controlled non-inferiority trial comparing a multidisciplinary approach including PDD-guided primary TURBT to reduce the patients' burden of second resection including a total of 327 patients has been presented.

Photocure公司于2014年建立的美国蓝光膀胱镜Cysview登记处（一个包含真实世界数据的大型多中心膀胱癌患者登记处，预计招募4400名患者）展示了三项摘要。此外，还介绍了一项随机对照非劣效性试验的研究方案，该试验比较了包括PDD引导的初次TURBT在内的多学科方法以减少患者二次切除的负担，总共包括327名患者。

This investigator-initiated trial is supported by Photocure..

这项由研究者发起的试验得到了Photocure的支持。

The abstract sessions on

抽象会议

Saturday, April 26

4月26日，星期六

：

'Upstaging and Risk Migration with BLC for NMIBC: Results from a prospective multicenter registry' by Alireza Ghoreifi,

‘使用BLC进行NMIBC的升级和风险迁移：来自前瞻性多中心注册研究的结果’，作者：Alireza Ghoreifi，

Duke University

杜克大学

The study looked at 2,854 NMIBC* patients from the US Blue Light Cystoscopy with Cysview Registry. A total of 201 (7%) patients had at least one malignant lesion detected exclusively by BLC while having a negative WLC. These lesions (335 in total) included carcinoma in-situ (CIS) (145; 43%), low-grade Ta (53; 16%), high-grade Ta (95; 28%), high-grade T1 (37; 11%), and high-grade T2 (5; 1%).

该研究调查了来自美国蓝光膀胱镜Cysview注册库的2,854名NMIBC*患者。共有201名（7%）患者至少有一处仅通过BLC检测到的恶性病灶，而WLC结果为阴性。这些病灶（总计335个）包括原位癌（CIS）（145个；43%）、低级别Ta（53个；16%）、高级别Ta（95个；28%）、高级别T1（37个；11%）和高级别T2（5个；1%）。

As a result of BLC-enhanced detection, the rate of upgrading or upstaging to a more advanced tumor using BLC was 9.3%. The authors concluded that resulting changes in grade/stage could impact patient management, such as the appropriate administration of intravesical therapy, duration of therapy, and when to perform radical cystectomy.

由于BLC增强了检测能力，使用BLC将肿瘤升级或提升到更高级别肿瘤的比例为9.3%。作者总结认为，等级/分期的变化可能会影响患者的治疗管理，例如膀胱内治疗的适当实施、治疗持续时间以及何时进行根治性膀胱切除术。

The results are expected to form the basis for further studies on how Blue Light Cystoscopy can support precision diagnostics and improve patient management in NMIBC..

预计这些结果将为进一步研究蓝光膀胱镜如何支持精准诊断和改善NMIBC患者的管理奠定基础。

Read the abstract:

阅读摘要：

https://www.auajournals.org/doi/abs/10.1097/01.JU.0001109740.05294.af.32

'Predicting Recurrence and Progression in Contemporary Patients with NMIBC Undergoing Blue Light Cystoscopy-Aided Transurethral Resection of Bladder Tumor' by

《预测当代NMIBC患者在蓝光膀胱镜辅助下经尿道膀胱肿瘤切除术后的复发和进展》

Boris Gershman

鲍里斯·格尔什曼

，

Harvard University

哈佛大学

, Beth Israel Deaconess Medical Center

贝斯以色列女执事医疗中心

Although blue light cystoscopy (BLC) is recommended by clinical practice guidelines to reduce recurrence, predictive models for patients undergoing BLC are lacking. The authors developed predictive models for recurrence and progression in patients treated with BLC using 1109 patients. Median age at diagnosis was 71 years, and 198 (18%) patients were female.

尽管临床实践指南推荐使用蓝光膀胱镜 (BLC) 以减少复发，但针对接受 BLC 治疗患者的预测模型仍然缺乏。作者利用 1109 名患者的数据，开发了针对接受 BLC 治疗患者的复发和进展预测模型。患者诊断时的中位年龄为 71 岁，其中 198 名（18%）患者为女性。

Tumor stage was Ta in 658 (60%), T1 in 241 (22%), and pure CIS in 210 (19%) patients. 759 (71%) patients had high-grade tumors, and 324 (29%) patients had multifocal disease. Median follow-up for relapse-free survival (RFS) and progression-free survival (PFS) was 18, and 24 months, respectively, during which time 360 recurrence and 79 progression events occurred.

肿瘤分期为Ta的患者有658例（60%），T1的患者有241例（22%），纯CIS的患者有210例（19%）。759例（71%）患者患有高级别肿瘤，324例（29%）患者患有多灶性疾病。无复发生存期（RFS）和无进展生存期（PFS）的中位随访时间分别为18个月和24个月，在此期间发生了360次复发事件和79次进展事件。

Results showed a greater number of tumors (unit HR 1.09), and recurrent tumor status (HR 1.32) were associated with increased risk of recurrence, while pure CIS (HR 0.69) and receipt of perioperative intravesical chemotherapy (HR 0.76) were associated with decreased risk of recurrence. In contrast, higher tumor stage (HR 3.88 for T1; HR 3.69 for T1+CIS) and lymphovascular invasion (HR 3.88) were associated with increased risks of progression.

结果显示，肿瘤数量较多（单位风险比 1.09）和肿瘤复发状态（风险比 1.32）与复发风险增加相关，而单纯原位癌（CIS，风险比 0.69）和接受围手术期膀胱内化疗（风险比 0.76）则与复发风险降低相关。相比之下，较高的肿瘤分期（T1 期风险比 3.88；T1+CIS 风险比 3.69）以及淋巴血管侵犯（风险比 3.88）与进展风险增加相关。

The impact of the data is that these models reflect contemporary treatment standards and can inform personalized, risk-adapted management of NMIBC..

这些数据的影响在于，这些模型反映了当代的治疗标准，并且可以为非肌层浸润性膀胱癌（NMIBC）的个性化、风险适应性管理提供信息。

Read the abstract:

阅读摘要：

https://www.auajournals.org/doi/abs/10.1097/01.JU.0001109740.05294.af.10

'Performance of the EORTC and CUETO Risk Prediction Models in Contemporary Patients Undergoing Transurethral Resection of Bladder Tumor with Blue Light Cystoscopy' by

《当代患者在蓝光膀胱镜下经尿道膀胱肿瘤切除术中EORTC和CUETO风险预测模型的表现》

Boris Gershman

鲍里斯·格什曼

，

Harvard University

哈佛大学

, Beth Israel Deaconess Medical Center

贝丝以色列女执事医疗中心

In a companion study, the performance of the BLC recurrence/ progression model was compared against EORTC and CUETO, a pair of widely recognized risk tools for predicting recurrence and progression in non-muscle invasive bladder cancer (NMIBC). Out of total of 899 patients included from the BLC Registry, Ta was found in 658 (73%) patients and T1 in 241 (27%) patients, and concomitant CIS was present in 116 (13%) patients.

在一项配套研究中，将BLC复发/进展模型的性能与EORTC和CUETO进行了比较，后者是被广泛认可的用于预测非肌层浸润性膀胱癌（NMIBC）复发和进展的风险工具。在来自BLC注册库的总计899名患者中，658名（73%）患者为Ta期，241名（27%）患者为T1期，116名（13%）患者伴有同时发生的CIS。

Median follow-up for RFS and PFS was 18 and 24 months, respectively. The discrimination of the EORTC model was c=0.59 for RFS and c=0.67 for PFS, while for the CUETO model it was c=0.53 for RFS and c=0.72 for PFS. Thus, overall, in a contemporary cohort of patients undergoing BLC-TURBT, the EORTC and CUETO models demonstrated poor performance in predicting RFS and PFS. .

RFS 和 PFS 的中位随访时间分别为 18 个月和 24 个月。EORTC 模型对 RFS 的判别能力为 c=0.59，对 PFS 为 c=0.67，而 CUETO 模型对 RFS 的判别能力为 c=0.53，对 PFS 为 c=0.72。因此，总体而言，在接受 BLC-TURBT 的现代患者队列中，EORTC 和 CUETO 模型在预测 RFS 和 PFS 方面表现较差。

Dr.

博士

Boris Gershman

鲍里斯·格尔什曼

, principal author of these two abstracts commented: 'Accurate prediction of recurrence and progression risk is essential for the management of non-muscle invasive bladder cancer. However, the established EORTC and CUETO risk models demonstrated poor performance forecasting these outcomes among contemporary patients receiving a TURBT with blue light cystoscopy.

这两篇摘要的主要作者评论道：“准确预测复发和进展风险对于非肌层浸润性膀胱癌的管理至关重要。然而，已建立的EORTC和CUETO风险模型在对接受蓝光膀胱镜TURBT手术的当代患者预测这些结果时表现不佳。”

We therefore used the multi-institutional Blue Light Cystoscopy Registry to develop modern predictive models for recurrence and progression in patients treated with BLC. Such tools as these reflect contemporary treatment paradigms, and can inform the personalized, risk-adapted management of NMIBC.'.

因此，我们利用多机构的蓝光膀胱镜检查登记数据，开发了针对接受BLC治疗患者的现代复发和进展预测模型。这些工具反映了当代的治疗模式，可以指导NMIBC的个性化、风险适应性管理。

'At AUA and EAU 2025 congresses we have seen important expert alignment these past weeks on the importance of early and accurate precision diagnosis in bladder cancer, and the role of blue light cystoscopy. Accurate diagnosis and risk stratification based on staging, grading impacts treatment decisions.

在AUA和EAU 2025年大会上，过去几周我们看到专家们就膀胱癌早期和准确的精准诊断的重要性以及蓝光膀胱镜的作用达成了重要共识。基于分期和分级的准确诊断与风险分层影响治疗决策。

It matters increasingly, the more advanced individualized treatment options a urologist is able to offer for the management of their patients' bladder cancer,' .

“泌尿科医生能够为患者的膀胱癌管理提供越先进的个体化治疗选择，这一点就变得越来越重要。”

said Anders Neijber, Photocure's Chief Medical Officer.

Photocure的首席医学官安德斯·内伊伯说。

Read the abstract:

阅读摘要：

https://www.auajournals.org/doi/abs/10.1097/01.JU.0001109740.05294.af.18

在

Monday, April 28

4月28日，星期一

, in 'Clinical Trials in Progress':

，在“进行中的临床试验”中：

'VI-RADS followed by Photodynamic Transurethral Resection of Non-muscle Invasive Bladder Cancer versus White-light Conventional and Second Resection: The CUT-LESS Randomized Trial' by

《VI-RADS联合光动力经尿道切除非肌层浸润性膀胱癌与白光常规及二次切除的比较：CUT-LESS随机试验》

Francesco del Guidici

弗朗切斯科·德尔·圭迪奇

et al. from 'Sapienza' University of

等人，来自‘Sapienza’大学

Rome, Italy

罗马，意大利

The CUT-less trial aims to evaluate if second resection can be safely omitted in selected patients by combining cross-sectional imaging and PDD-guided primary TURB in order to reduce the burden of early repeated TURB for the patient.

CUT-less试验旨在评估在选定患者中，通过结合横断面成像和PDD引导的初次TURB，是否可以安全地省略二次切除，以减轻患者早期重复TURB的负担。

This randomized controlled non-inferiority trial compares the short-term recurrence rates when combining preoperative staging using multiparametic magnetic resonance imaging (mpMRI) Vesical Imaging-Reporting and Data System (VI-RADS) and PDD-guided primary TURB vs. mpMRI Vi-RADs and white-light TURB only followed by second resection in patients which are candidates for second resection in NMIBC.

这项随机对照非劣效性试验比较了在符合第二次切除条件的非肌层浸润性膀胱癌（NMIBC）患者中，使用多参数磁共振成像（mpMRI）膀胱影像报告和数据系统（VI-RADS）进行术前分期联合光动力诊断（PDD）引导的初次经尿道膀胱肿瘤切除术（TURB）与仅使用mpMRI VI-RADS和白光TURB随后进行二次切除的短期复发率。

This study will include a total of 327 patients. Secondary endpoints include comparative evaluation of mid- and long-term recurrence and progression rates, health-related quality of life, and health-economic cost-benefit analysis. .

本研究将总共纳入 327 名患者。次要终点包括对中期和长期复发率和进展率、健康相关的生活质量以及健康经济学成本效益分析的比较评估。

Read the abstract:

阅读摘要：

https://www.auajournals.org/doi/10.1097/01.JU.0001110440.53375.7d

Beyond this groundbreaking volume and value of new data related to BLC, Photocure provided congress attendees with hands-on experience in the blue light cystoscopy with Cysview procedure on its booth that featured a Fortec Mobile Equipment Demo of the Saphira HD equipment and rental option. In addition, other tech talks and expert sessions by equipment partners featured more aspects of blue light cystoscopy..

除了与BLC相关的新数据的开创性数量和价值外，Photocure还在其展位上为参会者提供了使用Cysview进行蓝光膀胱镜检查的实际操作体验，展示了Saphira HD设备的Fortec移动设备演示及租赁选项。此外，其他技术讲座和专家会议由设备合作伙伴呈现，探讨了蓝光膀胱镜检查的更多方面。

*NMIBC: Non-muscle invasive bladder cancer

*NMIBC：非肌层浸润性膀胱癌

**TURBT: trans-urethral resection of bladder tumors

**TURBT：经尿道膀胱肿瘤切除术

Note to editors:

编辑注意：

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.

本发布中提到的所有商标均受法律保护，且均为Photocure ASA的注册商标。

This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin..

本新闻稿可能包含在您所在国家无效或无法获取的产品详细信息和信息。请注意，Photocure 对访问此类可能不符合您来源国任何法律程序、法规、注册或使用的资讯不承担任何责任。

About Bladder Cancer

膀胱癌相关信息

Bladder cancer ranks as the 8

膀胱癌排在第8位

most common cancer worldwide – the 5

全球最常见的癌症——第五种

most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)

男性中最常见 – 有1,949,000例普遍病例（5年患病率）

, 614 000 new cases and more than 220 000 deaths in 2022.

，2022年新增614,000例病例和超过220,000例死亡。

Approx. 75% of all bladder cancer cases occur in men.

约75%的膀胱癌病例发生在男性身上。

It has a high recurrence rate with up to 61% in year one and up to 78% over five years.

它的复发率很高，一年内复发率高达61%，五年内复发率高达78%。

Bladder cancer has the highest lifetime treatment costs per patient of all cancers.

膀胱癌是所有癌症中每位患者终生治疗费用最高的。

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike..

膀胱癌是一种高复发风险的疾病，患者需要接受多次膀胱镜检查，这不仅费用高昂，还可能逐步恶化。因此，迫切需要改进膀胱癌的诊断和管理方法，以造福患者和医疗系统。

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions.

膀胱癌根据其侵犯膀胱壁的深度分为两种类型：非肌层浸润性膀胱癌（NMIBC）和肌层浸润性膀胱癌（MIBC）。NMIBC 仍位于膀胱内衬细胞的内层。这些癌症占所有膀胱癌病例的 75%，是最常见的类型，包括 Ta、原位癌（CIS）和 T1 病变等亚型。

In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat..

在肌层浸润性膀胱癌 (MIBC) 中，癌症已侵入膀胱壁的更深层。这些癌症，包括 T2、T3 和 T4 亚型，更容易扩散且更难治疗。

Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at:

全球癌症观察。a) 5年患病率 / b) 发病率/死亡率按人口计算。可在：

https://gco.iarc.fr/today

, accessed [

，访问 [

February 2024

2024年2月

Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657

巴巴久克 M，等。《欧洲泌尿外科杂志》。2019年；76(5): 639-657

Sievert KD et al. World J Urol 2009;27:295–300

Sievert KD 等。《世界泌尿外科杂志》2009；27：295-300

Bladder Cancer. American Cancer Society.

膀胱癌。美国癌症协会。

https://www.cancer.org/cancer/bladder-cancer.html

About Hexvix

关于Hexvix

/Cysview

(hexaminolevulinate HCl)

（盐酸己氨基乙酰丙酸）

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC

Hexvix/Cysview是一种优先积聚在膀胱癌细胞中的药物，在蓝光膀胱镜检查（BLC）中使它们呈现出亮粉色。

). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.

). 与单独使用标准白光膀胱镜相比，使用Hexvix/Cysview的BLC改善了肿瘤的检测，导致更完全的切除、更少的残留肿瘤和更好的管理决策。

Cysview is the tradename in the U.S. and

Cysview 是美国的商标名称和

Canada

加拿大

, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and

，Hexvix 是其他所有市场的商标名。Photocure 正在美国直接推广 Cysview/Hexvix，并且

Europe

欧洲

and has strategic partnerships for the commercialization of Hexvix/Cysview in

并且在Hexvix/Cysview的商业化方面拥有战略合作伙伴关系

China

中国

，

Chile

智利

，

Australia

澳大利亚

，

New Zealand

新西兰

and

和

Israel

以色列

. Please refer to

. 请参阅

https://photocure.com/partners/our-partners

for further information on our commercial partners.

有关我们商业合作伙伴的更多信息，请参阅。

About Photocure ASA

关于Photocure ASA

Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in

Photocure：膀胱癌公司提供变革性的解决方案，以改善膀胱癌患者的生活。我们独特的技术使癌细胞呈现亮粉红色，已为全球患者带来了更好的健康结果。Photocure 总部位于

Oslo, Norway

挪威奥斯陆

and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at

并在奥斯陆证券交易所上市（OSE：PHO）。欲了解更多信息，请访问我们的网站

www.photocure.com/news

For further information, please contact:

如需更多信息，请联系：

Dan Schneider

丹·施耐德

President and CEO

总裁兼首席执行官