新BRAVO研究发表，进一步证实了BLC在降低膀胱癌复发风险方面的临床益处-动脉网

New BRAVO Study Publication Reinforces Clinical Benefits of BLC in Reducing Risk of Bladder Cancer Recurrence

CISION 等信源发布 2025-03-14 15:17

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OSLO, Norway

挪威奥斯陆

，

March 14, 2025

2025年3月14日

/PRNewswire/ --

Photocure ASA (

OSE: PHO)

操作系统环境：PHO）

, the Bladder Cancer Company, announces the publication of the study 'Oncologic Outcomes of Blue Light Cystoscopy in an Equal Access Setting: Results of the BRAVO study' in JU Open Plus this week. The research objective was to assess if

，膀胱癌公司，宣布本周在《JU Open Plus》上发表了研究《平等获取环境下蓝光膀胱镜检查的肿瘤学结果：BRAVO 研究的结果》。该研究的目的是评估是否

blue light cystoscopy (BLC

蓝光膀胱镜检查（BLC）

) aided TURBT has an impact on the clinical outcomes of patients with NMIBC*. Results of the real-world evidence study show that BLC was associated with a statistically significant 38% reduction in risk of recurrence compared to white light cystoscopy (WLC) use alone in a predominantly high-risk NMIBC patient cohort.

）辅助的TURBT对NMIBC患者的临床结果有影响。真实世界证据研究的结果表明，在主要为高危NMIBC患者群体中，与单独使用白光膀胱镜（WLC）相比，BLC与复发风险显著降低38%相关。

These results are in line with prior results from multiple randomized controlled clinical trials..

这些结果与之前多个随机对照临床试验的结果一致。

The BRAVO study (Bladder Cancer Recurrence Analysis in Veterans and Outcomes) is a propensity score matched, retrospective analysis evaluating clinical outcomes following BLC compared to WLC alone in patients from the Veterans Affairs Healthcare System.

BRAVO研究（膀胱癌复发分析在退伍军人和结果中）是一项倾向评分匹配的回顾性分析，评估来自退伍军人事务医疗系统的患者在BLC与单独WLC后的临床结果。

626 patients were included in this study, 313 in each study arm (WLC versus BLC). Outcomes data for BRAVO was measured at a 3-year time point in a predominately high-risk patient population. Median age at diagnosis was 71 years. Median follow-up was 3.7 years.

本研究共纳入626名患者，每组研究臂各313名患者（WLC对比BLC）。BRAVO的结果数据是在一个以高风险患者为主的群体中，在3年时间点测量的。诊断时的中位年龄为71岁。中位随访时间为3.7年。

Study results include:

研究结果包括：

Risk of recurrence at 3-years was significantly reduced following BLC vs. WLC (HR, 0.62; 95% CI, 0.45-0.86; p<0.01). The 38% reduction in the risk of recurrence is in line with prior results from multiple randomized controlled clinical trials. A positive trend for reduction in risk of progression was also observed (HR=0.71; 95% CI, 0.37-1.38; p=0.32) at 3-years although not statistically significant due to a low number of patients progressing on the study..

三年复发风险在BLC后显著低于WLC（HR，0.62；95% CI，0.45-0.86；p<0.01）。复发风险降低38%与之前多个随机对照临床试验的结果一致。尽管由于研究中进展的患者数量较少，三年时观察到进展风险降低的积极趋势（HR=0.71；95% CI，0.37-1.38；p=0.32），但未达到统计学显著性。

The study indicates that use of BLC can drive treatment decisions that lead to improved outcomes. Specifically highlighted in the study was that BLC patients were significantly more likely to receive intravesical BCG therapy (61% vs 43%; p<0.01) or intravesical chemotherapy (48% vs 27%, p<0.01). This data supports reasoning that using BLC enhances a clinician's ability to decide on the appropriate bladder cancer therapy based on precision risk stratification and a more complete TURBT..

研究表明，使用BLC可以推动治疗决策，从而改善治疗结果。研究特别强调，BLC患者接受膀胱内BCG治疗（61% vs 43%; p<0.01）或膀胱内化疗（48% vs 27%, p<0.01）的可能性显著更高。这些数据支持了这样的观点：使用BLC可以增强临床医生根据精确的风险分层和更完整的经尿道膀胱肿瘤切除术来决定适当的膀胱癌治疗的能力。

The Veterans' Affairs (VA) Healthcare system accepts all U.S. Veterans, regardless of financial background, and retains its patients, allowing for high-quality data capture over a long-term follow-up period, therefore serving as a robust real-world model for equal access.

退伍军人事务部（VA）医疗系统接受所有美国退伍军人，不论其经济背景如何，并且能够长期保留患者，从而在长时间的随访中获取高质量的数据，因此作为一个强有力的现实世界平等获取模型。

'Bladder cancer detection plays an important role in preventing cancer recurrence and optimizing appropriate treatment pathways, as previous research has shown that WLC alone may not comprehensively detect all NMIBCs. In this propensity-score matched cohort study, we found that the use of BLC vs. WLC alone was associated with significantly decreased 38% risk of recurrence.

膀胱癌的检测在预防癌症复发和优化适当的治疗路径方面发挥着重要作用，因为之前的研究表明，单独使用WLC可能无法全面检测所有NMIBC。在这项倾向评分匹配的队列研究中，我们发现与单独使用WLC相比，使用BLC可显著降低38%的复发风险。

Our results are in line with the recent Cochrane review of nearly 3,000 patients across 15 randomized trials, where the authors found that that BLC may reduce the risk of bladder cancer recurrence by 34%. These data support current AUA/SUO guidelines recommending BLC usage in patients with NMIBC to increase detection and decrease recurrence',.

我们的结果与最近的Cochrane综述一致，该综述涵盖了15项随机试验中的近3000名患者，作者发现BLC可能将膀胱癌复发的风险降低34%。这些数据支持当前AUA/SUO指南，推荐在NMIBC患者中使用BLC以提高检测率并减少复发。

said Dr.

博士说

Steven Williams

史蒂文·威廉姆斯

, Professor and Chief of the Division of Urology, at the

，教授兼泌尿科主任，于

University of Texas

德克萨斯大学

-Medical Branch, and one of the study authors.

- 医学分支，以及该研究的作者之一。

'The exciting long-term real-world results from the BRAVO study complement and confirm the generalizability of prior recurrence outcomes with BLC beyond the randomized controlled trial setting,

“BRAVO研究令人兴奋的长期现实世界结果补充并证实了BLC在随机对照试验环境之外的复发结果的普遍适用性，”

reflecting a routine clinical practice patient population',

反映常规临床实践的患者群体，

said Anders Neijber, Chief Medical Officer of Photocure.

Photocure首席医学官安德斯·内伊伯表示。

Read the full publication here:

在此处阅读完整出版物：

https://journals.lww.com/juop/fulltext/2025/03000/oncologic_outcomes_of_blue_light_cystoscopy_in_an.3.aspx

https://journals.lww.com/juop/fulltext/2025/03000/膀胱癌蓝光膀胱镜检查的肿瘤学结果。3.aspx

An editorial to the publication can be found here:

出版物的社论可以在这里找到：

https://journals.lww.com/juop/fulltext/2025/03000/editorial_comment__oncologic_outcomes_of_blue.4.aspx

https://journals.lww.com/juop/fulltext/2025/03000/编者评论__蓝色方案的肿瘤学结果.4.aspx

*NMIBC: Non muscle-invasive bladder cancer

*NMIBC：非肌层浸润性膀胱癌

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，并且是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的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所在国家的任何法律程序、法规、注册或使用的资讯不承担任何责任。

About Bladder Cancer

关于膀胱癌

Bladder cancer ranks as the 8

膀胱癌排名第八

most common cancer worldwide – the 5

全球最常见的癌症——第五

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

男性中最常见 – 有1949000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61.4万例，死亡超过22万例。

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

大约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身治疗费用最高的。

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..

膀胱癌是一种代价高昂、可能逐步进展的疾病，由于复发风险高，患者不得不接受多次膀胱镜检查。迫切需要改进膀胱癌的诊断和管理，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.

膀胱癌根据侵犯膀胱壁的深度分为两类：非肌层浸润性膀胱癌（NMIBC）和肌层浸润性膀胱癌（MIBC）。NMIBC停留在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，更容易扩散且较难治疗。

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。可访问：

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

巴布久克 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，在蓝色光膀胱镜检查（BLC）中使它们发出亮粉色的光。

). 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品名。Photocure 在美国正直接商业化 Cysview/Hexvix，并且

Europe

欧洲

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

并且在商业化Hexvix/Cysview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。

The following safety information is solely included to comply with U.S. regulatory requirements:

以下安全信息仅为了符合美国监管要求而包含：

Important Risk & Safety Information for Cysview® (hexaminolevulinate HCl)

Cysview®（盐酸己氨基乙酰丙酸）的重要风险和安全信息

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发出亮粉色的光，已为全球患者带来了更好的健康结果。Photocure 总部位于

Oslo, Norway

奥斯陆，挪威

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

。

CONTACT:

联系人：

For further information, please contact:

如需更多信息，请联系：

Dan Schneider