Chinese Trial Shows Blue Light Cystoscopy Superior for Bladder Cancer Detection - Hongxian Zhang
January 10, 2024
Ashish Kamat welcomes Hongxian Zhang to present a phase III study comparing blue light cystoscopy (BLC) with white light cystoscopy (WLC) for bladder cancer detection in China. Conducted across seven hospitals from November 2022 to June 2023, the study involved 158 patients, with 114 remaining in the final analysis. It demonstrates that BLC, especially with Hexaminolevulinate (HAL) and modern 4K LED equipment, is superior to WLC in detecting bladder cancer, particularly carcinoma in situ (CIS). About 43.3% of patients with confirmed bladder cancer and 84.6% with CIS had lesions detected exclusively by BLC. The study, a first of its kind in China using advanced technology, highlights the importance of BLC in early diagnosis and comprehensive treatment planning, potentially revolutionizing bladder cancer detection and management in the Chinese population.
Biographies:
Hongxian Zhang, Peking University Third Hospital, Beijing, China
Ashish Kamat, MD, MBBS, Professor of Urology, and Wayne B. Duddleston Professor of Cancer Research, University of Texas, MD Anderson Cancer Center, Houston, TX
Biographies:
Hongxian Zhang, Peking University Third Hospital, Beijing, China
Ashish Kamat, MD, MBBS, Professor of Urology, and Wayne B. Duddleston Professor of Cancer Research, University of Texas, MD Anderson Cancer Center, Houston, TX
Related Content:
Advancing Bladder Cancer Surveillance: The Impact of Flexible Blue Light Cystoscopy from the Nordic Registry - Karsten Zieger
Blue Light Cystoscopy Delays Time To Recurrence in NMIBC Patients Treated in a Real-World Setting - Sia Daneshmand
The Clinical Benefits of Blue Light Cystoscopy in the Ambulatory Surgical Centers - Neal Shore
Advancing Bladder Cancer Surveillance: The Impact of Flexible Blue Light Cystoscopy from the Nordic Registry - Karsten Zieger
Blue Light Cystoscopy Delays Time To Recurrence in NMIBC Patients Treated in a Real-World Setting - Sia Daneshmand
The Clinical Benefits of Blue Light Cystoscopy in the Ambulatory Surgical Centers - Neal Shore
Read the Full Video Transcript
Ashish Kamat: Hello, and welcome to UroToday's Bladder Cancer Center of Excellence. I'm Ashish Kamat, professor of Urologic Oncology at MD Anderson Cancer Center. And it's a pleasure to welcome today with us Professor Zhang, who's joining us all the way from the Peking University Third Hospital in China. Dr. Zhang has performed and has led a prospective comparative within-patient controlled multi-center phase three study comparing blue light cystoscopy with white light cystoscopy for the detection of patients with bladder cancer in China. And he's here today to share with us his experience. Dr. Zhang, please take it away.
Hongxian Zhang: Thank you for your kind introduction, and dear, all the colleagues on the internet, I'm Dr. Zhang from Peking University's Third Hospital, and it is my distinct pleasure to present the findings of our study, titled "Prospective, Comparative, Within-Patient Controlled Multicenter Phase Three Study Comparing Blue Light Cystoscopy versus White Light Cystoscopy for the Detection of Bladder Cancer in China." This study is conducted in collaboration with several leading hospitals in our country.
We have long known that BLC is superior to conventional WLC in the detection of bladder cancer, but there are no multicenter studies conducted in China with modern 4K LED equipment so far. From November, 2022 to June, 2023, we enrolled patients with known or suspected bladder cancer in seven renowned hospitals across China. Patients underwent intravesical HAL administration followed by WLC and BLC to prevent, or at least no regrowth. Some patients were randomized to undergo WLC only.
Each lesion was subjected to rigorous blended panel consensus and pathological evaluation. Our primary endpoint was to determine the percentage of patients with histologically confirmed tumors, Ta, T1 or CIS, who had at least one such lesion detected by BLC but not by WLC.
Our study involved 158 patients with 114 patients remaining in the final analysis set. Of the 97 patients with confirmed Ta, T1 or CIS, about 43.3% had at least one confirmed lesion, found by BLC, but not by WLC, highlighting the clear superiority of BLC in the Chinese population. Remarkably, among patients with CIS, about 84.6% had additional confirmed CIS lesions detected exclusively by BLC. We can see the efficiency of BLC with HAL for various tumor stages. Importantly, the incidence of adverse events related to HAL administration was reassuringly low. Therefore, we can see the first evidence based on 4K LED equipment.
Our research unequivocally confirms the superiority of BLC with HAL over conventional WLC in detecting bladder cancer in the Chinese population. This finding holds great promise for improving early diagnosis and subsequently, patients' outcomes in China.
I think this is the first RCT study with BLC, with HAL conducted with more than 4K LED equipment. And this study population is slightly different than the average in prior sponsor trials. The improved detection results are robust, and the papillary detection with BLC is similar to prior trials. Despite the improved HD WLC white light image quality, it does not appear that the blue light benefit is diminished due to HD. The CIS detection results appear to be substantially better with the newer BLC HD LED equipment than with standard SD equipment in this trial.
In the Chinese population, this study confirms the superiority of BLC based on innovative LED technology with HAL over WLC for the detection of bladder cancer, especially CIS, and HAL is well tolerated. Thank you.
Ashish Kamat: Thank you very much, Dr. Zhang, for presenting your study and the results. For our international audience, could you please describe the significance of the patient selection for this trial, and how it was different from other trials done in this space?
Hongxian Zhang: I think this trial enrolled Chinese patients with suspected or confirmed bladder cancer. And in the previous studies, the recruited patients may have been more specific, such as only with CIS lesions or only having papillary lesions, or those only in follow-up patients. But our study enrolled all these patients, and the provision set up in our study, we used the new 4K LED blue light equipment. This is the first time in China.
Ashish Kamat: And what would you say are the key learnings for the audience from this trial? Anything specific to the use of the intravesical agent? Any specific comments about the modern equipment that you used?
Hongxian Zhang: The specifics from our study are that Chinese urologists are very busy and their office schedules are very full. So it is very important to make the time arrangement because the HAL needs to be kept in the bladder for one hour. So we need a very good time arrangement and a very good connection.
Ashish Kamat: Did you have any experience with the modern equipment? Any thoughts on the modern scope, the 4K LED?
Hongxian Zhang: Yeah. So far as I know, there are no controlled studies that have been conducted with the modern 4K LED equipment. This system is from Richard Wolf, and this sophisticated image detection, together with the refined image processing, results in a unique differentiation between the pathological and the healthy tissue. It may be more conducive to the visualization of tumors under blue light. Thank you.
Ashish Kamat: And lastly, how do you think the results from this trial will affect or change what you and your colleagues are doing for the detection of bladder cancer in China?
Hongxian Zhang: I think the detection of bladder cancer lesions is very important for the diagnosis and treatment. Maybe the blue light cystoscopy will help us to detect more small lesions or CIS, and earlier in our country. And it can also help us to remove more completely during TURBT. I think, equally, it will help us to identify CIS easily. I think it is very clinically meaningful. If there's no CIS or there's CIS, I think the subsequent treatment may be completely different, so that patients can get a more accurate treatment plan. We also look forward to the approval of this advanced product in China as soon as possible, to benefit more Chinese bladder cancer patients. Thank you.
Ashish Kamat: Thank you. Thank you for taking the time. I think it's important, because blue light has been available and used in North America and Europe for many years, and of course, it's recommended by the guidelines. And it's important to see trials such as these being done in other countries, in China, for example, and seeing the results in a specific population. So really appreciate you taking the time and sharing the results with us. Thank you very much.
Hongxian Zhang: Thank you, Dr. Ashish.
Ashish Kamat: Hello, and welcome to UroToday's Bladder Cancer Center of Excellence. I'm Ashish Kamat, professor of Urologic Oncology at MD Anderson Cancer Center. And it's a pleasure to welcome today with us Professor Zhang, who's joining us all the way from the Peking University Third Hospital in China. Dr. Zhang has performed and has led a prospective comparative within-patient controlled multi-center phase three study comparing blue light cystoscopy with white light cystoscopy for the detection of patients with bladder cancer in China. And he's here today to share with us his experience. Dr. Zhang, please take it away.
Hongxian Zhang: Thank you for your kind introduction, and dear, all the colleagues on the internet, I'm Dr. Zhang from Peking University's Third Hospital, and it is my distinct pleasure to present the findings of our study, titled "Prospective, Comparative, Within-Patient Controlled Multicenter Phase Three Study Comparing Blue Light Cystoscopy versus White Light Cystoscopy for the Detection of Bladder Cancer in China." This study is conducted in collaboration with several leading hospitals in our country.
We have long known that BLC is superior to conventional WLC in the detection of bladder cancer, but there are no multicenter studies conducted in China with modern 4K LED equipment so far. From November, 2022 to June, 2023, we enrolled patients with known or suspected bladder cancer in seven renowned hospitals across China. Patients underwent intravesical HAL administration followed by WLC and BLC to prevent, or at least no regrowth. Some patients were randomized to undergo WLC only.
Each lesion was subjected to rigorous blended panel consensus and pathological evaluation. Our primary endpoint was to determine the percentage of patients with histologically confirmed tumors, Ta, T1 or CIS, who had at least one such lesion detected by BLC but not by WLC.
Our study involved 158 patients with 114 patients remaining in the final analysis set. Of the 97 patients with confirmed Ta, T1 or CIS, about 43.3% had at least one confirmed lesion, found by BLC, but not by WLC, highlighting the clear superiority of BLC in the Chinese population. Remarkably, among patients with CIS, about 84.6% had additional confirmed CIS lesions detected exclusively by BLC. We can see the efficiency of BLC with HAL for various tumor stages. Importantly, the incidence of adverse events related to HAL administration was reassuringly low. Therefore, we can see the first evidence based on 4K LED equipment.
Our research unequivocally confirms the superiority of BLC with HAL over conventional WLC in detecting bladder cancer in the Chinese population. This finding holds great promise for improving early diagnosis and subsequently, patients' outcomes in China.
I think this is the first RCT study with BLC, with HAL conducted with more than 4K LED equipment. And this study population is slightly different than the average in prior sponsor trials. The improved detection results are robust, and the papillary detection with BLC is similar to prior trials. Despite the improved HD WLC white light image quality, it does not appear that the blue light benefit is diminished due to HD. The CIS detection results appear to be substantially better with the newer BLC HD LED equipment than with standard SD equipment in this trial.
In the Chinese population, this study confirms the superiority of BLC based on innovative LED technology with HAL over WLC for the detection of bladder cancer, especially CIS, and HAL is well tolerated. Thank you.
Ashish Kamat: Thank you very much, Dr. Zhang, for presenting your study and the results. For our international audience, could you please describe the significance of the patient selection for this trial, and how it was different from other trials done in this space?
Hongxian Zhang: I think this trial enrolled Chinese patients with suspected or confirmed bladder cancer. And in the previous studies, the recruited patients may have been more specific, such as only with CIS lesions or only having papillary lesions, or those only in follow-up patients. But our study enrolled all these patients, and the provision set up in our study, we used the new 4K LED blue light equipment. This is the first time in China.
Ashish Kamat: And what would you say are the key learnings for the audience from this trial? Anything specific to the use of the intravesical agent? Any specific comments about the modern equipment that you used?
Hongxian Zhang: The specifics from our study are that Chinese urologists are very busy and their office schedules are very full. So it is very important to make the time arrangement because the HAL needs to be kept in the bladder for one hour. So we need a very good time arrangement and a very good connection.
Ashish Kamat: Did you have any experience with the modern equipment? Any thoughts on the modern scope, the 4K LED?
Hongxian Zhang: Yeah. So far as I know, there are no controlled studies that have been conducted with the modern 4K LED equipment. This system is from Richard Wolf, and this sophisticated image detection, together with the refined image processing, results in a unique differentiation between the pathological and the healthy tissue. It may be more conducive to the visualization of tumors under blue light. Thank you.
Ashish Kamat: And lastly, how do you think the results from this trial will affect or change what you and your colleagues are doing for the detection of bladder cancer in China?
Hongxian Zhang: I think the detection of bladder cancer lesions is very important for the diagnosis and treatment. Maybe the blue light cystoscopy will help us to detect more small lesions or CIS, and earlier in our country. And it can also help us to remove more completely during TURBT. I think, equally, it will help us to identify CIS easily. I think it is very clinically meaningful. If there's no CIS or there's CIS, I think the subsequent treatment may be completely different, so that patients can get a more accurate treatment plan. We also look forward to the approval of this advanced product in China as soon as possible, to benefit more Chinese bladder cancer patients. Thank you.
Ashish Kamat: Thank you. Thank you for taking the time. I think it's important, because blue light has been available and used in North America and Europe for many years, and of course, it's recommended by the guidelines. And it's important to see trials such as these being done in other countries, in China, for example, and seeing the results in a specific population. So really appreciate you taking the time and sharing the results with us. Thank you very much.
Hongxian Zhang: Thank you, Dr. Ashish.