Blue light cystoscopy versus white light cystoscopy for the detection of bladder cancer in China: An analysis of unpublished clinical trial and real-world data.
Authors
Hanzhong Li
Peking Union Medical College Hospital, Beijing, China
Hanzhong Li, Hailong Hu, Lulin Ma, Jianming Guo, Xiuheng Liu, Jian Huang, Yonglian Guo, Jin Wen, Shudong Zhang, Hongxian Zhang, Shuai Jiang, Cheng Liu, Wang He, Xinli Kang, Fei Wang
Organizations
Peking Union Medical College Hospital, Beijing, China, Second Affiliated Hospital of Tianjin Medical University, Tianjin, China, Peking University Third Hospital, Beijing, China, Sun Yat-sen Hospital Fudan University, Shanghai, China, Peopleâs Hospital of Wuhan University, Wuhan, China, Sun Yat-Sen Memorial Hospital Sun Yat-Sen University, Guangzhou, China, The Central Hospital of Wuhan, Wuhan, China, Sun Yat-Sen Memorial Hospital of Zhongshan University, Guangzhou, China, Hainan General Hospital, Haikou, Hainan, China
Abstract Disclosures
Research Funding
No funding sources reported
Background: Blue light cystoscopy (BLC) is superior to white light cystoscopy (WLC) in detection of bladder cancer, but no multi-center studies have been conducted in China with modern 4K LED equipment. The objective of this post hoc analysis of a randomized controlled trial (RCT) and a real-world study (RWS) was to compare BLC with WLC in the detection of bladder cancer and to determine the similarity between the RCT and RWS.
Methods: In RCT (NCT05600322), patients with known or suspected bladder cancer were enrolled at seven hospitals in China from November 2022 to June 2023. In the prospective RWS, patients with known or suspected bladder cancer were enrolled at Hainan General Hospital from December 2022 to July 2023. Patients received intravesical HAL (Hexvix, Photocure ASA) and underwent WLC before BLC (System blue, Richard Wolf GmbH). Some patients were randomized to WLC to avoid observational bias. The primary endpoint was the proportion of patients with histologically confirmed tumors (Ta, T1, or CIS) who have at least one such lesion found by BLC but not by WLC. Secondary endpoints included, detection of CIS, lesion specific detection rate, false positive rates, and adverse events (AE).
Results: 158 patients were enrolled in RCT, in which 37 patients were training patients, six patients were randomized to not undergo BLC, one patient withdrew. 114 patients remained in the full analysis set. 19 patients were enrolled in RWS. In patients confirmed with Ta, T1, or CIS, 42/97 patients (43.3%) in RCT and 4/12 patients (33.3%) in RWS had at least one confirmed lesion found by BLC but not by WLC (all p<0.0001). 11/114 patients (9.6%) with CIS in RCT and 1/14 patients (7.1%) with CIS in RWS showed at least 1 additional confirmed CIS lesion found by BLC but not by WLC. In RCT, detection rates for PUNLMP, CIS, Ta, T1 and T2-T4 tumors were NA, 94.7%, 100%, 98.2% and 100% for BLC and NA, 42.1%, 76.1%, 91.2% and 100% for WLC, respectively. In RWS, detection rates for PUNLMP, CIS, Ta, T1 and T2-T4 tumors were NA, 100%, 100%, 100% and 100% for BLC and NA, 50%, 81%, 100% and 100% for WLC, respectively. The false-positive rate was 23.2% and 16.0% for BLC and WLC in RCT and was 25.0% and 15.4% in RWS, respectively. In RCT, 200 AEs were observed in 95 patients, all mild to moderate, of which 191 were classified as unrelated to HAL. In RWS, 16 AEs were observed in 15 patients, all mild and were all unrelated to HAL.
Conclusions: Both RCT and RWS confirm the superiority of BLC based on innovative LED technology with HAL over WLC in detection of bladder cancer in Chinese populations, especially CIS, and HAL is well tolerated. Clinical trial information: NCT05600322.
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