(UroToday.com) The 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA between January 25th and 27th was host to a urothelial carcinoma poster session. Dr. Hanzhong Li presented the results of an analysis of unpublished clinical trials and real-world data comparing blue light to white light cystoscopy for the detection of bladder cancer in China.
While there is ample evidence demonstrating that blue light outperforms white light cystoscopy for the detection of bladder cancer, to date, there are no multicenter studies that have been conducted in China evaluating this with modern 4K LED equipment. The objective of this ad hoc analysis of a randomized controlled trial (RCT) and a real-world study was to compare white light and blue light cystoscopy for the detection of bladder cancer and to compare data from the RCT and real-world study.
In the included RCT (NCT05600322), patients with known or suspected bladder cancer were enrolled at seven hospitals in China between November 2022 and June 2023.
Conversely, in the prospective real-world analysis, patients with known or suspected bladder cancer were enrolled at Hainan General Hospital between December 2022 and July 2023. All patients received intravesical HAL ([hexaminolevulinate]; Hexvix, Photocure ASA) and underwent white light prior to blue light cystoscopy (System blue, Richard Wolf GmbH).
The primary endpoint was the proportion of patients with histologically confirmed tumors (Ta, T1, or CIS) who had at least one such lesion detected by blue light, but not white light cystoscopy. Secondary endpoints included:
- Detection of CIS
- Lesion-specific detection rate
- False positive rates
- Adverse events
The study cohort included 114 patients from the RCT component and 14 patients from the real-world component. Among all 97 patients with confirmed Ta, T1, or CIS disease, 43% of the RCT patients and 33% of the real-world study patients had ≥1 confirmed lesion found by blue light, but not white light cystoscopy.
With regards to secondary endpoints, 9.6% of CIS patients in the RCT component and 7% of patients in the real-world study showed ≥1 additional confirmed CIS lesion by blue light cystoscopy.
In the RCT patients, the false positive rate was higher for blue light cystoscopy (23% versus 16%), and similarly in the real-world study patients (25% versus 15%). 48% of patients in the RCT component developed mild-moderate adverse events, of which the vast majority were unrelated to HAL.
Dr. Li concluded that both RCT and real-world data confirm the superiority of blue light cystoscopy based on innovative LED technology with HAL, compared to white light cystoscopy, for the detection of bladder cancer in Chinese populations.
Presented by: Hanzhong Li, MD, Department of Urology, Peking Union Medical College Hospital, Beijing, People’s Republic of China
Written by: Rashid Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, San Francisco, CA, January 25th – January 27th, 2024