(UroToday.com) The 2023 EAU annual meeting included a session on the misconception of informed consent in locally advanced bladder cancer, featuring a discussant presentation by Dr. Morgan Roupret assessing data from the PHOTOdynamic trial in non-muscle invasive bladder cancer. Dr. Roupret started by highlighting that this trial has already been published in NEJM Evidence in September of 2022.1 With regard to the methodology and quality of the data, Dr. Roupret emphasized that we need to read between the lines. This was an open-label, pragmatic randomized clinical trial of 538 patients, however, data is only available on 426 patients. Importantly, this was a negative trial with a HR of 0.94 (95% CI, 0.69 to 1.28; p=0.70) for time to recurrence. Additionally, there were no differences in the arms with regard to progression to muscle-invasive disease, overall survival, and bladder cancer-specific death. Dr. Roupret also points out that this study was underpowered, with the original design for a relative risk reduction of 30% in 3-year recurrence rate (214 events), whereas by the end of the trial (median follow-up of 44 months), there were only 170 events. Furthermore, adjuvant instillations were not balanced between chemotherapy and BCG, with 63.6% of the PDD group and 79.7% of the white-light cystoscopy group receiving therapy:
Dr. Roupret then listed several of the drawbacks of this trial, suggesting that perhaps this was not the most relevant population to receive PDD:
- Over 22 UK centers, the median number of patients accrued per center was only 19 over 3 years
- As for many surgical procedures, operator experience, and equipment are fundamental to achieving good results from PDD-guided TURBT
- This trial was based on the old EORTC stratification of NMIBC
- 88% of the patients were intermediate risk
- High risk patients included only 9%, with only 13% of patients having CIS
With regards to the current evidence and the EAU guidelines for blue light TURBT, Dr. Roupret notes that the guidelines suggest that the addition of PDD to white-light cystoscopy improves detection of bladder tumors and reduces recurrence rates. This has been suggested by over 20 well-designed randomized clinical trials and 10 systematic reviews. In a Cochrane review, PDD reduced the risk of recurrence by 34% in a pooled population comprising 16 randomized clinical trials and >4,300 patients.
Dr. Roupret concluded his presentation by discussing the PHOTOdynamic trial in non-muscle invasive bladder cancer by emphasizing that he does not think this data will impact the EAU guidelines.
Presented by: Morgan Roupret, MD, PhD, Pitie-Salpetriere Hospital, Sorbonne University, Paris, France
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2023 European Association of Urology (EAU) 38th annual congress held in Milan, Italy between March 10-13, 2023
References:
- Heer R, Lewis R, Vadiveloo T, et al. A randomized trial of PHOTOdynamic Surgery in Non-Muscle-Invasive Bladder Cancer. NEJM Evid 2022;1(10).