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EAU (European Association of Urology) of Urology annual meeting was held on May 10-13,2023. Dr. Rakesh Heer- Chief investigator said the clinical trial was conducted in 22 UK hospitals, with 538 patients split to WLC and BLC (1:1) with follow up of 44 months. Dr. Heer said the study found no difference in long term in recurrence, progression and disease specific survival rate, and BLC was not cost effective. Below is the short presentation by Dr. Heer at EAU 23. It is noted that the clinical trial was not sponsored by Photocure, Karl Storz or Olympus. It was funded by The Newcastle upon Tyne Hospitals NHS (National Health Service) Foundation and coordinated by the Clinical Trials and Statistics Unit at The Institute of Cancer Research. The project was funded by the National Institute for Health and Care Research Health Technology Assessment program. As UK is also public funded universal health care system, I think it is relevant to Canada. I was not aware of this trial but I was pleased to see the result as it indicates that we Canadian patients should not worry much not being able to access BLC.
Below is the link to the presentation by Dr. Heer.
“urosource.uroweb.org/resource-centres/EAU23/252602/webcast”
Below is the link to
The publication by New England Medical Journal
“evidence.nejm.org/doi/full/10.1056/EVIDoa2200092”
Below is the link to youtube video of Dr. Rakesh Herr explaining what he think the reason why recurrence, progression and disease specific survival are not different between BLC and WLC. Also, the second part of short overview of sessions is discussed by Dr. M. Tutolo of Italy who talks about importance of discussion about expectation before cystectomy is done. It sounds like in her practice, discussion is held by multi-disciplined team including physio, surgeon, psychologist, patient and patient partner so the patient and his or her partner will not be disappointed with the result of cystectomy. Unfortunately, I cannot access to each webinar unless I pay 450 euro which I cannot afford. But the topic Dr. Tutolo may be interest yo female patients who need to have cystectomy.
“www.youtube.com/watch?v=luhuNwiKA3E”
Also, the link below is the debate held during AUA (American Urological Association) 23 conference.
The title of debate was “Optimal TURBT: Do Skilled Urologists Really Need PDD? ”
Dr. Michael Cookson, MD Professor and Chairman of the Department of Urology at University of Ohio took the stand of “No, skilled urologists do not need Photo Dynamic Diagnosis, i.e. BLC in this case.”
Dr. Trinity Bivalacqua, MD is Director of Urologic Oncology at the hospital of the University of Pennsylvania too the stand of the other side.
The detail of the debate is fully explained in the link
“www.urotoday.com/conference-highlights/aua-2023/aua-2023-bladder-cancer/144086-aua-2023-optimal-turbt-do-skilled-urologists-really-need-pdd.html”
Below is the key points of the debate
Dr, Cookson does not refute with regards to NMIBC:
- In most large RCTs (Randomized Clinical Trials), BLC enhances detection of papillary and flat (CIS) lesions.
- In most large RCTs, BLC reduces recurrence rate
- BLC is endorsed by major guidelines
- In large RCTs and in real world experience, BLC does not reduce progression to muscle invasion
Dr. Cookson is here to inform us with regards to
- In a recent large, practical multicenter RCT (UK trial), BLC did not reduce the rate of recurrence and was not cost effective
- In the US, despite more than a decade of approval and opportunity, BLC has not been adopted by most experienced urologists and has been abandoned by some early adopters.
- Barriers to adoption, unfavorable economics, and potential loss of access to flexible equipment will continue to relegate use to academic and select large volume centers.
Dr. Coolson showed a graph that percentage of providers (urologists) using BLC at hospitals with BLC availability peeked at July 2018, then it kept declining till January 2020. The graph did not show the tread in 2021-2023.
Dr. Cookson concluded with the following statemants
- Reduction in recurrence is not as significant in expert hands
- Investment in flexible blue light cystoscopy is now a sunk cost (lost)
- There is no impact on progression or overall survival
- Cost of equipment is substantial and potentially unrecoverable
- There may be a role for judicious and selective use of BLC
Dr. Triniy Bivalacqua presented taking the position that yes, skilled urologists need BLC.
Dr. does not refute the cost effectiveness of flexible BLC or the impact to MIBC or over all survival.
Dr. Bivalacqua is here to inform :
- Defining optimal TURBT and skilled surgeons
- Critical review on the UK trial
- Cost effectiveness of BLC over time
- The effect on heal related quality of life in bladder cancer patients undergoing BLC
Dr. Bivalacqua mentions
- The definition of an optimal TURBT is an 8 mm margin of tumor free urothelium around the lesion, which decreases local recurrence rate from 58% to 19%. Multiple studies have shown that experienced surgeons perform a more complete resection and have lower recurrence rates, compared to those with less experience.
- Dr. Bivalacqua pointed out several issues with UK trial.
- A phase 3 multi-center study has shown that there were decreased aanxiety levels after BLC.
Dr. Bivalacua concluded with the following statements
- BLC improves health related quality of life in NMIBC patients
- There is a large body of evidence to support BLC with major concerns about UK trial design and patient population
- We must acknowledge the potential underutilization in the US
- The cost of equipment is substantial, but recovered over time; there may be potential unrecoverable costs in low volume center
- We must employ judicious and selective use of BLC technology with target populations like those with high risk NMIBC
Hi Joe:
I haven’t taken the time yet to view any videos but would like to say that to me using the blue light at least during a TURBT makes the most sense if it highlights tumour sites better and could even hightlight lesions that are in the development stage and could be removed during a TURBT and potentially eliminating at least one future surgery. I know that it probably won’t aid in reducing recurrence rates much but if it can get more tumours at one time that would be better for a patient I would think.
Hi Marysye,
I think your observation is correct. In the UK trial, recurrences identified 0-12 months seem to be caused by missed tumors by WLC TURBT, 56 recurrence by WLC vs 45 recurrences by BLC ( 11 more in WLC group). Note WLC group had 217 patients and BLC group had 209 patients. But between 12-36 months, more recurrences (41) were identified in BLC group than in WLC group (22). The total # of recurrences between 0-66 months are almost the same between WLC group (84) and BLC group (86). Dr. Heer, the chief investigator of the UK trial pointed out this divergence of the trend and explained this divergence is that over time, biological transformation of vulnerable urothelial tissue become more dominant reason for cancer to raise. He did not explain about biological transformation in the short video interview. Anyway, the average number of TURBTs for intermediate and high risk non muscle invasive bladder patients seem to be the same in long run weather patient is treated with WLC or BLC according to the UK trial though early on patients treated with BLC will have less number of TURBT.
Hi Joe and MarySue,
Interesting findings! I know in my case, my Urologist actually uttered the words “We could have missed it” when it showed up for the second time. In fact all of my recurrences occurred in the first 8 months (if I recall correctly). So the statement that in the first year, it is likely that the tumour was missed under WLC. I’ll have to make time to view the videos. Thank you for sharing!
My best,
Hi Joe and Nightingale:
As I mentioned it just makes sense to use the BLC for TURBT surgeries to get the best view to eradicate everything possible at that given time. Even though I had a bad time with post op Epirubicin this past fall with my last TURBT, I wish that they could come up with some kind of combination of post op TURBT treatment like using the BLC during the actual surgery and then when the surgery is finished give the bladder a flush with something (maybe less inflammatory than Epirubicin) to help eradicate implantation of any cancer cells that escaped when the tumour(s) were removed.
I’m thinking if some kind of combo like this was used it would really reduce the recurrence rates. And as an after thought, for those that might need it if they have stage one disease, combine all that with a second TURBT procedure maybe within 3 months like the first to ensure all is gone. It would be a lot for a patient to undergo upfront but again I’m willing to bet it would reduce the need for so many follow up treatments like BCG or chemo instillations post op and/or eventual need for a radical cystectomy.
Also, if something like this became possible and there was less need for use of follow up BCG or chemo instills, we wouldn’t have to be as concerned about potential drug shortages. Anyhow, just my thoughts. ((((HUGS))))
Hi Marysue and Nightingale:
I had also thought BLC would benefit the welfare of bladder cancer patients. I thought the current BLC solution which Health Canada had approved was intuitively no right solution for Canada as the price of the solution was too high which would create disparities who could access it just like in the US , I was focusing finding alternative less expensive BLC solutions. Then, the result of the UK clinical study – PHOTO trial as a part of Health Technology Assessment, which had shown no benefits of using the current BLC solution (Karl Storz BLC equipment + Photocure Cysview compound) vs WLC, and concluded in the recommendation that “BLC is no longer used in the treatment of this group of patients ” (intermediate and high risk non muscle invasive). The UK Health Technology Assessment’s implication s for health care in UK includes “Recommendation for the disinvestment in photodynamic diagnosis-guided TURBT”. The implication to Canadian patients is that I would expect Health Canada will follow the result of the UK health Technology Assessment and will not invest in deploying BLC in Canada. The UK Health Technology Assessment describes future research implications as follows.
- Other clinical utility for photodynamic diagnosis in non-muscle-invasive bladder cancer
- The next generation of cystoscopic bladder imaging with or without novel photosensitizers
- narrow band imaging
- multispectral imaging
- optical coherence tomography
- artificial intelligence-enhanced visualization.
- Olympus who is a major supplier of cystoscopes in Canada has announced the launch of ENDO-AID, a AI assisted endoscopy for colon cancer. Why not for bladder cancer?
- Rapid biomarker assessment
- Modelling alternative surveillance strategies
- There are now emerging
data looking at conditional probabilities for recurrence, where the longer an individual goes without
recurrence, the more likely they are to avoid recurrence.97 These data, along with our contemporary
recurrence-free survival and those of other up-to-date studies, such as BOXIT, could lay the foundation
of a ‘lighter’, dynamic, risk-adaptive follow-up protocol that could produce savings in the massive
finance burden currently incurred with cystoscopy surveillance
- There are now emerging
Given the fact the UK clinical study concluding treating the first TURBT with BLC for intermediate and high risk patients do not give any advantage over WLC, all parties with vested interest in improvement of welfare of bladder cancer patients should sit back and review if pursuing the availability of BLC in Canada is a good investment of resources, and if it is determined it is not, we should pursue other methods such as listed above.
For reference, below is Plain English summary
Around 7500 people are diagnosed with early-stage bladder cancer in the UK each year. Early
bladder cancer is contained within the bladder and has not yet invaded the bladder’s muscle wall
or spread elsewhere in the body. The cancer will return (recur) in around half of people after initial
treatment and they have to attend hospital for regular check-ups, with costs to both them and the NHS.The first step in treating early bladder cancer is surgery to remove the tumour. This surgery is normally
performed under white light.Photodynamic diagnosis is a new technique in which a liquid is put into the patient’s bladder before
surgery and a blue light is used during the operation. This causes the bladder cancer to fluoresce so
that it can be seen more easily by the surgeon.The Photodynamic versus white-light-guided resection of first diagnosis non-muscle-invasive bladder
cancer (PHOTO) trial aimed to find out whether or not using photodynamic diagnosis at initial surgery
would reduce how often the cancer recurred and whether or not this could reduce the cost of treating
early bladder cancer.A total of 538 people with early bladder cancer who had a medium to high chance of their cancer
returning after treatment were enrolled in the PHOTO trial. They were included in one of two
treatment groups, at random: 269 had photodynamic surgery and 269 had standard white-light
surgery. People in both groups were monitored regularly for any recurrences, with further treatment
as appropriate.After 3 years, 4 out of 10 people in each group had a recurrence of their bladder cancer. We found
no difference between the treatment groups in the number of people with recurrences. We found
no evidence of a benefit to patients, and the total costs of photodynamic surgery were higher than
those of standard white light. We therefore recommend that it is no longer used in the treatment of
this group of patientsAs stated previously, the clinical trial (PHOTO) in UK reached the conclustion that the use of Bluelight cystoscopy during the initial TURBT did not reduce recurrences or progression compared to when only whitelight was used.
As Canada has her own universal healthcare as UK does, the decision of NHS on the use of PDD will likely affect Health Canada’s position PDD. So I reached out to Dr. Herr, Chair in Urology in Imperial College, Londong and the chief investigator of the clinical trial and asked a few questions. I have received his replies so I share it here.
Q: How will the result of the clinical trial affect the policy of NHS in the use of PDD?
NICE are looking at a new bladder cancer guidance, and I expect PHOTO’s findings to be actioned. Already, in the UK, we have GIRFT referencing the study.
NICE stands for The National Insitute for Health and Care Excellence. NICE helps practioners and commisioners get the best care to patientsm fast, whicle ensuring value to taxpayer.
GIRFT stands for Getting It Right First Time. GIRFT is a national programme designed to improve the treatment and care of patients through in-depth review of services,bentchmarking, and presenting a data-driving evidencer base to support change.
Q: Are EAU guidelines going to incorporate the fininding of the clinical trial?
EAUG will include PHOTO findings in their update.
Q: You have mentioned that some biological changes in the lining of the bladder overtake as the cause of recurrence and progression. I appreciate if you can explain what does it mean by biological changes,
The biology of the bladder is such, that there is field change which gives rise to new tumours accounting for recurrence as opposed to residual disease from the primary TURBT.
Dr. B Shayegan talked about field effect at Hamilton Patient Meeting, which was held on May 10, 2012. I will post on field affect seperately as I have locaed a new article.
“https://www.youtube.com/watch?v=gJSOMv1eLO0”
5:20-5:55
In terms of CUA guidlines, we have to wait and see what/how EAU guidelines include the result of clinical trial in its updates. Usually CUA refers to EAU guidlines and AUG guidelines, so lets see.
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