Photodynamic versus white-light-guided resection of first-diagnosis non-muscle-invasive bladder cancer: PHOTO RCT

• Published in: Health technology assessment (Winchester, England) England), 2022-10, Vol.26 (40), p.1-144
• Main Authors: Heer, Rakesh, Lewis, Rebecca, Duncan, Anne, Penegar, Steven, Vadiveloo, Thenmalar, Clark, Emma, Yu, Ge, Mariappan, Paramananthan, Cresswell, Joanne, McGrath, John, N'Dow, James, Nabi, Ghulam, Mostafid, Hugh, Kelly, John, Ramsay, Craig, Lazarowicz, Henry, Allan, Angela, Breckons, Matthew, Campbell, Karen, Campbell, Louise, Feber, Andy, McDonald, Alison, Norrie, John, Orozco-Leal, Giovany, Rice, Stephen, Tandogdu, Zafer, Taylor, Ernest, Wilson, Laura, Vale, Luke, MacLennan, Graeme, Hall, Emma
• Format: Article
• Language: English
• Subjects: Biomarkers; bladder cancer; Cost-Benefit Analysis; Humans; Light; non-muscle-invasive bladder cancer; phase iii: transurethral resection; Photochemotherapy; photodynamic detection; Quality of Life; Quality-Adjusted Life Years; randomised trial; surgery; Technology Assessment, Biomedical; transurethral resection of bladder tumour; urinary bladder neoplasms; Urinary Bladder Neoplasms - diagnosis; Urinary Bladder Neoplasms - surgery
• ISSN: 1366-5278; 2046-4924; 2046-4924
• DOI: 10.3310/PLPU1526

Around 7500 people are diagnosed with non-muscle-invasive bladder cancer in the UK annually. Recurrence following transurethral resection of bladder tumour is common, and the intensive monitoring schedule required after initial treatment has associated costs for patients and the NHS. In photodynamic diagnosis, before transurethral resection of bladder tumour, a photosensitiser that is preferentially absorbed by tumour cells is instilled intravesically. Transurethral resection of bladder tumour is then conducted under blue light, causing the photosensitiser to fluoresce. Photodynamic diagnosis-guided transurethral resection of bladder tumour offers better diagnostic accuracy than standard white-light-guided transurethral resection of bladder tumour, potentially reducing the chance of subsequent recurrence. The objective was to assess the clinical effectiveness and cost-effectiveness of photodynamic diagnosis-guided transurethral resection of bladder tumour. This was a multicentre, pragmatic, open-label, parallel-group, non-masked, superiority randomised controlled trial. Allocation was by remote web-based service, using a 1 : 1 ratio and a minimisation algorithm balanced by centre and sex. The setting was 22 NHS hospitals. Patients aged ≥ 16 years with a suspected first diagnosis of high-risk non-muscle-invasive bladder cancer, no contraindications to photodynamic diagnosis and written informed consent were eligible. Photodynamic diagnosis-guided transurethral resection of bladder tumour and standard white-light cystoscopy transurethral resection of bladder tumour. The primary clinical outcome measure was the time to recurrence from the date of randomisation to the date of pathologically proven first recurrence (or intercurrent bladder cancer death). The primary health economic outcome was the incremental cost per quality-adjusted life-year gained at 3 years. We enrolled 538 participants from 22 UK hospitals between 11 November 2014 and 6 February 2018. Of these, 269 were allocated to photodynamic diagnosis and 269 were allocated to white light. A total of 112 participants were excluded from the analysis because of ineligibility (  = 5), lack of non-muscle-invasive bladder cancer diagnosis following transurethral resection of bladder tumour (  = 89) or early cystectomy (  = 18). In total, 209 photodynamic diagnosis and 217 white-light participants were included in the clinical end-point analysis population. All randomised participants were included in the c