A Randomized Trial of PHOTOdynamic Surgery in Non–Muscle-Invasive Bladder Cancer

BACKGROUND: Recurrence of non–muscle-invasive bladder cancer (NMIBC) is common after transurethral resection of bladder tumor (TURBT). Photodynamic diagnosis (PDD) provides better diagnostic accuracy and more complete tumor resection and may reduce recurrence. However, there is limited evidence on the longer-term clinical effectiveness and cost-effectiveness of PDD-guided resection.

METHODS: In this pragmatic, open-label, parallel-group randomized trial conducted in 22 U.K. National Health Service hospitals, we recruited participants with a suspected first diagnosis of NMIBC at intermediate or high risk for recurrence on the basis of routine visual assessment before being listed for TURBT. Participants were assigned (1:1) to PDD-guided TURBT or to standard white light (WL)–guided TURBT. The primary clinical outcome was time to recurrence at 3 years of follow-up, analyzed by modified intention to treat.

RESULTS: A total of 538 participants were enrolled (269 in each group), and 112 participants without histologic confirmation of NMIBC or who had had cystectomy were excluded. After 44 months’ median follow-up, 86 of 209 in the PDD group and 84 of 217 in the WL group had recurrences. The hazard ratio for recurrence was 0.94 (95% confidence interval [CI], 0.69 to 1.28; P=0.70). Three-year recurrence-free rates were 57.8% (95% CI, 50.7 to 64.2) and 61.6% (95% CI, 54.7 to 67.8) in the PDD and WL groups, respectively, with an absolute difference of −3.8 percentage points (95% CI, −13.37 to 5.59) favoring PDD. Adverse events occurred in less than 2% of participants, and rates were similar in both groups, as was health-related quality of life. PDD-guided TURBT was £876 (95% CI, −766 to 2518; P=0.591) more costly than WL-guided TURBT over a 3-year follow-up, with no evidence of a difference in quality-adjusted life years (−0.007; 95% CI, −0.133 to 0.119; P=0.444).

CONCLUSIONS: PDD-guided TURBT did not reduce recurrence rates, nor was it cost-effective compared with WL at 3 years. (Funded by the National Institute for Health and Care Research Health Technology Assessment program; ISRCTN number, ISRCTN84013636.)

Rakesh Heer, F.R.C.S.(Urol)1, Rebecca Lewis, B.Sc.2, Thenmalar Vadiveloo, Ph.D.3, Ge Yu, Ph.D.1, Paramananthan Mariappan, F.R.C.S.(Urol)4, Joanne Cresswell, F.R.C.S.(Urol)5, John McGrath, F.R.C.S.(Urol)6, Ghulam Nabi, F.R.C.S.(Urol)7, Hugh Mostafid, F.R.C.S.(Urol)8, Henry Lazarowicz, F.R.C.S.(Urol)9, John Kelly, F.R.C.S.(Urol)10, Anne Duncan, B.Sc.3, Steven Penegar, B.Sc.2, Matt Breckons, Ph.D.1, Laura Wilson, B.Sc.1, Emma Clark, Ph.D.1, Andy Feber, Ph.D.10, Giovany Orozco-Leal, M.Sc.1, Zafer Tandogdu, Ph.D.10, Ernest Taylor11, James N’Dow, F.R.C.S.(Urol)12, John Norrie, M.Sc.13, Craig Ramsay, Ph.D.14, Stephen Rice, Ph.D.1, Luke Vale, Ph.D.1, Graeme MacLennan, M.Sc.3, and Emma Hall, Ph.D.2

  1. Newcastle University, Newcastle upon Tyne, United Kingdom
  2. The Institute of Cancer Research, London
  3. Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, United Kingdom
  4. Edinburgh Bladder Cancer Surgery, Department of Urology, Western General Hospital, Edinburgh
  5. South Tees Hospitals NHS Trust, Middlesbrough, United Kingdom
  6. Royal Devon and Exeter Hospital NHS Trust, Exeter, United Kingdom
  7. University of Dundee, Dundee, United Kingdom
  8. Basingstoke and North Hampshire NHS Foundation Trust, Basingstoke, United Kingdom
  9. Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, United Kingdom
  10. University College London Hospitals NHS Foundation Trust, London
  11. PHOTO Trial patient representative, United Kingdom
  12. Academic Urology Unit, University of Aberdeen, Aberdeen, United Kingdom
  13. Edinburgh Clinical Trials Unit, Edinburgh University, Edinburgh
  14. Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom
Source: 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) DOI:https://doi.org/10.1056/EVIDoa2200092 

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