title: Photodynamic therapy of bladder cancer - a phase I study using hexaminolevulinate (HAL).
abstract: OBJECTIVE
  To assess the safety and feasibility of hexaminolevulinate (HAL) based photodynamic therapy (PDT) as adjuvant treatment after transurethral resection of the bladder (TURB) in patients with intermediate or high-risk urothelial cell carcinoma (UCC) of the bladder.
  
  
  METHODS
  Seventeen patients received 50 ml of either a 16 mM (4 patients) or 8 mM HAL (13 patients) solution instilled intravesically. Bladder wall irradiation was performed using an incoherent white light source coupled via a quartz fiber assembled into a flexible transurethral irrigation catheter. Each patient received 3 treatments with HAL-PDT 6 weeks apart. After PDT, patients were followed by regular cystoscopy for up to 21 months to assess time to recurrence. Reported adverse events (AEs) were coded according the World Health Organization Adverse Reaction Terminology (WHO-ART). Efficacy was assessed by cystoscopy, cytology, and histology, and was defined as the number of patients who were tumor-free at 6 or 21 months after initial PDT treatment. Transient bladder irritability was reported by 15 of the 17 patients and resolved completely in all patients. No evidence of a cumulative effect of treatment on the incidence of AEs could be detected. PDT treatment was performed without any technical complications. Furthermore preliminary assessment of efficacy showed that of the 17 patients included, 9 (52.9%; 95% CI: 27.8-77.0) were tumor-free at 6 months, 4 (23.5%; 95% CI: 6.8-49.9) were tumor-free at 9 months, and 2 (11.8%, 95% CI: 1.5-36.4) were tumor-free after 21 months.
  
  
  CONCLUSIONS
  PDT using hexaminolevulinate and an incoherent white light system with the special flexible irradiation catheter system is technically feasible and safe and may offer an alternative in the treatment of non-muscle-invasive intermediate and high-risk bladder cancer.
authors.affiliation: Department of Urology, Ludwig Maximilians Universität München, Campus Groβhadern, Munich, Germany; Laser Research Laboratory, LIFE Center, Ludwig Maximilians Universität München, Campus Großhadern, Munich, Germany. Electronic address: markus.bader@med.uni-muenchen.de.
authors.forename: M J
authors.initials: MJ
authors.lastname: Bader
authors.forename: Herbert
authors.initials: H
authors.lastname: Stepp
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Beyer
authors.forename: Thomas
authors.initials: T
authors.lastname: Pongratz
authors.forename: Ronald
authors.initials: R
authors.lastname: Sroka
authors.forename: Martin
authors.initials: M
authors.lastname: Kriegmair
authors.forename: Dirk
authors.initials: D
authors.lastname: Zaak
authors.forename: Mona
authors.initials: M
authors.lastname: Welschof
authors.forename: Derya
authors.initials: D
authors.lastname: Tilki
authors.forename: Christian G
authors.initials: CG
authors.lastname: Stief
authors.forename: Raphaela
authors.initials: R
authors.lastname: Waidelich
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003558:Cystoscopy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D014552:Urinary Tract Infections / Q000209:etiology; D014570:Urologic Diseases / Q000209:etiology
chemical_list: D017319:Photosensitizing Agents; D000622:Aminolevulinic Acid; C419924:5-aminolevulinic acid hexyl ester