PMID- 22440147
OWN - NLM
STAT- MEDLINE
DCOM- 20140425
LR  - 20130930
IS  - 1873-2496 (Electronic)
IS  - 1078-1439 (Linking)
VI  - 31
IP  - 7
DP  - 2013 Oct
TI  - Photodynamic therapy of bladder cancer - a phase I study using hexaminolevulinate 
      (HAL).
PG  - 1178-83
LID - S1078-1439(12)00060-9 [pii]
LID - 10.1016/j.urolonc.2012.02.007 [doi]
AB  - OBJECTIVES: 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. MATERIALS AND 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.
CI  - Copyright (c) 2013 Elsevier Inc. All rights reserved.
FAU - Bader, M J
AU  - Bader MJ
AD  - Department of Urology, Ludwig Maximilians Universitat Munchen, Campus Grobetahadern, 
      Munich, Germany; Laser Research Laboratory, LIFE Center, Ludwig Maximilians 
      Universitat Munchen, Campus Grosshadern, Munich, Germany. Electronic address: 
      markus.bader@med.uni-muenchen.de.
FAU - Stepp, Herbert
AU  - Stepp H
FAU - Beyer, Wolfgang
AU  - Beyer W
FAU - Pongratz, Thomas
AU  - Pongratz T
FAU - Sroka, Ronald
AU  - Sroka R
FAU - Kriegmair, Martin
AU  - Kriegmair M
FAU - Zaak, Dirk
AU  - Zaak D
FAU - Welschof, Mona
AU  - Welschof M
FAU - Tilki, Derya
AU  - Tilki D
FAU - Stief, Christian G
AU  - Stief CG
FAU - Waidelich, Raphaela
AU  - Waidelich R
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20120321
PL  - United States
TA  - Urol Oncol
JT  - Urologic oncology
JID - 9805460
RN  - 0 (Photosensitizing Agents)
RN  - 88755TAZ87 (Aminolevulinic Acid)
RN  - G7H20TKI67 (5-aminolevulinic acid hexyl ester)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Aminolevulinic Acid/*analogs & derivatives/therapeutic use
MH  - Cystoscopy
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local
MH  - Photochemotherapy/adverse effects/*methods
MH  - Photosensitizing Agents/therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
MH  - Urinary Bladder Neoplasms/diagnosis/*drug therapy
MH  - Urinary Tract Infections/etiology
MH  - Urologic Diseases/etiology
OTO - NOTNLM
OT  - Bladder cancer
OT  - Hexaminolevulinate
OT  - Photodynamic therapy
OT  - Protoporphyrin fluorescence
EDAT- 2012/03/24 06:00
MHDA- 2014/04/26 06:00
CRDT- 2012/03/24 06:00
PHST- 2011/12/23 00:00 [received]
PHST- 2012/02/09 00:00 [revised]
PHST- 2012/02/09 00:00 [accepted]
PHST- 2012/03/24 06:00 [entrez]
PHST- 2012/03/24 06:00 [pubmed]
PHST- 2014/04/26 06:00 [medline]
AID - S1078-1439(12)00060-9 [pii]
AID - 10.1016/j.urolonc.2012.02.007 [doi]
PST - ppublish
SO  - Urol Oncol. 2013 Oct;31(7):1178-83. doi: 10.1016/j.urolonc.2012.02.007. Epub 2012 
      Mar 21.