title: Efficacy and safety of photodynamic therapy for recurrent, high grade nonmuscle invasive bladder cancer refractory or intolerant to bacille Calmette-Guérin immunotherapy.
abstract: OBJECTIVE
  We evaluated the effectiveness of photodynamic therapy using Radachlorin in patients with high grade, nonmuscle invasive bladder cancer refractory or intolerant to bacillus Calmette-Guérin therapy who refused radical cystectomy.
  
  
  METHODS
  Between July 2009 and December 2011 photodynamic therapy was performed in 22 men and 12 women. Radachlorin (0.5 to 0.6 mg/kg) was injected intravenously 2 to 3 hours before photodynamic therapy. After complete transurethral resection, a diffuser using a 22Fr cystoscope was placed in the bladder for irradiation with a 662 nm laser. Output beam power was adjusted to 1.8 W and the light dose was 15 J/cm(2). Photodynamic therapy was performed for 16 to 30 minutes. Recurrence after photodynamic therapy was followed by regular cystoscopy at 1, 2 and 3 months, and at 3-month intervals thereafter for up to 2.8 years. Efficacy was assessed by cystoscopy, cytology and histology, and defined as the number of patients who were tumor free after initial photodynamic therapy.
  
  
  RESULTS
  Mean ± SD patient age was 62.94 ± 8.71 years. Average followup was 26.74 ± 6.34 months (median 28.12). As the primary efficacy outcome, the recurrence-free rate was 90.9% at 12 months, 64.4% at 24 months and 60.1% at 30 months. As the secondary efficacy outcome, there was no statistical difference in mass size, carcinoma in situ, number of previous bacillus Calmette-Guérin administrations, number of transurethral bladder resections or tumor multiplicity on Kaplan-Meier analysis (each p >0.05). No evidence of severe adverse effects was detected after photodynamic therapy.
  
  
  CONCLUSIONS
  Photodynamic therapy with Radachlorin is a safe, effective treatment for nonmuscle invasive bladder cancer refractory or intolerant to bacillus Calmette-Guérin therapy in select patients.
authors: Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea; Severance Hospital and Urological Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors: Joo Yong
authors: JY
authors: Lee
authors: Richilda Red
authors: RR
authors: Diaz
authors: Kang Su
authors: KS
authors: Cho
authors: Meng Shi
authors: MS
authors: Lim
authors: Jae Seung
authors: JS
authors: Chung
authors: Won Tae
authors: WT
authors: Kim
authors: Won Sik
authors: WS
authors: Ham
authors: Young Deuk
authors: YD
authors: Choi
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use; D001500:BCG Vaccine / Q000009:adverse effects / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology; D017606:Chlorine Compounds / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010778:Photochemotherapy / Q000009:adverse effects; D010865:Pilot Projects; D011446:Prospective Studies; D017211:Treatment Failure; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine; D017606:Chlorine Compounds
keywords: 5-ALA; 5-aminolevulinic acid; AE; BCG; BCG vaccine; CIS; HAL; LUTS; NMIBC; PDT; PpIX; SAE; TURB; adverse effect; bacillus Calmette-Guérin; carcinoma in situ; chlorin e(6); hexaminolevulinic acid; lower urinary tract symptoms; nonmuscle invasive bladder cancer; photochemotherapy; photodynamic therapy; protoporphyrin IX; serious AE; transurethral bladder tumor resection; treatment failure; urinary bladder neoplasms