title: Outcomes of intrarenal Bacillus Calmette-Guérin/interferon-α2B for biopsy-proven upper-tract carcinoma in situ.
abstract: OBJECTIVE
  While nephroureterectomy (NU) remains the gold-standard treatment for upper-tract carcinoma in situ (UT-CIS), it may be unnecessarily aggressive in comparison with the treatment of bladder CIS. Upper-tract administration of bacillus Calmette-Guérin (BCG) has shown promise for UT-CIS, but with limited reports and varied results. Furthermore, all previous reports included patients with positive cytology results without biopsy-proven CIS, or combined BCG with other topical therapies that are used for bladder CIS. We report our experience using a novel technique to directly instill BCG with interferon-α2B (BCG/IFN) into the upper-tract in patients with biopsy-proven UT-CIS.
  
  
  METHODS
  Patients who received a diagnosis of isolated, biopsy-proven UT-CIS from September 2003 to January 2012 were included. After biopsy, all patients received a 6-week induction course of BCG/IFN, administered via an open-ended ureteral catheter. Initial follow-up was scheduled 1 month after the completion of the intrarenal therapy and consisted of flexible ureteroscopy, selective urinary cytology, retrograde pyelography, and rebiopsy of the upper tract. Complete response (CR) was defined as the absence of visualized lesions on ureteroscopy, negative selective cytology results, and absence of clinical progression. Absence of visualized lesions with persistently positive cytology results or persistence of lesions after induction was considered no response (NR). New upper-tract lesions after an initial CR were considered recurrences. Patients with a CR were placed on maintenance therapy for 2 years. Surveillance was performed every 3 months with ureteroscopy, selective cytology, and imaging.
  
  
  RESULTS
  Eleven patients (mean age=73 years) were followed for a median of 13.5 months (3.7-103.3 mos). Eight patients had an initial CR, while three initially had NR. Two of the NR patients had negative biopsy results but persistently positive cytology results; both of these patients underwent a second induction course and achieved a CR. The third NR patient had persistence of lesions after induction and was offered a nephroureterctomy. Total kidney preservation rate was 91% (10/11). There were no treatment-related adverse events.
  
  
  CONCLUSIONS
  This study demonstrates the safety and efficacy of intrarenal BCG/IFN maintenance therapy for patients with UT-CIS. Unlike other mechanisms of delivery, including percutaneous administration or reflux via double pigtail stents, this office-based technique spares the morbidity of a chronically indwelling nephrostomy tube or ureteral stent.
authors: Department of Urology, Columbia University Medical Center, New York, NY, USA.
authors: Edan Y
authors: EY
authors: Shapiro
authors: Michael J
authors: MJ
authors: Lipsky
authors: Doh Yoon
authors: DY
authors: Cha
authors: James M
authors: JM
authors: McKiernan
authors: Mitchell C
authors: MC
authors: Benson
authors: Mantu
authors: M
authors: Gupta
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000627:therapeutic use*; D001706:Biopsy; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000473:pathology; D003710:Demography; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D007668:Kidney / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome; D014513:Ureter / Q000473:pathology*; D014516:Ureteral Neoplasms / Q000188:drug therapy* / Q000473:pathology*
chemical_list: D001500:BCG Vaccine; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins