title: Prospective randomized phase II trial of a single early intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma: the THP Monotherapy Study Group Trial.
abstract: OBJECTIVE
  We evaluated the efficacy of a single early intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).
  
  
  METHODS
  From December 2005 to November 2008, 77 patients clinically diagnosed with UUT-UC from 11 institutions participating in the Tohoku Urological Evidence-Based Medicine Study Group were preoperatively enrolled in this study. Patients were randomly assigned to receive or not receive a single instillation of THP (30 mg in 30 mL of saline) into the bladder within 48 hours after nephroureterectomy. Cystoscopy and urinary cytology were repeated every 3 months for 2 years or until the occurrence of first bladder recurrence.
  
  
  RESULTS
  Seventy-two patients were evaluable for efficacy analysis, 21 of whom had a subsequent bladder recurrence. Significantly fewer patients who received THP had a recurrence compared with the control group (16.9% at 1 year and 16.9% at 2 years in the THP group v 31.8% at 1 year and 42.2% at 2 years in the control group; log-rank P = .025). No remarkable adverse events were observed in the THP-treated group. Based on multivariate analysis, THP instillation (hazard rate [HR], 0.26; 95% CI, 0.07 to 0.91; P = .035) and open surgery (HR, 0.28; 95% CI, 0.09 to 0.84; P = .024) were independently predictive of a reduced incidence of bladder recurrence.
  
  
  CONCLUSIONS
  In this prospective randomized phase II study, a single intravesical instillation of THP seemed to reduce bladder recurrence after nephroureterectomy. A phase III, large-scale, multicenter study is needed to confirm these observations.
authors: 1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan. itoaki@uro.med.tohoku.ac.jp
authors: Akihiro
authors: A
authors: Ito
authors: Ichiro
authors: I
authors: Shintaku
authors: Makoto
authors: M
authors: Satoh
authors: Naomasa
authors: N
authors: Ioritani
authors: Masataka
authors: M
authors: Aizawa
authors: Tatsuo
authors: T
authors: Tochigi
authors: Sadafumi
authors: S
authors: Kawamura
authors: Hiroshi
authors: H
authors: Aoki
authors: Isao
authors: I
authors: Numata
authors: Atsushi
authors: A
authors: Takeda
authors: Shunichi
authors: S
authors: Namiki
authors: Takashige
authors: T
authors: Namima
authors: Yoshihiro
authors: Y
authors: Ikeda
authors: Koichi
authors: K
authors: Kambe
authors: Atsushi
authors: A
authors: Kyan
authors: Seiji
authors: S
authors: Ueno
authors: Kazuhiko
authors: K
authors: Orikasa
authors: Shinnosuke
authors: S
authors: Katoh
authors: Hisanobu
authors: H
authors: Adachi
authors: Satoru
authors: S
authors: Tokuyama
authors: Shigeto
authors: S
authors: Ishidoya
authors: Takuhiro
authors: T
authors: Yamaguchi
authors: Yoichi
authors: Y
authors: Arai
mesh_terms: D000283:Administration, Intravesical; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D003558:Cystoscopy; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D015999:Multivariate Analysis; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D011446:Prospective Studies; D016896:Treatment Outcome; D014513:Ureter / Q000473:pathology / Q000601:surgery; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D014551:Urinary Tract / Q000473:pathology / Q000601:surgery; D013520:Urologic Surgical Procedures / Q000379:methods
chemical_list: D000970:Antineoplastic Agents; D004317:Doxorubicin; C027260:pirarubicin