title: Salvage chemotherapy with paclitaxel, ifosfamide, and nedaplatin in patients with urothelial cancer who had received prior cisplatin-based therapy.
abstract: OBJECTIVE
  The aim of the present phase II study was to evaluate the efficacy of combination chemotherapy of paclitaxel, ifosfamide, and nedaplatin (PIN regimen) in patients with recurrent urothelial cancer who had been treated with cisplatin-based chemotherapy.
  
  
  METHODS
  Eligible patients were those with histologically confirmed urothelial cancer who had progressed or relapsed after cisplatin-based chemotherapy. The PIN regimen consisted of paclitaxel 175 mg/m(2) on day 1; ifosfamide 4.5 g/m2 divided over days 1, 2, and 3; and nedaplatin 70 mg/m(2) on day 1; PIN was given every 28 days.
  
  
  RESULTS
  Among the 32 patients enrolled in the study (median age, 66 years), complete and partial responses were obtained in 5 patients and 19 patients, respectively, with an overall response rate of 75% (95% confidence interval [CI], 59-91%). The median time to progression was 8 months (range, 0-50+ months) and the median survival was 22 months (range, 4-52+ months). The 1- and 2-year overall survival rates were 53.7 and 42.9%, respectively. All patients experienced Grade 3 or 4 neutropenia, while Grade 3 or 4 thrombocytopenia was seen in 8 patients; Grade 3 or 4 anemia was seen in 6 patients; Grade 3 neuropathy was observed in 1 patient, for whom the PIN therapy was discontinued. There were no treatment-related deaths.
  
  
  CONCLUSIONS
  The PIN combination was highly active and tolerable in previously treated patients with urothelial cancer as a second-line treatment.
authors.affiliation: Department of Urology, Hokkaido University Graduate School of Medicine, Kitaku, Sapporo, Japan. nobuo-s@med.hokudai.ac.jp
authors.forename: Nobuo
authors.initials: N
authors.lastname: Shinohara
authors.forename: Toru
authors.initials: T
authors.lastname: Harabayashi
authors.forename: Shin
authors.initials: S
authors.lastname: Suzuki
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Nagao
authors.forename: Haruo
authors.initials: H
authors.lastname: Seki
authors.forename: Masashi
authors.initials: M
authors.lastname: Murakumo
authors.forename: Kimiyoshi
authors.initials: K
authors.lastname: Mitsuhashi
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Demura
authors.forename: Satoshi
authors.initials: S
authors.lastname: Nagamori
authors.forename: Hideyasu
authors.initials: H
authors.lastname: Matsuyama
authors.forename: Katsusuke
authors.initials: K
authors.lastname: Naito
authors.forename: Katsuya
authors.initials: K
authors.lastname: Nonomura
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016879:Salvage Therapy; D016896:Treatment Outcome; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
chemical_list: D009944:Organoplatinum Compounds; C053989:nedaplatin; D017239:Paclitaxel; D002945:Cisplatin; D007069:Ifosfamide