title: Combination therapy consisting of gemcitabine, carboplatin, and docetaxel as an active treatment for advanced urothelial carcinoma.
abstract: BACKGROUND
  To evaluate the efficacy and toxicity of a combination chemotherapy consisting of gemcitabine, carboplatin, and docetaxel (GCD) in patients with advanced urothelial carcinoma (UC) as a phase II trial.
  
  
  METHODS
  Patients with metastatic or locally advanced unresectable UC were eligible for this trial. All enrolled patients were considered to be "unfit" for cisplatin-based chemotherapy, or to have methotrexate, vinblastine, doxorubicin, cisplatin (MVAC)-refractory UC. The chemotherapy regimen consisted of gemcitabine 1000 mg/m(2) on days 1 and 8, and carboplatin (with a target area under the curve of 5) and docetaxel 70 mg/m(2) on day 1; this was repeated every 21 days.
  
  
  RESULTS
  Thirty-five patients were enrolled, with a median age of 68 years. A total of 89 cycles were administered (median, 2 cycles). Major toxicities were Grade 3/4 neutropenia in 28 (80.0%) patients and Grade 3/4 thrombocytopenia in 18 (51.5%). An objective response rate (ORR) was 11 of 21 patients (52.4%), including a complete response in 1 (4.8%). The median overall survival (OS) was 13.1 months (1-year survival rate, 60%) and the median progression-free survival (PFS) was 5.0 months. Among 16 patients who had previously received MVAC, the ORR, the median PFS, the median OS and 1-year survival rate was 56.3%, 5.0 months, 12.6 months and 54%, respectively.
  
  
  CONCLUSIONS
  GCD chemotherapy is active and well tolerated as a first- or second-line therapy for patients with advanced UC. Response rate, duration and survival did not differ between those with and without a history of MVAC treatment.
authors: Department of Urology, Akita University School of Medicine, Hondo 1-1-1, Akita, Akita, Japan. tsurutah@doc.med.akita-u.ac.jp
authors: Hiroshi
authors: H
authors: Tsuruta
authors: Takamitsu
authors: T
authors: Inoue
authors: Shintaro
authors: S
authors: Narita
authors: Yohei
authors: Y
authors: Horikawa
authors: Mitsuru
authors: M
authors: Saito
authors: Takashi
authors: T
authors: Obara
authors: Kazuyuki
authors: K
authors: Numakura
authors: Shinya
authors: S
authors: Maita
authors: Shigeru
authors: S
authors: Satoh
authors: Norihiko
authors: N
authors: Tsuchiya
authors: Tomonori
authors: T
authors: Habuchi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000627:therapeutic use; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D000077143:Docetaxel; D004317:Doxorubicin / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D014747:Vinblastine / Q000627:therapeutic use; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D014747:Vinblastine; D004317:Doxorubicin; D016190:Carboplatin; D002945:Cisplatin; D008727:Methotrexate; D000093542:Gemcitabine