title: Chemotherapy with gemcitabine, cisplatin, and docetaxel in the treatment for patients with muscle-invasive bladder cancer: a multicenter phase II study of the Hellenic Oncology Research Group (HORG).
abstract: OBJECTIVE
  To assess the antitumor activity and toxicity of gemcitabine, cisplatin, and docetaxel (GCD) regimen in patients with locally advanced or metastatic urothelial cancer.
  
  
  METHODS
  Chemotherapy-naïve patients, aged ≤70 years with measurable or evaluable disease and a performance status (PS) of 0-2 were treated with sequential cisplatin 80 mg/m(2) (d1), gemcitabine 1,100 mg/m(2) (d1 and d14), and docetaxel 80 mg/m(2) (d14) every 28 days.
  
  
  RESULTS
  Sixty patients with an ECOG PS of 0-2 were enroled. Most (71.7%) patients had stage IV disease. A median number of 4 chemotherapy cycles per patient (range, 1-9) was administered. Eight (13.3%) patients achieved a CR and 16 (26.7%) a partial response (PR) (intention-to-treat: ORR 40%; 95% CI 27.6-52.4%). Thirteen (21.7%) and 23 (38.3%) patients experienced stable and progressive disease, respectively. The median time to progression (TTP) was 7.7 months (range, 0.7-43.4), and the median overall survival 21.4 months (range, 0.7-68.6). Grade 3 and 4 neutropenia occurred in 27 (45%) patients and grade 3 and 4 thrombocytopenia in five (8.3%). Three (5%) patients developed febrile neutropenia. There were no treatment-related deaths. Severe non-haematological toxicity was infrequent.
  
  
  CONCLUSIONS
  The GCD combination is an active and well-tolerated regimen in patients with chemotherapy-naive locally advanced or metastatic TCC and merits to be further investigated.
authors: Hellenic Oncology Research Group (HORG), 55 Lomvardou str, 11740 Athens, Greece. georgsec@med.uoc.gr
authors: Ioannis
authors: I
authors: Boukovinas
authors: Nikolaos
authors: N
authors: Androulakis
authors: Nikolaos
authors: N
authors: Kentepozidis
authors: Aris
authors: A
authors: Polyzos
authors: Pavlos
authors: P
authors: Papakotoulas
authors: Nikolaos
authors: N
authors: Ziras
authors: Athanasios
authors: A
authors: Kotsakis
authors: Nikolaos
authors: N
authors: Vardakis
authors: Athanasios
authors: A
authors: Karampeazis
authors: Vassilis
authors: V
authors: Markos
authors: Athanasios
authors: A
authors: Kostakopoulos
authors: Constantine A
authors: CA
authors: Constantinides
authors: George
authors: G
authors: Samonis
authors: Dimitris
authors: D
authors: Mavroudis
authors: Vassilis
authors: V
authors: Georgoulias
mesh_terms: D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009132:Muscles / Q000187:drug effects* / Q000473:pathology; D009325:Nausea / Q000139:chemically induced; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D002945:Cisplatin; D000093542:Gemcitabine