TY - JOUR
TI - Sequential gemcitabine and cisplatin followed by docetaxel as first-line treatment of advanced urothelial carcinoma: A multicenter phase II study of the Hellenic Oncology Research Group
AU - Boukovinas, I.
AU - Androulakis, N.
AU - Vamvakas, L.
AU - Papakotoulas, P.
AU - Ziras, N.
AU - Polyzos, A.
AU - Kalykaki, A.
AU - Kotsakis, A.
AU - Xenidis, N.
AU - Gioulmbasanis, I.
AU - Mavroudis, D.
AU - Georgoulias, V.
JO - Annals of Oncology
PY - 2006
VL - 17
TODO - 11
SP - 1687-1692
PB - 
SN - 0923-7534, 1569-8041
TODO - 10.1093/annonc/mdl286
TODO - analgesic agent;  antiemetic agent;  carboplatin;  cisplatin;  docetaxel;  gemcitabine;  recombinant granulocyte colony stimulating factor, adult;  advanced cancer;  aged;  anemia;  area under the curve;  article;  bladder carcinoma;  blood toxicity;  cancer growth;  cancer staging;  clinical article;  clinical trial;  confidence interval;  constipation;  controlled clinical trial;  controlled study;  disease severity;  drug blood level;  drug dose regimen;  drug fatality;  drug hypersensitivity;  drug response;  fatigue;  febrile neutropenia;  female;  follow up;  human;  male;  multicenter study;  nausea and vomiting;  nephrotoxicity;  neutropenia;  overall survival;  phase 2 clinical trial;  priority journal;  recurrent cancer;  stomatitis;  survival rate;  thrombocytopenia, Adult;  Aged;  Antimetabolites, Antineoplastic;  Antineoplastic Combined Chemotherapy Protocols;  Cisplatin;  Deoxycytidine;  Female;  Greece;  Humans;  Kaplan-Meiers Estimate;  Male;  Middle Aged;  Neoplasm Staging;  Patient Compliance;  Taxoids;  Treatment Outcome;  Urologic Neoplasms
TODO - Background: The purpose of this study was to investigate the toxicity and efficacy of the sequential administration of gemcitabine (GMB) in combination with cisplatin (CDDP) followed by docetaxel (Taxotere) as first-line treatment of advanced urothelial carcinoma. Patients and methods: Patients [aged ≤70 years and performance status (PS) (Eastern Cooperative Oncology Group) 0-2] with previously untreated locally advanced/recurrent or metastatic urothelial carcinoma were eligible. Study treatment consisted of GMB (1000 mg/m2, days 1 and 8) and CDDP (70 mg/m2, day 1) (GP regimen), every 21 days for a total of four cycles followed by docetaxel (D; 100 mg/m2, day 1) every 21 days for four cycles. Results: Thirty-eight patients with a median age of 67 years were enrolled; 67% of them had PS 0 and 87% stage IV disease. Patients received a median of four GP and four D cycles per patient. Grade 3-4 neutropenia occurred in 27% and 63% patients with GP and D, respectively. Grade 3-4 thrombocytopenia occurred in 11% of patients, only with the GP regimen. Other toxic effects were mild. There was no toxic death. The objective response rate was 55.2% [95% CI: 39.45%-71.07%]. Five patients had complete response (13.15%) and 16 patients had partial response (42.1%), while nine patients had disease stabilization (23.7%) (intention-to-treat analysis). After a median follow-up period of 13 months (range 1.5-40.5 months), the median time to progression was 6.8 months (range 1-40.5 months), the median overall survival 13 months (range 1.5-40.5 months), and the 1-year survival rate 55.3%. Conclusion: The sequential administration of GP followed by D is active and well tolerated as first-line treatment of advanced urothelial carcinoma and merits to be further evaluated. © 2006 Oxford University Press.
ER -