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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

Ann Oncol. 2006 Nov;17(11):1687-92. doi: 10.1093/annonc/mdl286. Epub 2006 Sep 12.

ABSTRACT

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/m(2), days 1 and 8) and CDDP (70 mg/m(2), day 1) (GP regimen), every 21 days for a total of four cycles followed by docetaxel (D; 100 mg/m(2), 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.

PMID:16968872 | DOI:10.1093/annonc/mdl286

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.

I Boukovinas, N Androulakis, L Vamvakas, P Papakotoulas, N Ziras, A Polyzos, A Kalykaki, A Kotsakis, N Xenidis, I Gioulmbasanis, D Mavroudis, V Georgoulias

2006-09-14

Annals of oncology : official journal of the European Society for Medical Oncology

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