Annals of Oncology Advance Access published online on September 12, 2006
Annals of Oncology, doi:10.1093/annonc/mdl286
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1 Second Department of Medical Oncology, "Theagenion" Cancer Hospital of Thessaloniki, Thessaloniki
* To whom correspondence should be addressed.
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
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.
Received March 28, 2006
Revised June 30, 2006
Accepted July 3, 2006
original article
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
I. Boukovinas 1 *, N. Androulakis 2, L. Vamvakas 2, P. Papakotoulas 1, N. Ziras 3, A. Polyzos 4, A. Kalykaki 2, A. Kotsakis 2, N. Xenidis 1, I. Gioulmbasanis 2, D. Mavroudis 2, and V. Georgoulias 2
2 Department of Medical Oncology, University General Hospital of Heraklion, Heraklion; Crete
3 First Department of Medical Oncology, "Metaxa", Anticancer Hospital, Pireas
4 First Department of Propedeutic Medicine of University of Athens, Medical Oncology Unit, "Laikon" Hospital, Athens, Greece
I. Boukovinas, E-mail: ibouk{at}otenet.gr
Abstract 
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.
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