Annals of Oncology Advance Access published online on April 6, 2006
Annals of Oncology, doi:10.1093/annonc/mdl057
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1 Institut Gustave Roussy, Villejuif, France
* To whom correspondence should be addressed. Background: The aim of the study was to evaluate the activity and the safety of the gemcitabine-oxaliplatin (GEMOX) combination as first-line treatment in advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract. Materials and methods: Patients with metastatic or unresectable TCC, PS Results: A total of 123 cycles were administered to 30 patients (median 4, range 1-8). Three complete responses (CR) and 11 partial responses (PR) were observed. Overall response rate (ORR) was 47% (95% CI 28% to 66%). Median overall survival (OS) was 15 months (95% CI 8-31). Grade 3 and 4 neutropenia were reported in three and one patient, respectively; grade 3 anaemia in three patients; grade 3 and 4 thrombocytopenia in two and one patient, respectively; grade 1, 2 and 3 peripheral neuropathy in 14, 11 and two patients, respectively; grade 2 and 3 fatigue in 13 and seven patients respectively. Conclusions: The GEMOX combination is active in advanced/metastatic TCC with minimal toxicity and needs to be evaluated in a selected population of unfit patients and compared with other non-cisplatin-containing regimens.
Received August 30, 2005
Revised January 10, 2006
Accepted February 20, 2006
original article
A phase II monocentric study of oxaliplatin in combination with gemcitabine (GEMOX) in patients with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract
C. Theodore 1 *,
F. Bidault 1,
N. Bouvet-Forteau 1,
M. Abdelatif 1,
K. Fizazi 1,
M. di Palma 1,
P. Wibault 1,
R. de Crevoisier 1,
and
A. Laplanche 1
C. Theodore, E-mail: theodore{at}igr.fr
Abstract 
2, creatinine 1.5 upper limit of normal range (UNL) and measurable disease according to RECIST criteria were treated with a combination of gemcitabine (1500 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and 15 of a 28-day cycle.
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