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Annals of Oncology Advance Access originally published online on April 6, 2006
Annals of Oncology 2006 17(6):990-994; doi:10.1093/annonc/mdl057
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© 2006 European Society for Medical Oncology

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*, F. Bidault, N. Bouvet-Forteau, M. Abdelatif, K. Fizazi, M. di Palma, P. Wibault, R. de Crevoisier and A. Laplanche

Institut Gustave Roussy, Villejuif, France

* Correspondence to: Dr C. Theodore, Department of Medicine, Institut Gustave Roussy, 39 rue Camille Desmoulins, 94805 Villejuif, France. Tel: +33-1-42114898; Fax: +33-1-42115238; E-mail: theodore{at}igr.fr

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 ≤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.

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.

Key words: urothelial tract carcinoma, bladder cancer, chemotherapy, gemcitabine, oxaliplatin


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