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.

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 < or =2, creatinine < or =1.5 upper limit of normal range (UNL) and measurable disease according to RECIST criteria were treated with a combination of gemcitabine (1500 mg/m(2)) followed by oxaliplatin (85 mg/m(2)) 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.