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.


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.
Theodore
C
C
Institut Gustave Roussy, Villejuif, France. theodore@igr.fr
Bidault
F
F
Bouvet-Forteau
N
N
Abdelatif
M
M
Fizazi
K
K
di Palma
M
M
Wibault
P
P
de Crevoisier
R
R
Laplanche
A
A
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D007262:Infusions, Intravenous; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010146:Pain / Q000517:prevention & control; D010147:Pain Measurement; D010919:Placebos; D016896:Treatment Outcome; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D010919:Placebos; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000093542:Gemcitabine