Gemcitabine and paclitaxel chemotherapy for advanced urothelial carcinoma in patients who have received prior cisplatin-based chemotherapy.
BACKGROUND
The objective of this study was to evaluate the efficacy and toxicity of combination chemotherapy with gemcitabine and paclitaxel as a second-line regimen in patients with advanced urothelial carcinoma.


METHODS
Twenty patients with advanced urothelial carcinoma who were resistant to an M-VAC (methotrexate, vinblastine, doxorubicin, and cisplatin) chemotherapy regimen were administered chemotherapy consisting of intravenous gemcitabine 2500 mg/m(2) and paclitaxel 150 mg/m(2) (GP) every 2 or 3 weeks.


RESULTS
The patients received a median of 7.7 cycles of treatment (range, 2-20 cycles). Six of the 20 patients (30%; 95% confidence interval [CI], 10%-50%) had a major response to treatment (a complete response [CR] in 5% and a partial response [PR] in 25%). Seven patients (35%) had stable disease (SD). The median duration of response was 4.5 months (range, 1-9 months) and the disease control rate (CR + PR + SD) was 65%. The median survival was 11.5 months (range, 2-22 months) and the 1-year survival rate was 35%. The patients tolerated this regimen well, with only grade 3-4 neutropenia being observed in 6 patients (30%), anemia in 3 (15%), and thrombocytopenia in 1 (5%). The response rate to M-VAC in the first-line chemotherapy was significantly associated with the response to GP as the second-line chemotherapy.


CONCLUSIONS
The combination of gemcitabine and paclitaxel is active and well tolerated as a second-line treatment in patients with advanced urothelial carcinoma.
Kanai
Kunimitsu
K
Department of Urology, Keio University School of Medicine, Shinjuku-ku, Tokyo, 160-8582, Japan.
Kikuchi
Eiji
E
Ohigashi
Takashi
T
Miyajima
Akira
A
Nakagawa
Ken
K
Nakashima
Jun
J
Oya
Mototsugu
M
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D012189:Retrospective Studies; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
D003841:Deoxycytidine; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine