A 3-week gemcitabine-cisplatin regimen for metastatic urothelial cancer.
OBJECTIVE
To assess the efficacy and tolerability of a 3-week outpatient schedule of intravenous gemcitabine and cisplatin in patients with locally advanced unresectable or metastatic transitional cell carcinoma of the urothelial tract (TCC).


METHODS
A two-stage phase II trial enrolled TCC patients with Karnofsky performance status > or = 60, measurable disease, and adequate organ function. Prior adjunctive chemotherapy was allowed provided it had been completed at least 1 year prior to study entry. Treatment consisted of gemcitabine 1250 mg/m2 iv days 1 and 8 plus cisplatin 70 mg/m2 day 1 iv repeated every 21 days. The primary outcome was the objective response rate.


RESULTS
Thirty patients were enrolled at six Canadian centres. Three complete and 10 partial responses were observed in 29 eligible patients (overall response rate 45% [95%CI, 27-63%]). Three patients had stable disease and 13 had progressive disease. The relative dose-intensities of gemcitabine and cisplatin were 81% and 88%, respectively. Toxicity was primarily hematological, and 60% of patients experienced at least one episode of grade 3 or 4 toxicity. One patient died of neutropenic sepsis and two died of vascular events while on treatment.


CONCLUSIONS
The efficacy and tolerability of this schedule are similar to that reported with the standard 4-week schedule of gemcitabine-cisplatin. In the absence of a large randomized trial, the similarity of these results supports the use of this 3-week program in typical TCC patients treated in both community and academic cancer clinic settings.
Winquist
Eric
E
London Health Sciences Centre, London, Ontario, Canada.
Wilson
John J
JJ
Dorreen
Mark
M
Wong
Ralph
R
Jonker
Derek
D
Iscoe
Neil
N
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D016896:Treatment Outcome; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine