Long-term survival in phase II trials of gemcitabine plus cisplatin for advanced transitional cell cancer.
OBJECTIVE
To assess long-term survival and prognostic indicators of survival in patients with advanced urothelial cancer treated with gemcitabine and cisplatin.


METHODS
Survival data from three previously published phase II trials of gemcitabine/cisplatin were updated. Baseline hemoglobin, performance status, and presence of visceral metastases, which are known prognostic factors with other regimens, were examined. Survival curves were constructed by the Kaplan-Meier method and significance assessed using the log-rank statistic. Cox's Proportional Hazards Model was used to construct univariate and multivariate survival models.


CONCLUSIONS
Overall median survival of 121 included patients was 13.2 (11.0 to 14.9) months and estimated 4 year survival was 13 +/- 6%. In a univariate analysis, the presence of visceral metastases and a hemoglobin < 12.5 mg/dl had significant adverse prognostic implications (P < 0.001 and P = 0.02, respectively). Performance status was not a significant predictor of survival, perhaps due to the fact that only 14% of patients had a performance status of 2. In a multivariate analysis, only the absence of visceral metastases retained its prognostic importance with an estimated 24% 4-year survival in such patients. These results lend further evidence for the clinical benefit of this regimen in advanced transitional cell cancer.
Stadler
Walter M
WM
University of Chicago, Department of Medicine, 5841 S. Maryland, MC2115, Chicago, Illinois 60637, USA. wstadler@medicine.bsd.uchicago.edu
Hayden
Annamaria
A
von der Maase
Hans
H
Roychowdhury
Debasish
D
Dogliotti
Luigi
L
Seymour
Lesley
L
Kaufmann
Donald
D
Moore
Malcolm
M
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects* / Q000031:analogs & derivatives*; D005500:Follow-Up Studies; D006801:Humans; D009367:Neoplasm Staging; D011379:Prognosis; D016016:Proportional Hazards Models; D016019:Survival Analysis; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine