Fixed-dose-rate gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas.
BACKGROUND
Biliary tract cancers (BTC) have a poor prognosis, and there is no consensus on the best chemotherapy regimen. This study determined the response rate for fixed-dose-rate (FDR) gemcitabine combined with cisplatin.


METHODS
This multicentre phase II trial enrolled 50 patients with inoperable locally advanced or metastatic BTC. Treatment consisted of FDR gemcitabine 1,000 mg/m² (10 mg/m²/min) and cisplatin 20 mg/m² on days 1 and 8 of a 21-day cycle. The primary endpoint was response rate. Secondary endpoints included safety, response duration (RD), progression-free (PFS) and overall survival (OS), and cancer antigen 19-9 response.


RESULTS
Thirteen patients (26%, 95% CI 14.6-40.4) had a partial response, and 12 (24%) had stable disease. The median RD was 8.3 months (95% CI 6.91-9.99); median PFS 4 months (95% CI 2.5-6.77); and median OS 6.8 months (95% CI 5.0-8.7). Treatment was well tolerated. Grade 3 and grade 4 nausea, vomiting, and fatigue were uncommon. Thirty-eight per cent of patients discontinued treatment because of toxicity, patient or clinician preference.


CONCLUSIONS
This treatment combination had moderate activity with acceptable toxicity, supporting previous results that this combination has a role to play. The study does not suggest that FDR gemcitabine is superior to bolus infusion.
Goldstein
David
D
Department of Medical Oncology, Prince of Wales Hospital, Randwick, NSW, Australia. d.goldstein@unsw.edu.au
Gainford
M Corona
MC
Brown
Chris
C
Tebbutt
Niall
N
Ackland
Stephen P
SP
van Hazel
Guy
G
Jefford
Michael
M
Abdi
Ehtesham
E
Selva-Nayagam
Sid
S
Gebski
Val
V
Miller
Danielle
D
Shannon
Jenny
J
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018395:CA-19-9 Antigen / Q000378:metabolism*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013534:Survival; D016896:Treatment Outcome; D000093542:Gemcitabine
D018395:CA-19-9 Antigen; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine