Oxaliplatin as first-line treatment in inoperable biliary tract carcinoma: a multicenter phase II study.
BACKGROUND
A multicenter phase II study was conducted in order to evaluate the efficacy and safety of oxaliplatin as first-line treatment of patients with locally advanced or metastatic carcinoma of the biliary tract.


METHODS
Twenty-nine chemo-naïve patients with locally advanced or metastatic biliary tract carcinoma received oxaliplatin 130 mg/m(2) i.v. every 21 days. Patients were treated until tumor progression or unacceptable toxicity.


RESULTS
An objective response (3 complete responses, 3 partial responses) was achieved in 6 patients (20.6%, 95% CI 5.95-35.4). Disease control (complete response, partial response and stable disease) was observed in 14 patients (48.2%). The median time to tumor progression was 3 months (range 0.7-39) and the median overall survival was 7 months (range 1-39). The 1-year survival rate was 32%. Toxicity was mild.


CONCLUSIONS
Oxaliplatin is an active agent against biliary tract carcinoma and therefore should be further investigated in combination with other cytotoxic drugs.
Androulakis
Nikolaos
N
Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece. georgsec@med.uoc.gr
Aravantinos
Gerasimos
G
Syrigos
Kostas
K
Polyzos
Aris
A
Ziras
Nikolaos
N
Tselepatiotis
Evangelos
E
Samonis
George
G
Kentepozidis
Nikolaos
N
Giassas
Stylianos
S
Vamvakas
Lambros
L
Georgoulias
Vassilis
V
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000009:adverse effects*; D000077150:Oxaliplatin; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin