A multicenter phase II trial with irinotecan plus oxaliplatin as first-line treatment for inoperable/metastatic cancer of the biliary tract.
OBJECTIVE
To evaluate the efficacy and tolerability of oxaliplatin (L-OHP) in combination with irinotecan (CPT-11) as first-line treatment of advanced biliary tract cancer.


METHODS
Patients with histologically confirmed nonresectable biliary adenocarcinoma were treated with oxaliplatin (85 mg/m(2)) and irinotecan (200 mg/m(2)) every 3 weeks.


RESULTS
Twenty-eight patients were enrolled between May 2005 and March 2009. The overall objective response rate was 17.9% with an additional 21.4% of patients with stable disease (disease control rate 39.3%). The median overall survival time was 9.2 months (95% CI 5.8-12.5) and the median progression-free survival time 2.7 months (95% CI 2.2-3.2). Grades 3 and 4 neutropenia occurred in 1 (3.6%) and 4 (14.3%) patients, respectively, and febrile neutropenia in 3 (10.7%). Grade 3-4 diarrhea was observed in 2 (7.1%) patients and grade 3 asthenia in 1 (6%). There were no treatment-related deaths.


CONCLUSIONS
The combination of oxaliplatin and irinotecan has a modest antitumor activity with manageable toxicity as first-line treatment in metastatic cancer of the biliary tract and therefore it cannot be recommended as front-line treatment for unresectable biliary tract cancer.
Karachaliou
Niki
N
Hellenic Oncology Research Group, Athens, Greece.
Polyzos
Aris
A
Kentepozidis
Nikolaos
N
Kakolyris
Stylianos
S
Ziras
Nikolaos
N
Vardakis
Nikolaos
N
Kalykaki
Antonia
A
Milaki
Georgia
G
Georgoulias
Vassilis
V
Androulakis
Nikolaos
N
D000328:Adult; D000368:Aged; D014670:Ampulla of Vater / Q000473:pathology; D000970:Antineoplastic Agents / Q000627:therapeutic use* / Q000633:toxicity; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use* / Q000633:toxicity; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002166:Camptothecin / Q000031:analogs & derivatives* / Q000627:therapeutic use / Q000633:toxicity; D018281:Cholangiocarcinoma / Q000188:drug therapy / Q000473:pathology; D003138:Common Bile Duct Neoplasms / Q000188:drug therapy / Q000473:pathology; D005260:Female; D005706:Gallbladder Neoplasms / Q000188:drug therapy / Q000473:pathology; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000627:therapeutic use* / Q000633:toxicity; D000077150:Oxaliplatin
D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000077146:Irinotecan; D002166:Camptothecin