Phase II study of cisplatin, epirubicin and continuous infusion of 5-fluorouracil in patients with advanced intrahepatic cholangiocellular carcinoma (ICC).
OBJECTIVE
To clarify the efficacy and toxicity of cisplatin, epirubicin, and continuous infusion of 5-FU (CEF therapy) in patients with advanced intrahepatic cholangiocellular carcinoma (ICC).


METHODS
Chemo-naïve patients with advanced ICC were treated with cisplatin at 80 mg/m2 and epirubicin at 50 mg/m2 on day 1, and continuous infusion of 5-FU at 500 mg/m2/day on days 1 through 5. If there was no evidence of tumor progression or unacceptable toxicity, the treatment was repeated every 4 weeks, up to a maximum of 6 courses.


RESULTS
Thirty-nine patients were enrolled in this study. The median number of courses was 2 (range, 1-6). A partial response was obtained in 4 patients (10%) with a median duration of 2.3 months. Twenty-seven patients (69%) showed no change, and 7 patients (18%) had progressive disease. The median survival time was 9.1 months and the 1-year survival rate was 23%. The progression-free survival time was 5.1 months. Grade 3 to 4 adverse effects were leukocytopenia (51%), neutropenia (74%), thrombocytopenia (23%), and nausea/vomiting (10%). Most of the toxicities were reversible, but 2 patients died of neutropenic sepsis.


CONCLUSIONS
CEF therapy has marginal antitumor activity against advanced ICC, although hematological toxicity is the major and most frequent toxicity.
Takezako
Yoriko
Y
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
Okusaka
Takuji
T
Ueno
Hideki
H
Ikeda
Masafumi
M
Morizane
Chigusa
C
Najima
Mina
M
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D018281:Cholangiocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D015251:Epirubicin; D002945:Cisplatin; D005472:Fluorouracil