5-Fluorouracil and d,l-leucovorin calcium are active to treat unresectable hepatocellular carcinoma patients: preliminary results of a phase II study.
Twenty-five patients affected with unresectable hepatocellular carcinomas (HCCs) were treated with 370 mg/m2 5-fluorouracil (5-FU) plus 200 mg/m2 racemic leucovorin both for 5 consecutive days. The chemotherapy cycle was repeated every 4 weeks until disease progression. One complete remission (4%) and 6 partial responses (24%) were obtained, that is 7 objective responses in all (28%, ninety-five confidence interval: 10.1-45.9%). All responders had a good PS and only 1 of them presented with bulky disease. Five patients (20%) exhibited stable disease, while the remaining 13 patients (52%) progressed. Toxicity was mild: 11 patients (44%) had grade II/III mucositis, 10 patients (40%) grade II diarrhea, 7 patients (28%) grade II nausea, 2 patients grade III granulocytopenia and 1 patient only (4%) grade I skin toxicity. This regimen made it possible to obtain a high rate of objective responses even in inoperable HCCs which are commonly considered as chemoresistant lesions.
D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D016019:Survival Analysis
D000964:Antimetabolites, Antineoplastic; D002955:Leucovorin; D005472:Fluorouracil