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 carcino mas (HCCs) were treated with 370 mg/m(2) 5-fluorouracil (5-FU) plus 20 0 mg/m(2) racemic leucovorin both for 5 consecutive days. The chemothe rapy cycle was repeated every 4 weeks until disease progression. One c omplete remission (4%) and 6 partial responses (24%) were obtained, th at is 7 objective responses in all (28%, ninety-five confidence interv al: 10.1-45.9%). All responders had a good PS and only I of them prese nted 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 gr anulocytopenia and 1 patient only (4%) grade I skin toxicity. This reg imen made it possible to obtain a high rate of objective responses eve n in inoperable HCCs which are commonly considered as chemoresistant l esions.