A PHASE-II STUDY OF LEVOFOLINIC ACID AND 5-FLUOROURACIL PLUS CISPLATIN IN PATIENTS WITH ADVANCED HEAD AND NECK SQUAMOUS-CELL CARCINOMA

Forty patients with advanced squamous cell carcinoma of the head and n eck (SCHNC) were treated with a combination of levofolinic acid 100 mg /m2 + 5-fluorouracil 375 mg/m2 in a 4-hour infusion plus cisplatin 20 mg/m2 in a 2-hour infusion for 5 consecutive days, repeated every 21-2 8 days. In the group of 20 previously untreated patients, a 90% overal l response rate (ORR) with a 30% complete response rate (CRR) was obta ined. In the group of 20 pretreated patients with recurrent and/or met astatic SCHNC, a 55% ORR with 15% CRR was achieved. This treatment was given on an outpatient basis and was generally very well tolerated wi th only 2 patients requiring hospitalization. Grade 1-2 gastrointestin al and hematological side effects were the most frequent toxicities. O ne patient had grade 4 liver toxicity, 1 had grade 4 anemia, and 1 gra de 3 neurotoxicity. This treatment seems very active in both previousl y untreated and pretreated patients. However, in the latter group the mean duration of complete response (12.2+ months) and of partial respo nse (7.4+ months) are, in our opinion, still unsatisfactory.