title: A phase II study of levofolinic acid and 5-fluorouracil plus cisplatin in patients with advanced head and neck squamous cell carcinoma.
abstract: Forty patients with advanced squamous cell carcinoma of the head and neck (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 21-28 days. In the group of 20 previously untreated patients, a 90% overall response rate (ORR) with a 30% complete response rate (CRR) was obtained. In the group of 20 pretreated patients with recurrent and/or metastatic SCHNC, a 55% ORR with 15% CRR was achieved. This treatment was given on an outpatient basis and was generally very well tolerated with only 2 patients requiring hospitalization. Grade 1-2 gastrointestinal and hematological side effects were the most frequent toxicities. One patient had grade 4 liver toxicity, 1 had grade 4 anemia, and 1 grade 3 neurotoxicity. This treatment seems very active in both previously untreated and pretreated patients. However, in the latter group the mean duration of complete response (12.2+ months) and of partial response (7.4+ months) are, in our opinion, still unsatisfactory.
authors.affiliation: Chair of Chemotherapy, University of Palermo, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Gebbia
authors.forename: A
authors.initials: A
authors.lastname: Testa
authors.forename: R
authors.initials: R
authors.lastname: Valenza
authors.forename: G
authors.initials: G
authors.lastname: Zerillo
authors.forename: S
authors.initials: S
authors.lastname: Restivo
authors.forename: G
authors.initials: G
authors.lastname: Cupido
authors.forename: F
authors.initials: F
authors.lastname: Ingria
authors.forename: C
authors.initials: C
authors.lastname: Barbaccia
authors.forename: G
authors.initials: G
authors.lastname: Spadafora
authors.forename: G
authors.initials: G
authors.lastname: Cannata
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use / Q000633:toxicity*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage / Q000633:toxicity*; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000633:toxicity*; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000633:toxicity*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D013237:Stereoisomerism
chemical_list: D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil