title: Folinic acid plus 5-FU based chemotherapy in squamous cell carcinoma of the head and neck: Bologna experience.
abstract: BACKGROUND
  The principal aim of our policy in the cytotoxic treatment of advanced squamous cell carcinoma of the head and neck (SCCHN) is to reduce toxicity, to maintain or increase the response rate and consequently to improve the quality of life for these patients. In locally advanced disease the aim is to reduce the volume of the tumor and to treat micrometastases in order to achieve a better outcome of the subsequent local treatment (i.e., surgery and/or radiotherapy). In these patients the aim is to prolong survival.
  
  
  METHODS
  We have employed 3 different multi-drug regimens with 5-FU+FA combination in 87 consecutive patients with SCCHN. Two regimens (B1, C) have been used for recurrent and/or metastatic disease and only one (B2) for previously untreated patients with locally advanced SCCHN. Regimen B1: cisplatin (P) 30 mg/m2 i.v., 5-fluorouracil (5-FU) 500 mg/m2 i.v., folinic acid racemic form (d, 1-FA) 200 mg/m2 i.v., bleomycin (B) 15 mg im 1st and 2nd day; Regimen C: P 60 mg/m2 1st day, 5-FU 500-750 mg/m2 continuous infusion, FA 50 mg po every 4 hours, B 15 mg im 2nd and 3rd day; Regimen B2 is similar to the B1 but lasts 3 consecutive days (instead of 2) and for every 3 weeks (instead of 4). It consists of 3 cycles before surgical treatment or radiotherapy.
  
  
  RESULTS
  There are no statistical differences in the Objective Response (OR) for the regimens B1 (39%) and C (34%). Grade 3-4 toxicity is higher in regimen B1 (50%) than in regimen C (< or = 8%).
  
  
  CONCLUSIONS
  Regimen C is less toxic regimen B1 with no significant difference in the OR. The primary treatment study is still ongoing but the preliminary results are promising: the remission rate is 92% (22/24, 1CR + 21 PR) and the median survival is 18 months (range 3-38+).
authors.affiliation: Divisione di Oncologia Medica, Ospedale Policlinico S. Orsola-Malpighi, Bologna, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Pannuti
authors.forename: M
authors.initials: M
authors.lastname: Guaraldi
authors.forename: A
authors.initials: A
authors.lastname: Martoni
authors.forename: B
authors.initials: B
authors.lastname: Melotti
authors.forename: M G
authors.initials: MG
authors.lastname: Morritti
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004341:Drug Evaluation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D007558:Italy; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012074:Remission Induction
chemical_list: D001761:Bleomycin; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil