title: Methotrexate and leucovorin double-modulated 5-fluorouracil combined with cisplatin (MPFL) in metastatic/recurrent head and neck cancer.
abstract: BACKGROUND
  To determine the efficacy and safety profile of the combination of cisplatin and 5-fluorouracil modulated both by methotrexate and leucovorin in metastatic/recurrent squamous cell carcinoma of the head and neck.
  
  
  METHODS
  Twenty-eight patients were treated with cisplatin 40 mg/m2/day continuous infusion for 24 hours on day 1; high-dose 5-fluorouracil 2,000 mg/m2/day and leucovorin 100 mg/m2/day continuous infusion for 48 hours on days 1 and 2; methotrexate 40 mg/m2/day as a bolus infusion 4 hours before 5-fluorouracil and leucovorin on day 1. The treatment was repeated every 2 weeks in a cycle.
  
  
  RESULTS
  The overall response rate was 25%, and 14% of the patients achieved stable disease status. Subgroup analysis demonstrated significantly improved overall survival in the disease-control group (12.0 months vs. 5.3 months, p<0.001). Only 3 (10.7%) patients developed grade 3-4 neutropenia, and none developed grade 3-4 non-hematologic toxicity.
  
  
  CONCLUSIONS
  This multiagent-containing regimen has an excellent safety profile and improved survival in disease-control group of patients with metastatic/recurrent squamous cell carcinoma of the head and neck.
authors.affiliation: Division of Medical Oncology, Department of Medicine, Taipei Veterans General Hospital, and National Yang-Ming University School of Medicine, Taipei, Taiwan, ROC.
authors.forename: Peter Mu-Hsin
authors.initials: PM
authors.lastname: Chang
authors.forename: Hao-Wei
authors.initials: HW
authors.lastname: Teng
authors.forename: Po-Min
authors.initials: PM
authors.lastname: Chen
authors.forename: Shyue-Yih
authors.initials: SY
authors.lastname: Chang
authors.forename: Pen-Yuan
authors.initials: PY
authors.lastname: Chu
authors.forename: Tung-Lung
authors.initials: TL
authors.lastname: Tsai
authors.forename: Shyh-Kuan
authors.initials: SK
authors.lastname: Tai
authors.forename: Yi-Fen
authors.initials: YF
authors.lastname: Wang
authors.forename: Jui-Lin
authors.initials: JL
authors.lastname: Huang
authors.forename: Muh-Hwa
authors.initials: MH
authors.lastname: Yang
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000008:administration & dosage*
chemical_list: D000964:Antimetabolites, Antineoplastic; D014803:Vitamin B Complex; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil; D008727:Methotrexate