title: Phase I study of continuous mitomycin-C infusion in concomitant radiochemotherapy of primary inoperable advanced head and neck cancer.
abstract: OBJECTIVE
  A phase I trial to evaluate the maximum tolerated dose (MTD) of continuous mitomycin-C infusion in radiochemotherapy of inoperable HNSCC.
  
  
  METHODS
  Twenty-one patients were treated with 70 Gy (2 Gy/day) and simultaneous chemotherapy (5-FU 600 mg/m2/day and MMC, both as continuous infusion on days 1-5 and 36-40. The MMC dose was dependent on dose escalation levels I-IV: 2/2.6/3.2/4 mg/m2/day.
  
  
  RESULTS
  Dose limiting toxicity (DLT) (grade 3 mucositis and/or dysphagia) occurred at dose level IV (MMC 4 mg/m2/day). Accordingly, dose escalation level III (MMC 3.2 mg/m2/day) was set as the MTD. One and 2-year survival rate: 66.7 and 29.5%, disease free survival: 47.6 and 22.8%, respectively.
  
  
  CONCLUSIONS
  Our study demonstrates that continuous infusion of 5-FU/MMC can be safely administered at a MMC dose of 3.21 mg/m2/day on days 1-5 and 36-40 in concomitant radiochemotherapy. A phase II study should be initiated to establish the role of this regimen in the treatment of head and neck cancer.
authors.affiliation: Department of Radiation Oncology, University of Goettingen, Robert-Koch-Str. 40, Goettingen, Germany. hchrist@gwdg.de
authors.forename: Hans
authors.initials: H
authors.lastname: Christiansen
authors.forename: Robert M
authors.initials: RM
authors.lastname: Hermann
authors.forename: Andrea
authors.initials: A
authors.lastname: Hille
authors.forename: Heinz
authors.initials: H
authors.lastname: Schmidberger
authors.forename: Alexios
authors.initials: A
authors.lastname: Martin
authors.forename: Mirko
authors.initials: M
authors.lastname: Nitsche
authors.forename: Clemens F
authors.initials: CF
authors.lastname: Hess
authors.forename: Olivier
authors.initials: O
authors.lastname: Pradier
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009367:Neoplasm Staging; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D016685:Mitomycin