title: concomitant chemoradiotherapy with mitomycin C and cisplatin in advanced unresectable carcinoma of the head and neck: phase I-II clinical study.
abstract: OBJECTIVE
  To evaluate the toxicity and efficacy of concomitant chemoradiotherapy with mitomycin C and cisplatin in the treatment of advanced unresectable squamous cell carcinoma of the head and neck.
  
  
  METHODS
  Treatment consisted of conventional radiotherapy (70 Gy in 35 fractions), mitomycin C 15 mg/m(2) IV, applied after the delivery of 10 Gy, and cisplatin at an initial dose of 10 mg/m(2)/d IV, applied during the last 10 fractions of irradiation ("chemoboost"). The cisplatin dose was escalated with respect to the toxic side effects by 2 mg/m(2)/d up to the maximum tolerated dose (MTD) or at the most 14 mg/m(2)/d (Phase I study), which was tested in the subsequent Phase II study.
  
  
  RESULTS
  All 36 patients had Stage T4 and/or N3 disease, and the majority had oropharyngeal (50%) or hypopharyngeal (39%) primary tumors. Six patients were treated at each of the three cisplatin dose levels tested (Phase I study). Dose-limiting toxicity was not reached even at 14 mg/m(2)/d of cisplatin, which was determined as the MTD and tested in an additional 18 patients (Phase II study). After a median follow-up time of 48 months, 4-year locoregional control, failure-free, and overall survival rates were 30%, 14%, and 20%, respectively. In 24 patients treated at the cisplatin dose level of 14 mg/m(2)/d, the corresponding rates were 40%, 20%, and 22%, respectively.
  
  
  CONCLUSIONS
  Concomitant chemoradiotherapy with mitomycin C and cisplatin "chemoboost" at 14 mg/m(2)/d is feasible, with encouraging survival results if the extremely poor disease profile of the treated patients is considered.
authors.affiliation: Department of Radiation Oncology, Institute of Oncology, Ljubljana, Slovenia. pstrojan@onko-i.si
authors.forename: Primoz
authors.initials: P
authors.lastname: Strojan
authors.forename: Katarina
authors.initials: K
authors.lastname: Karner
authors.forename: Lojze
authors.initials: L
authors.lastname: Smid
authors.forename: Erika
authors.initials: E
authors.lastname: Soba
authors.forename: Igor
authors.initials: I
authors.lastname: Fajdiga
authors.forename: Boris
authors.initials: B
authors.lastname: Jancar
authors.forename: Aleksandar
authors.initials: A
authors.lastname: Anicin
authors.forename: Marjan
authors.initials: M
authors.lastname: Budihna
authors.forename: Branko
authors.initials: B
authors.lastname: Zakotnik
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy / Q000379:methods; D005240:Feasibility Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D016019:Survival Analysis
chemical_list: D016685:Mitomycin; D002945:Cisplatin