title: Phase I/II study of docetaxel, cisplatin, and concomitant boost radiation for locally advanced squamous cell cancer of the head and neck.
abstract: OBJECTIVE
  To investigate the feasibility of combining concomitant boost accelerated radiation with docetaxel and cisplatin and assess the regimen's toxicity, locoregional control rate, and survival in patients with locally advanced head and neck cancer (HNSCC).
  
  
  METHODS
  Patients with stage III-IV HNSCC were eligible. Phase I included two schedules of docetaxel and cisplatin: arm 1, once per week during weeks 1 to 4; arm 2, every 21 days for weeks 1 and 4. Radiation consisted of 72 Gy in 42 fractions over 6 weeks (concomitant boost).
  
  
  RESULTS
  Twenty patients were enrolled in phase I. The arm 1 maximum-tolerated dose (MTD) was defined at docetaxel 15 mg/m2 and cisplatin 20 mg/m2 based on prolonged mucositis in 29% of patients. The initial dose level in arm 2 was above the MTD. In total, 52 patients were treated using the arm 1 regimen in phase II. Acute toxicity included grade 3 mucositis and dermatitis in 81% and 44% of patients. The 2-year locoregional control rate was 71%. The 2-year progression-free and overall survival rates were 61% and 65%. Median survival was 37.8 months. Late effects included feeding tube dependence in 17% of patients alive and free of disease.
  
  
  CONCLUSIONS
  Locoregional control, survival, and acute toxicity with this regimen were comparable with other trials utilizing taxanes and/or platins and concomitant conventional or altered fractionation radiation. Our data suggest that chemotherapy added to concomitant boost fractionation may increase rates of long-term feeding tube dependence. Phase III trials are needed to assess the contribution of concomitant boost fractionation to chemoradiotherapy.
authors.affiliation: Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA.
authors.forename: Anne S
authors.initials: AS
authors.lastname: Tsao
authors.forename: Adam S
authors.initials: AS
authors.lastname: Garden
authors.forename: Merrill S
authors.initials: MS
authors.lastname: Kies
authors.forename: William
authors.initials: W
authors.lastname: Morrison
authors.forename: Lei
authors.initials: L
authors.lastname: Feng
authors.forename: J Jack
authors.initials: JJ
authors.lastname: Lee
authors.forename: Fadlo
authors.initials: F
authors.lastname: Khuri
authors.forename: Ralph
authors.initials: R
authors.lastname: Zinner
authors.forename: Jeffery
authors.initials: J
authors.lastname: Myers
authors.forename: Vassiliki
authors.initials: V
authors.lastname: Papadimitrakopoulou
authors.forename: Jan
authors.initials: J
authors.lastname: Lewin
authors.forename: Gary L
authors.initials: GL
authors.lastname: Clayman
authors.forename: K Kian
authors.initials: KK
authors.lastname: Ang
authors.forename: Bonnie S
authors.initials: BS
authors.lastname: Glisson
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D019583:Dose Fractionation, Radiation; D005240:Feasibility Studies; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin