title: Radiochemotherapy including cisplatin alone versus cisplatin + 5-fluorouracil for locally advanced unresectable stage IV squamous cell carcinoma of the head and neck.
abstract: OBJECTIVE
  The optimal radiochemotherapy regimen for advanced head-and-neck cancer is still debated. This nonrandomized study compares two cisplatin-based radiochemotherapy regimens in 128 patients with locally advanced unresectable stage IV squamous cell carcinoma of the head and neck (SCCHN).
  
  
  METHODS
  Concurrent chemotherapy consisted of either two courses cisplatin (20 mg/m(2)/d1-5 + 29-33; n = 54) or two courses cisplatin (20 mg/m(2)/d1-5 + 29-33) + 5-fluorouracil (5-FU; 600 mg/m(2)/d1-5 + 29-33; n = 74).
  
  
  RESULTS
  At least one grade 3 toxicity occurred in 25 of 54 patients (46%) receiving cisplatin alone and in 52 of 74 patients (70%) receiving cisplatin + 5-FU. The latter regimen was particularly associated with increased rates of mucositis (p = 0.027) and acute skin toxicity (p = 0.001). Seven of 54 (13%) and 20 of 74 patients (27%) received only one chemotherapy course due to treatment-related acute toxicity. Late toxicity in terms of xerostomia, neck fibrosis, skin toxicity, and lymphedema was not significantly different. The 2-year locoregional control rates were 67% after cisplatin alone and 52% after cisplatin + 5-FU (p = 0.35). The metastases-free survival rates were 79% and 69%, respectively (p = 0.65), and the overall survival rates 70% and 51%, respectively (p = 0.10). On multivariate analysis, outcome was significantly associated with performance status, T-category, N-category, hemoglobin level prior to radiotherapy, and radiotherapy break > 1 week.
  
  
  CONCLUSIONS
  Two courses of fractionated cisplatin (20 mg/m(2)/day) alone appear preferable, as this regimen resulted in similar outcome and late toxicity as two courses of cisplatin + 5-FU, but in significantly less acute toxicity.
authors.affiliation: Department of Radiation Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Silke
authors.initials: S
authors.lastname: Tribius
authors.forename: Stefanie
authors.initials: S
authors.lastname: Kronemann
authors.forename: Yasemin
authors.initials: Y
authors.lastname: Kilic
authors.forename: Ursula
authors.initials: U
authors.lastname: Schroeder
authors.forename: Samer
authors.initials: S
authors.lastname: Hakim
authors.forename: Steven E
authors.initials: SE
authors.lastname: Schild
authors.forename: Dirk
authors.initials: D
authors.lastname: Rades
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010039:Otorhinolaryngologic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000209:etiology; D012189:Retrospective Studies; D016019:Survival Analysis
chemical_list: D002945:Cisplatin; D005472:Fluorouracil