title: Comparison of acute toxicities in two primary chemoradiation regimens in the treatment of advanced head and neck squamous cell carcinoma.
abstract: OBJECTIVE
  The optimal dosage and frequency of platinum-based chemoradiotherapy (CRT) regimen for treating advanced head and neck squamous cell carcinoma remains unresolved. This study aims to compare the toxicity and efficacy of weekly versus more dose-intensive cisplatin-based CRTs.
  
  
  METHODS
  We reviewed 155 stage III/IV head and neck squamous cell carcinoma patients with no evidence of distant metastasis treated with one of two CRT regimens from 2000 to 2010 at Greater Baltimore Medical Center. Twice-daily radiation was provided as a split course over a 45-day period. Regimen A consisted of concomitant cisplatin (30 mg/m2/1 h) weekly for 6 cycles; regimen B consisted of concomitant cisplatin (12 mg/m2/1 h) and 5-fluorouracil (600 mg/m2/20 h) on days 1 through 5 and days 29 through 33. Main outcome measures included acute toxicities (myelosuppression, neurotoxicity, nephrotoxicity, gastrointestinal dysfunction), unplanned hospitalizations, and disease control at 12 months.
  
  
  RESULTS
  Patients on regimen A were much less likely to experience ototoxicity due to their treatment (0% vs. 9.8%, P = 0.04). They were more likely to experience thrombocytopenia acutely (46% vs. 26%, P = 0.02), but the toxicity was not limiting (grade 1–2). No significant differences exist in the incidence of other toxicities or unplanned hospitalizations. At 1 year, 97% of patients on A vs. 86% of patients on regimen B were free of disease (P = 0.11).
  
  
  CONCLUSIONS
  With concurrent radiotherapy, low-dose, single-agent, weekly cisplatin is less likely than higher-dose daily cisplatin plus 5-fluorouracil provided at the beginning and end of treatment to be associated with ototoxicity. The preliminary data suggest at least equivalent efficacy, but longer follow-up is required.
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Katherine Y
authors.initials: KY
authors.lastname: Fan
authors.forename: Hrishikesh
authors.initials: H
authors.lastname: Gogineni
authors.forename: David
authors.initials: D
authors.lastname: Zaboli
authors.forename: Spencer
authors.initials: S
authors.lastname: Lake
authors.forename: Marianna L
authors.initials: ML
authors.lastname: Zahurak
authors.forename: Simon R
authors.initials: SR
authors.lastname: Best
authors.forename: Marshall A
authors.initials: MA
authors.lastname: Levine
authors.forename: Mei
authors.initials: M
authors.lastname: Tang
authors.forename: Eva S
authors.initials: ES
authors.lastname: Zinreich
authors.forename: John R
authors.initials: JR
authors.lastname: Saunders
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Califano
authors.forename: Ray G
authors.initials: RG
authors.lastname: Blanco
authors.forename: Sara I
authors.initials: SI
authors.lastname: Pai
authors.forename: Barbara
authors.initials: B
authors.lastname: Messing
authors.forename: Patrick K
authors.initials: PK
authors.lastname: Ha
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000628:therapy*; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011832:Radiation Injuries / Q000209:etiology*; D012189:Retrospective Studies; D015996:Survival Rate
chemical_list: D002945:Cisplatin; D005472:Fluorouracil