• Primary treatment with concurrent chemotherapy and radiation:
    • Has been accepted widely as a standard of care:
      • Since the publication of the Meta-Analysis of Chemotherapy on Head and Neck Cancer in 2000
    • This meta-analysis was later updated in 2009:
      • Involving an analysis of 50 trials that showed an absolute survival benefit of 6.5% at 5 years:
        • Associated with administering chemotherapy concurrently with radiation
  • Bolus cisplatin (100 mg/m2 on days 1, 22, and 43) concurrent with radiation therapy:
    • Has been extensively studied and may be considered the standard to which other chemotherapy regimens are compared in clinical research
  • The intergroup trial conducted by Adelstein and colleagues was influential in establishing this regimen as a standard of care (Figure):
    • In a three-arm randomized phase III trial of 295 patients:
      • With locally advanced stage M0 head and neck squamous cell carcinoma (SCC):
        • The treatment groups were:
          • Radiation therapy alone (70 Gy) versus
          • Identical radiation plus concurrent cisplatin (100 mg/ m2 administered intravenously on days 1, 22, and 43) versus a split course of radiation with cisplatin plus 5-FU
      • With a median follow up of 41 months:
        • The concurrent cisplatin / radiation arm had a significant advantage in survival at 3 years compared with radiation alone:
          • 37% versus 23%, p = .014
        • Survival in the split-course concurrent arm (27%):
          • Was not significantly better than that in the radiation arm
        • This improved efficacy comes at the cost of an increased incidence of acute toxicities:
          • Including mucositis and nausea / vomiting
        • Four toxic deaths occurred among 95 patients enrolled in the cisplatin chemoradiation arm

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