TAX 324 Cisplatin and Fluorouracil Alone or with Docetaxel in Head and Neck Cancer

👉 TAX 324 Posner, M.D et al Cisplatin and Fluorouracil Alone or with Docetaxel in Head and Neck Cancer.

👉Background

• A randomized phase 3 trial of the treatment of squamous-cell carcinoma of the head and neck:
  • Compared induction chemotherapy with docetaxel plus cisplatin and fluorouracil (TPF) with cisplatin and fluorouracil (PF), followed by chemoradiotherapy

👉 Methods

• In the TAX 324 they randomly assigned 501 patients:
  • All of whom had stage III or IV disease with no distant metastases and tumors considered to be unresectable or were candidates for organ preservation:
    • To receive either TPF or PF induction chemotherapy, followed by chemoradiotherapy:
      • With weekly carboplatin therapy and radiotherapy for 5 days per week
• The primary end point was overall survival

👉 Results

• With a minimum of two-years of follow-up (≥ 3 years for 69% of patients):
  • Significantly more patients survived in the TPF group than in the PF group:
    • Hazard ratio for death, 0.70; P=0.006
• Estimates of overall survival at three-years were:
  • 62% in the TPF group
  • 48% in the PF group
• The median overall survival was:
  • 71 months in the TPF
  • 30 months in the PF:
    • P = 0.006
• There was better locoregional control in the TPF group than in the PF group (P=0.04)
• The incidence of distant metastases in the two groups did not differ significantly (P=0.14)
• Rates of neutropenia and febrile neutropenia were higher in the TPF group
• Chemotherapy was more frequently delayed because of hematologic adverse events in the PF group

👉 Conclusions

• Patients with squamous-cell carcinoma of the head and neck who received docetaxel plus cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy:
  • Had a significantly longer survival than did patients who cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy:
    • ClinicalTrials.gov number, NCT00273546