TAX 323 Trial – Cisplatin, Fluorouracil, and Docetaxel in Unresectable Head and Neck Cancer

👉TAX 323 Jan B. Vermorken, M.D et al. Cisplatin, Fluorouracil, and Docetaxel in Unresectable Head and Neck Cancer

👉Background

• Phase 2 studies suggest that the standard regimen of cisplatin and fluorouracil (PF) plus docetaxel (TPF):
  • Improves outcomes in squamous cell carcinoma of the head and neck.
• In the TAX 323 they compared:
  • TPF with PF as induction chemotherapy in patients with locoregionally advanced, unresectable disease.

👉Methods

• The TAX 323 randomly assigned eligible patients between the ages of 18 and 70 years who had stage III or stage IV disease and no distant metastases to:
  • Receive either TPF (docetaxel and cisplatin, day 1; fluorouracil by continuous infusion, days 1 to 5) or PF every 3 weeks for four cycles.
• Patients without progression of disease:
  • Received radiotherapy within 4 to 7 weeks after completing chemotherapy.
• The primary end point was progression free survival.

👉Results

• A total of 358 patients underwent randomization:
  • With 177 assigned to the TPF group and 181 to the PF group.
• At a median follow-up of 32.5 months.
• The median progression-free survival was:
  • 11.0 months in the TPF group
  • 8.2 months in the PF group
    • Hazard ratio for disease progression or death in the TPF group:
      • 0.72; P=0.007.
• Treatment with TPF resulted in a reduction in the risk of death:
  • Of 27% (P=0.02).
• With a median overall survival of:
  • 18.8 months in the TPF, as compared with 14.5 months in the PF group.
• There were more grade 3 or 4 events of leukopenia and neutropenia in the TPF group.
• More grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group.
• The rates of death from toxic effects were:
  • 2.3% in the TPF group and 5.5% in the PF group.

👉Conclusions

• As compared with the standard regimen of cisplatin and fluorouracil, induction chemotherapy with the addition of docetaxel:
  • Significantly improved progression- free and overall survival in patients with unresectable squamous-cell carcinoma of the head and neck:
    • ClinicalTrials.gov number, NCT00003888.

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