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 there 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.

#Arrangoiz #HeadandNeckSurgeon #CancerSurgeon #SurgicalOncology #Teacher #Surgeon #PharyngealCancer

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