Long-Term Survival Results of a Phase III Intergroup Trial (RTOG 95-01) of Surgery Followed by Radiotherapy vs. Radiochemotherapy for Resectable High Risk Squamous Cell Carcinoma of the Head and Neck

Reviewer: Charles Wood, MD
Abramson Cancer Center of the University of Pennsylvania
Last Modified: November 6, 2006

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Presenter: Jay S. Cooper, MD
Presenter's Affiliation: Maimonides Cancer Center; NY, NY
Type of Session: Scientific

Background

  • Preliminary results of this study suggested a benefit in locoregional control and disease-free survival in patients with high-risk head and neck cancer receiving concurrent cisplatin and radiotherapy following resection.
  • This study sought to evaluate differences in survival following a 5-year follow-up period.

Materials and Methods

  • This study looked at 410 patients with squamous cell carcinoma of the head and neck status post surgical resection. Patients with pathologic evidence of extracapsular extension, involvement of at least 2 lymph nodes, or microscopically positive resection margins were included.
  • Eligible patients were randomized to one of two arms: either 60 Gy in 6 weeks (with or without a 6 Gy boost), or 60 Gy in 6 weeks (with or without a 6 Gy boost) plus cisplatin chemotherapy on days 1, 22, and 43.

Results

  • The median follow-up for all living patients was 6.1 years.
  • There was no statistical difference in locoregional control between the 2 groups (p=0.083).
  • There was no statistical difference in disease-free survival between the 2 groups (p= 0.098).
  • There was no statistical difference in overall survival between the 2 groups (p=0.23).

Author's Conclusions

  • This trial does not demonstrate the superiority of concurrent cisplatin and radiation for the head and neck population studied.
  • The rates for locoregional control, disease-free survival, and overall survival have changed very little since the initial report.
  • However, this trial does not refute the superiority of concurrent cisplatin and radiation for patients with high-risk head and neck cancer.
  • This regimen of concurrent chemoradiation does not provide an adequate benefit for those patients with node-positive disease found only following resection.
  • This regimen does, however, provide an adequate benefit for those patients with the worst prognosis (i.e. extracapsular extension and/or microscopically positive mucosal margins)

Clinical/Scientific Implications

  • The discrepancy in the results shown here as compared to the originally published manuscript likely is a reflection of one and/or two important factors:

 1) a more specific patient cohort (i.e. those with the worst prognostic characteristics) should be evaluated to demonstrate benefits in the concurrent chemoradiation regimen utilized in this trial or 2) a superior systemic agent is needed to provide a clinically significant benefit in the population of patients included in this trial



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