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

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