Objective: To comment on the use of surgery after the failure of radiotherapy in patients with advanced laryngeal, oropharyngeal, and hypopharyngeal carcinomas.
Design: Randomized, controlled, clinical trial, with a mean follow-up period of 3.1 years.
Setting: The Princess Margaret Hospital, Toronto, Ontario.
Patients: Patients with advanced laryngopharyngeal carcinoma (T3 or T4 or N+).
Intervention: Three hundred thirty-six patients who met the eligibility criteria were enrolled in a randomized, controlled, clinical trial and treated with primary radiotherapy using either the standard fractionation regimen or the hyperfractionation regimen. One hundred eight patients with recurrent disease underwent salvage surgery and were observed prospectively, with careful documentation of surgical and tumor data, complications, recurrences, and survival.
Main outcome measures: Surgical complication rate and survival.
Results: Of the 108 patients who underwent surgery, 29 (27%) had complications. One third of these had multiple complications. There was no statistical difference between the surgical complication rates of the 2 radiotherapy groups (16 patients [28%] in the standard fractionation radiotherapy group and 13 [25%] in the hyperfractionation radiotherapy group). Survival after surgery was statistically correlated with the TNM system for the stage of the recurrent tumor, the pathologic nodal status, and the surgical margin status. The overall 3-year survival rate, which was calculated from the date of surgery, for the group of patients who underwent surgery was 22%.
Conclusions: In this patient population, the hyperfractionation regimen was not associated with a higher surgical complication rate. Using the policy of primary radiotherapy and reserving surgery for the management of failures of radiotherapy, 140 patients (71%) at highest risk (laryngeal and hypopharyngeal primary tumor sites) retained an intact larynx until the end of the study or death. Since it is the stage of the recurrent tumor that correlates with survival rather than the stage of the tumor at initial presentation, we suggest that tumors be restaged at the time of recurrence.