Date of Award


Document Type

Open Access Thesis

Degree Name

Medical Doctor (MD)

First Advisor

Bruce G Haffty


Purpose: Recent prospective randomized trials have shown concurrent chemo-radiation improves local-regional control in post-operative patients with squamous cell carcinomas of the head and neck (SCCHN) using cis-platinum based regimens. This report pools data from three randomized trials performed at Yale that employed mitomycin-C (MC), selecting those patients treated postoperatively, to evaluate the long term benefit of MC in the postoperative setting and to compare these results with other recently published randomized trials. Methods and Materials: Between 1980 and 1999, a total of 331 SCCHN patients from the three prospective trials were enrolled. Of those patients, 205 were post-operative of which 103 were randomized to receive mitomycin-C and radiation, while 102 received radiation alone or radiation with porfiromycin in the third trial. Patients were treated with daily radiotherapy to a total median dose of 60 Gy over 47 days. Patients who were randomized to MC received 15 milligrams per square meter (mg/M2) of mitomycin-C on days 5 and 47 (or last day). Results: The 5-year rate of local-regional control was higher in the MC arms (85.3% vs. 69.9%, p = .008). There was no statistically significant difference in overall survival or distant metastasis. Patients had a lower percentage of high risk factors in both arms of the study, compared to patients of the large prospective trials, including positive margins, 2 or more positive lymph nodes, or oropharynx primary. The gains in local-regional control realized with MC were similar to the improvements in the recently published randomized trials using cis-platinum. Conclusions: These results confirm significant gains in local-regional control using concurrent chemo-radiotherapy in the postoperative setting for patients with SCCHN. The lack of consensus over a benefit in overall survival and distant metastasis emphasizes the need for further prospective trials in the postoperative management of SCCHN.