Postoperative concurrent chemoradiotherapy with mitomycin in advanced squamous cell carcinoma of the head and neck: results from three prospective randomized trials.

UNLABELLED: Recent prospective randomized trials have shown concurrent chemoradiotherapy improves locoregional control in postoperative patients with squamous cell carcinoma of the head and neck using cisplatin-based regimes. This report presents data pooled from three randomized trials employing mitomycin, selecting those patients treated postoperatively, to evaluate the long-term benefit of mitomycin in the postoperative setting and to compare these results with those of two other recently published randomized trials. METHODS AND MATERIALS: Between 1980 and 1999, a total of 331 patients with squamous cell carcinoma of the head and neck from the three prospective trials were enrolled. Of the 205 postoperative patients in these trials, 103 were randomized to receive mitomycin and radiation, while 102 received radiation alone or radiation with porfiromycin in the third trial. Patients were treated with standard daily radiotherapy to a total median dose of 60 Gy over 47 days. Patients who were randomized to mitomycin C received 15 mg/m2 of the drug on days 5 and 47 (or last day). RESULTS: The 5-year rate of locoregional control was higher in the mitomycin arms. There was no statistically significant difference in the rates of overall survival or distant metastasis. Patients had a lower percentage of high-risk factors in both arms of the study, compared with patients in the large prospective trials, including positive margins, two or more positive lymph nodes, or oropharynx primary tumors. The gains in locoregional control realized with mitomycin were similar to the improvements in the recently published randomized trials using platinum. CONCLUSIONS: These results confirm significant gains in locoregional control using concurrent chemoradiotherapy in the postoperative setting for patients with squamous cell carcinoma of the head and neck. The lack of consensus over a benefit in the rates of overall survival and distant metastasis emphasizes the need for further prospective trials in the postoperative management of squamous cell carcinoma of the head and neck.