Concomitant Chemoradiotherapy With Mitomycin C and Cisplatin in Advanced Unresectable Carcinoma of the Head and Neck: Phase I–II Clinical Study

Purpose To evaluate the toxicity and efficacy of concomitant chemoradiotherapy with mitomycin C and cisplatin in the treatment of advanced unresectable squamous cell carcinoma of the head and neck. Patients and Methods Treatment consisted of conventional radiotherapy (70 Gy in 35 fractions), mitomycin C 15 mg/m 2 IV, applied after the delivery of 10 Gy, and cisplatin at an initial dose of 10 mg/m 2 /d IV, applied during the last 10 fractions of irradiation (“chemoboost”). The cisplatin dose was escalated with respect to the toxic side effects by 2 mg/m 2 /d up to the maximum tolerated dose (MTD) or at the most 14 mg/m 2 /d (Phase I study), which was tested in the subsequent Phase II study. Results All 36 patients had Stage T4 and/or N3 disease, and the majority had oropharyngeal (50%) or hypopharyngeal (39%) primary tumors. Six patients were treated at each of the three cisplatin dose levels tested (Phase I study). Dose-limiting toxicity was not reached even at 14 mg/m 2 /d of cisplatin, which was determined as the MTD and tested in an additional 18 patients (Phase II study). After a median follow-up time of 48 months, 4-year locoregional control, failure-free, and overall survival rates were 30%, 14%, and 20%, respectively. In 24 patients treated at the cisplatin dose level of 14 mg/m 2 /d, the corresponding rates were 40%, 20%, and 22%, respectively. Conclusion Concomitant chemoradiotherapy with mitomycin C and cisplatin “chemoboost” at 14 mg/m 2 /d is feasible, with encouraging survival results if the extremely poor disease profile of the treated patients is considered.