(1) Department of Radiation Oncology, University of Goettingen, Robert-Koch-Str. 40, Goettingen, Germany;(2) Department of Otorhinolaryngology, University of Goettingen, 37075 Goettingen, Germany
Abstract:
Purpose: A phase I trial to evaluate the maximum tolerated dose (MTD) of continuous mitomycin-C infusion in radiochemotherapy of inoperable HNSCC. Methods: Twenty-one patients were treated with 70 Gy (2 Gy/day) and simultaneous chemotherapy (5-FU 600 mg/m2/day and MMC, both as continuous infusion on days 1–5 and 36–40. The MMC dose was dependent on dose escalation levels I–IV: 2/2.6/3.2/4 mg/m2/day. Results: Dose limiting toxicity (DLT) (grade 3 mucositis and/or dysphagia) occurred at dose level IV (MMC 4 mg/m2/day). Accordingly, dose escalation level III (MMC 3.2 mg/m2/day) was set as the MTD. One and 2-year survival rate: 66.7 and 29.5%, disease free survival: 47.6 and 22.8%, respectively. Conclusions: Our study demonstrates that continuous infusion of 5-FU/MMC can be safely administered at a MMC dose of 3.21 mg/m2/day on days 1–5 and 36–40 in concomitant radiochemotherapy. A phase II study should be initiated to establish the role of this regimen in the treatment of head and neck cancer.
