Phase I study of continuous mitomycin-C infusion in concomitant radiochemotherapy of primary inoperable advanced head and neck cancer
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- Christiansen, H., Hermann, R.M., Hille, A. et al. J Cancer Res Clin Oncol (2005) 131: 815. doi:10.1007/s00432-005-0028-x
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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.