Journal of Cancer Research and Clinical Oncology

, Volume 131, Issue 12, pp 815–820

Phase I study of continuous mitomycin-C infusion in concomitant radiochemotherapy of primary inoperable advanced head and neck cancer

  • Hans Christiansen
  • Robert M. Hermann
  • Andrea Hille
  • Heinz Schmidberger
  • Alexios Martin²
  • Mirko Nitsche
  • Clemens F. Hess
  • Olivier Pradier
Original Paper

DOI: 10.1007/s00432-005-0028-x

Cite this article as:
Christiansen, H., Hermann, R.M., Hille, A. et al. J Cancer Res Clin Oncol (2005) 131: 815. doi:10.1007/s00432-005-0028-x

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.

Keywords

Mitomycin-C Radiochemotherapy Continuous infusion Head and neck cancer Phase I trial 

Copyright information

© Springer-Verlag 2005

Authors and Affiliations

  • Hans Christiansen
    • 1
  • Robert M. Hermann
    • 1
  • Andrea Hille
    • 1
  • Heinz Schmidberger
    • 1
  • Alexios Martin²
    • 1
  • Mirko Nitsche
    • 1
  • Clemens F. Hess
    • 1
  • Olivier Pradier
    • 1
  1. 1.Department of Radiation OncologyUniversity of GoettingenGoettingenGermany
  2. 2.Department of OtorhinolaryngologyUniversity of GoettingenGoettingenGermany

Personalised recommendations