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.
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.
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Authors: M F Adam; E C Gabalski; D A Bloch; J W Oehlert; J M Brown; A A Elsaid; H A Pinto; D J Terris Journal: Head Neck Date: 1999-03 Impact factor: 3.147
Authors: L Smid; H Lesnicar; B Zakotnik; E Soba; M Budihna; L Furlan; M Zargi; Z Rudolf Journal: Int J Radiat Oncol Biol Phys Date: 1995-06-15 Impact factor: 7.038
Authors: Hans Christiansen; Robert M Hermann; Andrea Hille; Elisabeth Weiss; Mirko Nitsche; Alexios Martin; Clemens F Hess; Olivier Pradier Journal: Head Neck Date: 2004-10 Impact factor: 3.147
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Authors: J T Hartmann; A Harstrick; T Daikeler; C Kollmannsberger; C Müller; S Seeber; L Kanz; C Bokemeyer Journal: Anticancer Drugs Date: 1998-06 Impact factor: 2.248