Gemcitabine and vinorelbine in recurrent head and neck cancer: pharmacokinetic and clinical results.

摘要: Objectives To evaluate the pharmacokinetic parameters, efficacy and toxicity of a combination gemcitabine (GEM) vinorelbine (VNB) in recurrent heavily pre-treated squamous cell head neck carcinoma. Materials methods Twenty-four patients previously treated with concomitant chemo-radiotherapy (n = 13), surgery plus radiotherapy 10) + 1) were enrolled; 7 had received one or more courses palliative chemotherapy. Twenty local-regional recurrence 4 metastases. The doses 1200 mg/m2 for GEM 30 VNB on days 1 8 every 21 days; maximum 6 cycles was allowed. Pharmacokinetic investigations performed 9 receiving VNB. As PK control, second group 5 given as single agent, at same i.v. infusion length. Results total 135 (median per patient, 5). Neutropenia most frequent side-effect (92% patients; grade 3-4 50%). overall response rate 25% which included 24 complete responses (4%) partial (21%). Responses observed only good prognostic characteristics. median duration 5.5 months (2-16 months) survival (range, 2-25+). Vinorelbine serum levels showed no evidence any interaction GEM; all, rebound disposition can be produced by pre-administration. Conclusion GEM-VNB has role favourable characteristics; results seem better than those alone. Moreover, this drug association does not alter profile both drugs, also compared to monotherapy.