Objectives: To evaluate the pharmacokinetic parameters, efficacy and toxicity of a combination of gemcitabine (GEM) and vinorelbine (VNB) in recurrent heavily pre-treated squamous cell head and neck carcinoma. Materials and Methods: Twenty-four patients previously treated with concomitant chemo-radiotherapy (n=13), surgery plus radiotherapy (n=10) and surgery + concomitant chemo-radiotherapy (n=1) were enrolled; 7 patients had received one or more courses of palliative chemotherapy. Twenty patients had a local-regional recurrence and 4 patients had metastases. The doses were 1200 mg/m(2) for GEM and 30 mg/m2 for VNB on days 1 and 8 every 21 days; a maximum of 6 cycles was allowed. Pharmacokinetic investigations were performed on 9 patients receiving GEM and VNB. As a PK control, a second group of 5 patients was given GEM as single agent, at the same doses and with the same i.v. infusion length. Results: Twenty-four patients received a total of 135 cycles (median per patient, 5). Neutropenia was the most frequent side-effect (92% of patients; grade 3-4 in 50%). The overall response rate was 25% which included 1 of 24 complete responses (4%) and 4 of 24 partial responses (21%). Responses were observed only in patients with good prognostic characteristics. The median response duration was 5.5 months (2-16 months) and the overall median survival was 9 months (range, 2-25+). Vinorelbine serum levels showed no evidence of any pharmacokinetic interaction with GEM; most of all, no rebound in VNB disposition can be produced by GEM pre-administration. Conclusion: The GEM-VNB combination has a palliative role in patients with favourable characteristics; the results seem no better than those observed with VNB alone. Moreover, this drug association does not alter the pharmacokinetic profile of both drugs, also compared to. GEM monotherapy.
Gemcitabine and vinorelbine in recurrent head and neck cancer: pharmacokinetic and clinical results
CATTEL, Luigi;
2003-01-01
Abstract
Objectives: To evaluate the pharmacokinetic parameters, efficacy and toxicity of a combination of gemcitabine (GEM) and vinorelbine (VNB) in recurrent heavily pre-treated squamous cell head and neck carcinoma. Materials and Methods: Twenty-four patients previously treated with concomitant chemo-radiotherapy (n=13), surgery plus radiotherapy (n=10) and surgery + concomitant chemo-radiotherapy (n=1) were enrolled; 7 patients had received one or more courses of palliative chemotherapy. Twenty patients had a local-regional recurrence and 4 patients had metastases. The doses were 1200 mg/m(2) for GEM and 30 mg/m2 for VNB on days 1 and 8 every 21 days; a maximum of 6 cycles was allowed. Pharmacokinetic investigations were performed on 9 patients receiving GEM and VNB. As a PK control, a second group of 5 patients was given GEM as single agent, at the same doses and with the same i.v. infusion length. Results: Twenty-four patients received a total of 135 cycles (median per patient, 5). Neutropenia was the most frequent side-effect (92% of patients; grade 3-4 in 50%). The overall response rate was 25% which included 1 of 24 complete responses (4%) and 4 of 24 partial responses (21%). Responses were observed only in patients with good prognostic characteristics. The median response duration was 5.5 months (2-16 months) and the overall median survival was 9 months (range, 2-25+). Vinorelbine serum levels showed no evidence of any pharmacokinetic interaction with GEM; most of all, no rebound in VNB disposition can be produced by GEM pre-administration. Conclusion: The GEM-VNB combination has a palliative role in patients with favourable characteristics; the results seem no better than those observed with VNB alone. Moreover, this drug association does not alter the pharmacokinetic profile of both drugs, also compared to. GEM monotherapy.
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