Docetaxel and vinorelbine in recurrent head and neck cancer: Pharmacokinetic and clinical results

Mario Airoldi, Luigi Cattel, Sara Marchionatti, Valeria Recalenda, Fulvia Pedani, Valentina Tagini, Cesare Bumma, Fabio Beatrice, Giovanni Succo, Anna Maria Gabriele

Research output: Contribution to journalArticlepeer-review


The purpose of this study was to evaluate pharmacokinetic parameters, efficacy, and toxicity of a combination of docetaxel (DTX) and vinorelbine (VNB) in recurrent heavily pretreated squamous cell head and neck cancer. Twenty-nine patients previously treated with concomitant chemoradiotherapy (n = 14), surgery plus radiotherapy (n = 13), surgery + concomitant chemoradiotherapy (n = 1) and radiotherapy alone (n = 1) were enrolled; 9 patients had received 1 or more courses of palliative chemotherapy. Twenty-one patients had a local-regional recurrence, and 8 patients had metastases. The doses were 80 mg/m2 for DTX and 20 mg/m2 for VNB on day 1 every 21 days for a maximum of 6 cycles. Pharmacokinetic evaluations were performed on 24 patients; in a group of 12 patients, VNB administration immediately followed DTX infusion (schedule A), and in 12 patients VNB administration was immediately followed by DTX infusion (schedule B). Twenty-nine patients received a total of 137 cycles (median per patient, 5). Neutropenia was the most frequent and severe side effect (grade IV in 79%; grade III in 21%). Grade IV (7%) and III (14%) infections were observed in the first 12 patients; ciprofloxacin prophylaxis in the following 17 patients reduced the severe toxicity to 0%. The overall response rate was 49%, which included 3 of 29 complete responses (10%) and II of 29 partial responses (38%). Median complete and partial response durations were 20+ and 5.5 months, respectively. Overall median survival was 10 months (range, 2-30+). The mean values of area under the curve, mean residence time (MRT), and Cmax of VNB were significantly lower for schedule A than for schedule B. The mean values of VNB clearance were significantly higher for schedule A than for schedule B. Neutrophil count at the nadir was much lower for patients receiving schedule B. The DTX-VNB combination is effective in heavily pretreated patients with a short-lasting manageable toxicity. Pharmacokinetic evaluations suggested that the sequence DTX → VNB is safer than the sequence VNB → DTX.

Original languageEnglish
Pages (from-to)378-381
Number of pages4
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number4
Publication statusPublished - Aug 2003


  • Chemotherapy
  • Docetaxel
  • Head and neck cancer
  • Pharmacokinetic
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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