Docetaxel and irinotecan in recurrent or metastatic head and neck cancer: A phase 2 trial of the eastern cooperative oncology group

Athanassios Argiris, Ashley Buchanan, Bruce Brockstein, Jill Kolesar, Musie Ghebremichael, Michael Pins, Kristine Hahn, Rita Axelrod, Arlene Forastiere

Research output: Contribution to journalArticlepeer-review

20 Scopus citations


BACKGROUND: Docetaxel and irinotecan have single-agent antitumor activity in squamous cell carcinoma of the head and neck (SCCHN). The authors sought to evaluate their combination in the treatment of patients with recurrent or metastatic SCCHN. METHODS: Eligibility criteria included recurrent or metastatic SCCHN with measurable disease, good performance status, and adequate laboratory parameters. Patients received docetaxel 35 mg/m2 and irinotecan 60 mg/m2, intravenously, on Days 1 and 8, every 21 days, until disease progression. The authors assessed UGT1A1 genotype, vascular endothelial growth factor (VEGF) in serum, and cyclooxygenase-2 and VEGF in baseline tumor tissue. RESULTS: Fifty-two patients were analyzable: 20 chemotherapy naive (Group A) and 32 previously treated with 1 chemotherapy regimen (Group B); 73% of patients had distant metastasis, and 60% were paclitaxel-exposed. In Group A, 3 (15%) patients achieved a partial response; in Group B, 1 (3%) patient achieved a partial response. Median progression-free survival (PFS) and overall survival were 3.3 and 8.2 months in Group A and 1.9 and 5.0 months in Group B, respectively. Common serious toxicities were diarrhea, fatigue, and anorexia. Patients with high serum VEGF had a median PFS of 2.8 months versus 1.7 months for patients with low VEGF (P = .085). CONCLUSIONS: Docetaxel and irinotecan had acceptable toxicities, but efficacy results in unselected patients with recurrent or metastatic SCCHN did not suggest an advantage over docetaxel alone or platinum-based regimens.

Original languageEnglish
Pages (from-to)4504-4513
Number of pages10
Issue number19
StatePublished - Oct 1 2009


  • Docetaxel
  • Head and neck cancer
  • Irinotecan
  • Vascular endothelial growth factor

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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