A phase I/II trial of gefitinib and radiotherapy in patients with locally advanced inoperable squamous cell carcinoma of the head and neck

Francesco Caponigro, Carmen Romano, Amalia Milano, Raffaele Solla, Giovanni Franchin, Vincenzo Adamo, Ettore Mari, Brunello Morrica, Stefano Pepe

Research output: Contribution to journalArticlepeer-review

Abstract

Two different doses of gefitinib, administered along with standard radiation therapy, were tested in locally advanced inoperable head and neck cancer with the aim of finding the maximum tolerated dose and assessing the toxicity and activity of the combination. The standard 3+3 design was used for the phase I study. Radiation therapy was given according to conventional dose and schedule. Gefitinib dose escalation was stopped if more than one-third of patients of a given cohort had dose-limiting toxicity. Dose-limiting toxicity was observed in three of four patients treated at the dose of 500ĝ€‰mg, and included grade 3 stomatitis in three patients and grade 3 liver toxicities in one patient. The dose level of 250ĝ€‰mg was recommended for the phase II study. Six confirmed objective responses were observed among 16 patients. Our results do not support further trials with gefitinib and radiation therapy, according to our schedule, in this patient population. Integration of gefitinib within chemoradiotherapy regimens and combination with other biological therapies may represent the next challenge.

Original languageEnglish
Pages (from-to)739-744
Number of pages6
JournalAnti-Cancer Drugs
Volume19
Issue number7
DOIs
Publication statusPublished - Aug 2008

Keywords

  • Epidermal growth factor receptor
  • Gefitinib
  • Head and neck cancer
  • Phase I/II study
  • Tyrosine kinase inhibitor

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Cancer Research
  • Oncology

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