Phase II study of erlotinib and docetaxel with concurrent intensity-modulated radiotherapy in locally advanced head and neck squamous cell carcinoma

Head Neck. 2016 Apr;38 Suppl 1(Suppl 1):E1770-6. doi: 10.1002/hed.24313. Epub 2016 Feb 26.

Abstract

Background: The purpose of this study was to establish the efficacy and toxicities of concurrent erlotinib and docetaxel with intensity-modulated radiotherapy (IMRT) for locally advanced head and neck squamous cell carcinoma (HNSCC).

Methods: Patients received daily erlotinib for 2 weeks, followed by daily IMRT with concurrent weekly docetaxel and daily erlotinib, followed by daily erlotinib for up to 2 years. The primary objective was disease-free survival (DFS). Secondary objectives included overall survival (OS), patterns of failure, and toxicities. Forty-three patients were recruited for this study.

Results: With a median follow-up of 48.7 months, the 3-year DFS, OS, locoregional failure-free survival, and distant metastasis-free survival was 69.5%, 81%, 82.4%, and 83.7%, respectively. The most common grade III/IV local toxicities were dysphagia, dermatitis, and mucositis. Patients with p16-positive tumors had significantly better outcomes.

Conclusion: The regimen is tolerable and effective. It is worthy of further investigation in selected patients and may be useful in patients who cannot tolerate cisplatin. © 2016 Wiley Periodicals, Inc. Head Neck 38: E1770-E1776, 2016.

Keywords: chemoradiation; docetaxel; erlotinib; head and neck cancer; radiation.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols
  • Carcinoma, Squamous Cell / therapy*
  • Chemoradiotherapy*
  • Cisplatin
  • Disease-Free Survival
  • Docetaxel
  • Erlotinib Hydrochloride / therapeutic use*
  • Female
  • Head and Neck Neoplasms / therapy*
  • Humans
  • Male
  • Middle Aged
  • Radiotherapy, Intensity-Modulated*
  • Taxoids / therapeutic use*

Substances

  • Taxoids
  • Docetaxel
  • Erlotinib Hydrochloride
  • Cisplatin