title: Phase II study of erlotinib and docetaxel with concurrent intensity-modulated radiotherapy in locally advanced head and neck squamous cell carcinoma.
abstract: 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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Radiation Oncology, University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
authors.forename: Min
authors.initials: M
authors.lastname: Yao
authors.affiliation: Department of Radiation Oncology, University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
authors.forename: Charles
authors.initials: C
authors.lastname: Woods
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
authors.forename: Pierre
authors.initials: P
authors.lastname: Lavertu
authors.affiliation: Department of Epidemiology and Biostatistics, Case Western Reserve University School of Medicine, Cleveland, Ohio.
authors.forename: Pingfu
authors.initials: P
authors.lastname: Fu
authors.affiliation: Department of Internal Medicine (Medical Oncology), University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
authors.forename: Michael
authors.initials: M
authors.lastname: Gibson
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
authors.forename: Rod
authors.initials: R
authors.lastname: Rezaee
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
authors.forename: Chad
authors.initials: C
authors.lastname: Zender
authors.affiliation: Department of Pathology, University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
authors.forename: Jay
authors.initials: J
authors.lastname: Wasman
authors.affiliation: Department of Internal Medicine (Medical Oncology), University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
authors.forename: Neelesh
authors.initials: N
authors.lastname: Sharma
authors.affiliation: Department of Radiation Oncology, University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
authors.forename: Mitchell
authors.initials: M
authors.lastname: Machtay
authors.affiliation: Department of Internal Medicine (Medical Oncology), University Hospitals Case Medical Center, Seidman Cancer Hospital, Cleveland, Ohio.
authors.forename: Panayiotis
authors.initials: P
authors.lastname: Savvides
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin; D018572:Disease-Free Survival; D000077143:Docetaxel; D000069347:Erlotinib Hydrochloride / Q000627:therapeutic use*; D005260:Female; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D050397:Radiotherapy, Intensity-Modulated; D043823:Taxoids / Q000627:therapeutic use*
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000069347:Erlotinib Hydrochloride; D002945:Cisplatin
keywords: chemoradiation; docetaxel; erlotinib; head and neck cancer; radiation