title: Phase 1 study of erlotinib plus radiation therapy in patients with advanced cutaneous squamous cell carcinoma.
abstract: OBJECTIVE
  To assess the toxicity profile of erlotinib therapy combined with postoperative adjuvant radiation therapy in patients with advanced cutaneous squamous cell carcinoma.
  
  
  METHODS
  This was a single-arm, prospective, phase 1 open-label study of erlotinib with radiation therapy to treat 15 patients with advanced cutaneous head-and-neck squamous cell carcinoma. Toxicity data were summarized, and survival was analyzed with the Kaplan-Meier method.
  
  
  RESULTS
  The majority of patients were male (87%) and presented with T4 disease (93%). The most common toxicity attributed to erlotinib was a grade 2-3 dermatologic reaction occurring in 100% of the patients, followed by mucositis (87%). Diarrhea occurred in 20% of the patients. The 2-year recurrence rate was 26.7%, and mean time to cancer recurrence was 10.5 months. Two-year overall survival was 65%, and disease-free survival was 60%.
  
  
  CONCLUSIONS
  Erlotinib and radiation therapy had an acceptable toxicity profile in patients with advanced cutaneous squamous cell carcinoma. The disease-free survival in this cohort was comparable to that in historical controls.
authors.affiliation: Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA.
authors.forename: C Hope
authors.initials: CH
authors.lastname: Heath
authors.forename: Nicholas L
authors.initials: NL
authors.lastname: Deep
authors.forename: Lisle
authors.initials: L
authors.lastname: Nabell
authors.forename: William R
authors.initials: WR
authors.lastname: Carroll
authors.forename: Renee
authors.initials: R
authors.lastname: Desmond
authors.forename: Lisa
authors.initials: L
authors.lastname: Clemons
authors.forename: Sharon
authors.initials: S
authors.lastname: Spencer
authors.forename: J Scott
authors.initials: JS
authors.lastname: Magnuson
authors.forename: Eben L
authors.initials: EL
authors.lastname: Rosenthal
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D018572:Disease-Free Survival; D000069347:Erlotinib Hydrochloride; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D011855:Radiodermatitis; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D012878:Skin Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D013280:Stomatitis / Q000209:etiology
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride