Phase 1 study of erlotinib plus radiation therapy in patients with advanced cutaneous squamous cell carcinoma.

Academic Article

Abstract

  • PURPOSE: To assess the toxicity profile of erlotinib therapy combined with postoperative adjuvant radiation therapy in patients with advanced cutaneous squamous cell carcinoma. METHODS AND MATERIALS: 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.
  • Keywords

  • Aged, Aged, 80 and over, Carcinoma, Squamous Cell, Disease-Free Survival, Erlotinib Hydrochloride, Female, Head and Neck Neoplasms, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Prospective Studies, Protein Kinase Inhibitors, Quinazolines, Radiodermatitis, Radiotherapy Dosage, Radiotherapy, Adjuvant, Skin Neoplasms, Stomatitis
  • Digital Object Identifier (doi)

    Author List

  • Heath CH; Deep NL; Nabell L; Carroll WR; Desmond R; Clemons L; Spencer S; Magnuson JS; Rosenthal EL
  • Start Page

  • 1275
  • End Page

  • 1281
  • Volume

  • 85
  • Issue

  • 5