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. © 2013 Elsevier Inc.
  • 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