Annals of Surgical Oncology

, Volume 21, Issue 13, pp 4263–4269 | Cite as

Assessment of Erlotinib as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer Patients

  • Eben L. RosenthalEmail author
  • Thomas K. Chung
  • William R. Carroll
  • Lisa Clemons
  • Renee Desmond
  • Lisle Nabell
Head and Neck Oncology



To determine the tolerability and efficacy of long-term treatment with erlotinib for head and neck squamous cell carcinoma after salvage surgery.


An open-label study was conducted of 150 mg of daily erlotinib for 12 months in patients who completed definitive surgical therapy for recurrent head and neck squamous cell carcinoma. The primary outcome measures were tolerability of prolonged erlotinib therapy and disease-free survival and overall survival at 1 and 2 years.


Thirty-one patients were enrolled onto this study. Mean duration of erlotinib therapy was 5 months (range 2–374 days), with 8 patients completing the full 12-month course of erlotinib. Of the remaining patients, 8 discontinued therapy as a result of recurrence, 10 for medical or surgical complications deemed unrelated to the study medication, and 3 for drug-related toxicities. There were 25 grade 3 adverse events; 4 were classified as possibly related to study medication. The most common adverse events included acneiform rash (n = 26 patients), fatigue (n = 22), and diarrhea (n = 22). Overall survival was 61 % at 1 year and 56 % at 2 years. Disease-free survival was 54 % at 1 year and 45 % at 2 years. Mean time to recurrence (n = 16) was 8.7 months.


Long-term erlotinib is safe and demonstrates some potential survival benefit compared to historical controls. However, despite the absence of grade 3/4 adverse events attributable to the drug, tolerance of long-term erlotinib was a significant barrier to completion of a 12-month course of therapy.


Epidermal Growth Factor Receptor Erlotinib Neck Squamous Cell Carcinoma Measurable Disease Acneiform Rash 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



Work was supported by Grants from the National Institutes of Health (T32CA091078) and an institutional Grant from Genentech.

Conflict of interest


Supplementary material

10434_2014_3878_MOESM1_ESM.doc (44 kb)
Supplementary material 1 (DOC 43 kb)


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Copyright information

© Society of Surgical Oncology 2014

Authors and Affiliations

  • Eben L. Rosenthal
    • 1
    Email author
  • Thomas K. Chung
    • 1
  • William R. Carroll
    • 1
  • Lisa Clemons
    • 1
  • Renee Desmond
    • 2
  • Lisle Nabell
    • 3
  1. 1.Division of Otolaryngology, Department of SurgeryUniversity of Alabama at BirminghamBirminghamUSA
  2. 2.Division of Preventive MedicineUniversity of Alabama at BirminghamBirminghamUSA
  3. 3.Division of Hematology/Oncology, Department of MedicineUniversity of Alabama at BirminghamBirminghamUSA

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