Multicenter Phase II Study of Erlotinib, an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck
Abstract
Purpose: To determine the efficacy and safety profiles of erlotinib in patients with advanced recurrent and/or metastatic squamous cell cancer of the head and neck (HNSCC). Patients and Methods: Patients with locally recurrent and/or metastatic HNSCC, regardless of their HER1/EGFR status, were treated with erlotinib at an initial dose of 150 mg daily. Dose reductions or escalations were allowed based on tolerability of erlotinib. Results: One-hundred fifteen patients were enrolled onto this study. Forty-seven percent of patients received erlotinib at 150 mg daily throughout the entire study, 6% had dose escalations, and 46% required dose reductions and/or interruptions. Five patients achieved partial responses on study, for an overall objective response rate of 4.3% (95% CI, 1.4% to 9.9%). Disease stabilization was maintained in 44 patients (38.3%) for a median duration of 16.1 weeks. The median progression-free survival was 9.6 weeks (95% CI, 8.1 to 12.1 weeks), and the median overall survival was 6.0 months (95% CI, 4.8 to 7.0 months). Subgroup analyses revealed a significant difference in overall survival favoring patients who developed at least grade 2 skin rashes versus those who did not (P = .045), whereas no difference was detected based on HER1/EGFR expression. Rash and diarrhea were the most common drug-related toxicities, encountered in 79% and 37% of patients, respectively, though the severity was mild to moderate in most cases. Conclusion: Erlotinib was well tolerated in this heavily pretreated HNSCC population and produced prolonged disease stabilization; hence, further evaluation of its role in this tumor type is warranted.
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Erlotinib blocked p-EGFR in POS-fed RPE-J cells at 3 h and 6 h.
“Incubation of RPE-J cells with erlotinib, a specific EGFR tyrosine kinase inhibitor 38,39 blocked p-EGFR in POS-fed RPE-J cells at 3 h and 6 h (Fig. 6B, bottom images).”
From RUBCN/rubicon and EGFR regulate lysosomal degradative processes in the retinal pigment epithelium (RPE) of the eye (2017) · cites this paper as [38]
Erlotinib is a specific EGFR tyrosine kinase inhibitor.
“Incubation of RPE-J cells with erlotinib, a specific EGFR tyrosine kinase inhibitor 38,39”
From RUBCN/rubicon and EGFR regulate lysosomal degradative processes in the retinal pigment epithelium (RPE) of the eye (2017) · cites this paper as [38]
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- Authors
- Soulieres, D., Senzer, N. N., Vokes, E. E., Hidalgo, M., Agarwala, S. S., & Siu, L. L.
- Affiliations
- From the CHUM, Hospital Notre Dame, Montreal, Quebec; Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada; US Oncology, Dallas; Cancer Therapy and Research Center, San Antonio, TX; the University of Chicago, Chicago, IL; and the Pittsburgh Clinical Research Network, Pittsburgh, PA.
- University Health Network (CA)
- Venue
- Journal of Clinical Oncology
- Published
- 2004-01-01
- Volume
- 22
- Issue
- 1
- Pages
- 77-85
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2103134643
- Cited by
- 807
- References
- 25
- Citations by year
- 2026: 10 · 2025: 7 · 2024: 14 · 2023: 15 · 2022: 18 · 2021: 22 · 2020: 18 · 2019: 21 · 2018: 21 · 2017: 29 · 2016: 30 · 2015: 35 · 2014: 32 · 2013: 44 · 2012: 68
- FWCI
- 56.25
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Keywords
- erlotinib, head and neck squamous cell carcinoma, recurrent or metastatic cancer, EGFR tyrosine kinase inhibitors, rash, diarrhea, drug toxicity, stable disease, progression-free survival, overall survival
- MeSH terms
- Erlotinib Hydrochloride, Administration, Oral, Adult, Aged, Aged, 80 and over, Diarrhea, Exanthema, Female, Head and Neck Neoplasms, Humans, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Quinazolines, Disease Progression, Disease-Free Survival, ErbB Receptors
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