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Phase II Trial of ZD1839 in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Ezra E. W. Cohen, Fred Rosen, Walter M. Stadler, Wendy Recant, Kerstin Stenson, Dezheng Huo, Everett E. Vokes

From the Sections of Hematology/Oncology, Otolaryngology-Head and Neck Surgery, and Urology, and Departments of Medicine, Pathology, Surgery, Health Studies, and Radiation and Cellular Oncology, University of Chicago; and Section of Hematology/Oncology, Department of Medicine, University of Illinois-Chicago, Chicago, IL.

Address reprint requests to Ezra E.W. Cohen, MD, University of Chicago, 5841 S Maryland Ave, MC 2115, Chicago, IL 60637-1470; email: ecohen{at}medicine.bsd.uchicago.edu.

Purpose: The epidermal growth factor receptor (EGFR) is a mediator of squamous cell carcinoma of the head and neck (SCCHN) development. ZD1839 is an orally active, selective EGFR tyrosine kinase inhibitor. This phase II study sought to explore the activity, toxicity, and pharmacodynamics of ZD1839 in SCCHN.

Patients and Methods: Patients with recurrent or metastatic SCCHN were enrolled through the University of Chicago Phase II Consortium. Patients were allowed no more than one prior therapy for recurrent or metastatic disease and were treated with single-agent ZD1839 500 mg/d. Patient tumor biopsies were obtained and stained immunohistochemically for EGFR, extracellular signal-regulated kinase 1 (ERK1), and phosphorylated ERK1 (p-ERK). Study end points included response rate, time to progression, median survival, and inhibition of p-ERK.

Results: Fifty-two patients were enrolled (40 male and 12 female) with a median age of 59 years (range, 34 to 84 years). Fourteen patients received ZD1839 through a feeding tube. Half the cohort received ZD1839 as second-line therapy. Forty-seven patients were assessable for response, with an observed response rate of 10.6% and a disease control rate of 53%. Median time to progression and survival were 3.4 and 8.1 months, respectively. The only grade 3 toxicity encountered was diarrhea in three patients. Performance status and development of skin toxicity were found to be strong predictors of response, progression, and survival. Ten biopsy samples were assessable and revealed no significant change in EGFR or p-ERK expression with ZD1839 therapy.

Conclusion: ZD1839 has single-agent activity and is well tolerated in refractory SCCHN. In contrast to other reports, development of skin toxicity was a statistically significant predictor of response and improved outcome.

Supported in whole or in part by Federal funds from the National Cancer Institute, National Institutes of Health, Bethesda, MD, under Contract No. N01-CM-17102; the University of Chicago Cancer Research Center, Chicago, IL (grant no. P30 CA14599); and a private donation from The Francis Lederer Foundation, Chicago, IL.

Presented in part at the Second International Chicago Symposium on Cancers of the Chest, Head, and Neck, Chicago, IL, October 4–6, 2001, and the Annual Meeting of the American Society of Clinical Oncology, May 18–21, 2002.

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				R. Perez-Soler, A. Chachoua, L. A. Hammond, E. K. Rowinsky, M. Huberman, D. Karp, J. Rigas, G. M. Clark, P. Santabarbara, and P. Bonomi Determinants of Tumor Response and Survival With Erlotinib in Patients With Non--Small-Cell Lung Cancer J. Clin. Oncol., August 15, 2004; 22(16): 3238 - 3247. [Abstract] [Full Text] [PDF]

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				R. Perez-Soler HER1/EGFR Targeting: Refining the Strategy Oncologist, February 1, 2004; 9(1): 58 - 67. [Abstract] [Full Text] [PDF]

				D. Soulieres, N. N. Senzer, E. E. Vokes, M. Hidalgo, S. S. Agarwala, and L. L. Siu 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 J. Clin. Oncol., January 1, 2004; 22(1): 77 - 85. [Abstract] [Full Text] [PDF]

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