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| |  Gefitinib Shows Promise as Treatment for Advanced Head and Neck Cutaneous Squamous Cell Carcinoma: Presented at IAOO By Louise Gagnon TORONTO -- July 13, 2009 -- Gefitinib produces a significant response in patients with advanced head and neck cutaneous squamous cell carcinoma (cSCC) prior to standard treatment, according to a phase 2 study presented here at the 2nd World Congress of the International Academy of Oral Oncology (IAOO). "We want to shrink the tumour as much as we can prior to surgery, so the patient will have the best outcome," said Shirley Taylor, University of Texas M. D. Anderson Cancer Center, Houston, Texas, on July 9. Taylor noted that patients with advanced squamous cell carcinoma on the head and neck face a poor prognosis with standard treatments of surgery and radiation, so clinicians are exploring other therapies to improve prognosis for this patient population. Since epidermal growth factor receptor (EGFR) is a tyrosine kinase that is overexpressed in cSCC, it was logical to use a compound that inhibits the catalytic activity of the tyrosine kinase, explained Taylor. "It is a more targeted therapy," noted Taylor. The study enrolled 23 patients, 22 of whom were evaluable for responses and toxicities to gefitinib. Patients received oral gefitinib 250 mg/day for 2 cycles of 30 days each and were evaluated for response via computed tomography (CT) or magnetic resonance imaging (MRI) at 15 days after therapy "If patients showed a response, they continued to receive therapy," explained Taylor. "If they showed stable disease, the dose was escalated to 500 mg per day. If they showed progression of disease, they were taken off the drug." They were evaluated again at the end of 2 cycles of therapy, using CT and MRI. If patients were deemed resectable and had achieved stable disease, they were sent for surgery and radiation, if indicated. If there was no tumour shown after surgery, they did not receive radiation. If patients were not deemed resectable, they received radiation and gefitinib. Three patients reached a complete response to therapy, and 7 reached a partial response. Five patients had stable disease, and 7 had disease progression. The most common side effects that occurred with gefitinib were skin rashes and diarrhoea, noted Taylor. "The drug was well tolerated," she said. "Anti-EGFR therapy may have a role in adjuvant treatment of head and neck cutaneous skin cancer." Investigators did not identify any patient demographic information, such as age or gender, which predicted response to gefitinib therapy. Funding for this study was provided by AstraZeneca Pharmaceuticals and the National Cancer Institute. [Presentation title: A Phase II Trial of ZD 1839 (Gefitinib) for Advanced Cutaneous Squamous Cell Carcinoma of Head and Neck. Abstract P2.90]
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