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New Treatment Combination Proves Safe, Effective For Head And Neck Cancer Patients, UPCI Study Finds

CHICAGO , June 2, 2008 — Patients treated for locally advanced head and neck cancer may respond better to treatment with the addition of cetuximab to chemotherapy, according to a University of Pittsburgh Cancer Institute (UPCI) phase II study. The results will be presented at the 44th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago as an oral presentation.

In the study, 39 patients with stages 3 or 4 head and neck cancer were treated initially with a combination of docetaxel, cisplatin and cetuximab, after which they received radiation therapy and additional cisplatin and cetuximab. Cetuximab, approved by the U.S. Food and Drug Administration in March 2006 and also known as Erbitux, is often prescribed for metastatic colorectal cancer and is used in conjunction with radiation therapy to treat squamous cell carcinomas of the head and neck. This is the first time it has been used in combination with docetaxel and cisplatin as induction therapy.

“We found that adding cetuximab to standard chemotherapy helped head and neck cancer patients respond better to treatment.  Out of 37 patients, 32 responded to induction treatment for an 86 percent response rate, and all patients had their tumors reduced, either partially or completely, after radiation was completed,” said Ethan Argiris, M.D., lead investigator and medical director of the aerodigestive cancers program and co-leader of the head and neck cancer program of UPCI.

Further evaluation of this treatment shows that the complete disappearance of the primary tumor occurred in about 80 percent of patients. More importantly, after two years the same percentage of patients remained cancer-free. “Given that the majority of our patients had stage 4 disease, our efficacy results are thus far very encouraging,” said Dr. Argiris. In addition, the UPCI investigators noted that treatment-related toxicities were expected and manageable.

Dr. Argiris and his colleagues are planning more clinical studies using this regimen.

“While longer follow-up will be needed to assess long-term efficacy and side effects, the addition of cetuximab to chemotherapy and radiotherapy is very promising and could become the standard of care in the next few years,” said Dr. Argiris. “The results from this trial, and the possibilities we are witnessing with novel agents, are allowing us to be optimistic about the future of patients with head and neck cancers,” he added.

Head and neck cancers are a group of biologically similar cancers originating from the upper aerodigestive tract, including the lip, mouth, nasal cavity, paranasal sinuses, pharynx and larynx that affect more than 45,000 individuals in the U.S. each year. Most head and neck cancers are classified as squamous cell carcinomas. Head and neck cancers are strongly associated with environmental and lifestyle risk factors, including tobacco smoking, alcohol consumption and certain strains of the sexually transmitted human papilloma virus.

Co-investigators of the study include M. Gibson, M.D.; D.E. Heron, M.D.; R. Smith, M.D.; R.L. Ferris, M.D., Ph.D.; S.Y. Lai, M.D., Ph.D.; S. Kim, Ph.D.; B.F. Branstetter, M.D.; J.T. Johnson, M.D.; and J.R. Grandis, M.D., all of the University of Pittsburgh. The study was partially supported by Bristol-Meyers Squibb, cetuximab’s manufacturer.

The study is published as abstract number 6002 in the 2008 ASCO Annual Meeting Proceedings and will be accompanied by an oral presentation given by Dr. Argiris at 3:30 p.m. CT, June 2.

Founded in 1984, the University of Pittsburgh Cancer Institute became a National Cancer Institute (NCI)-designated Comprehensive Cancer Center in record time (by 1990). UPCI, the only cancer center in western Pennsylvania with this elite designation, serves the region’s population of more than six million. Presently, UPCI receives a total of $154 million in research grants and is ranked 10th in funding from the NCI.

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