• 1/18/2007
  • web-based article
  • press release
  • EurekAlert (www.eurekalert.com)

Preliminary findings show adding the chemotherapy drug cetuximab (brand name Erbitux) to radiation therapy and chemotherapy may help some patients with head and neck cancer live longer, according to a study presented today at the plenary session of the Multidisciplinary Head and Neck Cancer Symposium, co-sponsored by the American Society for Therapeutic Radiology and Oncology, the American Society for Clinical Oncology and the American Head and Neck Society. Researchers are recommending a larger trial to prove definitively if cetuximab combined with radiation helps improve survival for these patients.

Researchers at the University of Maryland Medical Center in Baltimore designed the study to evaluate the efficacy of the addition of cetuximab with concurrent chemotherapy and radiation in patients with locally advanced squamous cell carcinoma of the head and neck in order to improve local regional control and overall survival. Currently 21 patients are enrolled in this study. Initially they received an initial dose of cetuximab followed then by weekly doses of the drug. Patients also received daily radiation therapy treatments and weekly doses of chemotherapy.

Of the 21 patients, 18 have completed all therapy and were available for analysis of toxicity and response. No grade 4 toxicities were reported, however 89 percent reported mouth pain and 11 percent reported skin problems. Other toxicities included difficulty swallowing, fever and a drop in white blood cell count. Seventy-two percent achieved a complete response two months after completion of therapy. Ultimately, 95 percent were disease free after all therapy.

“Given the advanced stages of disease that patients have on this study, these results point to the potential of increasing the therapeutic gain for patients. We now need a phase III study to determine if adding this drug is better than the current standard of care,” said Mohan Suntharalingam, M.D., lead author of the study and a radiation oncologist at the University of Maryland. “I encourage people with disease and their family members to ask their doctors about participating in this clinical trial.”

Source:
The abstract, “Initial Report of Phase II Trial of Weekly Cetuximab, CBDCA, Paclitaxel and Daily RT in Patients with Locally Advanced SCCHN,” will be presented at the plenary session on January 18, 2007. To speak to the lead author of the study, Mohan Suntharalingam, M.D., please call Beth Bukata.