• 2/8/2006
  • New York, NY
  • staff
  • Forbes.com

Adding the drug cetuximab to radiation therapy for head and neck cancer can boost patient survival rates by about 20 months without significantly increasing side effects, researchers report.

Average overall survival for head and neck cancer patients was more than four years for patients treated with both radiation and the monoclonal antibody drug cetuximab (brand name Erbitux).

That’s a major improvement over the average 2.5 year survival seen in patients treated with radiation alone, according to the authors of the multi-national study.

“This is the first targeted antibody therapy that showed a survival advantage. In this particular study, we’re seeing the benefit of adding a targeted therapy to conventional therapy and not increasing toxicity,” said the study’s lead author, Dr. James Bonner, the head of radiation oncology at the University of Alabama in Birmingham.

His team reported their findings in the Feb. 9 issue of the New England Journal of Medicine.

Each year, approximately 39,000 Americans are diagnosed with head and neck cancers, according to the National Cancer Institute (NCI). These cancers include those of the tongue, the rest of the mouth, the salivary glands and inside the throat, the voice box and the lymph nodes in the upper neck. The malignancies are most common in people over 50 and tobacco users — both smokers and those who use smokeless tobacco products. The NCI estimates that about 85 percent of head and neck cancers are tobacco-related.

When surgery to remove the entire tumor isn’t possible, the current standard for treating these tumors is platinum-based chemoradiotherapy, according to the author of an accompanying editorial, Dr. Marshall Posner, medical director of the Head and Neck Oncology Program at Dana-Farber Cancer Institute in Boston. Platinum-based chemoradiotherapy includes chemotherapy with a platinum-based agent, such as cisplatin, combined with radiation therapy.

In the new study, Bonner’s team tracked outcomes for more than 400 patients from the United States, Spain, South Africa, Poland and Germany. Two hundred and thirteen patients received radiation alone, while 211 received cetuximab followed by high-dose radiation.

Cetuximab binds to tumor-stimulating epidermal growth factor, effectively blocking tumor growth, Bonner said. It can also enhance the effects of radiation therapy.

The average time of “locoregional control” — the time elapsed before cancer spread further — was 14.9 months for those in the radiation-only group and 24.4 months for those receiving the combo therapy.

Overall survival rates were also increased. The average overall survival was 29.3 months in the radiation-only group and 49 months for those in the combination group, the researchers found.

Bonner said this benefit occurred without any increase in debilitating side effects.

Funding for the study was provided by ImClone Systems and Merck, manufacturers of Erbitux.

While Posner said the findings were exciting and a “great advance,” he added that chemoradiotherapy with an agent like cisplatin may still the best choice for most patients — at least until studies are done comparing chemoradiotherapy to cetuximab plus radiation, or perhaps a combination of cetuximab with chemoradiotherapy.

Posner said that platinum-based chemoradiotherapy is generally the first treatment he recommends unless a patient can’t tolerate chemotherapy because of kidney problems or severe cardiac problems. In those instances, he recommends cetuximab plus radiation instead.

Bonner agreed that treatment decisions must be individualized for each patient and each cancer. Patients should discuss all of their options, and the risks and benefits of each, with their oncologists, he suggested.