Study: Cancer drug Erbitux nearly doubles survival

Patients with head and neck cancer appear to survive nearly twice as long after receiving a new drug known as Erbitux (scientific name: cetuximab) in conjunction with radiation therapy compared with patients treated solely with radiation therapy.

In findings announced at the American Society of Clinical Oncology (ASCO) 2004 Annual Meeting, Paul M. Harari, a UW Comprehensive Cancer Center radiation oncologist, said the findings of the phase III international study are highly promising.

“Head and neck cancer, which includes tumors of the mouth and throat, are among the most aggressive and debilitating types of cancer,” said Harari, one of three principal investigators of the international study of 424 advanced head and neck cancer patients. “A drug that appears to nearly double survival time with relatively minor side effects is very good news for patients with head and neck cancer,” he said. The lead investigator of the study is James A. Bonner, MD, of the University of Alabama at Birmingham.

In the study, researchers in the United States, Europe and elsewhere compared survival between two groups of patients:

• 211 patients with locally advanced squamous cell cancer of the head and neck who received high-dose radiation therapy alone; and
• 213 matched patients who received high-dose radiation therapy plus Erbitux.

Median survival was nearly twice as long in the Erbitux group (54 months vs. 28 months). In addition, more of the Erbitux patients were alive at two years (62 percent vs. 55 percent) and three years (57 percent vs. 44 percent). Side effects among the Erbitux patients were relatively minor compared with conventional chemotherapy, with skin reactions being the most common.

A part-mouse, part-human protein, Erbitux appears to enhance the cancer-killing effect of radiation therapy by binding to the epidermal growth factor receptor (EGFR) found in abnormally high amounts in many cancer cells. Preclinical studies published by the Harari research group between 1999-2004 at the University of Wisconsin predicted strong potential for benefit in using the combination of EGFR inhibitors like Erbitux with radiation.

“The new Erbitux clinical results show great promise, not only for extending survival, but for curing more head and neck cancer patients of their disease.” Harari said. In addition to the favorable survival impact, new molecular agents like Erbitux do not commonly induce nausea, vomiting, hair loss, decreased blood counts and other side effects that frequently accompany conventional chemotherapy.

“Over the coming years,” Harari said, “Erbitux and other molecular drugs that work in a similar fashion could become a new standard of treatment not only for head and neck cancer, but perhaps for other cancers that rely on the EGFR signaling pathway for tumor growth.”