Cetuximab With Chemotherapy Prolongs Survival in Head and Neck Cancer

Zosia Chustecka

June 03, 2007

June 3, 2007 (Chicago) -- The longest survival ever seen in patients with recurrent or metastatic head and neck cancer has been reported from a trial in which cetuximab ( Erbitux, ImClone Systems, Bristol-Myers Squibb) was added to a first-line chemotherapy regimen based on a platinum compound. The median overall survival was 7.4 months in the chemotherapy group, compared with 10.4 months in the group receiving cetuximab as well as chemotherapy (hazard ratio, 0.797; P = .036).

"This is a unique observation, never seen before," said lead researcher Jan Baptist Vermorken, MD, PhD, professor of oncology at the University of Antwerp, in Belgium. "This is the first systemic therapy in 25 years to show a survival benefit over platinum-based chemotherapy in head and neck cancer."

Dr. Vermorken was speaking at a press briefing here at the American Society of Clinical Oncology (ASCO) 43rd Annual Meeting yesterday. "With targeted agents such as cetuximab, we are on the brink of changing the way we treat head and neck cancers," he told journalists.

Head and neck cancer is very difficult to treat, Dr. Vermorken commented, and these patients have a very poor outcome. He noted that cetuximab is already approved for use in head and neck cancer, based on a trial, reported at the 2004 ASCO meeting, showing an improvement in survival when it was added to radiotherapy. He predicted that these new data showing an improvement in survival when the drug is added onto chemotherapy "will change clinical practice." Moderator of the press conference, Roy Herbst, MD, PhD, from the University of Texas MD Anderson Cancer Center, in Houston, agreed with this prediction, adding, "I think people will start to use it."

The trial that Dr. Vermorken presented, known as Erbitux in First-Line Treatment of Recurrent or Metastatic Head and Neck Cancer (EXTREME), involved 442 patients. About a third had cancer in the oral cavity or hypopharynx, nearly half had metastases, and most patients had already received treatment with radiotherapy (77% - 80%) and chemotherapy (36% - 41%). In this trial, all patients were treated with a chemotherapy regimen containing either carboplatin (in about a third of patients) or cisplatin plus 5-fluorouracil, and 1 group of patients also received cetuximab (400 mg/m 2 as an initial dose, followed by 250 mg/m 2 weekly).

The survival curves for the 2 groups differed significantly from each other, Dr. Vermorken told the meeting, and the median overall survival was prolonged by 2.7 months by the addition of cetuximab (from 7.4 to 10.1 months). "This is an impressive 35% increase in survival," commented the discussant for this abstract, Marshall Posner, MD, from the Dana Farber Cancer Institute, in Boston, Massachusetts.

The incidence of adverse events was very similar in the 2 groups, apart from the reports of skin reaction and infusion reactions among the patients taking cetuximab, Dr. Vermorken commented. "In the interim safety analysis, the addition of cetuximab did not modify the characteristic adverse-event profile of the platinum-based chemotherapy," he added.

"The EXTREME trial is extremely important," Dr. Posner told attendees at the meeting. "It showed a significant improvement in survival when cetuximab was combined with a platinum compound and 5-fluorouracil in the treatment of recurrent disease." Asking rhetorically whether this now means that every patient with recurrent head and neck cancer should get cetuximab or another product that also targets epidermal growth factor receptor (EGFR), he answered that there are still variations in the treatment approach to these patients -- they can be treated with a single agent or double or triple agents, but "it is reasonable for every patient to receive EGFR therapy at some point in their treatment," he said.

American Society of Clinical Oncology 43rd Annual Meeting 2007. Presented June 2, 2007.

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