Three-drug regimen improves survival in advanced head and neck cancers

Taxotere combined with standard chemotherapy reduces mortality by nearly 30 percent

ATLANTA--The addition of docetaxel (Taxotere) to an initial chemotherapy regimen for inoperable head and neck cancers reduced mortality by nearly 30 percent over three years following treatment compared to the standard two-drug combination, researchers from Dana-Farber Cancer Institute in Boston will report at the American Society of Clinical Oncology's annual meeting in Atlanta.

The survival advantage emerged from an international clinical trial of more than 500 patients with squamous cell carcinoma of the head and neck treated with a sequential regimen that included induction chemotherapy and chemoradiotherapy, explains Marshall R. Posner, MD, director of head and neck oncology at Dana-Farber.

"This changes the standard of care for chemotherapy and radiation for head and neck cancer in this country," says Posner, who will present the data at a scientific special session on head and neck cancers on Sunday, June 4, 1 p.m., Building C, Level 1, Hall C4.

In recent years, Posner and colleagues at Dana-Farber have developed a multi-modality therapy for inoperable, locally advanced head and neck cancers that can reduce the need to remove critical organs while giving the patient good odds of survival. The first phase is induction chemotherapy with a combination of drugs followed by simultaneous fractionated radiation therapy and weekly treatment with carboplatin chemotherapy. Patients then have surgery if needed.

A combination of cisplatin and fluorouracil (5-FU) has been used for the induction chemotherapy. Posner's team has added docetaxel (Taxotere) as a third drug, and the clinical trial compared the three-drug versus the two-drug regimen. From 1999 to 2003, a total of 538 patients were randomized to the two treatments; 501 patients were evaluable. The patients were followed for at least two years, and 79 percent were followed for three years.

Survival estimates for three years showed that the addition of docetaxel reduced the risk of mortality by 30 percent: Survival at three years was 62 percent with the three-drug combination compared to 48 percent on the standard regimen. The safety profiles were similar in both arms of the study, says Posner, who is also an associate professor of medicine at Harvard Medical School.

Almost 40,000 cases of head and neck cancers will be diagnosed in 2006, according to the American Cancer Society, and an estimated 7,400 deaths.

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Authors of the report also include Robert Haddad, MD, and Phillip Devlin, MD, of Dana-Farber and researchers from Sanofi-Aventis Oncology.

The trial was designed by a team lead by. Posner and was supported by Sanofi-Aventis.

Dana-Farber Cancer Institute (www.dana-farber.org) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.


Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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