Taxotere improves survival in head-neck cancer

By Gene Emery

BOSTON (Reuters) - Adding the Sanofi-Aventis cancer drug Taxotere to standard chemotherapy helps people with head and neck cancer live more than three years longer, two teams of researchers reported on Wednesday.

The inclusion of Taxotere also did not worsen side-effects, the researchers, whose studies were sponsored by the company, reported in the New England Journal of Medicine.

"Here you see the first improvement in head and neck cancer treatment in almost 25 years and it's basically the addition of this drug Taxotere," said Marshall Posner of the Dana-Farber Cancer Institute in Boston, leader of one of the studies.

"And this isn't some small 5 percent improvement. There was a 30 percent reduction in mortality. This was pretty impressive."

Any increase would be welcome for people who suffer tumors in the mouth, larynx and pharynx, which make up about 5 percent of newly diagnosed adult cancers in the United States and 8 percent worldwide.

Most of those growths are not identified until their later stages and, at that point, they can be difficult to treat.

Fewer than half of such patients are alive after three years and in some instances the survival rate is even lower. About 11,000 people in the United States die from head and neck cancer each year, with 46,000 new cases reported annually, according to the American Cancer Society.

In the Posner study, 48 percent of patients who received the standard regimen of cisplatin and fluorouracil as their initial treatment survived for three years, versus 62 percent of those who also received Taxotere, known generically as docetaxel.

EXTRA YEARS OF LIFE

Median survival time was 71 months versus 30 months for those who received the conventional therapy -- more than three years of extra life.

All 500 patients received radiation treatments combined with the chemotherapy soon after drug treatment was initiated.

Posner said most clinics now used Taxotere for head and neck cancer. "This is considered state of the art," he said.

In the second study, also published in the New England Journal of Medicine but originally reported at a cancer meeting in 2004, a team led by Jan Vermorken of University Hospital Antwerp in Belgium used a similar strategy for treating 358 volunteers with inoperable tumors.

Those who received the three-drug combination had a median survival time of 18.8 months compared to 14.5 months among those who just received cisplatin and fluorouracil.

In the Posner study, one person in each group died from toxic effects of the treatment.

In the smaller study, four patients (or 2.3 percent) died from side effects of the three-drug treatment. But those getting just the two older drugs were even more likely to die -- 10 volunteers or 5.5 percent died from side effects of the cisplatin-fluorouracil combination.

Taxotere tended to cause more loss of hair and infection-fighting white blood cells but less nausea and thrombocytopenia, which can produce excessive bleeding.

"I frankly feel we can cure about 70 percent of patients with this kind of combination chemotherapy and chemoradiation therapy," Posner said. "I think that's a huge advance and people should take heart."