Addition of docetaxel improved efficacy and reduced toxicity, studies find,,,,
WEDNESDAY, Oct. 24 (HealthDay News) -- The addition of the chemotherapy drug, docetaxel, to the standard two-drug regimen used for head and neck cancers improved the efficacy of the treatment while reducing the toxicity, two new studies report.
The triple drug chemotherapy regimen was so effective that it increased survival in both studies and more than doubled the average overall survival in one of the studies.
"This is a study that demonstrates that a three-drug regimen is better by a substantial amount in terms of survival for head and neck cancer. There was a 30 percent reduction in mortality with less toxicity," said Dr. Marshall R. Posner, lead author of the first study and medical director of the head and neck oncology program at the Dana-Farber Cancer Institute in Boston. "This is a wonderful step forward for patients."
Results from both clinical trials are published in the Oct. 25 issue of the New England Journal of Medicine. Both studies were funded, at least partially, by Sanofi-Aventis, the manufacturer of docetaxel.
About 3 percent to 5 percent of all cancers in the United States are head and neck cancers, according to the National Cancer Institute. That means almost 40,000 Americans are diagnosed with these cancers each year. They most commonly occur in people over 50, and the biggest risk factor for head and neck cancers is tobacco use.
Treatment for these cancers can be difficult, because surgical removal of tumors can affect the way a person chews, talks and swallows. In some cases, it's impossible to surgically remove some of these cancers, because the risk of harm outweighs the potential benefit. The cancer is then referred to as unresectable.
The study done by Posner and his colleagues included 501 people with advanced -- stage III or IV -- head and neck cancers. None of the volunteers had any signs of cancer in areas far from the original tumor site. Posner said his study included people who had both unresectable and resectable tumors.
The study participants were randomly assigned to receive the standard two-drug regimen (cisplatin and fluorouracil) or the new three-drug treatment which included cisplatin, fluorouracil and docetaxel. People in both groups then received seven weeks of weekly chemoradiotherapy (chemotherapy and radiation combined) with carboplatin, and radiotherapy (radiation treatment) for five days a week. Those who became eligible for surgery were able to have surgery six to 12 weeks after completing chemoradiotherapy.
Overall survival after three years was estimated to be 62 percent for the three-drug group compared to 48 percent for the two-drug group. Median overall survival was 71 months for the newer treatment versus just 30 months for the older regimen, according to the study.
The second study, conducted by European researchers, randomly assigned 358 people with unresectable stage III or IV head and neck cancer to receive either the two-drug regimen or the newer three-drug treatment. If there was no progression of disease after the study participants completed chemotherapy, they were given radiotherapy.
Overall survival increased from 14.5 months for the two-drug group to 18.8 months for the three-drug group in this study.
In both studies, the three-drug regimen had a similar, though slightly reduced, side-effect profile than the two-drug therapy. Posner said that's because they were able to use less fluorouracil in the three-drug regimen.
"We maximized efficacy and reduced toxicity. With the inclusion of the [three-drug induction chemotherapy] followed by chemoradiotherapy, we saw unprecedented survival," said Posner.
Of the new research, Dr. David Pfister, chief of the head and neck medical oncology service at Memorial Sloan-Kettering Cancer Center in New York City, said that the "triple-drug regimen is more effective than the standard regimen alone when given prior to radiation-based treatment and not at a cost of side effects. There was no increase in overall toxicity."
But, what he said oncologists want to know is whether induction chemotherapy (as was done in these studies) plus chemoradiotherapy is more effective than chemoradiotherapy alone. The addition of induction therapy, said Pfister, adds about three months to the treatment process.
He said studies are currently under way to determine which treatment is best, and, in the meantime, said that chemoradiotherapy alone is the current standard of care.
To learn more about head and neck cancers, visit the National Cancer Institute.
SOURCES: Marshall R. Posner, M.D., associate professor, medicine, and medical director, head and neck oncology program, Dana-Farber Cancer Institute, Boston; David Pfister, M.D., chief, head and neck medical oncology service, Memorial Sloan-Kettering Cancer Center, New York City; Oct. 25, 2007, New England Journal of Medicine
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