updated 4/21/2004 3:53:33 PM ET 2004-04-21T19:53:33

Surprising U.S. experts, a Japanese study has found that a drug combination rejected as a cancer treatment in the United States can add years to the lives of people with early lung cancer.

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Lung cancer is one of the most common and lethal types of cancer, killing 85 percent of its sufferers. Only one other drug, cisplatin, has been shown to improve survival in early stages, and it adds only months.

“This is a big surprise to American oncologists,” said Dr. Herman Kattlove of Los Angeles, medical editor for the American Cancer Society.

In addition, the two-drug combination, called uracil-tegafur, or UFT, is a pill, rather than something which must be dripped into a vein, and it has few side effects, Dr. Yukito Ichinose and others at hospitals around Japan reported in Thursday’s New England Journal of Medicine.

However, UFT apparently would be useful for only a small percentage of the 174,000 people diagnosed with lung cancer each year in the United States — as few as 10,000, by some estimates. It works only against adenomas, also called non-small-cell cancers, and only among patients with small tumors that have not spread out of the lung.

The Japanese researchers looked at 979 such patients. All had surgery to remove the tumor. Half — 488 — also got the pills, which were taken twice a day for two years.

After five years, there was no difference among the 412 patients with the smallest tumors, those less than eight-tenths of an inch across.

But patients with larger tumors were more likely to live longer with the drug. After five years, 85 percent of the UFT patients with tumors more than 1.2 inches across were still alive, versus 74 percent of those who got no chemotherapy.

The effect on survival after five years was much less marked for people with tumors in between those two sizes: Eighty-nine percent of the UFT patients versus 86 percent of the comparison group.

“The more advanced the cancer the more likely it is to kill you, so the more likely a treatment is to help you,” Kattlove said.

Rejected in the U.S.
Uracil-tegafur was not tested for lung cancer in the United States. Bristol Myers Squibb and Taiho Pharmaceutical Co. did test it against colon cancer, but the Food and Drug Administration rejected their application for approval. However, it is used in Asia, Europe, and Latin America.

Kathy Baum, a spokeswoman for drug-maker Bristol Myers Squibb, would not say whether the findings would prompt a new application for UFT as a lung cancer treatment.

Kattlove said most cancer doctors would want to see more studies. “Finding a drug as simple as this, as free of side effects, that works is just too good to be true,” he said.

Dr. Alfred Munzer, past president of the American Lung Association, said the drug could offer some hope to patients who have the best chances to start with.

“But the message for lung cancer still is that prevention is far more important than cure, and far more effective,” he said. “That’s, of course, to stop smoking.”

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