WEDNESDAY, April 21, 2004 (HealthDayNews) -- Japanese researchers say two chemotherapy drugs given together after surgery showed promise in patients with certain types of early lung cancer.
But the benefit depended greatly on the size of the tumor, with the most improvement seen in patients with tumors between 2 centimeters and 3 centimeters and more than 3 centimeters in size.
"This is not going to help people who are caught at the very earliest stage -- those who have cancer at three-quarters of an inch [1.9 centimeters] or less," said Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society. "But when they have a cancer that's larger than that but hasn't spread outside the area, this treatment is probably going to help them."
"Even in the earlier stages [of cancer], I and II, you have about 40 percent of patients who will not survive beyond five years. That's the best that we're doing," added Dr. Stephen C. Malamud, an attending physician in hematology and oncology at Beth Israel Cancer Center in New York City. "Here we have an oral agent with minimal side effects. . . and some improvement in overall five-year survival. That's impressive."
The chemotherapy, a combination of uracil-tegafur, however, is not approved for use in the United States. That leaves open the question of what practical effect this news will have for people suffering from lung cancer in this country.
The therapy essentially involves a two-step mechanism. Tegafur is converted in the body into the drug fluorouracil by a common liver enzyme. Uracil keeps the blood levels of fluorouracil up. "You can get away with giving an oral administration and keeping high drug levels over time," Lichtenfeld said.
The study, by researchers at the Japan Lung Cancer Research Group on Postsurgical Adjuvant Chemotherapy, looked specifically at adenocarcinoma, a relatively common form of lung cancer. Their work appears in the April 22 issue of the New England Journal of Medicine. It was funded by Taiho Pharmaceutical Co. of Tokyo, maker of the drug.
Almost 1,000 patients were randomly assigned to receive either oral uracil-tegafur for two years after surgery or no treatment at all. All patients were followed for a median of slightly more than seven years.
Those taking uracil-tegafur did live longer, but the rates differed depending on how advanced the cancer was.
Overall, the five-year overall survival rate was 88 percent in the drug group and 85 percent in the control group. Patients with the earliest stage of lung cancer, T1 disease, had a survival rate of 89 percent in the drug group and 90 percent in the control group.
Among patients with T2 disease (more than 3 centimeters), however, the differences were more pronounced. The five-year survival rate in the uracil-tegafur group was 85 percent vs. 74 percent in the control group. "There's a larger risk [than T1 disease], ergo a larger benefit," Malamud explained.
It's not clear from these results whether patients with later-stage lung cancer would also benefit, or whether a treatment course of one year would be just as good as two years.
Despite the fact that the drugs had few adverse effects, only 61 percent were still taking them at two years.
"The compliance may not be related to the severity of adverse effects but the normal human tendency not to take medications for the time instructed," Lichtenfeld hypothesized. "When people are feeling good, it's hard to get them to do something which has adverse effects."
Still, all this discussion is academic if the drug is not approved in the United States. "The drug does have benefits and it would be appropriate to be used, but we don't have it available," Lichtenfeld pointed out.
In the meantime, Dr. Alfred Munzer, past president of the American Lung Association, said the best medicine is to try to ward off the disease. "The message still remains that lung cancer prevention is better than any cure," he said. "And that means, of course, no smoking."
More information
The American Lung Association has more on lung cancer staging and treatment.
