New Warning on Hormone Replacement

Hormone therapy taken by women to counter the effects of menopause can increase the risk of dying from lung cancer, researchers reported here on Saturday.

The findings represent the latest black mark against a therapy already being used much more sparingly than it once was. But researchers said the new data should serve as a caution to women who did continue to take hormones not to smoke.

“We shouldn’t be using both combined hormone therapy and tobacco at the same time,” said Dr. Rowan Chlebowski of the Harbor-U.C.L.A. Medical Center in California and lead author of the study, which was presented at the annual meeting of the American Society of Clinical Oncology.

Dr. Chlebowski said there was one avoidable lung cancer death over eight years for every 100 women who both smoked and took hormone therapy.

The new analysis used data from the Women’s Health Initiative study, in which women took either Prempro, a drug combining estrogen and progestin, or a placebo. The study was discontinued in 2002 after it was found that the hormone therapy increased the risk of breast cancer.

The new analysis looked specifically at lung cancer for the five and a half years that the women took either the drug or the placebo and for more than two years afterward.

There were 96 cases of non-small-cell lung cancer, the most common type of the disease, among the roughly 8,000 women who used hormone therapy, compared with 72 cases among the nearly equal number who took the placebo. That difference was not statistically significant, meaning it could have occurred by chance.

But there were 67 deaths from lung cancer among the hormone users versus 39 among those who took the placebo, a result that was statistically significant.

Among smokers, 3.4 percent of hormone users died from lung cancer, compared with 2.3 percent of those who got the placebo. Among women who never smoked, 0.2 percent of hormone users died from lung cancer, compared with 0.1 percent of those who got the placebo.

Dr. Otis Brawley, the chief medical officer of the American Cancer Society, said he was not convinced that the results were not due to chance, given that there was a meaningful difference in deaths but not in number of cases.

In another study presented here, researchers reported that the drug Avastin showed signs that it could help prevent the recurrence of colon cancer, but the effect wore off after patients stopped taking it.

Avastin, which blocks the flow of blood to tumors, has been a best-selling cancer drug that is used for late-stage cancers. But the new study, involving 2,700 patients, looked at whether the drug could be given earlier, immediately after a colon tumor was removed by surgery. The idea was to keep cancer from coming back and effectively “cure” the patient.

Genentech, the manufacturer of the drug, announced in April that the drug had failed to prevent recurrence, though it provided no details at that time.

The data released here on Saturday showed that after three years, 77.4 percent of those who received a year of Avastin along with six months of standard chemotherapy were alive and disease free. That compared with 75.5 percent of those who got the chemotherapy alone, an insignificant difference.

After only the first year, however, when patients were taking Avastin, 94.3 percent of those who got the drug were cancer-free and alive compared with 90.7 percent of those who got chemotherapy alone, a difference that was statistically significant.

“It was effective, but that efficacy disappeared after the year in which bevacizumab was given,” said Dr. Norman Wolmark, chairman of the group of researchers, sponsored by the National Cancer Institute, who conducted the trial. Bevacizumab is the generic name for Avastin.

Dr. Wolmark said the research group hoped now to conduct a trial in which the drug would be given for two or more years.

But the prospect of giving Avastin for such a long duration is already raising concerns among doctors, not least because the drug costs about $50,000 a year when used to treat colon cancer. Moreover, the majority of patients with early colon cancer are already kept from relapsing by surgery and chemotherapy alone. So Avastin might have to be given for a long time to a lot of people to prevent a relatively few relapses.

“We have to think hard about long-term chemotherapy in our patients due to the impact on quality of life and the costs,” said Dr. Jennifer C. Obel, a gastrointestinal oncologist at NorthShore University HealthSystem in Chicago. “Are we going to be giving bevacizumab for three years, four years?”

Dr. Hal V. Barron, chief medical officer for Genentech, which is now owned by the Swiss drug company Roche, said the results “suggest promise for future trials.” He said the company offered programs to help patients obtain its drugs.

Source : www.nytimes.com