Newer breast
cancer drug better than the gold standard

A second member of a new class of drugs has proved more effective than the gold standard, tamoxifen, at preventing breast cancer from recurring in women who received the medicine as initial therapy right after surgery.

The drug, Femara, is expected to win Food and Drug Administration approval soon for women who are past menopause and have early breast cancer. It is already approved for treating advanced cases of the disease.

Femara and Arimidex, a similar drug already licensed for early breast cancer, are aromatase inhibitors, which block production of estrogen, a hormone that fuels the growth of most tumors that develop after menopause. Tamoxifen works differently, by blunting the ability of estrogen to enter cells.

A study reported earlier this year in Europe and published in Thursday's New England Journal of Medicine estimated that 84% of women given Femara versus 81% of those on tamoxifen would be alive without any signs of cancer five years after starting treatment. The estimates were based on roughly two years of information on relapses among the 8,000 women in the study done by researchers in the United States, Europe, and Australia.

The study was financed by Femara's maker, Novartis. Many of the researchers own stock in or are consultants for Novartis or companies with rival drugs.

Several other studies have shown Femara or Arimidex to be better either as initial treatment or after a couple years of tamoxifen.

"These trials, with close to 30,000 participants, consistently demonstrate that treatment with an aromatase inhibitor alone or after tamoxifen treatment is beneficial," Sandra Swain of the National Cancer Institute wrote in an editorial in the journal. The challenge now is figuring out how long women should take these drugs, which drug is best, and whether switching drugs at some point is helpful, she wrote.

Tamoxifen remains the top choice for women who get breast cancer before menopause because aromatase inhibitors aren't thought to be effective then. Aromatase inhibitors do not raise the risk of blood clots or endometrial cancer as tamoxifen does, but they do increase the chances of bone problems such as osteoporosis. Women are often advised to take supplements or other medications to maintain bone density.

A third aromatase inhibitor, Pfizer's Aromasin, also has shown promise for preventing recurrence when given after several years of tamoxifen. But it has not yet been tested against tamoxifen as an initial therapy, as Femara and AstraZeneca's Arimidex have been.

Each year, about 800,000 women around the world are diagnosed with early breast cancer and about three-fourths of them might benefit from these drugs. (AP)