The chemotherapy drug Taxotere may help women with breast cancer live longer while keeping the disease at bay.

That's in comparison to an older drug, fluorouracil, say researchers in The New England Journal of Medicine's June 2 edition.

Taxotere "significantly improves the rates of disease-free and overall survival among women with operable node-positive breast cancer," write researchers. Aventis Pharmaceuticals, Taxotere's maker, funded the study. Aventis is a WebMD sponsor.

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4-Year Study

Doctors working on the study included Miguel Martin, MD, of the Hospital Universitario San Carlos in Madrid. Nearly 1,500 women with breast cancer took part. The women lived in 20 countries, were 18-70 years old, and were followed for about 4.5 years (on average).

The women had "node-positive" breast cancer, meaning the cancer had spread to their lymph nodes. Like millions of women with early breast cancer, they first got surgery and then chemotherapy. These anticancer drugs have been repeatedly shown to reduce the risk of the cancer coming back and the risk of death in women with breast cancer. They stop cancer growth by killing cancer cells that have spread to other parts of the body.

The women all got six cycles -- a day of chemotherapy treatment with periods of days or weeks off between treatments. They either got Taxotere or fluorouracil, along with two other standard chemotherapy drugs. Each group had similar numbers of women, and most completed all of the cycles (91 percent with Taxotere and 97 percent with fluorouracil).

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Better Survival

After five years, three out of four women that received Taxotere had survived without cancer's return, compared with 68 percent of those that received fluorouracil. That amounts to a 28 percent cut in the risk of relapse with Taxotere, the study notes.

The reduction in breast cancer's return did not seem to be driven by certain risk factors that would make it more likely such as lymph node status or by HER2/neu status, they write. Disease-free survival was also independent of menopausal status, they say.

Overall five-year survival was 87 percent with Taxotere and 81 percent with fluorouracil, giving the Taxotere group a 30 percent lower risk of death.

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Side Effects

Taxotere was not without side effects. Significantly more women who got Taxotere had low levels of infection-fighting white blood cells (neutropenia), a common side effect of chemotherapy. Infections were also more common in the Taxotere group, but none were fatal.

Two women in each group died during treatment. Congestive heart failure, a side effect seen with in some cancer-fighting drugs, affected 1.6% of those who received Taxotere and 0.7 percent of the fluorouracil group. Two women in the Taxotere group and one in the fluorouracil group developed acute myeloid leukemia.

Understandably, quality of life dipped for women in both groups during chemotherapy. Their scores fell from 72 (out of 100) before treatment to 62 at the end of chemotherapy with Taxotere and 69 with fluorouracil. But the women had bounced back to or surpassed their original scores at follow-up, says Martin.

He and several of his colleagues had consulted for or received grants or speaker's honoraria from drug companies including Aventis, says the journal.

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New Standard?

Chemotherapy with Taxotere can be considered a standard of care, says Edith Perez, MD, of the Mayo Clinic in Jacksonville, Fla.

However, she notes that Martin's study didn't include any women older than 70, so it's not clear if they stand to gain the same benefits. Other studies are in the works and breast cancer treatments will keep evolving as new information becomes available, writes Perez in a journal editorial.

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By Miranda Hitti, reviewed by Brunilda Nazario, MD

SOURCES: Martin, M. The New England Journal of Medicine, June 2, 2005; vol 352: pp 2302-2313. Perez, E. The New England Journal of Medicine, June 2, 2005; vol 352: pp 2346-2348. WebMD Medical Reference from Healthwise: "Docetaxel."