New Breast Cancer Chemo Drug May Aid Survival
Study: Longer Cancer-Free Survival, Fewer Deaths With Taxotere Than With Older Chemo Drug
June 1, 2005 -- 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.
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% with
Taxotere and 97% with fluorouracil).
After five years, three out of four women that received Taxotere had
survived without cancer's return, compared with 68% of those that received
fluorouracil. That amounts to a 28% 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% with Taxotere and 81% with fluorouracil,
giving the Taxotere group a 30% lower risk of death.
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% 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
He and several of his colleagues had consulted for or received grants or
speaker's honoraria from drug companies including Aventis, says the
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.