WEDNESDAY, Oct. 5 (HealthDay News) -- Treating women with an
aggressive form of early stage breast cancer using Herceptin and
not turning to a third type of drug known as an
anthracycline, improves survival while posing less danger to the
heart, researchers report.
They tested three different regimens, one of which did not
include any anthracyclines. When Herceptin is given with
doxorubicin (Adriamycin), an anthracycline, toxic cardiac effects
have been seen.
"What the study shows is you have comparable effectiveness in a Herceptin-based regimen when you don't use the anthracyclines," said Dr. Dennis Slamon, director of clinical and translational research at the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles. Earlier research of his led to the development of Herceptin (trastuzumab).
He contends that the new regimen should be the new standard of
care, but one expert who wrote an accompanying commentary
The new study is published in the Oct. 6 issue of the
New England Journal of Medicine.
Slamon and his colleagues from the Breast Cancer International
Research Group tested one of three different treatments in 3,222
women who had HER2-positive early-stage breast cancer. This breast
cancer is more aggressive and is linked with a worse outlook and
shorter survival times.
One group got a regimen called ACT-- the standard therapy of
doxorubicin (Adriamycin) and paraplatin (Carboplatin) followed by
docetaxel (Taxotere). A second group got that same standard regimen
plus a year of Herceptin -- called ACTH. The third group got the
anthracycline-free regimen, called TCH -- doxetaxel (Taxotere) and
paraplatin (Carboplatin) with a year of Herceptin.
Herceptin targets HER2, a protein known as human epidermal
growth factor receptor 2. In about one of five breast cancers, a
gene mutation leads to excess production of HER2 in the cancer
The researchers evaluated disease-free survival and overall
survival at five years. The addition of the one year of Herceptin
improved both disease-free and overall survival. The disease-free
survival rates at five years were 75 percent in the ACT group, 84
percent in the ACTH group and 81 percent in the TCH group.
Overall survival was 87 percent for the ACT group, 92 percent
for the ACTH and 91 percent in the TCH group.
However, the rates of congestive heart failure and other cardiac
problems were higher in the ACTH group than in the TCH group.
Twenty-one of those on ACTH had congestive heart failure, compared
with four in the TCH group.
There were fewer reports of side effects such as joint pain and
vomiting with the TCH group compared with the ACTH group, Slamon
found. "And you get comparable effects," he noted.
Sanofi-Aventis and Genentech (which makes Herceptin) funded the
study; Slamon reports receiving honoraria and reimbursement for
travel expenses from both companies.
The latest report echoes findings from several previous ones,
Slamon said. Doctors have been using the TCH regimen in women at
risk for cardiac problems; it is approved by the U.S. Food and Drug
Administration. "We're saying it should be used for everybody,"
Slamon said. "We are saying we think it is the standard of care,
with comparable effects, and you lose all the anthracycline
However, Dr. Daniel F. Hayes, clinical director of the breast
oncology program at the University of Michigan Comprehensive Cancer
Center in Ann Arbor, disagreed.
"I think TCH is a standard of care, it's not the standard of care," he said.
"Herceptin itself can cause heart failure," Hayes said. In the study, there were fewer cases of it in those who got Herceptin without anthracyclines, but it did still occur.
He suggests a risk-adapted approach, in which a doctor would
decide which regimen to use based on a woman's cardiac risk.
Oncologists have had the option of anthracycline-free regimens
for a number of years, Hayes noted, although the new study does add
some more solid numbers to the outcomes for each regimen.
To learn more about breast cancer, visit the
American Cancer Society.
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