SUNDAY, June 3 (HealthDay News) -- An experimental drug designed
to treat patients with a specific kind of breast cancer known as
HER2-positive appeared to boost survival compared to the standard
treatment, a new study shows.
The drug, known as trastuzumab emtansine (T-DM1), is in the
final stage of research necessary before the U.S. Food and Drug
Administration can approve its sale. For now, it is only available
in clinical trials.
"The drug worked. It was significantly better than a very
effective approved therapy for HER2-overexpressing metastatic
breast cancer," study author Dr. Kimberly Blackwell, a professor of
medicine and an assistant professor of radiation oncology at Duke
Cancer Institute in Durham, N.C., said in a news release from the
American Society of Clinical Oncology.
"Also, as a clinician who takes care of a lot of breast cancer
patients, I'm pleased that this drug has very little dose-limiting
toxicity," she added. "Patients don't lose their hair from this
drug. For patients facing metastatic breast cancer, this is a
breakthrough."
Patients with HER2-positive breast cancer have a protein called
human epidermal growth factor receptor 2 that promotes cancer cell
growth.
The drug T-DM1 is a dual drug made up of the antibody
trastuzumab (Herceptin) and the cytotoxic drug emtansine (DM1).
In the study, nearly 1,000 patients received either T-DM1 or a
regimen of capecitabine (Xeloda) and lapatinib (Tykerb), a
combination referred to as XL. They took the assigned treatment
until the disease got worse or side effects became
unmanageable.
After two years, 65.4 percent of those who took T-DM1 were
alive, compared to 47.5 percent of those who took the other
treatment.
The median progression-free survival time was 9.6 months for
those who got T-DM1, compared to 6.4 months for the others.
Several side effects were more common in the T-DM1 patients,
including a low platelet count, but the regimen was generally
well-tolerated, the researchers said. Those who got the standard
treatment were more likely to experience diarrhea, stomach upset
and redness, swelling and pain in their palms and the soles of
their feet.
Dr. Daniel Hayes, clinical director of the breast oncology
program at the University of Michigan Comprehensive Cancer Center
in Ann Arbor, said the study "suggests that T-DM1 will provide us
with yet another effective and meaningful agent to use in women
with HER2-positive breast cancer."
The study was scheduled to bepresented Sunday at the American
Society of Clinical Oncology annual meeting in Chicago.
Data and conclusions presented at medical meetings should be
considered preliminary until published in a peer-reviewed medical
journal.
More information
For more about
breast cancer, see the U.S. National Library of
Medicine.
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