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The US Food and Drug Administration has approved another test that can
help doctors determine whether a breast cancer patient is a good
candidate for the drug Herceptin (trastuzumab). The test, called the
SPOT-Light HER2 CISH kit, may help labs run more efficiently, but it
won't ultimately change who gets the drug.
Herceptin, manufactured by Genentech, is given to breast
cancer patients whose cancer cells have a lot of copies of the HER2/neu
gene. Women who have a lot of copies of this gene usually have cancers
that grow and spread more aggressively than other breast cancers.
Herceptin has been shown to dramatically slow that growth and help
women live longer.
However, the drug is expensive and it can cause side effects.
It has been linked to congestive heart failure, especially in women who
are taking the drug along with the chemotherapy drugs doxorubicin
(Adriamycin) and epirubicin (Ellence).
Two tests are currently used to figure out if a patient's
cancer is HER2-positive and will likely respond to Herceptin: fluorescent in situ
hybridization (FISH) and immunohistochemistry (IHC).
The FISH test counts copies of the HER2 gene, and immunohistochemistry
identifies the amount of HER2 receptor protein.
The new test measures the number of copies of the HER2 gene in
a patient's tumor tissue, similar to FISH. But unlike FISH, which is
expensive and requires specimens be shipped to a lab that has the
equipment to view fluorescent probes, SPOT-Light uses a stain that can
be viewed with standard microscopes. Unlike FISH, this kit allows labs
to store the patient's tumor sample at the lab for future reference,
cutting down on the number of repeat tests. IHC-stained slides can also
be looked at later, but some doctors feel the test isn't quite as
accurate.
The kit should be available in mid-August, according to manufacturer
Invitrogen Corp.
HER2-positive cancers can also be treated with lapatinib
(Tykerb). For more information on these drugs and the HER-2 gene, see
"Breast Cancer: Targeted Therapy" and "How Is Breast Cancer Diagnosed?"
ACS News Center stories are provided as a source of cancer-related
news and are not intended to be used as
press releases.
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