The Walls St. Journal published a story this morning, “Bad Cancer Tests Drawing Scrutiny” that detailed how “thousands of breast-cancer patients may be getting the wrong treatment because of errors in two laboratory tests widely used to determine which drugs are prescribed.”

The reporter was referring to the tests pathologists use to determine a tumor’s HER2 and hormone receptor status. These tests are important because only tumors that are HER2-positive will respond to the drug trastuzumab (brand name Herceptin) while only those that are estrogen receptor (ER) and/or progesterone receptor (PR) positive will respond to hormone therapy.

The article mentions “recent studies” that found that these tests are not always accurate. However, none of the studies are really that new. In fact, none of this is really “news” at all. Oncologists have known about this problem for years.

I’m not really sure why this story is coming out now. I find it more of a scare story to alert people to the standard of care. It is true that, as the article says, these laboratory tests are not always accurate. We’ve known for some time that these tests are accurate about 80 percent of the time. This is also true about x-rays, doctor’s diagnoses, recommendations for surgery, pathological diagnosis, etc. Medicine is rarely about 100 percent certainty. Not only are all medical tests wrong sometimes, but there is no quality control on most procedures, other than mammography

Having said that, it is true that, as the article points out, there is no external quality control for these tests, and that any lab can start doing them, regardless of how much experience they have. Moreover, as we increase our understanding of the different types of breast cancer and begin to develop treatments for each of them, we are undoubtedly going to rely more and more on the use of complicated tests to determine which targeted therapies are needed to treat each tumor type. This means it will probably be necessary to develop some controls and standards for these tests that address who performs them and how.

Until then, I would encourage women to ask for second opinions on their pathology and test results if there is any question about their tumor type. Most likely, this will be women whose tumors are found to be ER, PR and/ HER2-negative. For them, re-testing may be important as it could mean they have another treatment option.

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15 Responses to Bad Cancer Tests Drawing Scrutiny

  1. misslisa72 says:

    I have a question then..I have DCIS and my radiation dr said I am HER + and could treat any micros left behind with radiation and then take tomoxifen for some years…but then I see my oncologist and he said I was only 40% + so now I may also need chemo. Isn’t being positive in any way, no matter the percents, mean you are positive?? He didn’t say in the begining that..I had to be 100% positive. Can you please help explain the 40% part of the HER testing??

  2. Dianne says:

    I won’t comment on the HER2 positive, but I’m sure Dr. Love will. I am curious also to know if HER2 positive makes any difference in longevity/survival if you are 1+, 2+, or 3+++? Can you explain the ramifications of these numbers?

    My diagnosis last month was invasive ductal carcinoma right breast, grade 3, 2 cm tumor, HER2 positive (3+, I believe), weakly ER positive. I had bilateral mastectomies almost 2 weeks ago even though the left breast did not have cancer – I didn’t trust it anymore. My surgeon removed 8 lymphs (is this enough?) which were all negative for cancer.

    What is the survival outcome for HER2 positive, node negative with weak estrogen receptors? I don’t think Herceptin has been out for more than a few years for HER2 positive women, yet a MedScape article said the survival rates were 70% at 10 years for HER2 positive node negative or positive. Is this true? Isn’t node negative a better outcome, or was I thrilled to get this news for nothing?

    Also, Dr. Love, do you have any idea what my chemo treatment should be?
    As well, are my chances any better since I removed both breasts? I don’t miss them but do hope I did something to improve my survival. There doesn’t seem to be a lot of info on Her2 positive, node negative women. Thanks so much for your help.

  3. Bonnie says:

    Did Dr Love reply to the Sept 22/08 question from Diane? My case is very similiar (except tumor .6cm). I would be interested in the response for treatment.

  4. Jan Skoglund says:

    Helpful write-up. Thank you for posting

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