Hard to Believe !!

Joe · 10-07-2009, 11:12 AM

Breast Cancer Gene Testing for Roche’s Herceptin Often Lacking

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By Elizabeth Lopatto
Sept. 14 (Bloomberg) -- A genetic test used to determine if breast cancer patients should receive Roche Holding AG’s Herceptin is often not given to patients, according to a report.
Two-thirds of women with invasive breast cancer had no documentation of having undergone testing for abnormalities on the HER2 gene that makes cancer more dangerous, according to a report in the journal Cancer. The article also found about 1 in 5 tests for HER2 done by local laboratories are inaccurate when compared with larger laboratory results on the same tissue.
Healthy breast cells contain two copies of HER2, according to the American Society of Clinical Oncology. About 20 percent of women with invasive breast cancer have extra copies, and these tumors, called “HER2-positive,” are aggressive forms of the disease that are more difficult to treat. The doctors’ group recommends that all patients with invasive breast cancer be tested to find out their HER2 status.
“Our review of the literature suggests that there are important knowledge gaps regarding the real-world use of HER2 testing” and Herceptin, said Elena Elkin, a researcher at Memorial Sloan-Kettering Cancer Center in New York and one of the study’s authors, in a statement released by the journal.
Today’s report reviews previously published studies to determine how testing is used in the clinic, and was led by Kathryn Phillips of the University of California, San Francisco.
Cancer Spread
Invasive breast cancer occurs when the cancer has spread beyond its initial point of origin, usually in the milk ducts or milk-producing glands, to other breast tissue. From there, it is easier for the disease to spread to other parts of the body, according to the Mayo Clinic. Invasive ductal carcinoma, which begins in the milk ducts, accounts for about 70 percent of all breast cancer, the Mayo Clinic says on its Web site.
For the 20 to 30 percent of patients who over-express HER2, Herceptin is “highly effective,” the authors wrote. Without the ability to target that population, the drug wouldn’t have been approved, according to the report. Testing for the gene is important because withholding Herceptin from patients who may benefit from it may mean they miss an opportunity to reduce their risk of death.
Additionally, providing Herceptin to a woman without the abnormality exposes her to “an unnecessary risk of heart failure” as well as incurring a cost to the health-care system of $100,000 annually. About 1 in 5 women who were taking Herceptin had no proof of a test in their health insurance records, the review found.
Standardize Testing
“It is possible that a test had been performed and given a positive result but wasn’t properly documented,” Elkin said in an e-mail.
The authors recommended the testing be standardized to help ensure it is provided to patients. More information on the technologies used for tests also may help, they said.
Herceptin, first cleared for use in the U.S. in 1998, had $4.74 billion in sales last year for Basel-based Roche. The company is also seeking marketing approval for the drug in stomach cancer outside the U.S.
Herceptin isn’t the only treatment approved for use in HER2 breast cancer. GlaxoSmithKline Plc.’s Tykerb was also approved for that use in 2007, and some doctors recommend certain chemotherapy regimens, according to the Mayo Clinic.
To contact the reporter on this story: Elizabeth Lopatto in New York at elopatto@bloomberg.net.
Last Updated: September 14, 2009 00:01 EDT

Regards
Joe

StephN · 10-07-2009, 11:25 AM

GADS! I thought we had come out of the Dark Ages ...

hutchibk · 10-07-2009, 03:18 PM

Again, I will share my new mantra... welcome to the shape of things to come. I fear this will become something else known as "excessive use of the system $$".

Chelee · 10-07-2009, 03:23 PM

Brenda, I have one thing to say, "You got that right!"

Chelee

tricia keegan · 10-07-2009, 03:33 PM

I posted earlier on my friends problem who was miss diagnosed as her2 neg back in '05!!!

This report is scary, and I wonder how many other women did nt receive herceptin when they shouldn have ???

ElaineM · 10-07-2009, 04:22 PM

It happens. One doctor sometimes does not know everything there is to know about his or her specialty. That is why it is important for us to learn as much as we can about our situations and ask alot of questions. It is important to get second or third opinions whenever things are not going well or we feel we need more information about our situation that our doctors may not be providing.

Diane H · 10-08-2009, 07:57 AM

Very hard to believe, what's going on here?
But I'm not going to take it as evidence that it is the shape of things to come. Just that some doctors are woefully ignorant.

caya · 10-08-2009, 11:51 AM

I cannot speak for every physician in Canada, but I know my oncologist checks every patient for Her2 status, and has been doing this for many years. The cost of Herceptin in Ontario when I had my treatment (2007) was $40,000 CDN, totally covered by our universal health care system.

all the best
caya

suzan w · 10-08-2009, 07:43 PM

it still amazes me that most of my friends who have had breast cancer do not even know what kind of breast cancer they had/have, much less the Her2 status...they just blindly go along with whatever the doctor says without any question.

ElaineM · 10-09-2009, 10:31 AM

I know some people like Suzan described. This is not limited to breast cancer patients. Some people don't even know what kind of chemo they are taking much less anything else. They leave everything up to the doctor and just do what they are told to do. They don't ask questions and just accept everything without question.

Rich66 · 10-10-2009, 10:53 PM

I think maybe previous experience influences trust in doctors. If someone has never had a reason to question docs prior to cancer dx, they are probably going to go along with things. I really wanted to be a pssive supporter of my mom as she just went with the treatments. Unfortunately, things went a bit off the rails from the beginning and I ended up neck deep in things. At this point, I've seen questionable situations at every institution, with every doctor. Just a matter of degree.
But yes, after initial diagnosis (11/04), I took mom for a second opinion and saw that when the onc read the pathology, he scrambled his nurse to arrange to have the tissue tested for Her2. Found this website shortly after. I'd love to share consult notes at Mayo where another onc basically said I was overreacting regarding HER2 status and he took extra time to set me straight. Another onc at a "progressive" NCI academic facility folded his arms declaring he would not administer Herceptin off label in adjuvant. Such informed forward thinking.

StephN · 10-11-2009, 11:36 AM

Rich -
My humble opinion feels that whether we go "blindly along" with our cancer treatments or want to know the whys and wherefores, does not correlate to past experience with doctors.

I think it is a matter of PERSONALITY in the individual patient. In my case I did not have any bad past medical experiences. Always had good docs who interacted well and answered my queries.

Some of us are just more curious by nature when it comes to what is being done to our bodies, especially when it involves a real threat to our lives. Some people are fatalisitic (I know some like that), who figure there is little they could do other than what the docs prescribe.

It also can be a matter of energy level as well as fear whether a patient wants to get down and dirty with the details.

Rich66 · 10-11-2009, 02:09 PM

Wasn't making a global statement. Yes, different personalities as well as experiences play into this at an idividual level. But I can't help but think there has been a shift from blind reverence to medical folk to more tendency to seek additional information and input. My mom's position on this has evolved from reverence to thoughtful consideration as things have unfolded. In her case, less a personality issue, more experiential. Less nature, more nurture.

tricia keegan · 10-11-2009, 02:53 PM

Who knows, maybe a bit of both come into play here??
I had my surgery and chemo with a very well educated woman, and was amazed after tx that she blindly insisted on going along with all her Dr said and asking no questions.
When I printed out an explanation for her path report for her she refused to read it and simply stated "This will never come back"!!!!
I don't know if this is a type of ignorance in some or just not wanting to get dirty as Steph stated. I know in my own case I wanted to know as much as possible from day one and still feel puzzled how other's can accept soley their Dr's views blindingly at times???