genetic testing for recurrence risk

[repopter]

I'm interested in hearing thoughts about the pros and cons of testing for recurrence risk with the new Mammaprint test or OncotypeDX. Mammaprint was just "cleared" by the FDA (don't know how that differs from FDA approval).

The tests say they can help me decide whether to have chemo. But if my risk in in the intermediate range, wouldn't it make more sense to simply go ahead with chemo, but have chemosensitivity testing to determine how effective specific drugs would be against my particular cancer cells?

[Cleveland Clinic]

Dear repopter:  The mammaprint test was cleared by the FDA for marketing on February 7, 2007.  It was cleared for use in women with stage l or stage ll (lymph node negative) disease to predict time to distant metastasis.  The FDA intends to publish a guidance document in the next 60 days.  The intent of the test is to attempt to predict when or how likely a person is to develop metastasis and that this will help to guide which women should receive chemotherapy.  Currently, the test is not yet available at most centers.  OncotypeDX is used in much the same way  and is available for use in the evaluation of hormone receptor positive, lymph-node negative breast cancers.  The decision about adjuvant treatment is frequently based on data such as tumor size, histology, grade, hormone status, her2 status, the health of the patient, etc.   These tests may provide additional information about the biology of an individual's tumor and should probably be viewed as such and not necessarily be the only determining factor in the decision to get or not get chemotherapy.  Ultimately, this is data that should be discussed with one’s oncologist.  Chemosensitivity testing is another matter.  This has been around at least 20 years and is quite controversial.  In other words, because a drug works, or does not work, in a test tube does not necessarily correlate to what works, or does not work, in the body.  Many drugs have been tested in clinical trials for breast cancer and  these  data  are probably more reliable as  the studies use disease free survival or overall survival as endpoints and  are  generalizable to the population.  Further, I am not aware of chemosensitivity testing being used in the adjuvant setting.

[Avidhiker]

I had the Oncotype DX test performed on my tumor specimen in July of 2006.  At that time, it was the ONLY genomic (not genetic) test available.  You are correct:  The test does not say, yes, chemo is recommended or yes, this tumor will respond to XYZ chemo treatment.  It only quantifies by a number the risk of recurrence in ten years.  A percentage is also affixed to the number.  1-18 low risk; 19-30 intermediate risk; over 30 high risk.  My number was 25 with a 16% risk of recurrence in ten years. This percentage INCLUDES hormonal treatment with Tamoxifen.  The intermediate risk is "neither high, nor low" but it is there.

I really placed a lot of creedence in the test and along with two separate oncologists' opinions, I opted for the chemo.  Had my number been lower?  In retrospect, I probably still would have taken the chemo for the peace of mind of knowing that I did everything I can to avoid having this rotten disease come back.

Chemo was recommended for me becauseof the 2.4 cm tumor size and because HER2+ was overexpressed.  I questioned the benefit of chemo because I was node negative.  I researched until I was exhausted. I had access to a medical teaching university's library where there I read JAMA articles with the assistance of a nurse friend.  Of course, as my luck would have it, I found hardly anything that would substantiate my opinion that chemo would not benefit me.  The results of the Oncotype test made my mind up.

It is a very difficult decision to make, only you can make it.  The test is expensive, I recalled @$3,400.  Medicare pays for it and a lot of private insurers are now also covering the cost.

By the way, chemo is not that bad.  Mind over matter plays a big time role, and oncologists today have LOTS of remedies in their bags for just about any and all side effects that MAY occur.  I pretty much breezed through 4 rounds of AC.  Everyone is different.

Good luck with your decision.  Only you can make it.

[repopter]

Avidhiker: Thanks so much for your thoughtful answer. I'd really like to talk directly to you. Would you email me at ***@****?

[boninclyde]

I had wide spread DCIS, 0.09mm invasion, no lymph node involvement, ER+, PR+, HER2-. Right masectomy August 25th, 2006. My onco score was 20 1/2. No recommendation for chemo or radiation. Now on tamoxifen. By some rules I was borderline. I don't think the 3600.00 onco test helped me much. What was your diagnosis? If you don't mind me asking.

[hollyanne]

I had the same issue, being borderline on the Oncotype:  score 24.  Age 50, ER+, PR+, node negative, 6 mm tumor.  Because of the score, and a family history of BC, my onc. recommended chemo.  I got 2nd and 3rd opinions, from top (e.g. nationally known) oncs. at MSK and Dana Farber, who recommended NO chemo simply on the basis of the oncotype score, but radiation and tamoxifen following a lumpectomy, if all other indications were as above.  The reasoning was that the data the oncotype test is based on was, at the time, drawn from women >50 and not with "tiny tumors" .. this is a gray area, and there is an ongoing clinical study on this (which obviously doesn't help anyone now).  Onc. #2 said with my indicators, she wouldn't be alarmed unless it was in the mid-thirties.

After many sleepless nights, I opted for no chemo.  Finished radiation and am now on tamoxifen -- I hope I made the right decision!  It is a personal one based on your level of comfort with the unknown, and I would completely support any decision someone would make to the contrary.  

[repopter]

Thanks to each of you for responding. Now my disclosure: I'm a reporter at the Philadelphia Inquirer, doing a story about gene profiling tests. I've interviewed lots of academics and "experts," but wanted to hear from actual patients. I'd very much like to talk directly to you by phone (if you're willing.) Please call me at 215-854-2720. Even if you do not want to be interviewed, please call and tell me that.

[boninclyde]

So do you have breast cancer or are you preying on us that do? I should have picked up on the name but dummy me. If you don't have cancer you could have told us you were a reporter and ask our opionn but from your post it seems you a in the same boat we are. I don't play mind games. Until you explain further I am very frustrated with you.

[ziggy123]

Boninclyde-I agree with you 100%. I was a little taken aback by the admission that she is a reporter. If indeed she is following up on this story because she has a personal interest due to her own cancer, that is one thing. But, if she has used this forum just to find out info for a her story, I am annoyed with her lack of sensitivity. Until she clarifies her interst, I am willing to give her the benefit of the doubt, but she needs to explain herself.

[hollyanne]

I am with the others .. my writing on this board was to share with other individuals in the same boat; women with cancer tend to support each other in difficult decision making, and it is only on this premise that we share incredibly personal medical information.  I would be leary about sharing my personal medical journey in a widespread way, and I am also protecting the confidentiality of my conversations with my doctors.  I would only assist with a story if it would help other women in the same boat and I am not sure a newspaper is the way to do it; they really need to consult with their own physicians and make the decision best for them.