For Alaska Angel and others--policy statement on use of herceptin

[Lani]

For Immediate Release
November 10, 2006

American Society of Breast Disease Issues Statement on the Use of Adjuvant Trastuzumab in Women with HER2-Positive, Operable Breast Cancer

Interest among patients and clinicians on use of adjuvant trastuzumab for breast cancer treatment requires clear statement of what we know and do not know. While acknowledging that this is a rapidly changing field, the Consensus Committee of the American Society of Breast Disease presents the following conclusions on the present status of trastuzumab use for HER2-positive, operable breast cancer.

Invasive breast cancers should be tested for over-expression or amplification of the HER2 proto-oncogene.
Women with HER2-positive, operable, lymph node positive breast cancer should be offered trastuzumab. While data are less robust for women with HER2-positive, operable, lymph node negative breast cancer, those with high risk disease should be offered adjuvant trastuzumab.
The optimal schedule of trastuzumab administration remains to be determined, although weekly administrations and three-weekly administrations are both associated with similar levels of benefit.
Adjuvant trastuzumab with dose-dense chemotherapy is presently being investigated and recommendations cannot yet be made.
The optimal timing and duration of adjuvant treatment with trastuzumab remains to be established. The bulk of evidence was based on regimens utilizing one year of trastuzumab.
Women should be without clinically significant cardiac disease at outset and monitored for cardiac toxicity during treatment. The Committee supports the published guidelines for monitoring cardiac toxicity and for dose modifications. Women older than age 60 have higher risk of cardiac toxicity, as do those with preexisting risk factors. Cardiac toxicity appears lower for sequential chemotherapy-trastuzumab regimens compared to the simultaneous regimens.
Trastuzumab was beneficial across all adjuvant and neo-adjuvant chemotherapy regimens in clinical trials.
Data suggest that co-amplification of TOPO2A with HER2 is associated with greater benefit from anthracycline-containing regimens than non-anthracycline regimens whereas co-amplification of cMYC with HER2 is associated with greater benefit from trastuzumab.
There are no data on the use of trastuzumab without chemotherapy in the adjuvant setting.
For an individual woman who has completed adjuvant chemotherapy beyond the time specified by the clinical trials, we believe it is reasonable to evaluate risk of recurrence at her given point in time when deciding to recommend adjuvant trastuzumab.
The American Society of Breast Disease encourages participation in clinical trials.

[Joannie]

So what does this really mean. There still doesn't seem to be adequate research for those of us who didn't receive Herceptin during chemo. I read and read about those of us in this situation and I am always unclear how I should proceed. I'm currently looking into the TEACH trial. I left a message on Friday to get more information.

Does this article suggest I should try to get Herceptin this late in the game? I was diagnosed in April 2003, took A/C and Taxol, dose dense. Finished chemo in August 2003. Herceptin was never an option for me. I wish I would have pursued getting it in trial.

Thoughts?
Joannie

[AlaskaAngel]

Thanks, Lani, for remembering those of us who are struggling with this question.

Joannie, because there is this group of us that were somehow considered at enough danger to need chemotherapy but not at enough danger to be included in the Herceptin trial (!????!), as you know we are left somewhere in the Outer Limits...!

The "system" for categorizing who gets what therapy is having a hard time catching up with the information that expanded with computers, internet contact between different scientific endeavors, the Human Genome Project, etc. I keep wondering when the NCCN guidelines are going to change so that we all don't continue to get swept away to treatment based on the 1 cm guideline for chemo, now that it is clearer that it doesn't fit as well as things like genetic tests.

The guidelines are what put us at "high risk but how high"? but each of our tumors have more tumor characteristics that aren't part of the guidelines, so making a judgement call might include those kinds of things. (For example, BRCA positivity.)

Take a look at the basic guidelines and then think of any characteristics of your particular tumor in addition to those guidelines. :

http://www.nccn.org/patients/patient.../3_work-up.asp

But what I keep wondering is why there doesn't seem to be any info on doing the genetic tests on our tumors in retrospect to help us get a better handle on our risk. Lani? Becky? Macmaze?

AlaskaAngel

[Lani]

once you open the Pandora's box of looking retrospectively at what a patient's tumors genetic characteristics were you will get lots of angry patients who realize they got chemo when chances were less than 10% that they would recur, angry patients who did not get herceptin...and the genetic testing and THE INTERPRETATION of the genetic testing in terms of what it means regarding the best treatment and true prognosiss are still in their infancy, inexact and NOT YET ready for prime time.

I certainly hope it will be soon. Hope is on the horizon as the Wall St. Journal reported that due to a price war, the cost of the Affymetric chips on which they do microgene arrays is plummeting. If this could be passed on, the speed with which genetic testing of individual tumors begins to be routine will be accelerated. In the meantime, tell anyone who is recently diagnosed to ask for a small bit of their tumor or core/needle biopsy to be fresh frozen. Testing is best done on fresh (not available yet except in trials), then fresh-frozen, and last on paraffin-embedded, where different techniques are used as I understand it.

Advocacy and fund-raising are ways to push research in this much needed direction.