finally they are developing a test to see if patients are taking their tamoxifen, AIs

[Lani]

or if they are poor metabolizers?
Now some studies as to results of treatment may have more meaning as it may become more certain that the patients whose outcome is being evauated and statistics derived therefrom actually took the prescribed treatment

Anal Bioanal Chem. 2010 Aug 22. [Epub ahead of print]
Development and validation of a liquid chromatography-tandem mass spectrometry method for the simultaneous quantification of tamoxifen, anastrozole, and letrozole in human plasma and its application to a clinical study.
Beer B, Schubert B, Oberguggenberger A, Meraner V, Hubalek M, Oberacher H.

Institute of Legal Medicine, Innsbruck Medical University, Muellerstrasse 44, 6020, Innsbruck, Austria.
Abstract
There is substantial evidence that circulating estrogens promote the proliferation of breast cancer. Consequently, adjuvant hormonal treatment strategies targeting estrogen action have been established. Such hormonal therapies include selective estrogen receptor modulators, such as tamoxifen, which interfere at the estrogen receptors directly, or non-steroidal aromatase inhibitors, such as anastrozole and letrozole, which inhibit estrogen synthesis through blocking the aromatase, a key enzyme of estrogen production. Despite considerable therapeutic success, in several cases, the use of these drugs is limited by side effects that have been described to significantly impair the adherence of patients to endocrine treatment. However, objective data concerning patient adherence and its clinical relevance are limited. One promising approach to check patient-reported adherence is drug monitoring in human plasma. Therefore, a liquid chromatography-tandem mass spectrometry method to determine the plasma concentrations of tamoxifen, anastrozole, and letrozole has been developed and fully validated according to guidelines for clinical and forensic toxicology. The validation criteria evaluated were selectivity, linearity, accuracy and precision, limit of quantification, recovery and matrix effects, sample stability, and carryover. The six-point calibration curves showed linearity over the range of concentrations from 25 to 500 ng/ml for tamoxifen, 5 to 200 ng/ml for anastrozole, and 10 to 300 ng/ml for letrozole. The intra- and inter-day precision and accuracies were always better than 15%. The validated procedure was successfully applied to a clinical study (Patient-Reported Outcomes in Breast Cancer Patients undergoing Endocrine Therapy, PRO-BETh). A major aim of PRO-BETh study is the comprehensive evaluation of adherence to treatment in pre- and post-menopausal women with breast cancer. Plasma samples of 310 breast cancer patients undergoing anti-estrogen therapy were analyzed. Eight samples did not contain a quantifiable amount of drug, strongly indicating non-adherence of the corresponding patients to adjuvant breast cancer treatment. Furthermore, plasma concentrations at the lower end of the observed plasma level distribution might represent a hint but not a confirmation for non-adherence in terms of non-daily and irregular intake of the prescribed drug.

PMID: 20730580

[hutchibk]

"finally they are developing a test to see if patients are taking their tamoxifen, AIs"

Perhaps a lie detector test would be more cost effective? Just joshing... but when one's life is on the line, I can't imagine why folks would choose NOT to adhere to the plan and take their meds, and then be dishonest with their doc about it... if you're not taking it then say so.

[tricia keegan]

I agree Brenda, I take mine religously each day and would be scared not to!!!!

I don't understand the mindset of people who are horrified at a cancer dx and yet don't take these meds:(

[Patb]

Brenda you are right on. I would never forget
my AI no matter what. Love your picture.
patb

[Rich66]

I'm curious how this is tied to patient education/information level. After all, when my mom finished rads, the radiologist declared it "a cured cancer". Why take meds that make your joints stiff you're cured?

[Hopeful]

I stopped AI tx early (after 3 years) but was upfront with my onc about it. We discussed it for 6 months before I made the decision, and he was ok with it. Why do we need this test? Who, exactly, does it benefit?

Hopeful

[Lani]

It benefits everyone who wants accurate statistics on which to base a decision regarding treatmentl.

If x% of patients on a certain regimen recur, was it because that treatment (which the patient had as well as antihormonal treatment) was failed or because that same patient was not compliant in taking her antihormonal?

Non-compliance throws off all the statistics, which assume patients are like lab rats and their intakes exactly the same.

In addition, this may also differentiate those whose antihormonal levels are altered because of genetics or their simultaneously taking other drugs which changes their metabolism of the antihormonals (eg. antidepressants,etc)
It would be beneficial to detect this PRIOR to having have a recurrence, don't you think? and certainly to advise others in the future which medicine and how much to take based on their genetics or other drugs they take

[tricia keegan]

I'd welcome this test and love to know it's helping me avoid a recurrance despite the side effects!

[ElaineM]

A test to see if someone is taking meds seems like a silly waste of time----------like treating women like little girls. Whether or not a woman takes the meds is up to her and her doctor.

[Lani]

I think you are missing my point. When people sign up for clinical trials they allow a lot of testing to be done to see if the drug works, if it works better on some than others, what issues may determine who it works better on.

If there was a way to determine which participants in clinical trials who are assumed to be taking their antihormonals actually were taking them, the conclusions of the trials would be more accurate and meaningful. Since trial results are the basis for drug approvals and funding for further trials, I could only see that this would help. Who was or was not taking their drugs would be anonymous.

If trial participants are recurring because they are not taking their antihormonals rather than because the drug they are testing is not working and this can be demonstrated by this testing , a potentially efficacious drug may make it onto further testing and onto the market.

Would you want to be denied a drug that might work for you because the drug company stopped work on it or the FDA did not approve it because the statistics were influenced in a negative way by noncompliance from some participants in the trial?

I do not see this as a personal freedom issue. Noone is forced to participate in a trial.

If eating hot chili peppers was known to make tumors recur or grow faster, would you object to trial organizers testing participants blood levels of the active ingredient responsible (assuming it were known)? How is a test to detect NOT taking something different than a test to detect someone TAKING something.

Everyone is free to decide to take or not take any part of recommended treatment, but if those on a clinical trial do so and do not inform those running the trial so they can exit the trial, the trial results can become meaningless.

It seems I have hit some kind of raw nerve here or am I just not expressing myself well???!!!!

[AlaskaAngel]

I'm not sure how this test would distinguish between those who were not taking the drug and those who are just poor metabolizers?

Prior reatment like chemotherapy also changes the body's ability to utilize drugs through such things as liver damage from the steroid use that occurs with treatment, so that although they take the tamoxifen or AI faithfully, and the test shows they are taking it faithfully, and they might have had the genetics to begin with that would have allowed them to be good metabolizers, their system may process the drugs without benefit.

There are very real reasons for patients not to be honest about whether they are taking a drug they have been prescribed--especially drugs that have difficult side effects that their providers don't experience personally and discount (lie to patients about). If, for example, a patient doesn't want to take a drug, but wants to be considered a cooperative patient for the purposes of getting the scans or other tests authorized by the provider when the patient wants them, they might lie about taking the drug.

I agree that if a patient is in a trial specifically demonstrating only whether patients are actually taking a drug or not and not whether the drugs were actually effective or not, it would be less likely.

A.A.