New Warnings about Androgen Deprivation Therapy

It has long been known that HT increased the risk of heart disease and diabetes. Many of the top oncologists attribute this to the weight gain caused by HT and not HT itself. This is why all recommend a heart healthy diet and plenty or excercise including weight training to keep weight down and muscle mass. If you eat healthy and don't gain weight there is no additional risk.
JT

It is important to note that in many cases the benefits of an LHRH agonist outweigh the risks. We still don't have a replacement for it other than low dose DES which has no study data available over the longer terms. It is at least now known that these drugs have these complications and as John says there are measures in place to help lighten the SE's. Diet and exercise is among them.

The FDA released these warning labels with a very tentative message. Because they have high incidence of diabetes and heart issues among men in the class, they felt was a good time to require the warning label while this is still being investigated. I think it is incumbant upon every doctor issuing these prescriptions to be monitoring weight gain and blood sugar as well. I gained over 20 pounds on lupron and my doctor was on my case about it quickly. I am off the drug now but it has still proven difficult to lose the weight. My blood pressure meds have had to be increased but my hypertension is under control.

Kind of an off topic question but does anybody still want to discuss using this drug as a front line therapy?

Tony

John, no there is not a lot of data that support your post. And you forgot one big question:

Is treating prostate cancer with a therapy that has a potentially higher risk of mortality than the disease itself a good plan to control biochemical relapse rates in prostate cancer?

I have seen Leibowitz state it at our UsTOO groups, but he is very clear that more work needs to be done to compare the efficacy of the regimen to the morbidities. This release by the FDA just may make his approach to do so a liability he may need to contend with.

You know where I come from by now on prostate cancer studies. Dr. Bob and his practice is not a study, and certainly I am not interested in any short term studies on the use of front line HT as a primary therapy except in intermediate or high risk cases. What studies that we do see have consistently shown front line HT to not perform as well as other options and we do have some pretty long ones.

John T said <my comments are in brackets>:
The positives:
1. For localized PC has cure rates similar to other therapies.
<there is no study that shows this anywhere, in fact I can produce many that disagree entirely with this statement including the CaPSURE database. HT is not a cure for prostate cancer. Controlling PSA may work well for some patients, but that doe not make it a cure. HT does not offer the same cure rates of any generally accepted front line therapy>
2. All side affects are reversible once stopped.
<This is just plain false, in fact the release by the FDA indicates that many very serious side effects may linger forever and remain life threatening when the cancer never was>
3. Is not an invasive treatment
<Again this is entirely false. HT is a highly invasive systemic chemical therapy. The affected areas may and likely will include any of the following: the nervous system, endocrine system, cardiovascular system, and cause diabetes, cause severe depression and so much more. I can't imagine a more invasive therapy than a systemic therapy like this one. You must be thinking in terms of localized morbidities but with experience in three therapies, HT was by far the most invasive life altering one I was on>
4. Good option for patients that refuse surgery or radiation for personal reasons. <This one I agree with depending on the patients expectations. If a person is not well enough for surgical therapies or radiation then the use of HT as a front line therapy is reasonable. As long as he understands all the risk factors>

I agree with the negatives you posted. I will add a few that I personally witnessed:
5. Depression. Caused by low T levels, this one can affect your ability to maintain a good work out regimen that will bring all of the other SE's into play.
6. Many men suffer from severe respiratory ailments and are forced to stop the therapy. These ailments can lead to allergic reactions and even death.
7. Many men who go on HT even for a short time suffer from hypogonadism forever (low T levels). Typically the use of androgen replacement therapy is common.

I'm sure I can add more. I am not down on Lupron or any of it's competition and recognize that some can indeed do well on it as a front line therapy. But to tell people that have localized or locally spread prostate cancer that HT works just as good as other local therapies, all side effects go away, or it is not invasive is not a good representation of the facts that we do have. But HT does have it's place in our disease. And for those of us unlucky enough to qualify for it, we end up being thankful it is an option.

Tony

I remember your posts, zufus. I can understand why no one get's to up about it and that's not meant to be said in a critical way. I believe the story quite well. And I know of men myself with extended remissions after ADT or ADT3 with low risk disease. What's more, I have never known anyone of a single case where they died due to their therapy, either.

Rick's story sounds great. And I thoroughly believe in the performance of hormonal therapies. But I have lived that experience, too. I'll do it again if I have to but, doggone it ~ I didn't like it, and I don't like the implications of this warning. If 13 months on cycles need to be evaluated then we need that information from a correctly run study. The FDA warning requirement made no mention of the length of term for the on cycles. Like DES, which was originally administered in varying levels of 3 to 5 mg and found to be more dangerous than the cancer, HT may be better used in lighter doses. As you know I have investigated the possibility of using DES in replacement of ADT with an LHRH agonist. You know that experience better than I do.

But let's not mix up the risks either. What we lack in online advocacy is the data that the FDA used to mandate this warning. I have a pretty strong feeling it was warranted.

Tony

Not that I know. All LHRH agonists work pretty much the same way so I don't know that brand matters. This is a very rare occurrence just as all that I named are. Hypogonadism is a reversible condition with testosterone replacement therapy. My oncologist suggests that patience is the best policy with it because once you start using a testosterone therapy you can become dependent on it. But he has prescribed Androgel in these rare cases.

Tony

There is a clear demarcation that the benefits of HT on a high risk case is likely less deadly than the cancer itself. That isn't known to be true for just any patient.

Tony