New Warnings about Androgen Deprivation Therapy

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Drums
Regular Member


Date Joined Mar 2010
Total Posts : 134
   Posted 10/27/2010 9:01 AM (GMT -6)   

darned if you do and darned if you don’t. Here’s an article on new warnings regarding androgen deprivation therapy (ADT) used to shrink or slow the growth of prostate cancer.

 

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230334.htm

 


John T
Veteran Member


Date Joined Nov 2008
Total Posts : 4223
   Posted 10/27/2010 10:01 AM (GMT -6)   
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
65 years old, rising psa for 10 years from 4 to 40; 12 biopsies and MRIS all negative. Oct 2009 DXed with G6 <5%. Color Doppler biopsy found 2.5 cm G4+3. Combidex clear. Seeds and IMRT, no side affects and psa .1 at 1.5 years.

Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 10/27/2010 10:08 AM (GMT -6)   
this must make every guy on ht feel real warm and cozy, as if they didnt have enough to worry about
Age: 58, 56 dx, PSA: 7/07 5.8, 10/08 16.3
3rd Biopsy: 9/08 7 of 7 Positive, 40-90%, Gleason 4+3
open RP: 11/08, on catheters for 101 days
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos marg
Incont & ED: None
Post Surgery PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, 8/6 .06 11/10 ?
Latest: 6 Corr Surgeries to Bladder Neck, SP Catheter since 10/1/9, SRT 39 Sess/72 gy ended 11/09, on Catheter #21, will be having Ileal Conduit Surgery in Sept.

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 10/27/2010 10:55 AM (GMT -6)   
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
Disease:
Advanced Prostate Cancer at age 44 (I am 48 now)
pT3b,N0,Mx (original PSA was 19.8) EPE, PM, SVI. Gleason 4+3=7

Treatments:
RALP ~ 2/17/2007 at the City of Hope near Los Angeles.
Adjuvant Radiation Therapy ~ IMRT Completed 8/07
Adjuvant Hormone Therapy ~ 28 months on Casodex and Lupron.

Status:
"I beat up this disease and took its lunch money! I am in remission."
I am currently not being treated, but I do have regular oncology visits.
I am the president of an UsTOO chapter in Las Vegas

Blog : www.caringbridge.org/visit/tonycrispino

John T
Veteran Member


Date Joined Nov 2008
Total Posts : 4223
   Posted 10/27/2010 1:13 PM (GMT -6)   
Tony,
I think there is some, but not a lot of data that support that HT is a viable treatment as a front line therapy. Liebowitsz on his web site publishes a few studies he did years ago which showed that 93 patients were given ADT3 for 13 months and about 90% or so achieved long term remission. He has more data from other patients and has requested that if anyone would compile the data they can have it as he is way too busy with his practice. If you look at the published papers on his website they are interesting reading. (Compassionateoncology.com)
I think it it as viable a treatment option as any other and as other treatments require some tradoffs.
The positives:
1. For localized PC has cure rates similar to other therapies.
2. All side affects are reversible once stopped.
3. Is not an invasive treatment
4. Good option for patients that refuse surgery or radiation for personal reasons.
 
Negatives:
1. No long term studies of effectiveness as a 1st line therapy, only a few studies that have not been verified.
2. Has some severe side affects including complete loss of libido while on the drugs.
3. Need a specialist to monitor and get the best results.
4. Treatment is long term, 13 to 24 months, and there is no fast closure.
 

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 10/27/2010 4:57 PM (GMT -6)   
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
Disease:
Advanced Prostate Cancer at age 44 (I am 48 now)
pT3b,N0,Mx (original PSA was 19.8) EPE, PM, SVI. Gleason 4+3=7

Treatments:
RALP ~ 2/17/2007 at the City of Hope near Los Angeles.
Adjuvant Radiation Therapy ~ IMRT Completed 8/07
Adjuvant Hormone Therapy ~ 28 months on Casodex and Lupron.

Status:
"I beat up this disease and took its lunch money! I am in remission."
I am currently not being treated, but I do have regular oncology visits.
I am the president of an UsTOO chapter in Las Vegas

Blog : www.caringbridge.org/visit/tonycrispino

Post Edited (TC-LasVegas) : 10/27/2010 5:04:15 PM (GMT-6)


zufus
Veteran Member


Date Joined Dec 2008
Total Posts : 3149
   Posted 10/27/2010 7:30 PM (GMT -6)   
I posted many times about Rick K. and his first line therapy with ADT3...nobody seemed to excited about it..except for me and Rick and few others perhaps. I won't bother again right now, but 15 yrs. and no know PCa found and normacly as a man using Leibowitz protocol...doesn't smell to bad. Plus he could still do any treatment. He is very pleased at that huge decision (gamble) made back in 1995.

There are some long term side effects possible from LHRH and it is not risk free in total. Why bother discussing it, it is sold like it is health food from our purveyors of it. Rick's shorter term useage 13 months, seems to be a reasonable trade off and benefits scenario.
Dx-2002 total urinary blockage, bPsa 46.6 12/12 biopsies all loaded 75-95% vol.; Gleasons scores 7,8,9's (2-sets), gland size 35, ct and bone scans look clear- ADT3 5 months prior to radiations neutron/photon 2-machines, cont'd. ADT3, quit after 2 yrs. switched to DES 1-mg, off 1+ yr., controlled well, resumed, used intermittently, resumed useage

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 10/27/2010 9:33 PM (GMT -6)   
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
Disease:
Advanced Prostate Cancer at age 44 (I am 48 now)
pT3b,N0,Mx (original PSA was 19.8) EPE, PM, SVI. Gleason 4+3=7

Treatments:
RALP ~ 2/17/2007 at the City of Hope near Los Angeles.
Adjuvant Radiation Therapy ~ IMRT Completed 8/07
Adjuvant Hormone Therapy ~ 28 months on Casodex and Lupron.

Status:
"I beat up this disease and took its lunch money! I am in remission."
I am currently not being treated, but I do have regular oncology visits.
I am the president of an UsTOO chapter in Las Vegas

Blog : www.caringbridge.org/visit/tonycrispino

pogmothoin
Regular Member


Date Joined May 2010
Total Posts : 84
   Posted 10/28/2010 7:08 AM (GMT -6)   
"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."

Is there any data on one HT drug versus another presenting a higher risk factor for this?

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 10/28/2010 9:19 AM (GMT -6)   
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
Disease:
Advanced Prostate Cancer at age 44 (I am 48 now)
pT3b,N0,Mx (original PSA was 19.8) EPE, PM, SVI. Gleason 4+3=7

Treatments:
RALP ~ 2/17/2007 at the City of Hope near Los Angeles.
Adjuvant Radiation Therapy ~ IMRT Completed 8/07
Adjuvant Hormone Therapy ~ 28 months on Casodex and Lupron.

Status:
"I beat up this disease and took its lunch money! I am in remission."
I am currently not being treated, but I do have regular oncology visits.
I am the president of an UsTOO chapter in Las Vegas

Blog : www.caringbridge.org/visit/tonycrispino

John T
Veteran Member


Date Joined Nov 2008
Total Posts : 4223
   Posted 10/28/2010 9:21 AM (GMT -6)   
Tony,
I'm not advocating HT as a 1st line therapy, but you asked a question and I answered it. There are no studies as you have mentioned, but there are a lot of patients that have taken this option and have done well.
Instead of trashing the idea we should be asking the question: If it works so well on men with matastized disease, why wouldn't it work on men with much lower stage disease.
Younger men such as yourself usually have more severe side affects, and some individuals tolorate side affects much better. My cousin's only treatment has been HT for 12 years, two courses for 2 years and is living a normal life, and my nieghbor is going on 15 years of continious treatment and is more active than a normal 76 year old. It may not be the best 1st line option, but it surely is an option especially for older patients. You can cite severe side affects for every treatment.
JT
65 years old, rising psa for 10 years from 4 to 40; 12 biopsies and MRIS all negative. Oct 2009 DXed with G6 <5%. Color Doppler biopsy found 2.5 cm G4+3. Combidex clear. Seeds and IMRT, no side affects and psa .1 at 1.5 years.

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 10/28/2010 9:29 AM (GMT -6)   
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
Disease:
Advanced Prostate Cancer at age 44 (I am 48 now)
pT3b,N0,Mx (original PSA was 19.8) EPE, PM, SVI. Gleason 4+3=7

Treatments:
RALP ~ 2/17/2007 at the City of Hope near Los Angeles.
Adjuvant Radiation Therapy ~ IMRT Completed 8/07
Adjuvant Hormone Therapy ~ 28 months on Casodex and Lupron.

Status:
"I beat up this disease and took its lunch money! I am in remission."
I am currently not being treated, but I do have regular oncology visits.
I am the president of an UsTOO chapter in Las Vegas

Blog : www.caringbridge.org/visit/tonycrispino
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