pT3B ~ Adjuvant HT not strong evidence?

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Tony Crispino
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Date Joined Dec 2006
Total Posts : 8128
   Posted 2/7/2011 4:02 PM (GMT -6)   
This one hits a lot of guys here who are diagnosed with pT3B after prostatectomy and are stuck on the what next. The overall survival benefit for adjuvant ADT is approximately 4 in 100 but once again we have a study that can be quite flawed. The center doing this work is the respected Mayo Clinics. It is a retrospective look at 191 men who were originally treated with RP between 1987 and 2002 and the median follow up is 10 years...From the Infolink:

prostatecancerinfolink.net/2011/02/06/limited-value-of-immediate-adjuvant-adt-in-men-with-pt3b-prostate-cancer/

Overall survival of this 191 men cohort is as follows:
Adjuvant ADT 74% had survived to date
no Adjuvant ADT 69% had survived to date

Several things to keep in mind. First there is better therapies today. And once again we could see a significant change in 5 or ten years follow up. I know there are several follow up studies for adjuvant radiation versus adjuvant radiation with combination ADT that show much better benefits. The study does no give us the information about other forms of therapy that were also applied. This is one reason that retrospective studies are not the best evidence. There are other trials out there that meet level 1 evidentiary criteria but we have to wait for them to complete and that will be years.

These results, while not encouraging, do indicate that there is survival benefit but it also brings into question whether there is enough benefit to counter the morbidities that come with ADT.

I am in this class of patient on year 4 after RP/ADT/RT. Over 31% of men in this class has died at the ten year mark after electing for whatever reason to bypass adjuvant HT. It's 26% on those who chose ADT. I believe that we are doing better that today than we were a decade ago.

At least I certainly hope so...

Tony
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:
Da Vinci Surgery ~ 2/17/2007
Adjuvant Radiation Therapy ~ IMRT Completed 8/07
Adjuvant Hormone Therapy ~ 28 months on Casodex and Lupron.
Undetectable PSA.

Blog: www.caringbridge.org/visit/tonycrispino

Post Edited (TC-LasVegas) : 2/7/2011 10:04:16 PM (GMT-7)


Jerry L.
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Date Joined Feb 2010
Total Posts : 3055
   Posted 2/7/2011 7:22 PM (GMT -6)   
Tony,
 
Thanks for the heads up.  I actually ran across this yesterday.
 
It is only one study and like you said - it is a retrospective study of guys who had their RP 9 to 24 years ago.
 
Therapies have gotten better over the years including RT.  Specifically, I know for a fact that yours and mine hit the spot and really neither of us need ADT.  smilewinkgrin
It would be interesting to see what other therapy(s) they had.
 
◦A better 10-year BPFS (60 vs 16 percent, P < 0.001)
◦A better LRFS (87 vs 76 percent, P = 0.002)
◦A better SPFS (91 vs 78 percent, P = 0.004)
◦A better CSS (94 vs 87 percent, P = 0.037)
◦No significant improvement in overall survival (75 vs 69 percent, P = 0.12).
 
Don't you have those numbers reversed? 
- No Adjuvant ADT 69% had survived to date
- Adjuvant ADT 75% had survived to date
 
Either way, why isn't 6% significant?  And what is the P?
 
Sorry, I just can't understand these studies sometimes...
 
In any event, we t3bs are hanging in there...
 
Thanks,
Jerry L.

 
Nov. 2009 Dx at Age 44
Dec. 2009 DaVinci Robotic Surgery
Jan. 2010 T3b, Gleason 9
Feb. 2010 Adjuvant Radiation

PSA History:
-----------------
Nov. 2009 4.30
Feb. 2010 <.05
May 2010 <.05
Aug. 2010 <.05
Nov. 2010 <.05

tarhoosier
Regular Member


Date Joined Mar 2010
Total Posts : 486
   Posted 2/7/2011 7:30 PM (GMT -6)   
Actually most of these men were treated in the early part of the study period, 1987-1995 or so. The use of orchiectomy at prostate removal or shortly afterward as an important method of hormone control should tell you how far we have come in the many intervening years.
See:
http://www.ncbi.nlm.nih.gov/pubmed/15794776

Also we have the SWOG 8794 which showed conclusively that adjuvant (not salvage) radiation was also a life extender.
Thus these numbers should tell us what the MINIMUM survival percentages should be. A man thus treated today would expect better numbers than these. Statistics in mortality and morbidity in our disease always trail the reality by many years.

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 2/7/2011 11:10 PM (GMT -6)   
Jerry,
I was reversing the numbers to show the percent that died when I also reversed the other numbers. My mistake. I have since corrected the numbers to reflect what the study said. But I am with you, and Tarhoosier as well. The numbers are not bit but they are significant. And we are talking about an old way of doing things.

In either case the facts are that the longer we see study the clearer a picture becomes. We saw it last week with ChrisR's post on the long term survival of patients post RP.

Tar,
Thank you for the post. We are missing the effects of combination therapies as this study does not have that data. Adjuvant RT is definately showing better survival benefits and we have learned that combining HT with adjuvant RT improves the biochemical control of PSA. But... and that's a bit but... We need the survival statistics... We have a lot of studies telling us very little without them...

Tony
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:
Da Vinci Surgery ~ 2/17/2007
Adjuvant Radiation Therapy ~ IMRT Completed 8/07
Adjuvant Hormone Therapy ~ 28 months on Casodex and Lupron.
Undetectable PSA.

Blog: www.caringbridge.org/visit/tonycrispino

English Alf
Veteran Member


Date Joined Oct 2009
Total Posts : 2215
   Posted 2/8/2011 2:38 AM (GMT -6)   
Tony,
I’m a T3b SVI guy too. We T3b guys seem to be a very small group.

If I’m reading this new report correctly, then HT seems to keep the PSA down, but doesn’t actually seem to have a big impact on survival at 10 years. (I can understand why my RT team don't do HT at the same time as RT: they feel that the HT will mask the effect of the RT.)

Survival rates of 75% with HT and 69% without HT mean that the overall survival at 10 years is about 70% regardless of what you do or when you do it. Seems like another conclusion to be drawn is simply that 1 in 4 have a nastier type of PCa.

I also note that it seemed to make no difference to these guys to do HT chemically or via an orchidectomy. I think my plan will thus be not to have an orchidectomy if the time comes.

I’d be interested to know the ages of the guys in the survey too. Guys, like us, who were diagnosed in their 40s want to know how other guys who were diagnosed in their 40s are doing at 10/15/20 years.

I remember not long after seeing my path report that I thought that I had been close to the truth when right at the beginning I had told a friend that I was going to make my 50th birthday (I was 49 at surgery) but might not make my 60th.

Alf
Born Jun ‘60
Apr 09 PSA 8.6
DRE neg
Biop 2 of 12 pos
Gleason 3+3
29 Jul 09 DaVinci AVL-NKI Amsterdam
6 Aug 09 Cath out
PostOp Gleason 3+4 Bladder neck & Left SVI -T3b
No perin’l No vasc invasion Clear margins
Dry at night
21 Sep 09 No pads daytime
17 Nov 09 PSA 0.1
17 Mar 10 PSA 0.4 sent to RT
13 Apr CT
66Gy 28 Apr to 11 Jun 10
Tired + weird BMs
14 Sep 10 PSA <0.1
12 Jan 11 PSA <0.1
Erection OK

zufus
Veteran Member


Date Joined Dec 2008
Total Posts : 3149
   Posted 2/8/2011 5:35 AM (GMT -6)   
Can't say us patients enjoy hearing those particular stats, especially when many docs are putting people on LHRH and similar HT drugs, long term or for life, even when in the uncontrollable psa scenarios towards perhaps the end of their life, got to slide in that last shot. Makes you question whom is served or serviced in these processes.

Also, these types of HT abstracts usually do not include many other forms of drugs used to control the disease and so alot people have no clue on those and who knows if there will ever be abstracts fairly conducted on those. Tons of money being made of LHRH and it costs the most, only in America than anywhere else.

Noteable too in getting primary radiations with ADT (neoadj.) via Bolla Studies, shows a significant percentage difference in survival (of course this is not surgery related as per your thread). But for some patients with high risk factors very important to consider in their possible choices and planning for treatment therapy. As usual in PCa we should question everything and always.

Post Edited (zufus) : 2/8/2011 4:38:34 AM (GMT-7)


John T
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Date Joined Nov 2008
Total Posts : 4223
   Posted 2/8/2011 2:01 PM (GMT -6)   
My take on this study is that it shows significant benefit against biochemical reoccurrance of PC, but a slight benefit in overall survivial.
This could mean that patients are dieing from other causes at equal rates before the PC has a chance to kill them.
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.

English Alf
Veteran Member


Date Joined Oct 2009
Total Posts : 2215
   Posted 2/8/2011 2:30 PM (GMT -6)   
John T the text refers to cancer specific survival at some point, so I think it has ruled out people who died from other causes!
Alf

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 2/10/2011 3:01 PM (GMT -6)   
Just a bump.

The "Comments" section of this article is still ongoing and some great input was added by Jim Waldenfels.

When Mike posted this there was a bit of concern floating around not just here but elsewhere. It is very important to note what jim is saying. Here are the primary points:

1> The vast majority of this cohort had surgery before 1995 and thus there adjuvant HT consisted of either physical castration or an LHRH agonist. 5ARI drugs, like dutasteride or finesteride had not even hit the market yet. And very importantly, there was no bicalutamide (Casodex) either.

2> 2nd line hormonal therapy drugs were highly unavailable as well. While some existed, we know that Abiraterone didn't exist, and Leukine, Ketocanazole, Nilandron, etc. were not mainstream. Failed HT even ten years ago (and in some clinics today) meant chemotherapy was Mitaxantrone with Prednisone.

3> Surgical techniques are quite different as well. We have seen recent evidence that this cohort could have benefitted highly from larger scale lymph node removal and this is not outlined in the study.

4> Adjuvant radiation techniques such as IMRT/IGRT and SBRT have allowed for greater coverage of lymphatic system radiation (WPRT) for unremoved lymph nodes.

My reason to bump this is to let the pT3b and the stage 4 guys have reasons to look at this study as a worst case scenario. I would be willing to bet that mortality has been greatly reduced and even in cases where mortality occurs, life extention and QoL have also greatly improved...

Stay positive...

Tony

Post Edited (TC-LasVegas) : 2/10/2011 7:47:09 PM (GMT-7)


ralfinaz
Veteran Member


Date Joined Jan 2011
Total Posts : 735
   Posted 2/10/2011 3:51 PM (GMT -6)   
Hey Gents,
The key word in this study is the 10-year followup. The fact that at 10 years there was less local and systemic spread is an indication that in time results will be better. ADT is hard on all of us, but it should be an option for those that decide to opt to beat PCa.

Bottom line: no need to despair! And never, give up!
Surviving prostate cancer since 1992. RP; Orchiectomy (OUCH!)
GS (4 + 2); bilateral seminal vesicle invasion; tumor attached to rectal wall. Last PSA September, 2010: <0.1 ng/ml
Laughter is the best medicine!

proscapt
Veteran Member


Date Joined Aug 2010
Total Posts : 644
   Posted 2/10/2011 5:41 PM (GMT -6)   
If I understand this correctly, it's interesting to note that only 6% of the adjuvant ADT group died of PC and only 13% of the non-ADT group died of PC in ten years. So while the non-ADT group had twice the risk, the chances of not dying of cancer are still 87% (7 out of 8) in the no-adjuvant therapy group.

The overall survival rates are lower of course, 69-75%, but that is to be expected in a group of older guys. (And the average at treatment was higher ten years ago than it is now.) It would be really helpful if these studies reported how many people would have been expected to die in ten years in a prostate-cancer-free population of the same average age.

Another way to look at it, a pT3B with adjuvant ADT has a 75% chance of living at least 10 years, and of those who lived less than 10 years, a 75% chance that they died of something OTHER THAN their prostate cancer. A pT3B without adjuvant ADT has a 69% change of living at least 10 years and of those who died sooner, they had a 58% chance that they died of something OTHER THAN their prostate cancer.

Jerry L.
Veteran Member


Date Joined Feb 2010
Total Posts : 3055
   Posted 2/10/2011 7:35 PM (GMT -6)   
Tony,
 
I think you mentioned this, but can they give us data for 15 years?  For example, for those that have had RP from 1987-1996.  Can they also show us other stats?  Gleason? Age?
 
What does the "P" stand for in these studies?
 
This study does not help my decision to go on ADT early.
 
Thanks,
Jerry

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 2/10/2011 9:02 PM (GMT -6)   
Jerry,

In a pair of words that represent my thoughts ~ apparently not. They did not take the time to show us much about risk factors in the abstract. I don't have the entire paper so I can't say if they just left some more information out of the abstract or not.

But patients probably didn't ask either. The patients back then lacked another valuable resource to help them advocate their journey that I did not mention above ~ the internet... :-)

I don't imagine that this cohort had access to more information than what they were told in examination rooms. I believe that matters...

Tony

Post Edited (TC-LasVegas) : 2/10/2011 8:46:31 PM (GMT-7)

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