Are these really great breakthroughs

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compiler
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   Posted 4/29/2011 2:00 PM (GMT -6)   
I keep reading about Provenge and the more recent drug approvals. Everybody is just thrilled and they are considered major breakthroughs.
 
Now, I can understand Provenge being considered a breakthrough in the sense that maybe this is a new and better way to treat cancers so that down the road real cures/remissions using these ideas will be found.
 
But, when I read some of the articles, we find that new tx. did better than old tx. yyy. But the median is 14.5 months compared to 10 months. Okay, I realize that's a median. Half of the people do better for longer. But, that's incomplete information. HOW MUCH LONGER? Are we talking the REASONABLE possibility of an additional year? Then I read about the horrendous SE of many of these drugs. Even provenge has a whole new group of SE in the auto-immune arena.
 
I really do want to get excited and jump up and down, because there is a high probability that these drugs are in my future (heck, for anyone who fails SRT, we KNOW these drugs are probably in your future). I'm personally hoping I can stave off this beast long enough for some real good drug developments. But, why am I not as excited as it appears I should be.
 
Mel
PSA-- 3/08--2.90; 8/09--4.01; 11/09--4.19 (PSAf: 24%), PCA3 =75 .Biopsy 11/30/09. Gleason 4+3. Age: 64. Surgery: Dr. Menon @Ford Hospital, 1/26/10. Pathology Report: G 4+3. Nodes: Clear. PNI: yes. SVI: No. EPE: yes. Pos. Margin: Yes-- focal-- 1 spot .5mm. 100% continent by 3/10. ED- yes.. PSA on 3/10/10-: 0.01. PSA on 6/21/10--0.02. 9/21/10--0.06; 1/4/11-0.13,3/1/11--0.27. Now doing SRT

142
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Total Posts : 7082
   Posted 4/29/2011 2:16 PM (GMT -6)   
Mel,
 
I had the same initial reaction to Provenge, but without that sort of focused research, the one-step-at-a-time progression stops. I would like to know how many other ideas will come from this that also help just a little. Probably many. Perhaps one will be a cure.
 
 

Purgatory
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Date Joined Oct 2008
Total Posts : 25393
   Posted 4/29/2011 2:22 PM (GMT -6)   
I think the Provenge is in the category of its better than nothing new. For what it costs, and the side effects, I cant personally see it as a major breakthrough drug. Hopefully, neither of us will need to find out.

David in SC
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 margin
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, 2/11 1.24, 4/11 3.81
Latest: 6 Corr Surgeries to Bladder Neck, SP Catheter since 10/1/9, SRT 39 Sess/72 gy ended 11/09, 21 Catheters, Ileal Conduit Surgery 9/10

Tim G
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   Posted 4/29/2011 2:35 PM (GMT -6)   
To me, four months extended life expectancy at a cost of $100,000, is not a breakthrough. What is needed is a preventive prostate cancer vaccine, given to young men before they develop prostate cancer. Now that's a real breakthrough.

F8
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Date Joined Feb 2010
Total Posts : 3989
   Posted 4/29/2011 2:48 PM (GMT -6)   
TimG -- we all want a cure for cancer but for now i'll take what i can get.
 
ed
age: 56
PSA on 12/09: 6.8
gleason 3+4 = 7
HT, BT and IGRT
received 3rd and last lupron shot 9/14/10
2/8/11 PSA <.1, T= 6 ng/dl

Casey59
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Date Joined Sep 2009
Total Posts : 3172
   Posted 4/29/2011 3:12 PM (GMT -6)   
compiler said...
But the median is 14.5 months compared to 10 months. Okay, I realize that's a median. Half of the people do better for longer. But, that's incomplete information. HOW MUCH LONGER? Are we talking the REASONABLE possibility of an additional year?
 

A couple comments…

The 3-year report of the double-blind placebo-controlled phase-3 Provenge clinical trial reported that 34% of patients were still living…a right-sided skewed distribution curve with the median at 14.5 months.  Translation:  It works for some men, but not universally for everyone in the same way. 

Provenge is an exciting novel breakthrough because it is considered a vaccine…a first-ever.  The patient’s cells are collected and processed off-site with proteins which helps activate the patient’s immune system and then infused back into the patient.  The treatment basically “re-trains” the patient’s own immune system to fight PC cells.  Very novel.

Finally, Mel, Provenge is for castration-resistant metastatic PC…given the natural history of PC and where you are at, you are probably a decade or two away from this stage (if it ever progresses that far in you).  The scientific process is a road of discovery and incremental improvements.  Provenge is a novel concept, but it will not be the endpoint.  This vaccine breakthrough will lead to another more intriguing breakthrough, and then another.  Probably many breakthroughs in the next few decades.

 


don826
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Date Joined May 2008
Total Posts : 1010
   Posted 4/29/2011 3:18 PM (GMT -6)   
Hi Mel,
 
I have had the same thoughts. However, the shape of the distribution curve is what is lacking in most reports. Left skewed bad news. Right skewed could be good news and normal distribution you would need to know the standard deviation. I.E. what is the spread.
 
My personal opinion is that Provenge was given a thumbs down several years ago. Administrations change the company does a little more research and re packages the results and Voila! there is approval. Otherwise how would the company get back the $1B investment. Estimates I have seen on line indicate they will make this back the first year. It will take two years for the medical community to realize they have been had on this one.
 
Seems that the Aberiterone (sp?) has similar characteristics.
 
On my darker days I realize that there is more money to made in treating than in curing this disease and sink into a feeling that no one is looking for a cure. Only a device to prolong the cash flow.
 
Don

compiler
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Date Joined Nov 2009
Total Posts : 7269
   Posted 4/29/2011 4:26 PM (GMT -6)   
Casey:
 
Nice to hear from you; it's been a while since I've seen you post.
 
You are much more optimistic than I am when you say I'm a decade away from utilizing such a drug.
 
How do you figure that?
 
If SRT works, I may not need anything else; but if it fails -- and the odds are that it will -- then I see myself 5-7 years at the most before needing these last ditch drugs. Here's my thinking. 1-5 years on HT before the PC gets resistant then  1-2 years on chemo or something else. What am I missing?
 
Mel
PSA-- 3/08--2.90; 8/09--4.01; 11/09--4.19 (PSAf: 24%), PCA3 =75 .Biopsy 11/30/09. Gleason 4+3. Age: 64. Surgery: Dr. Menon @Ford Hospital, 1/26/10. Pathology Report: G 4+3. Nodes: Clear. PNI: yes. SVI: No. EPE: yes. Pos. Margin: Yes-- focal-- 1 spot .5mm. 100% continent by 3/10. ED- yes.. PSA on 3/10/10-: 0.01. PSA on 6/21/10--0.02. 9/21/10--0.06; 1/4/11-0.13,3/1/11--0.27. Now doing SRT

goodlife
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Date Joined May 2009
Total Posts : 2692
   Posted 4/29/2011 6:08 PM (GMT -6)   
Ohio State,

Good to hear from you. Hope all is well.

I know this is an area that you have expertise and personal experience with.

Goodlife

Newporter
Regular Member


Date Joined Sep 2010
Total Posts : 225
   Posted 4/29/2011 11:28 PM (GMT -6)   
I am more optimistic about Provenge. The phase III double blind trial were for treating terminal cancer cases - patients who had no more treatment options and were too late for anything else. In that situation, 14.5 months survival vs 10 months survival is very significant. I suspect when the treatment is used for moderate or early PC, the result could be dramatic.

Casey59
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Date Joined Sep 2009
Total Posts : 3172
   Posted 4/29/2011 11:34 PM (GMT -6)   
compiler said...
You are much more optimistic than I...
 
 

Mel,

From the little that I know about you, and what I know about me, you will take a more pessimistic perspective and I will take a more optimistic perspective…hey, that’s what makes the world go around.  That being said, you should read the opening of THIS PCRI article by Dr Charles “Snuffy” Myers on optimists & pessimists...really, you should read it.  You’ve expressed here many times that you are comfortable and set in your ways regarding lifestyle modification, or non-modification as the case may be (nutrition, exercise, stress reduction to help reduce PC progression), but these are the factors that appear to help stack the odds in one’s favor for a better-than-average outcome.

So if you want to talk about just the average outcome, you can get a prediction of the probability of progression after 5 & 10 years after your SRT as a starting point from a nomogram…I’m sure you’ve already done that.  Keeping in mind that many men do not progress, extrapolate to find the year where the probability crosses 50%.  After that there is the HT-induced remission; Dr Mohler uses 5-years as typical (not 1-5 years; except for particularly aggressive cancers, that’s a myth).  The Myers article I linked above says this in addressing the myth about the short-term benefit of HT:

“I conclude that hormonal therapy is far more durable than generally thought. In fact, almost all men who recur after radical prostatectomy or radiation therapy will continue to respond to hormonal therapy after five years and about half will continue to respond after ten years.”

 

Nobody can predict with certainty any particular outcome for anybody with any cancers--certainly you understand the statistical concept of variation--but the key is to do everything in your power to push yourself to the right-hand side of the skewed survival curve.  What variables can you affect?  If you want a conventional outcome, then just stick to conventional treatment.  In my humble opinion, anyone who uses only alternative medicine techniques (and completely foregoes traditional medical approaches such as surgery, radiation, HT, etc) to combat prostate cancer is foolish.  At the same time, anyone who uses only traditional aggressive medical techniques (previously listed) without supplementing with integrative medicine techniques such as lifestyle changes (diet, exercise, stress reduction, etc) is similarly imprudent.


compiler
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Date Joined Nov 2009
Total Posts : 7269
   Posted 4/29/2011 11:52 PM (GMT -6)   
Casey:
 
I do not disagree with your points.
 
The pessimism you sense has developed during this journey as a result of having each test worse than the one before.
 
I guess we can't all be total optimists!
 
Mel

Tony Crispino
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Date Joined Dec 2006
Total Posts : 8128
   Posted 4/29/2011 11:58 PM (GMT -6)   
I love you, Mel,
Hang in there. I had everything bothering me at one point of this stupid journey and I really hated that feeling. Just to let you know I'm cheering for you every inch of the way.

Tony

compiler
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Date Joined Nov 2009
Total Posts : 7269
   Posted 4/30/2011 12:07 AM (GMT -6)   
TC:
 
Thanks. It's not quite that bad. I have been able to go to work with full energy and totally enjoy it.
 
I'm just going to post and express my thoughts as honestly as possible on HW, and that includes many concerns/comments that are ONLY expressed here.
 
This is a good sounding board for me and I suspect for most of us.
 
Mel

Tony Crispino
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Date Joined Dec 2006
Total Posts : 8128
   Posted 4/30/2011 12:34 AM (GMT -6)   
Mel,
These are terrific breakthroughs. Along with other short term life extending drugs we are seeing some guys lives extended many years. I for one am watching this stuff closely as I view it impossible that I don't deal with this again. There is my pessimistic moment. But if I have to I like seeing what we have seen in the last year : Provenge, Cabazetaxel, Abiraterone...etc.

Very nice. I know we need more but these are good ones.

Tony

petersedwin
New Member


Date Joined Apr 2011
Total Posts : 2
   Posted 4/30/2011 3:09 AM (GMT -6)   
thanks for all the information you've shared. hope there are continued developments on this.

petersedwin
New Member


Date Joined Apr 2011
Total Posts : 2
   Posted 4/30/2011 3:16 AM (GMT -6)   
what are the side effects of Provenge? thanks

Edwin J. Peters
peters_edwin@yahoo.com
http://www.prostatebiopsyprocedure.com/prostate-biopsy-procedure

zufus
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Date Joined Dec 2008
Total Posts : 3149
   Posted 4/30/2011 7:04 AM (GMT -6)   
Ed you can get an anonomous email address thru this website. The Mods suggest you do not use your own, spammers and phishermen could be lurking in scum pond, looking for innocent ones. However some of us will send you an email, just verify whom.

Piy
Regular Member


Date Joined Mar 2010
Total Posts : 145
   Posted 4/30/2011 8:24 AM (GMT -6)   
Newporter said...
I am more optimistic about Provenge. The phase III double blind trial were for treating terminal cancer cases - patients who had no more treatment options and were too late for anything else. In that situation, 14.5 months survival vs 10 months survival is very significant. I suspect when the treatment is used for moderate or early PC, the result could be dramatic.
This is the kind of thing that I wonder about.  I believe in the "throw everything including the kitchen sink" method at the beast as early as possible to knock it's feet out from under it as much as possible.  Are trials being done with Provenge at an earlier stage for patients who have not yet failed HT?

Dx June 2007 - age 48

davinci RRP October 2007
75% of prostate involved
G9
Positive margin
Scans clear
No detectable mets
SRT - Feb 2008
PSA:
At Dx: 8
Mar 09: 0.4
Jun 09: 0.7
Aug 09: 1.7
Feb 10: .008
Apr 10: .007
Jul 10: .006
Sep 10: .005

Commenced Dr. Robt Leibowitz "Three Pronged Approach" protocol in August 2009

Completed chemo Dec 28 2009

Casey59
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Date Joined Sep 2009
Total Posts : 3172
   Posted 4/30/2011 8:55 AM (GMT -6)   
Piy said...
Are trials being done with Provenge at an earlier stage for patients who have not yet failed HT?
 
 

Pre-clinical testing (which precedes costly clinical trials) of the therapeutic vaccine Provenge have shown it to be most effective in men with advanced prostate cancer who had Gleason scores lower than 8.

That being said, THIS list shows the dozen trails listed at clinicaltrials.gov (search criteria:  “provenge”), including one neoadjuvant treatment (before RP).


reachout
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Date Joined May 2009
Total Posts : 739
   Posted 4/30/2011 9:54 AM (GMT -6)   
Interesting comments. Overall, I think I feel more optimistic than pessimistic after reading this thread. At least at my age (66), for which 15 years is a really long time. I would feel different if I were younger, and pray for a real breakthrough for the younger guys.
Age: 66
PSA: 7 tests over 2 years bounced around from 2.6 to 5.6
Biopsy 8 of 12 positive, Gleason 3+4, T2a
DaVinci August 2009, pathology Gleason 4+3, neg margins, T2c
Continent right away, ED
Viagra, Cialis did't work, Trimix works well
Post-surgery PSA:
3, month: undetectable <.1; 6 month: undetectable <.014 (ultrasensitive); 9, 12, 15 month: undetectable <.1; 18 month detectable .05

compiler
Veteran Member


Date Joined Nov 2009
Total Posts : 7269
   Posted 4/30/2011 11:30 AM (GMT -6)   
I think the big hope might not be with Provenge per se, but with the concept of immuno technology.
 
I, too, am curious to see if some of these drugs might provide a better increase in survival if started earlier. That's probably difficult to do since surgery and then SRT are still curative bullets and HT can still provide some years. How many patients are willing to forego these tx. and try drug xyz?
 
David might be a candidate with his view/concern about HT, but then again the SE from these new drugs sound just about as bad as HT.
 
Mel

Fairwind
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Date Joined Jul 2010
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   Posted 4/30/2011 12:33 PM (GMT -6)   
These "Breakthroughs" are are mostly in the stock price of the labs that develop them. If they can't get a patent on it, they are not interested in it..Pomegranate Juice seems to work as well as many of these "breakthrough" drugs and treatments with zero side-effects..What good is a little extra time if you are bed-ridden with advanced cancer symptoms and drug side-effects?? Quality of life becomes very important at this point..

The side-show that goes on back-stage to get these drugs patented, tested, passed clinical trials, FDA approved, and then marketing agreements negotiated, price-points set, takes ten years while countless cancer victims continue to die. If the FDA only approves the drug for late-stage cancer, then no insurance company will pay for it's use on early-stage patients..If you have enough money, $5000/month, sure, go for it...We have spent many $Billions$ of dollars of taxpayer money on cancer research. But when a useful, patentable drug is found, it's always held by a private for profit company..

Remember the Salk Polio Vaccine?? Now THERE was a major breakthrough in medicine. Within 6 months of discovery, it was being distributed FREE in public school across the country..Times have changed..
Age 68.
PSA age 55: 3.5, DRE normal.
age 58: 4.5
61: 5.2
64: 7.5, DRE "Abnormal"
65: 8.5, " normal", biopsy, 12 core, negative...
66 9.0 "normal", 2ed biopsy, negative, BPH, Proscar
67 4.5 DRE "normal"
68 7.0 3rd biopsy positive, 4 out of 12, G-6,7, 9
RALP Sept 3 2010, pos margin, one pos vesicle nodes neg. Post Op PSA 0.9 SRT, HT. 2-15-'11 PSA 0.0

reachout
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Date Joined May 2009
Total Posts : 739
   Posted 4/30/2011 1:10 PM (GMT -6)   
Don't discount that a true breakthrough drug for Prostate Cancer may be out there among the clinical trials. Such a drug exists for forms of Leukemia. A family member is on Gleevec and her leukemia has been stable with no progression for several years. That pill has now been shown to also work on some stomach cancers, and is in trials for prostate cancer.

Wouldn't it be something if they found a magic pill? We could have a real party when we shut down this site :)
Age: 66
PSA: 7 tests over 2 years bounced around from 2.6 to 5.6
Biopsy 8 of 12 positive, Gleason 3+4, T2a
DaVinci August 2009, pathology Gleason 4+3, neg margins, T2c
Continent right away, ED
Viagra, Cialis did't work, Trimix works well
Post-surgery PSA:
3, month: undetectable <.1; 6 month: undetectable <.014 (ultrasensitive); 9, 12, 15 month: undetectable <.1; 18 month detectable .05

F8
Veteran Member


Date Joined Feb 2010
Total Posts : 3989
   Posted 4/30/2011 2:33 PM (GMT -6)   
Fairwind -- so are you for or against pomegranate...you seem to go back and forth on that one?
 
ed
 
 
age: 56
PSA on 12/09: 6.8
gleason 3+4 = 7
HT, BT and IGRT
received 3rd and last lupron shot 9/14/10
2/8/11 PSA <.1, T= 6 ng/dl
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