Don't get this about Provenge

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Purgatory
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Date Joined Oct 2008
Total Posts : 25380
   Posted 11/27/2010 6:00 PM (GMT -6)   
For all the talk I have heard about the new "breakthrough" PC fighter Provenge, doesn't look like it offers much survival time, and I understand it is ungodly high in price.  I am missing the obvious again.  I paste a quote from an article that talks about "improved" survival time using it, doesn't seem it would be worth the cost or effort if this is all it offers.  Got to be more to the story.
 
"One such treatment that is now available, PROVENGE® (sipuleucel-T), was shown to extend median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months)"
 
David in SC

Jerry L.
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Date Joined Feb 2010
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   Posted 11/27/2010 6:39 PM (GMT -6)   
David,

I'm no expert, but isn't it a breakthrough because it's one of the first drug/vaccine to use the patient's own immune system to attack the cancer.

If I understand it, Provenge is currently used if HT is no longer effective. What I'm curious is if done earlier in the game would it produce better results? In other words, when reoccurance starts after RP / RT....or even before PSA rises or before HT.

Have an extra 90K so I can see what happens?

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

John T
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Date Joined Nov 2008
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   Posted 11/27/2010 6:46 PM (GMT -6)   
David,
An increase in survival time of 4 months is considered very good in any advanced cancer. Many patients don't respond at all to provenge and their score is 0 so to get an average of 4 months many patients have to survive much longer than 4 months.
What we don't know about provenge is that how it works on less advanced PC as all the trials were conducted on patients that had already gone refactory.
We knew Provenge had an advantage way back in 2003 and it took another 7 years just to get it approved for only advanced PC.
It does cost $90k; but this is cheap in relation to most other Chemo Therapy for other cancers which is usually $100 to 200K for a treatment course.
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
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Date Joined Oct 2008
Total Posts : 25380
   Posted 11/27/2010 8:10 PM (GMT -6)   
John, I had read that it was around 33k per injection, and you need 3, and that most private health insurance won't pay for it, and if I understood correctly, Medicare won't pay for it unless it was in pill form.

Why would chemo therapy be so expensive? Do the drugs really justify the cost, or is it just extortion from the drug makers taking advantage of a terminally ill person? I ask this in all simplicity and honesty.

David
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 Not taking it
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 9/23/10

Gordy
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Date Joined Jun 2005
Total Posts : 528
   Posted 11/27/2010 8:23 PM (GMT -6)   
It's $31,000 for each of the three treatments, Medicare and most insurance companies will pay for it, although the same dirty politics which has/have plagued this treatment from the beginning still plague it and "Medicare won't pay for it unless it was in pill form" is incorrect.

Although my insurance company didn't pay anywhere near those amounts, my last two chemo treatments (Taxotere) and their side effects were billed at $40,000 and $19,000. There's nothing wrong with $93,000.

Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 11/27/2010 8:49 PM (GMT -6)   
Why do you say there's nothing wrong with 93k, you are saying that is justified for 3 injections?
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 Not taking it
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 9/23/10

Gordy
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Date Joined Jun 2005
Total Posts : 528
   Posted 11/27/2010 8:51 PM (GMT -6)   
Is $40,000 for sitting in a recliner for an hour worth it? How much is your life worth to you?

Post Edited (Gordy) : 11/27/2010 7:57:44 PM (GMT-7)


Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 11/27/2010 8:55 PM (GMT -6)   
I stand corrected on the Medicare part of my post, I looked back, and mis-read something, had it reversed.

If you are talking about a complex operation compared to having a shot in the arm, don't think you are being fair and sure not doing apples to apples.

If the average survival time extension is really only a little over 4 months over the placebo, sounds like a major hose job to me, the drug company should be so ashamed of themselves to exploiting someone terminally ill in my opinion.
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 Not taking it
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 9/23/10

Gordy
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Date Joined Jun 2005
Total Posts : 528
   Posted 11/27/2010 9:02 PM (GMT -6)   
You stand corrected on the survival time, too. 4.something months is the median time - some guys have survived for years.

Getting chemo, for the most part consists of sitting in a recliner for a certain period of time with a needle in your arm. How much is that worth?

I think you should write to Mitch Gold, CEO of Dendreon and tell him what you think of his business practices and his concern for humanity.

Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 11/27/2010 9:18 PM (GMT -6)   
I did see how the other chemo drug is coming off patent at the end of this year, sure hope that drives the price down low, and no, having never underwent chemo for any of my cancers, I do see what you mean about sitting in a recliner having an infusion. This end of cancer treatment is new to me, and I am researching for possible future reference. No offense intended.

David
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 Not taking it
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 9/23/10

BobCape
Regular Member


Date Joined Jun 2010
Total Posts : 416
   Posted 11/28/2010 7:10 AM (GMT -6)   
Seems to me the excitement about Provenge is that it extends life by ANY measurable amount.
To those with 4 mo left, 4 more months is another lifetime. But that's not the point.
HOW does it work? How can what works about it be bottled, refunes and improved. If given as initial treatment when patients are otherwise healthy, perhaps 4 months adds up to 4 years. 4 turns into 8. They using a group of patients who are in tough shape to begin with..close to passing.. you really cant expect a drug to solve EVERYTHING at that stage..

Re price, company spends hundreds of millions it does need to make a profit when it comes up with a successful result. They could have 50 other hundred million drugs that make them nothing. Otherwise there is no motivation for them to try. Then we're all screwed. I understand that much of the expense for this 'treatment" is that removing and adding blood.. and not simply about the drug itself.

If you can find a substance that delays the effects of PCA in the worst case patients like this... that might just be the start. Combined with other treatments in the pipleine. I have hope.

I am particularly excited about this XL184. Understanding all the qualifyers, the preliminary stage, the minute number of patients, STILL, 19 OF 20 OF THE WORST CASE PATIENTS BENEFITED.

Consider this statement/result:
"The most important finding was the complete or partial resolution of bone lesions in 19 out of 20 evaluable patients with bone mets. This finding by itself, which is preliminary and should be corroborated in larger studies, could represent a breakthrough in the treatment of prostate cancer."
http://seekingalpha.com/article/238374-promising-data-puts-exelixis-back-on-track

Happy and safe holidays.

BobCape
Regular Member


Date Joined Jun 2010
Total Posts : 416
   Posted 11/28/2010 7:17 AM (GMT -6)   
Quick follow up (and I dont mean to steal a thread, I just awake in my own little panic and felt that my reason for hope may also be your's)... here is the NYT srticle about XL184:

Quick quote:
"“There’s really no precedent for another drug that does this,” said Dr. Matthew R. Smith, a prostate cancer specialist at the Massachusetts General Hospital."


http://www.nytimes.com/2010/11/18/health/18prostate.html

Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 11/28/2010 7:58 AM (GMT -6)   
Bob,

Thanks for the insight and the info on the xl184. I have since researched it (never heard of it before), almost sounds too amazing with some of the outcomes with not only PC, but other hard to stop cancers. Wonder how long it will take to get it to the market?

David
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 Not taking it
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 9/23/10

dkob131
Regular Member


Date Joined Apr 2008
Total Posts : 364
   Posted 11/28/2010 8:18 AM (GMT -6)   
David:  I haven't read all of the posts completely on this topic so excuse me if this has already been said but one of the main reasons the Provenge has made headlines is that the side effects are minimal.  Chemo as we have all heard is terrible for QOL, it can extend your life for up to 18-24 months but I hear that you're pretty miserable during this time.  Provenge on the other hand has few side effects so not only is your life being extended on average of 4 months but the 22-26 months that you are alive are much better QOL.
 
Provenge is usually given in three injections spaced around 2-3 weeks apart I believe.
 
I've talked to 2 guys who have had the treatment(clinical trial), they both are chugging along 1 year later.
 
The Other David
54 y.o.
Diagnosed 4/10/08

DRE Normal

PSA-5.5

Biopsy- 12 cores, 4 positive highest 4+4=8

Bone scan, CT scan and Chest X-ray clear 4/16/08

Urologist suggested surgery 4/16/08

MRI on 4/24/08 clear no suggestion of lymph node involvement.

4/24/08 -Started on Lupron and Casodex preparing for HDRT and IMRT in late July. This treatment will not preclude me from surgery if I change my mind.

Decide to have DaVinci surgery after another consult with surgeon.

6/19/08- DaVinci surgery at University of Washington.

6/25/08- Path report, clear margins, no noted extension

9/12/08- PSA <0.02

12/05/08-PSA <0.02 Six months after surgery

3/02/09-PSA <0.02 Nine months after surgery

5/02/09-PSA .10

8/17/09-PSA .21 Begin HT and set up for SRT to begin in 2 months.

12/31/09- SRT completed, still on HT and will be for 2 years, PSA is <0.01

7/30/10- PSA still <0.01, on HT 1 year with 1 to go.

BobCape
Regular Member


Date Joined Jun 2010
Total Posts : 416
   Posted 11/28/2010 8:53 AM (GMT -6)   
Dave, I dont know how long it wIll take, I'm not sure "we" (PCA patients) have a loud enough voice out there to effect policy.

WHO IS IT THAT SPEAKS FOR US? ARE THEY ON THIS WEBSITE? DID 'WE' DECIDE WHO THAT WOULD BE? IF THERE ISN'T AN INDIVDUAL ENTITY, WHY NOT?

I know this, if you can find a situation where 19 of 20 patients of any kind show progress from a disease than can kill them - SOMEBODY better get up and say very clearly "GET THIS FRIGGEN THING SPEEDED UP!"

I think currently it is simply market forces that will drive it..as the story states, just this past July Bristol-Myers Squibb decided to pass on codevelopment rights. Let's hope they regret that decision forever. Not because I have anything against them, but because that will mean this drug can save countless lives.

DJBearGuy
Veteran Member


Date Joined Dec 2008
Total Posts : 732
   Posted 11/28/2010 11:49 AM (GMT -6)   
Bob, thanks for the reference. From the article, it sounds like xl184, which stop formation of blood vessels that feed tumors, and Provenge, which trains the immune system to attack the tumor, are both very different from the drugs that are historically used in typical chemotherapy, which work against mitosis. All fast-dividing cells are attacked, which is why your hair falls out. My wife has experienced this. "Chemotherapy" is a broad term, sounds to me like if you're treated with any chemical at all then it can be called chemotherapy. But I think it's important to realize that xl184 and Provenge are newer and very different. The Wikipedia article on chemotherapy has a good summary.

Speaking of pharmaceutical companies, just saw the movie Love and other Drugs, which portrays the blatant commercialism of the system. It's loosely based on the book Hard Sell: The Evolution of a Viagra Salesman by Jamie Reidy.
Diagnosis at 53. PSA 2007 about 2; 2008 4.3
Biopsy Sept 2008: 6 of 12 cores pos; Gleason 4+3 = 7
CT & Bone scan neg
Da Vinci at City of Hope Dec 8, 2008
Rad prostatectomy & lymph node dissection
Cath out on 7th day, in on 8th day, out again 14th day after neg cystogram
Path: pT2c; lymph nodes neg; margins involv; 41 grams,
PSA 1/08, 4/09,7/09, 10/09, 11/09,2/10 <0.01, 10/10 0.1

John T
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Date Joined Nov 2008
Total Posts : 4227
   Posted 11/28/2010 12:20 PM (GMT -6)   
David,
I think the cost involved in developing a new drug is so staggering with all the trials, hearings and liability involved that in order to recoup development costs and the costs of developing all the other drugs that didn't work or make it to market a high price must be charged.
The process of Provenge is also quite different that other drugs in that a special facility must be built to process the patients blood in which imune cells are added.
Seeing all the expense that getting the Combidex imaging agent approved and having the manufacturer discontinue it because of the approval time and expense woke me up to the other side of bringing a drug to market. We also have to be aware of all the political considerations and the lobbying by interests that would be replaced by the introduction of any new drug or procedure.
There are a lot of road blocks to the introduction of a new drug, and why is provenge not being tested on less agressive cases?

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.

pattersson
Regular Member


Date Joined Apr 2010
Total Posts : 97
   Posted 11/28/2010 12:20 PM (GMT -6)   
Some thoughts about median survival times, please correct me if I'm wrong.

Median survival is the time it takes for half of the people in a group to die. Comparing median survival times of people that get treatment to a group that don't get it is a very crude way to measure treatment benefit. To take an extreme example, think about an imaginary situation where some treatment totally cures cancer in 49 % of people, but it is totally ineffective in 51 % of people. Median survival benefit would then be zero, since more than half of the people are not helped by the treatment. So it may be that many treatments that have been deemed ineffective in Stage III trials during the past years could have helped some people, The reason they were not approved was that if they did give a benefit (which is not known), it was for a minority in the treatment group.

So when they say that Provenge gives about 4 month median survival benefit does not say much about how much it helps any given person. It just means that it took about 4 months longer for the middlle guy in the treatment group to die compared to the non-treated group.
Radical prostactemy 10/2006 @42, PSA 3.9, Gleason 3+4
PSA <0.2 2006-2009

PSA 0.14 01/2010
0.07 05/2010
0.06 10/2010

tarhoosier
Regular Member


Date Joined Mar 2010
Total Posts : 487
   Posted 11/28/2010 1:17 PM (GMT -6)   
Purgatory:
I think you raise some valid points. If half of the men on Provenge survived less than four months longer than the placebo group, yet all of the men paid the equivalent of 93,000$, where is the value calculation? In addition, the men who benefitted in survival continued to suffer from pain and other symptoms since Provenge had no effect on the progression of the disease. Also many of the men treated with Provenge on the trial went on to taxotere chemo therapy during the remainder of their life, with such loss of quality of life as it entails.
In my mind the real benefit of Provenge lies in two areas: There are some men in whom Provenge creates a robust immune response, somehow highlighting the cancer cells to be attacked by any later treatment, as well as the immune system itself. These men will have the greatest benefit range among those on the trial. As in all cases, the median is not the message. The range is a large part of the story. Pattersson alludes to this. The other area in which Provenge may well show great benefit is in earlier disease stages. At first recurrence, at first sign of metastasis or anywhere along, Provenge may show a greater survival than four months. Any such greater survival becomes easier to justify compared to the cost.

F8
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Date Joined Feb 2010
Total Posts : 3804
   Posted 11/28/2010 1:24 PM (GMT -6)   
if i'm dying the cost of drug, assuming i have the ability to get it, would be the least of my concerns.
 
ed
age: 55
PSA on 12/09: 6.8
no symptoms, no prostate enlargement
12/12 cores positive....gleason 3+4 = 7
HT, BT and IGRT
received 3rd and last lupron shot 9/14/10

Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 11/28/2010 1:27 PM (GMT -6)   
JohnT - you brought up some good points, even though my whole life has been in the biz world, I was acting from the heart only on this subject. You are quite right about the costs and hassles of bringing any drug to the market here in the US. And we all know that the drug firms are non-profit entities.

pattersson - your point is well taken too, median means just that.

tar - you brought a good perspective to the subject as well, thanks. thinking about the chemo phase of PC is new ground for me, just now thinking about and trying to get a handle on that whole world. None of it sounds good to me.
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 Not taking it
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 9/23/10

Tony Crispino
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Date Joined Dec 2006
Total Posts : 8128
   Posted 11/28/2010 2:42 PM (GMT -6)   
I just got back from our vacation and noticed this thread and think there is a very important point about this discussion.

1st, the 4.1 month extension seen in the trial is the MEDIAN not the absolute. John points out that there could be a benefit to use the protocol and I believe that we will eventually see thatt. However the median is the number where half are located above and below that number for patients that failed all other forms of conventional treatment ~ HT, 2nd line HT, chemotherapy, etc. For many in this protocol, they are still alive today years after therapy. What Provenge carries is hope. And as they work to increase it's effectiveness there is yet even more hope.

Taxotere, generically called docetaxel, carried a life extension of 19 months for HRPC patients when it was in trial. Then it's sister came out earlier this year ~ Cabazetaxel offering yet 4 additional months at the median. But it is important to note that many have lived much longer on Taxotere, Cabazetaxel, and Provenge.

For 93k you are buying the opportunity to live far longer than the study median.

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

BobCape
Regular Member


Date Joined Jun 2010
Total Posts : 416
   Posted 11/28/2010 4:05 PM (GMT -6)   
If $93,000 bought you 4 months, and that 4 months allowed you to take the XL184, and the XL184 removed the cancer from your bones, you'd probably think the $93k was well spent. When the price becomes $46,500 and they effecte is doubled, it will be bettwer spent. But it's a start.


Millions of people have walked away from half million dollar mortgages in the past 2-3 years. "Cost" is relative.

Numvers are funny, "PROVENGE® (sipuleucel-T), was shown to extend median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months)" ..

That sounds to me like PEOPLE WHO TOOK THE DRUG LIVED 20% LONGER.

Reminds me of the " A billion here, billion there, before you know it were talking serious money"..
4.1 months here, 20% there, 19 of 20 over there, before you know it, your talking significant time in someone's life.

And then you're talking significant time in alot of people's lives.

My warm thoughts to all of you!

Bob from Cape Cod.

Jerry L.
Veteran Member


Date Joined Feb 2010
Total Posts : 3057
   Posted 11/28/2010 7:08 PM (GMT -6)   
Stupid question from a rookie (aside from costs, etc...):
 
Provenge takes immune cells out of a patient's blood, alters them, and infuses them back in.  It appears that it is currently used for patients where HT is no longer effective.  You would think that a patient's immune system would be better earlier in the battle. 
 
Could it be possible to use blood drawn from year's past?  And, can you even store blood that long?  Point being, that perhaps this would increase the survival periods.  Think about it, we could give blood and if we needed it down the road, it would be there.
 
I'm sure this is completely flawed....and I'm done now playing mad scientist.
 

Tony Crispino
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Date Joined Dec 2006
Total Posts : 8128
   Posted 11/28/2010 7:38 PM (GMT -6)   
Jerry, that's the $64,000.00 question.

We don't know. All cases that led to the drugs approval were mostly refractive of not just hormonal therapies, but also chemotherapy. Like Abiraterone, Provenge may be even better when used earlier. We will have to await those studies to make us feel feel better about our blind faith. But it certainly looks like these will be able to help in the early stages as well...


Tony
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