Provenge approved

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Galileo
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Date Joined Nov 2008
Total Posts : 697
   Posted 4/29/2010 12:39 PM (GMT -6)   
"The U.S. Food and Drug Administration approved Provenge, a novel technique for fighting prostate cancer, on Thursday. The treatment involves taking a patient's own white blood cells and using a drug that trains them to more actively attack cancer cells..."
Full story: http://www.cnn.com/2010/HEALTH/04/27/provenge.prostate.cancer.fda/index.html?hpt=T2
Galileo

Dx Feb 2006, PSA 9 @age 43
RRP Apr 2006 - Gleason 3+4, T2c, NX MX, pos margins
PSA 5/06 <0.1, 8/06 0.2, 12/06 0.6, 1/07 0.7.
Salvage radiation (IMRT) total dose 70.2 Gy, Jan-Mar 2007@ age 44
PSA 6/07 0.1, 9/07 and thereafter <0.1
http://pcabefore50.blogspot.com


el perro
Regular Member


Date Joined Mar 2010
Total Posts : 46
   Posted 4/29/2010 1:35 PM (GMT -6)   
CNBC reported $31,000 per treatment, with 3 treatments needed over a month or 6 weeks, so total cost ends up $93,000.

I'm curious if they released any info on how the treatment was working in men with intact prostates in their press conference?
Dx 11/2008, Gleason 3+3
Active surveillance for now


Jim is sick
Regular Member


Date Joined Mar 2010
Total Posts : 118
   Posted 4/29/2010 2:10 PM (GMT -6)   
I remember watching a show on public TV, Nova I think it was. It was a few years ago. It discussed a treatment for cancer where they took some of the patients blood and (did something cool) and put it back. It cured the cancer. It was not done in the US. I tried on several occasions to find the show again, but could not. I didn't have cancer at the time... I remember saying to the wife, that's pretty amazing, and thought it won't be long till it was mainstream. I don't think it was the same as this, but it was close. I wish I could remember the name of the episode so I could watch it again.

If it's helping prolong life, couldn't it have enormous potential to cure this?
48, Caucasian, 5' 8", 200lb, general good health.
PSA: 8-7-09 3.22, 11-13-09 4.25.
Biopsy: 32 cores. 3 cores reveal PCa, 10%, Gleason 3+3=6, T1C.
Diagnosed: 2-12-10.
Current Treatment: Active Surveillance, next appointment Oct. 2010. 
Treatment Options: Proton Therapy in Bloomington IN
Mode: Vicious cycle of learning, freaking out, repeat...
Process: Reading Dr. Strums book.


el perro
Regular Member


Date Joined Mar 2010
Total Posts : 46
   Posted 4/29/2010 2:23 PM (GMT -6)   
Ok, I still have CNBC on. If anyone is interested they're supposed to have Dendreon (Provenge-maker) CEO on tonight at 5:00 Eastern.
Dx 11/2008, Gleason 3+3
Active surveillance for now


Carlos
Regular Member


Date Joined Nov 2009
Total Posts : 486
   Posted 4/29/2010 2:28 PM (GMT -6)   
WebMD has a well writen article about Provenge.  It covers recent trial results and also mentions another ongoing trial looking at the feasibility of using it as a primary treatment.  Try this link:   www.webmd.com/prostate-cancer/news/20100429/fda-oks-provenge-prostate-cancer-therapy.
 
Carlos

Diagnosed 2/2008 at age 71, Gleason score 5+3=8, stage T1c, PSA 9.1. 
Robotic surgery 5/2008, nerves spared, stg. pT2c, N0, MX, R0, Gleason 5+3=8 
PSA <0.1 at 20 months and each test since surgery.


deer hunter
Regular Member


Date Joined Jan 2010
Total Posts : 246
   Posted 4/29/2010 2:53 PM (GMT -6)   
I posted about 2 months ago and ask had anyone knew anything about this ,There was a clinic or research lab doing research and they gave their results and it is logical that with help that your own imume system should be able to fight ofcance like it does other dieases
ps I don;t remeber where th clinic was it was on the net
DEERHUNTER
dx age 57 01/06 open RP 4/06 psa in 01/06 8.1  surgery path report Gleason 3+4=7 poorly differentiated  tumor was 90%involved in both lobes surgical margins postive. in the right apex and right radial margins tumor grade G3  perineural invasion present high grade of PIN found  T2c NX MX PSA 0706  .01 10/06 .02 01/07 .03 04/07 .04  06/07 .05  07/07 .08 07/07 bone scans pelvic ct neg. 08/07 proscintic scan neg.9/07 psa.10 net with rad onc. wanted to do SRT but i did not do it 10/07  saw a new dr at Emory University [my old dr urg. suggested second opinion ]  bone scans negs ct scans pelvics neg. biopies of the bladder and adrinal glands neg.another proscintic scan neg.12/07 Psa .11 clinial trial Emory injected with protons to try and find the cancer cells no luck 3/08 psa .17 06/08 psa .23 psa 09/08 psa .32 12/08 psa .39 3/09 psa .39 6/09 psa .43  meet with medical onc. he said  i might have waited to long to start SRT 7/09 psa .50  another bone scan ct scan all neg.MRI neg. meet rad. psa the last of 7/09was .55 onc. 7/09 started casdex 50mg 1 day for 30 days 2 shots of lupron started rad treament 10/09 40 treatments 75 gm 12 shots each time all aroud pelvic finished 12/09  psa .07 and psa 01/10.05 next dr visit 03/10 wait and see 3/10 psa.05


deer hunter
Regular Member


Date Joined Jan 2010
Total Posts : 246
   Posted 4/29/2010 2:58 PM (GMT -6)   
I went to the site Carlosand that was the co Denderon corp they showed a video of the operation, Thats were i saw it
DEERHUNTER
dx age 57 01/06 open RP 4/06 psa in 01/06 8.1  surgery path report Gleason 3+4=7 poorly differentiated  tumor was 90%involved in both lobes surgical margins postive. in the right apex and right radial margins tumor grade G3  perineural invasion present high grade of PIN found  T2c NX MX PSA 0706  .01 10/06 .02 01/07 .03 04/07 .04  06/07 .05  07/07 .08 07/07 bone scans pelvic ct neg. 08/07 proscintic scan neg.9/07 psa.10 net with rad onc. wanted to do SRT but i did not do it 10/07  saw a new dr at Emory University [my old dr urg. suggested second opinion ]  bone scans negs ct scans pelvics neg. biopies of the bladder and adrinal glands neg.another proscintic scan neg.12/07 Psa .11 clinial trial Emory injected with protons to try and find the cancer cells no luck 3/08 psa .17 06/08 psa .23 psa 09/08 psa .32 12/08 psa .39 3/09 psa .39 6/09 psa .43  meet with medical onc. he said  i might have waited to long to start SRT 7/09 psa .50  another bone scan ct scan all neg.MRI neg. meet rad. psa the last of 7/09was .55 onc. 7/09 started casdex 50mg 1 day for 30 days 2 shots of lupron started rad treament 10/09 40 treatments 75 gm 12 shots each time all aroud pelvic finished 12/09  psa .07 and psa 01/10.05 next dr visit 03/10 wait and see 3/10 psa.05


ChrisR
Veteran Member


Date Joined Apr 2008
Total Posts : 825
   Posted 4/29/2010 3:28 PM (GMT -6)   
Prostate cancer info. Link has all the info. about this. There is a phone number on their website to call dendron to setup treatment
Dx 42
Gleason 6 (tertiary score 0)
OPEN RP 10/08  Johns Hopkins
pT2 Organ confined Gleason 6
PSA Undetectable as of 10/15/09
Next PSA 10/15/2010


Gordy
Veteran Member


Date Joined Jun 2005
Total Posts : 528
   Posted 4/29/2010 4:22 PM (GMT -6)   
I can't believe how ignorant of Provenge all you guys are!

ChrisR
Veteran Member


Date Joined Apr 2008
Total Posts : 825
   Posted 4/29/2010 6:37 PM (GMT -6)   
Gordy. I agree the survival benefit is crap. 4 months. Big deal. What I am hoping is that it does much better in early stage and younger people. I found a guy that took it three years ago who had pca in his bones and so far he is clean. He said the cancer is gone even from his bones. I can send you the link if you want.
Dx 42
Gleason 6 (tertiary score 0)
OPEN RP 10/08  Johns Hopkins
pT2 Organ confined Gleason 6
PSA Undetectable as of 10/15/09
Next PSA 10/15/2010


profman
Regular Member


Date Joined Jan 2010
Total Posts : 55
   Posted 4/29/2010 7:16 PM (GMT -6)   
The average is 4.5 months, but some guys have survived longer - still the mystery of PC, there is no one "type" that responds to this treatment. Clearly, more research is required to understand - I look forward to the day when each individual tumor can be genotyped, and individualized medicine utilized to tailor a treatment specific for the variety of PC the individual has.
Diagnosed 9/4/09, age 59
PSA 3.5, up from 1.8 year before
First biopsy showed 3/10 positive cores, Gleason 3+3, less than 10% involvement in all three cores, diagnosed as T2a; prostate size estimated at 32 gram
Thinking of Active Surveillance but
Second biopsy showed 5/10 positive cores, Gleason 3+3, left side (4 postitive cores) had 40% involvement
RRP on 12/15/09, home 12/16
Catheter out on 12/29/09 (failed cystogram earlier)
Path report was all good news, Gleason 3+3, no margin involvement, no perineural involvement, everything clean other than core of prostate, tumor on both sides, but more prevalent on left side, 5% involvement, 42 gram organ
Within two days down to one pad a day, pad free at six weeks
Back to work 1/4/10
First PSA 1/28/10 - nondetectable (<0.1), next scheduled June 2, 2010
ED present, although blood does flow after Viagra. working with pump now - still trying!


Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 4/30/2010 6:57 AM (GMT -6)   
The CNN Morning News show (Friday morning) is making a big deal about it. What concerns me, if he really costs 93,000 USD for the treatments, and the average life extension is four months, couldn't see many insurance companies going for that. My entire open surgery and 4 days in the hospital cost less than that.

I am, how ever, glad to see anything related directly to prostate cancer getting so much attention of national and world news.

David in SC
Age: 57, 56 dx, PSA: 7/07 5.8, 7/08 12.3, 9/08 14.5, 10/08 16.3
3rd Biopsy: 9/08 - 7/7 Positive, 40-90% Cancer, Gleason 4+3
Open RP: 11/08, Rht nerves saved, 4 days in hospt, on catheters for 63 days, 5th one out 1/09
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos margin
Incontinence:  1 Month     ED:  Non issue at any point post surgery, no problem post SRT
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, next one:  July
Latest: 7/9 met 2 rad. oncl, 7/9 cath #6 - blockage, 8/9 2nd corr surgery, 8/9 cath #7 out 38 days, 9/9 - met 3rd rad. oncl., mapped  9/9, 10/1 - 3rd corr. surgery - SP cath/hard dialation, 10/5 - 11/27 IMRT SRT 39 sess/72 gys ,cath #8 33 days, Cath #9 35 days, 12/7 - Cath #10 43 days, 1/19 - Corr Surgery #4,  Caths #11 and #12  same time, 2/8-Cath #11 out - 21 days, 3/2- Cath #12 out - 41 days, 3/2- Corr Surgery #5, 3/6 Cath #13 out - 4 days, Cath #14- 27 days, Cath #15 - 26 days, Cath #16 - 4/23 put in


Drums
Regular Member


Date Joined Mar 2010
Total Posts : 134
   Posted 4/30/2010 7:46 AM (GMT -6)   
The attention is good, although the media may be playing it up a bit because of the word "vaccine," which it really isn't. It's big news in the medical world because it's one of the first times a tailored treatment using immune therapy for cancer shows a sign of working. The next set of studies are oriented on early treatment. Also, right now it's only available via clinical trials. The manufacturing plants aren't scheduled for clearance until mid 2011.
 
Here are other articles about it. Most of the info is the same, but there are bits of different news in each.
Bill
 
 
 
Age 52, father died of PCa, PSA: 10/16/09 - 2.8; 1/11/10 - 3.8
Biopsy 11/25/09, 11 core samples - HG PIN on right side
Biopsy 2/17/10, 11 core samples - left side, adenocarcinoma, Gleason 6, one core at 5%
Notified of dx on 3/12/10 (27th wedding anniversary)
MRI 3/17/10 and bone scan, 3/23/10, indicate: gland volume is 27mL, PCa is confined to prostate, seminal vesicles and vas deferens are unremarkable.


Gordy
Veteran Member


Date Joined Jun 2005
Total Posts : 528
   Posted 4/30/2010 10:22 AM (GMT -6)   
Drums- See what I mean about ignorance? It will be available starting next week. The New Jersey plant has been set up for production for years. The new new plants in Georgia and California will be up and running in 2011.

The trials were done on the sickest patients. No reason not to believe that those of us who are incurable, but still kicking will do much better.

The next drug in Dendreon's pipeline is Neuvenge, which they expect will work the same way as Provenge, but on other types of cancer.

BTW - The bill submitted to my insurance company for my last Taxotere infusion was $40,000. Compare that to $31,000 for each of 3 Provenge infusions with side effects which are about as severe as a mild case of the flu.

Chrisr - thanks for the offer of a link, but I'm pretty well versed on Provenge.

Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 4/30/2010 10:55 AM (GMT -6)   
Just some of the challenges I know...
My understanding is that there will be 2,000 patients accepted in the first year. I was interviewed by the marketing team and Dendreon about 4 months ago, and the first limitations will be because there still is still a need for more facilities to be able to process the vaccine. Doing the math at 93k per patient, the first year will fund 186m. I am certain there are huge overhead expenses, and I am not certain the cost of building out a new lab or subcontracting a lab but for now, this is only for those who really need it. Using it in the early stages while there is no scientific data that it helps, will also be a challenge. I am excited about the use of the drug in certain high risk cases before the onset of the disease. But we are years away from that information. For now it is good that at least we have something.

Gordy, how many sessions did you have with Tax? Also, have you begun the Sutant trial?

Tony
Disease:
Advanced Prostate Cancer at age 44 (I am 47 now)
pT3b,N0,Mx (original PSA was 19.8) EPE, PM, SVI. Gleason 4+3=7

Treatments:
LARP ~ 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


Gordy
Veteran Member


Date Joined Jun 2005
Total Posts : 528
   Posted 4/30/2010 12:43 PM (GMT -6)   
Hey Tony- I had 6 cycles with the Sprycel trial and then 5 cycles of Taxotere alone after I "flunked" the trial.

I got "that close" to entering the Sutent trial, but someone talked me into doing the Budwig Protocol instead. Check out Budwig if you're not familiar with her. What finally convinced me, was when this woman asked me what conventional medicine has done for me these past five years and I couldn't come up with an answer. I go to MDA in 2 weeks and will have been on Budwig for 10 weeks by that time - long enough to see a little improvement if it works. If not, I figure I haven't lost much. the woman who convinced me was Dx'd with fallopian tube cancer five and a half years ago and has been cured for several years now with no therapy other than Budwig. And a modified, more palatable version of Budwig, at that.

Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 4/30/2010 2:21 PM (GMT -6)   
"I can't believe how ignorant of Provenge all you guys are!"

"Drums- See what I mean about ignorance?"

Gordy, don't you think those quotes of yours are a bit on rude and condenscending side? There are a lot of new guys/girls here that may not know who you are, and it comes across that way. Also, it really helps to post your stats, again, a lot of folks don't know you or your journey, and it would help put your remarks in perspective if you did. Just something to think about.

David in SC
Age: 57, 56 dx, PSA: 7/07 5.8, 7/08 12.3, 9/08 14.5, 10/08 16.3
3rd Biopsy: 9/08 - 7/7 Positive, 40-90% Cancer, Gleason 4+3
Open RP: 11/08, Rht nerves saved, 4 days in hospt, on catheters for 63 days, 5th one out 1/09
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos margin
Incontinence:  1 Month     ED:  Non issue at any point post surgery, no problem post SRT
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, next one:  July
Latest: 7/9 met 2 rad. oncl, 7/9 cath #6 - blockage, 8/9 2nd corr surgery, 8/9 cath #7 out 38 days, 9/9 - met 3rd rad. oncl., mapped  9/9, 10/1 - 3rd corr. surgery - SP cath/hard dialation, 10/5 - 11/27 IMRT SRT 39 sess/72 gys ,cath #8 33 days, Cath #9 35 days, 12/7 - Cath #10 43 days, 1/19 - Corr Surgery #4,  Caths #11 and #12  same time, 2/8-Cath #11 out - 21 days, 3/2- Cath #12 out - 41 days, 3/2- Corr Surgery #5, 3/6 Cath #13 out - 4 days, Cath #14- 27 days, Cath #15 - 26 days, Cath #16 - 4/23 put in


el perro
Regular Member


Date Joined Mar 2010
Total Posts : 46
   Posted 4/30/2010 2:38 PM (GMT -6)   
According to WebMD link above, some guys are seeing years of survival benefit, so it seems as good as chemo on average and possibly much better with less side effects.

Dendreon's website states the NJ facility is only 25% complete.... "The remaining 75 percent is under construction and expected to be complete and available following FDA validation in the first half of 2011. In addition, Dendreon is building out manufacturing facilities in Atlanta, Georgia and Orange County, California, and both are expected to provide additional capacity in mid-2011."

Still wondering about their neo-adjuvant trial at UCSF. Guys get Provenge before having RP and then their prostates are diced up to see what went on inside. I realize it'll take many years to know real outcome, but I'm curious if they're seeing any effect.
Dx 11/2008, Gleason 3+3
Active surveillance for now


RickyD
Regular Member


Date Joined Dec 2009
Total Posts : 163
   Posted 4/30/2010 2:47 PM (GMT -6)   
We all were informed of Provenge and its on going Clinical Trial NCT00715104 in this thread:
 
You are required to have your Provenge treatment and post treatment surgery at UCSF.
For anyone seriously interested in this clinical trail, you should call their new patient scheduler Sarah at 415-353-9692.
 
Rick
Age 55,  PSA = 4.97 on 11/17/09, DRE negative,
Biopsy 12/2/09: 1 of 12 cores positive with less than 5% volume
Gleason 3 + 3 = 6
Prostate Size Estimate on 12/2/09 = 28 cc
RALP performed on 4/7/10 at Vanderbilt University MC with Dr. Joseph Smith (3000+ RALPs)
Final Pathology on removed prostate:
Prostatic Adenocarcinoma present bilaterally from apex to base and extending to inked margin at right apex.  Gleason 3 + 3 = 6, stage pT2c
Prostate Size  = 59 grams, Tumor 5% of total prostate volume.
SV negative, EPE negative, PNI present. Lymph nodes - not checked
 
 
 


Gordy
Veteran Member


Date Joined Jun 2005
Total Posts : 528
   Posted 4/30/2010 3:01 PM (GMT -6)   
RickyD- If you read the link you posted, you'll see that the study start date was July 2008.

Again, the drug was approved yesterday and in Dendreon's conference call yesterday, Dr. Gold stated that patients would start treatment next week.

Purgatory- I apologize to the newbies, but some of the posters above have been here since 2008.

Post Edited (Gordy) : 4/30/2010 4:14:29 PM (GMT-6)


ChrisR
Veteran Member


Date Joined Apr 2008
Total Posts : 825
   Posted 4/30/2010 3:01 PM (GMT -6)   
We all know it's not a cure.  It is just the first step in a new direction that showed some benefit.  The side effects are much less then what you would get with chemo.  I have read they are simply mild flu like symptoms.  Some doctors are hoping the real benefit will be in "mopping up" left over cancer cells.   You also have to consider that this treatment, as they use it on more men, may get better over the years.   Nobody knows what will happen.  I am as cinical as anyone.  I am not holding my breath for this, but hoping.....
 
 
 
 


Dx 42
Gleason 6 (tertiary score 0)
OPEN RP 10/08  Johns Hopkins
pT2 Organ confined Gleason 6
PSA Undetectable as of 10/15/09
Next PSA 10/15/2010


el perro
Regular Member


Date Joined Mar 2010
Total Posts : 46
   Posted 4/30/2010 3:18 PM (GMT -6)   
I wasn't interested in participating in the UCSF/Provenge trial, just curious if anyone had seen/heard if they were seeing a positive response from it.
Dx 11/2008, Gleason 3+3
Active surveillance for now


Gordy
Veteran Member


Date Joined Jun 2005
Total Posts : 528
   Posted 4/30/2010 4:20 PM (GMT -6)   
Purgatory- My stats/signature would be of no help to anybody else, save to satisfy curiosity, and I ask no help from anyone here. I only visit to see if Tony has posted any news from the Pca community.

Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 4/30/2010 4:30 PM (GMT -6)   
Free country, Gordy, a person's stats when they post here help explains their PC journey and situation. If you need nothing from anyone else here, why not correspond directly to Tony? Your attitude is puzzling at best.
Age: 57, 56 dx, PSA: 7/07 5.8, 7/08 12.3, 9/08 14.5, 10/08 16.3
3rd Biopsy: 9/08 - 7/7 Positive, 40-90% Cancer, Gleason 4+3
Open RP: 11/08, Rht nerves saved, 4 days in hospt, on catheters for 63 days, 5th one out 1/09
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos margin
Incontinence:  1 Month     ED:  Non issue at any point post surgery, no problem post SRT
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, next one:  July
Latest: 7/9 met 2 rad. oncl, 7/9 cath #6 - blockage, 8/9 2nd corr surgery, 8/9 cath #7 out 38 days, 9/9 - met 3rd rad. oncl., mapped  9/9, 10/1 - 3rd corr. surgery - SP cath/hard dialation, 10/5 - 11/27 IMRT SRT 39 sess/72 gys ,cath #8 33 days, Cath #9 35 days, 12/7 - Cath #10 43 days, 1/19 - Corr Surgery #4,  Caths #11 and #12  same time, 2/8-Cath #11 out - 21 days, 3/2- Cath #12 out - 41 days, 3/2- Corr Surgery #5, 3/6 Cath #13 out - 4 days, Cath #14- 27 days, Cath #15 - 26 days, Cath #16 - 4/23 put in


Piy
Regular Member


Date Joined Mar 2010
Total Posts : 145
   Posted 4/30/2010 8:15 PM (GMT -6)   
Gordy said...
Purgatory- My stats/signature would be of no help to anybody else, save to satisfy curiosity, and I ask no help from anyone here. I only visit to see if Tony has posted any news from the Pca community.
It's not only a courtesy to post your stats, (should be obvious I would have thought on a site such as this), but can assist in providing perspective.  Gordy it sounds like you are pretty well informed and since one of the primary reasons to visit this site is to learn from others, your knowledge could be of great benefit.  But you're free not to share as well and I for one would not hold it against you.
Although easily dismissed, your minor insults of ignorance should be witheld given your stated motive.
Dx June 2007 - age 48
davinci RRP October 2007
75% of prostate involved
Gleason 9
Positive margin
Scans clear
No detectable mets
SRT - February 2008
PSA:
Mar '09-0.4
Jun '09-0.7
Aug '09-1.7
Feb '10-.008
Apr '10 - .007
Commenced Dr. Robt Leibowitz "Three Pronged Approach" protocol in August 2009
Completed chemo Dec 28 2009

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