PCRI CONFERENCE REPORT

Ok, first some general comments

it was extremely well-organized. Everything went off without a hitch.

Lots of sessions.

One problem --in some of the sessions, when the speaker was done, he would go across the hall and answer questions. This was fine as I wanted to hear, for example, Dr. Lam's responses to questions. I did but then discovered I missed half of Snuffy Myers' talk.

There was zero time between sessions.

Also, there was information overload. The speakers all had their act together with lots of supporting slides. But it was hard to assimilate all the information.

Basically, they did so much in the brief time we had. They could have gone slower and used another day!

Incidentally, there were no handouts. Eventually there will be a DVD available with all the sessions on it.

But it was a fantastic conference.

I am going to relay my notes herein. I only captured a snippet of all the great information presented. So, here we go.

Dr. Lam spoke about dealing with High Risk patients. There were many criteria of what constitutes high risk. I didn't copy it down, but you can guess (G8-10 or PSA>20, etc.),

ADT after surgery showed MUCH higher survival. He discussed extensive lymph node removal. If the PC is in one or two, the removal can effect a cure. But removing lots of lymph nodes creates some bad SE, so we have a QOL balancing issue.

Radiation to entire pelvis is much better than radiation only to prostate bed with very little difference in morbidity.

ADT plus radiation is MUCH better than rad. alone

Rad. plus ADT plus taxotere --70% are still in remission after 7 years.

RECENT STUDY HAD AMAZING RESULT--they tried abiraterone plus ADT pre-SURGERY. Only 29 patients. After surgery, 3 men had absolutely no cancer found and 7 had almost no cancer. This is very intriguing, suggesting much earlier use for abiraterone.

SUPPLEMENTS -- the latest on what works

A Medit. Heart healthy diet
VIT D
Pomegranate
Celebrex if no heart problems. Prescription item
Avodart (prescrip. drug)
Curcumin
Resveratol

The above list is the latest from Snuffy Myers

For bad hot flashes due to ADT they recommend low dose estradol patches

Robert Dreicer spoke. He works at the Cleveland Clinic. He pointed out that in the not too distant past, before PSA routine testing, loads of patients presented with advanced metastatic disease. This is VERY RARE today.

There has been an unprecedented explosion of new drugs that extend survival. He mentioned 5 or 6 that came online just in the past decade. This puts tremendous pressure on local general urologists and oncologists. They CANNOT keep up. He emphasized the importance of finding specialists who only deal with PC and traveling to see them if you have a significant PC. (Editorial Comment -- I agree. This does not mean one is casting stones on local medicos, but it is what it is).

Abiraterone Acetate was mentioned with very high regard by many speakers. They really praise this drug. It is like Super ADT, stopping the testosterone at many levels. It is currently given with prednisone due to a major SE of edema. It is given only after chemo fails.HOWEVER studies are indicating that this will work very well before chemo. They are hoping for a label change that will allow this. It could happen in 2013 or 2014.

Even better is the just-approved MDV3100. This is again given after chemo fails and they hope eventually it will be moved up before chemo. It does not require prednisone, which has its own Nasty SE.

Current costs are $5000 per month for abiraterone and $7500 per month for MDV3100. Medicare covers the former and I think the latter. Consequently, many insurances will come on board since they tend to follow Medicare. I did not hear how long these drugs are given for.

Sipuleveel-T (sp?), better known as Provenge (and easier to spell!) is "driving everyone nuts."

It will absolutely NOT lower PSA. But it will slow the PSADT and consequently without a doubt patients live longer. But it is hard to track progress as PSA is unreliable here.

Provenge should not be used for end stage patients or in lieu of other therapies. Currently they require patients to be castrate resistant with little or no symptoms.

It can be used before chemo.

Cost is $90k, covered by Medicare.

SE of Provenge is generally mild flu like symptoms for a few days.

Radium 223 is another big one and it helps prevent or retard bone mets. It will probably be approved in 2013.

Conclusion is that PC will be managed sequentially. It is more of a chronic illness. Even castrate resistant patients can expect 5-7 year survival right now (implication is that this number will go up).


Lots of good comments about brachytherapy. Less severe SE. It is much harder to find top-notch practitioners. This is because surgery and IMRT are much more profitable.

Strum and Myers highly criticized the study suggesting IADT is inferior to CADT. They both said the study was greatly flawed.

For example, in the study on IADT, when patients went off ADT, they did not go back on until the PSA went above 20, which is crazy.

At the round table at the end, the question came up about Avodart turning an indolent PC into an aggressive PC. They said not true. The 8 experts were also given assorted hypothetical cases. They did not always agree on the best tx.

That's all I got and remember, I'm just the messenger. I hope to attend again next year.

Unfortunately, my Tigers got their butts kicked by the Angels.

I'll be returning home Tuesday night. Meanwhile, spending quality time with our daughter.

My wife attended sessions and she was very impressed with the expertise.

Mark Moyad was a great coordinator. He is well-spoken, highly intelligent, knowledgeable, and has a wonderful sense of humor. He had us laughing. Not easy with such a sobering topic. Richard Simmons was a surprise guest at the opening session and had us old folks MOVING.

Mel






Sent from my iPad

Mel great report.

I missed it this year because going there over the weekend and leaving for DC today was just too much for me. Did you get a chance to find my friend at the 21st Century Oncology booth? Her name is Sara and you'll know if you met her...(Pretty young blonde). She is a huge pit bull and my co-Founder and Co-Director for the "This One's For the Boy's" race she should have been promoting...

On the CADT v. IADT thing. It has flaws but I disagree that the data isn't important. Those doctors offer no studies or proof at any level and the study period and participation was huge. I received some more info on it and they do acknowledge some flaws but stated that only in a small percentage of patient would the data not be useful. I'll send you a copy of that data if you like.

The one thing I am quite cautious about is critical comments where there is no better data offered. There has been plenty of time to prove the effectiveness of IADT especially in patients that never come down below a PSA of 4. Some argue that if 4 is as low as a PSA response goes the of course it won't work to stop the regimen. But the PSA data does go lower with better survival rates in the CADT arm.

Still great report. Thx...

PS: The Myers skit is the same no matter how many times you see him. If you get another chance you'll hear a lot of familiar stuff...

Tony

Here's a comparison of the three major drugs reviewed above:

Provenge (sipuleucel-T; approverd for pre-chemo use only):
Cost: $93,000, three treatments, two weeks apart. Total treatment time: one month. Kaplan-Meier curves separated at 6 months. Label: median 4.1 months life extension. (Not reimbursed as a pill. Currently, 75% of patients have no or little out-of-pocket expenses. The other 25% may have to pay up to $22,000, depending on what supplemental insurance they have.) Has NCCN Category 1 rating (the highest) in its space.

Zytiga (abiraterone acetate; approved for post-chemo use; is being prescribed off-label pre-chemo):
Cost: $5,700 per month. Recently unblinded Phase 3 pre-chemo trial protocol used 14-month administration in treatment arm (with co-administered prednisone) for a total of almost $80,000 in cost. (Reimbursed as would be any other pill, which means Medicare patients would face Donut Hole charges.) Currently has NCCN Category 2B rating (second lowest) in Provenge's space on the basis of a small Phase 2 study (68 patients). In the recently unblinded Phase 3 pre-chemo trial, no separation in the K-M curves (that is, no life extension benefit) was seen until the 18th month (4 months after patients in the treatment arm came off the drug). Trial achieved stat sig for progression free survival but NOT stat sig for overall survival.

Xtandi (enzalutamide; approved for post-chemo use)
Trial is still underway. Drug was just approved for post-chemo use. No NCCN rating pre-chemo. Cost is $7,500 per month. Importantly, Xtandi does not require co-administration with prednisone. If we assume a nominal 12-month treatment regimine pre-chemo, cost would be ~$90,000...right up there with Provenge. (Xtandi is reimbursed as would be any other pill, which means Medicare patients would face Donut Hole charges.)

Regarding the co-administration of Provenge and Zytiga (that is, the sequencing of these two treatments), the Journal of Clinical Oncology recommends Provenge be used first:

http://jco.ascopubs.org/content/29/27/3595.full?sid=a9e276db-0ac1-4ca1-8fd4-a16a19e7151f#sec-14

However, if a patient's disease load is great and increasing rapidly, the physician may decide Zytiga is the first treatment of choice.

Great summary...thanks for sharing..

I had 29 lymph nodes removed all negative 5 1/2 operation, surmise it was done by surgeons students staff. didn't bother me. Main Se' i had were not that bad but disturbing if you have any anxiety issues.Pratt drain was in for 5 weeks, 2 mos after op, I had 2 golf ball lymphecels. Had to try another ct scan. Had low-grade fever for 3 weeks. Self resolved after 5weeks. no problems sense

Mel,
I find the discussion of Abiraterone Acetate and its associated cost particularly interesting. Given that the drug was discovered and researched by British doctors and and scientists working within the UK (socialist ) health system why on earth is it now so outrageously expensive? Perhaps big pharma foresaw the potential goldmine and bought up the patents with an offer too good to refuse.
It sounds like you gained a great deal of valuable info and insight at the conference. Well done
Bill

Hi Mel, just a quick thanks for taking the time to share your notes from the conference. Awful good of you to do that, sounds like lots of interesting updates - too bad they didn't do handouts. I attend and do a number of presentations related to work and have found it best to at least handout copies of the slide decks presented, for the audience to jot notes down on.

I'll be keeping my eye out for the CD's when they are available.

Regarding the costs of many of these drugs, we always read about the amount quoted, but rarely read what the insurance and/or medicare has negotiated to pay. My Elligard/Lupron is charged by the uro at about $3,000 per shot, but my insurance pays the doc about $1,400. I am guessing the other pills are in a similar situation, but I have read that Provenge $93k is a firm number.

SUPPLEMENTS -- the latest on what works

A Medit. Heart healthy diet
VIT D
Pomegranate
Celebrex if no heart problems. Prescription item
Avodart (prescrip. drug)
Curcumin
Resveratol

I thought Metforim might make the list and I wasn't expecting to see Celebrex. 

 

Jerry L.

In the last "Prostate forum" newsletter by Myers, he says this about Metformin, which is why he probably has not included it in the list:

"It is one of the most widely prescribed drugs in
the world. It is very useful in the treatment of dia-
betes. More recently, studies have suggested it may
favorably impact various diseases of aging, like
dementia. There is also some suggestion of anticancer
activity, specifically including prostate cancer.
Having said that, I have used metformin extensively
in our diabetic patients and have not been impressed
with its anticancer activity. At present, I would rank it
relatively uninteresting compared with drugs like
Zytiga and MDV3100."