Abiraterone- Zytiga approved an in useage now...so what do we know about it thus far?

New Topic Post Reply Printable Version
[ << Previous Thread | Next Thread >> ]

zufus
Veteran Member


Date Joined Dec 2008
Total Posts : 3149
   Posted 5/19/2011 7:10 AM (GMT -6)   
Others can add what they found or know on this, I wish to see is this more of a breakthrough drug now or is it more of a re-engineering of Ketoconazole with a new patent and huge price tag...thus a method to cashin on PCa patients?
 
Some of the info I got from their website: (blue is my words of course)
 

What are the ingredients of ZYTIGA?

Active ingredient: abiraterone acetate

Inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium stearate and colloidal silicon dioxide. (does this look like it is worth $5000/mo. for 1000mg of pills used at 4 per day of 250 mg)???

 

Symptoms of using such: 

 

                        urinate more often than normal

                        need to get up at night to urinate

                        heartburn

                        cold like sympto

21

                        joint swelling or pain

                        muscle aches

                        hot flushes

                        diarrhea

                        urinary tract infection

                        cough

                        irregular heartbeats

What are the possible side effects of ZYTIGA?

ZYTIGA may cause serious side effects including:

High blood pressure (hypertension), low blood potassium levels (hypokalemia) and fluid retention (edema). Tell your healthcare provider if you get any of the following symptoms:

                        dizziness

                        fast heartbeats

                        feel faint or lightheaded

                        headache

                        confusion

                        muscle weakness

                        pain in your legs

                        swelling in your legs or feet

                        Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress.

                        Liver problems. Your healthcare provider will do blood tests to check your liver before treatment with ZYTIGA and during treatment with ZYTIGA.

------------------------------------------------------------------------

Ok so we know also this is used with prednisone, just like Ketoconazole and back when in trials they barred prior patients whom used Keto (there is a clue right there). They both target the enzyme  Cyp17  (mentioned by Dr. Sawyers inventor of MDV-3100 on a interview blog on internet). They have very similar overlapp on side effects and perhaps on other drug interactions.  Keto has strick useage adherences as to 8 hour time frame for taking it, acidic stomach prior maybe with juices (they both say that is how to take it), they both have some drug interaction variables to be aware of that could even be threatening (doc should know all your drugs taken prior). In trials this drug showed a 4 month survival advantage and that is always misleading, Provenge showed similar too but in some patients (all were high risk in trials) lived 4 years thereafter. So it could do way better than a 4 months thing...so you see I am being fair minded on that.

 

Other things with useage possible:  high BP, edema, low potassium levels which are now mentioned. The company is  Centocor Ortho Biotech (part of (J&Johnson-?) and mfg. company is  Patheon Inc.-toronto, canada.

 

I think the website was:  www.zytiga.com   for informations on it.

I don't know if this is good news or not at this point, I am highly suspecious of this being way overpriced and more companies are looking at such things in making profits. They now offer an assistance program for people whom cannot afford it  (that should be most people on the planet).

Seems like spending $5000 a month on PCa protocols is not big deal now...I hope this is not the 'new' trend these days. My opinion of course...I do like more choices and anything that helps. This needs price competiton, look at the ingredients listed....see $5000 a month in that for pills??? Just my observation and .02 cents and definitely pro-patient.


tarhoosier
Regular Member


Date Joined Mar 2010
Total Posts : 495
   Posted 5/19/2011 8:15 AM (GMT -6)   
There are many clever chemists in India

Sonny3
Veteran Member


Date Joined Aug 2009
Total Posts : 2448
   Posted 5/19/2011 9:56 AM (GMT -6)   
Here is the FDA news release on approval of the drug.

www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253055.htm

Of note is this statement in the release:

The study was designed to measure overall survival, the length of time from when the treatment started until a patient's death. Patients who received the Zytiga and prednisone combination had a median overall survival of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone combination.

If I read this correctly, they studied 1195 patients. Do these results mean that they waited until all 1195 had died to collect their data. Not a very nice thought in my mind.

FWIW,

Sonny

Sonny3
Veteran Member


Date Joined Aug 2009
Total Posts : 2448
   Posted 5/19/2011 10:08 AM (GMT -6)   
Okay after further reading, I would have a real tough decision to make. Take the placebo or pay five grand a month for the MEDIAN of 14.8 months, plus or minus, and have the following issues for the time I am taking the drug until I expire;

The most commonly reported side effects in patients receiving Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention (usually of the legs and feet), muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion, and upper respiratory tract infection.

Oh, never mind for me. I think personally I would rather have the shorter period, get my affairs in order, and spend time with my family without all of these added issues.

JMHO,

Sonny
60 years old - PSA 11/07 3.0 PSA 5/09 6.4
da Vinci 9/17/09 Post Surgery Pathology: GS 4+3=7
Stage: T3a
Tumor Volume 12.5% positive margin, extra-prostatic extension
PSA .6 IMRT completed 1/15/10 35 treatments- 70Gy
2/23/10 Post IMRT PSA 1.0
3/22/10 PSA 1.5
4/19/10 PSA 1.2
5/22/10 PSA 1.3
8/9/10 Radiation for MET
9/7/10 PSA 2.2
1/5/11 PSA 3.9
3/7/11 PSA 4.2
4/10/11 PSA 3.8

James C.
Veteran Member


Date Joined Aug 2007
Total Posts : 4463
   Posted 5/19/2011 10:13 AM (GMT -6)   
makes casteration looks attractive, doesn't it?
James C, 64, East TN
Gonna Make Myself A Better Man tinyurl.com/28e8qcg
4/07: PSA 7.6, 7/07 Biopsy: 3 of 16 PCa, 5% inv, lf. lobe, GS6
9/07: Nerve Spar. open RP, Path: pT2c, 110 gms., clear except:
Probable microscopic involvement-left apical margin -GS6
3 Years: PSA's .04 each test until 4/10-.06, 9/10-.09, 12/10-.09, 2/11-.08, 5/11-.08
Bimix .30

don826
Veteran Member


Date Joined May 2008
Total Posts : 1010
   Posted 5/19/2011 11:08 AM (GMT -6)   
I tend to agree with Zufus that this is of marginal benefit but priced high enough to return the drug companies investment in a short period of time if enough desperate patients are found. Of course the other part of that is the shape of the curve. Google a paper called "The Median Is not the Message" for a good disertation on how the sahpe of the curve can be more meaningful for some.
 
I, like Sonny, would prefer to enjoy the time I have left and leave a bit more for my families future vs that of the drug company. One other thing is there is never any discussion of the QOL for the additional months. Hail and hearty of the same degree of dissipation as without?
 
By the way at least four of the ingredients cited are fillers and sell for pennies per pound.
 
Don

Jerry L.
Veteran Member


Date Joined Feb 2010
Total Posts : 3072
   Posted 5/19/2011 8:54 PM (GMT -6)   
15 months * $5000= $75000

Provenge is starting to look reasonable. Or, it"s all unreasonable.
Nov. 2009 Dx at Age 44
Dec. 2009 DaVinci Robotic Surgery
Jan. 2010 T3b, Gleason 9
Feb. 2010 Adjuvant Radiation
March 2011 PSA Rise/scan indicates spot
April, 2011 Casodex / Lupron
May 2011 Radiation to pelvic bone

PSA History:
-----------------
Nov. 2009 4.30
Feb. 2010 <.05
May 2010 <.05
Aug. 2010 <.05
Nov. 2010 <.05
March, 2011 .09
April, 2011 .06

don826
Veteran Member


Date Joined May 2008
Total Posts : 1010
   Posted 5/20/2011 10:09 AM (GMT -6)   
Jerry,

I had a visit with my Urologist last week and asked about the Provenge. He said it was $120,000 (this is more than the $93,000 referenced on the internet and I assume includes the Uro fee). He also said it was not available as a routine treatment but was a last ditch treatment.

Don
Diagnosed 04/10/08 Age 58
Gleason 4 + 3
DRE palpable tumor on left side
100% of 12 cores positive for PCa range 35% to 85%
Bone scan and chest x ray clear
CT scan shows potential lymph node involvement in pelvic region
IGRT/IMRT with adjuvant HT (lupron) 2yrs
PSA:
02/08 21.5
07/08 0.82
10/08 .642
09/09 0.32
03/10 0.32
06/10 0.32
07/10 0.10
09/10 1.00
03/11 2.38
New Topic Post Reply Printable Version
Forum Information
Currently it is Monday, September 24, 2018 10:11 PM (GMT -6)
There are a total of 3,006,315 posts in 329,326 threads.
View Active Threads


Who's Online
This forum has 161827 registered members. Please welcome our newest member, a8166008.
172 Guest(s), 5 Registered Member(s) are currently online.  Details
sparkleplenty, PeterDisAbelard., BillyBob@388, Squarsh, InTheShop