twolf
Junior Member
Posts: 16
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Post by twolf on Aug 21, 2014 13:57:42 GMT -8
lol, I just wanted to get the facts straight. Since Medicare pays for it, cost may not be an issue for most of us (you are excluded, Tony!).
My endocrinologists downplays the side effects of osteonecrosis caused by Prolia with respect to those from Zometa and Xgeva treatment. Problem here is that these drugs are mostly administered by urologists or oncologists, who are not familiar with bones. On the reverse, an endocrinologists may be familiar with these drugs, but it is tough to find one who has knowledge re prostate cancer. I fired my first endocrinologist as she wanted to put me on Forteo. The idea of having to inject yourself DAILY with Forteo, is not appealing to me (and probably not to anybody else), but of course that is not her "fault". Forteo is associated with possibly resulting in osteocarcoma (well, admittedly at least in rats). It should not be taken if you have cancer in your bones, there are warnings about taking it after radiation treatment and it is believed that it will accelerate metastases (which will include possibly existing micro-metastases). See you in a few weeks, Tony!
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Post by Tony Crispino on Aug 21, 2014 15:19:05 GMT -8
Also to set the Prolia debate aside, the studies shown by Allen in the original post are for monthly regimens of ZA. I don't think that in that case, Prolia would qualify as a substitute. The Prolia regimen now as I understand it is ONLY for men with high risk of fracture with non-metastatice PCA who are on HT. I may be assuming this. But a more comparative use of denosumab may be 60mg of Xgeva given monthy subcutaneously.
But yes, Wolf. I am excited to finally get a chance to shake your hand, sir!
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Post by Allen on Sept 3, 2014 8:59:11 GMT -8
Dr. Matthew Raymond Smith at Mass General was the lead author of the Alliance trial, and had this to say:
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Post by Allen on Sept 3, 2014 9:33:18 GMT -8
So ignoring the Japanese study, what we are left with are the contradictory conclusions: • Zometa delays PSA progression and delays time to secondary treatment if the patient has no bone mets ( TROG RADAR) • Zometa does not delay PSA progression, incidence of bone mets, or overall survival among high risk men with no bone mets ( ZEUS) • Zometa does not delay the time to the first SRE if the patient already has bone mets ( Alliance) TROG RADAR tells us to use Zometa, along with long term ADT, before bone mets are detected, while ZEUS & Alliance tell us not to bother. It seems the only possible benefit to Zometa, other than BMD, is before bone mets are detected.
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Post by Allen on Sept 4, 2014 11:43:44 GMT -8
Some enlightenment arrived today! The journal Endocrine Related Cancers published the findings of a mouse study that demonstrates a plausible biological mechanism by which ADT creates a bone environment favorable for growth of metastases and that Zoledronic Acid can prevent that: Castration-induced bone loss triggers growth of disseminated prostate cancer cells in boneThere is also an analysis of the implications of that study, as well as the other studies cited in this thread. The authors infer that: (1) ADT actually causes a change to the bone that makes it more hospitable to met growth (2) Zometa- at the time of ADT initiation - prevents the bone from becoming more hospitable to mets (3) Zometa - after ADT initiation, or when mets are already detected - is too late to mitigate the deleterious effect of ADT They say, "Thus, neither ZOL nor ADT alone were effective, but in combination, they prevented further disease progression, but only when the two were administered together and simultaneously." Zoledronic acid at the time of castration prevented castration-induced bone metastasis in mice.
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Post by Allen on Sept 16, 2014 22:06:34 GMT -8
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Post by lupronjim on Sept 17, 2014 13:59:25 GMT -8
Tony, you make it sound like Fosomax and Prolia are the same, but they are quite different. If you read up on Forteo, it is not recommended for patients with POSSIBLE metastases; as a matter of fact, it might accelerate metastases for prostate cancer. You might add Atelvia and Actonal to your list. Back to Prolia (Denosumab): FDA approved for men on ADT and no indication of bone metastases. Though NOT approved for THAT purpose, there are studies indicating that Prolia (and Xgeva) MAY slow down development of metastases. Anybody in here on Prolia? Side effects? When I was originally diagnosed as G9 (4+5) Oligometastatic with bony mets to spine and right sacral ala. I was on Monthly Xgeva from the month I became Medicare eligible 8-1-13 to when my bone scans showed I no longer had any bony mets. So I had my first 6-month Prolia shot in June, 2014 and am due for another at end of this year. I am still Oligometastatic but that is now due to 3 micro lymph nodes contained in pelvic area deemed suspicous on an F18 sodium scan and confirmed on C-11 Acetate by Dr Fabio Alemida in Phoenix AZ Molecular Imaging. I recommend him highly BTW. Not on either long enough to answer your question about longer term SE's, but so far so good on Xgeva for 10 months and Prolia only 3 months into my first 6-month shot. My DEXA bone density scan was clear in May 2013 just after I started Lupron 3-28-13 to get a baseline. Medicare/AARP not willing for me to have another yet since they have paid for so many other scans already. I also recently started 1000 Mg Zytiga but instead of 5 Mg Prednisone twice a day, taking 50 Mg Inspra once a day since I also started Provenge last weekend (no SE's so far but only 1 of 3) and will be having high dose SBRT by Dr Chris King at UCLA starting Oct 6 thru Oct with 15 5 fractions @ 8 Gy each, with Provenge last infusion on Oct 20. As you no doubt can tell I was fortunate to have Allen as my mentor to leverage theabscopal effect with combination of treatments. I am probably a continuous Lupron/Zytiga patient but am fortunate to have minimal SE's other than the less than minimal libido. LupronJim
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Post by cspivak on Sept 18, 2014 3:55:16 GMT -8
I am not used to interpreting medical legalese so probably mistaken, but wouldn't this: Approved for prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors www.cancer.gov/cancertopics/druginfo/fda-denosumab#Anchor-SREgive approval to a much broader class? (MO is prescribing Xgeva for Dave, hence my interest.) I see that the studies involved included only hormone refractory prostate cancer so I'm just asking about the way this approval line is written and what it really means.
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Post by Allen on Sept 18, 2014 8:35:10 GMT -8
It appears to me that Prolia (denosumab- 60 mg every 6 months) is approved for men with non-metastatic (to bone) PC who are at high risk for fracture because of ADT-induced bone loss.
Xgeva (denosumab - 120 mg every 4 weeks) is approved for men with metastatic (to bone) PC for prevention of SREs.
I think you're right that while the research was done on men who were castrate resistant, the prescribing indications make no mention of that for either dose level.
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Post by lupronjim on Sept 18, 2014 11:57:20 GMT -8
It appears to me that Prolia (denosumab- 60 mg every 6 months) is approved for men with non-metastatic (to bone) PC who are at high risk for fracture because of ADT-induced bone loss. Xgeva (denosumab - 120 mg every 4 weeks) is approved for men with metastatic (to bone) PC for prevention of SREs. I think you're right that while the research was done on men who were castrate resistant, the prescribing indications make no mention of that for either dose level. Correct as usual Allen. That's why Dr. Jeffrey Turner an associate of Mrk Scholz and Richard Lam at Prostate Oncology in Marina del Rey CA switched me to 6-month Prolia in June, 2014 when bony mets no longer deemed present, after I had previously been on Xgeva since 8-1-13 whem deemed to then have had bony mets. LupronJim
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twolf
Junior Member
Posts: 16
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Post by twolf on Nov 28, 2014 18:22:27 GMT -8
OK, had my first Prolia shot 2 weeks ago; tiniest needle I have ever seen - injected into the arm. Cost to me by pharmacy: $40 (I am on Medicare with supplemental insurance); will know more about who paid what once the paperwork is in. No side effects (so far) that I am aware of. Had DEXA scan just a few hours before the Prolia shot; this should be a good baseline for evaluating the effectiveness of Prolia. Medicare pays for DEXA scans every two years, but makes exceptions for osteoporosis patients with ADT for prostate cancer. Note: I am on IADT and had two 6-months Lupron shots. Last Lupron shot in June 2009; PSA fluctuated between 1.2 and 1.5 for the last 15 months. Next Prolia shot in 6 months.
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Jerry
Junior Member
Posts: 44
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Post by Jerry on Dec 20, 2014 17:25:05 GMT -8
For what it's worth, I am one of those guys that have been on Xgeva for awhile. I was put on it immediately after a small PSA rise and bone mets discovered. At the same time I did spot radiation and placed on hormone therapy for close to 18 months. I took Xgeva monthly for a year then every 6 months as a maintenance dose for the next 2 years or so.
I didn't give the ONJ side effect much thought until I had trauma to my bone in my mouth which resulted in a small piece of exposed bone. It healed completely, but trust me...it made me think. I'm due for my 6 month shot, but am now wondering if it is worth the risk. (It would be nice to know what the possible rewards are for the risk taken.)
In any event Xgeva was approved for me -- metastatic, hormone sensitive.
Also in the news just recently: Too Few Prostate Cancer Patients Get Bone-Strengthening Meds: Study
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Post by lupronjim on Dec 29, 2014 9:55:49 GMT -8
Jerry -
I had a similar issue with some bone loss that caused a gap in 2 prior root canals. No ONJ issues, just wallet issues to have the 2 root canals redone by a specialist due to the Xgeva complications.
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