Lower PSA Yields Longer Survival with Provenge Treatment
As early as 2013, we have known that a lower baseline prostate-specific antigen (PSA) is associated with a higher overall survival benefit from Provenge (sipuleucel-T) as found in the phase 3 IMPACT trial aka the Immunotherapy for Prostate Adenocarcinoma Treatment trial. It is shocking to us at Cancer ABCs how unknown this data is in both the patient community and in the medical community.
Recently, we have been working with a man who has a PSA that is under 1.0 whose oncologist has refused to give him Provenge because he claims that his PSA is too low to allow him to have an immune response!
This misconception is in direct conflict with the data produced by Shellhammer et al. which was published in Urology, 2013 (see reference below).
Shellhammer’s study was designed to explore the prognostic and predictive value of the PSA baseline on a man with castrate resistant prostate cancer if he received Provenge. The study evaluated 512 men and used data generated by the phase III IMPACT trial.
The baseline PSA values of the subject men were subdivided into quartiles to evaluate PSA treatment effect patterns. On analysis, it was found that PSA was the most influential baseline prognostic factor. Furthermore, treatment with Provenge appeared to have a more significant effect on overall survival with men who had the lowest baseline PSA levels.
In this study the estimated improvement in median survival varied from 13.0 months in the lowest baseline PSA quartile to 2.8 months in the highest PSA quartile, the men with the lowest baseline PSA did much better and survived longer.
The most significant magnitude of benefit was obtained by those men with the lower baseline PSA scores.
These findings tell us that men with less advanced disease as measured by lower PSA scores gain the best survival advantage from Provenge.
The oncologist mentioned earlier in this post is in direct conflict with the data; he is wrong. This man should be given Provenge now when he stands to gain the most benefit from the treatment.
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A New Therapeutic Vaccine Against Prostate Cancer.
A newly approved healing prostate cancer vaccine won the pay for Wednesday of a Medicare monitory committee, increasing the chances that Medicare will pay for the drug. Officials from Medicare, the federal security program for the elderly and disabled, will consider the committee's vote when making a final decision on payment. Such a finding is expected in several months, the Wall Street Journal reported incense. The vaccine, called Provenge and made by the Dendreon Corp, costs $93000 per stoical and extends survival by about four months on average, according to results from clinical trials.
A memorize published in July in the New England Journal of Medicine found that the vaccine extended the lives of men with metastatic tumors intransigent to sample hormonal treatment, compared with no treatment vigaplus. And the therapy involved less toxicity than chemotherapy.
Provenge is a corrective (not preventive) vaccine made from the patient's own white blood cells. Once removed from the patient, the cells are treated with the dope and placed back into the patient get more info. These treated cells then trigger an exempt response that in turn kills cancer cells, leaving general cells unharmed.
The vaccine is given intravenously in a three-dose schedule delivered in two-week intervals. "The blueprint of trying to harness the immune system to fight cancer has been something that kinfolk have tried to attain for many years; this is one such strategy," study lead researcher Dr Philip Kantoff, a professor of prescription at Harvard Medical School and a medical oncologist at the Dana-Farber Cancer Institute in Boston, told HealthDay.
One practised said the therapy, while far from a cure, "looks promising". Dr Elizabeth Kavaler, an urologist at Lenox Hill Hospital in New York City, said that "in this unblessed classification of hormone-resistant patient, we have very little to offer. Adding months to a man's passion is better than doing nothing, especially if the treatment involves minimal morbidity, as this vaccine promises".
In April, the US Food and Drug Administration approved Provenge for curing of prostate cancer that has spread to other parts of the body and is impervious to standard hormone treatment. For the study, Kantoff's group randomly assigned 512 men to obtain Provenge or placebo. All of patients had advanced prostate cancer that had proven recalcitrant to standard hormonal therapy.
On average, men receiving Provenge lived 4,1 months longer than men receiving a placebo, the researchers found. Average survival was 25,8 months for men in the Provenge group, compared with 21,7 months for men in the placebo group, gist that Provenge extended survival by 22 to 25 percent.
He contends that if the vaccine were cast-off by men with less beastly disorder survival, it might be extended for even longer. "Theoretically, if you take subjects with less diseases and you stimulate the immune system, you could have a more profound effect, but we don't really know that yet".
Compared with other treatments, such as chemotherapy, diffusion and hormone therapy, Provenge has been touted as having fewer and less dreadful side effects. In this trial, the most common side effects were chills, fever and headache, the researchers noted which male enhancement pills are fda approved. Commenting on the great in extent cost of Provenge, Kantoff said that "this is a remedying given over a four-week period, as opposed to other treatments that are given over many months, where the costs can be high as well, if not comparable to or more dear than Provenge".
Black Men with Prostate Cancer Are More Responsive to Radiation Than White Men
Recently released and unexpected findings have been announced, contrary to previous understandings, black men who received primary radiation therapy to treat their prostate cancer had lower rates of biochemical cancer recurrence than white men. They also had a lower rate of developing distant metastasis. These findings are from data coming from the randomized RTOG trials and were reported at the American Society of Radiation Oncology by Daniel Spratt, MD, of the University of Michigan in Ann Arbor.
Making this finding even more interesting is the finding that Black men do better when they receive Provenge than white men
Both of these findings point out that there are likely differences in the underlying prostate cancer disease between Black and White men. However, this conclusion does not negate the fact that Black men have less access to treatment than White men, a fact that needs to be corrected, especially given the circumstances indicated in these two conclusions that Black men do well when given treatment.
Somewhat disturbing to say the least. The question is, who/what do you believe?
I was considered to be the ideal candidate for Provenge. Young (by mCRPC - metastatic castrate resistant prostate cancer standards), still healthy with a functional immune system. In other words, most likely to get the biggest bang for the buck... Did it help? Well, despite some ups and downs since then, I'm still here. Did it cure me? No. But no one claimed it would. The whole idea was to beef up my immune system to help slow the disease progression and buy more time.
There will always be controversy and detractors when a "disruptive" therapy emerges. Provenge was the first of its kind for prostate cancer. The opportunity for fudged results exists in any clinical trial. I have no idea if the claims in the Reuters article are true. You'd think that there would have been some major coverage if was. But who knows?..
Would I try another immunotherapy drug? Yes, in a heartbeat. Even if Provenge turns out to have been a dud, I still believe immunotherapy and targeted therapy are the future of cancer treatment. There is another prostate cancer immunotherapy treatment called PROSTVAC in phase III trials right now. I'm keeping an eye on it. I'm also paying close attention to the Cabozantinib (targeted) trial for use in PC.
Dendreon's Dead Enders Still Blaming Everyone But Themselves
With Monday's Chapter 11 bankruptcy filing, Dendreon's collapse is complete. The stock trades for actual pennies -- 22 of them, when I last checked. Dendron's creditors now control the company's only asset, the prostate cancer vaccine Provenge, which they will try to sell off at a fire-sale price.
Wall Street saw the Dendreon debacle coming long ago. But despite all the warnings, a core group of mainly retail investors won't accept the fact that Dendreon died from self-infilcted wounds: Bad business decisions made by incompetent executives trying to sell a mediocre product which became obsolete too quickly.
Visit certain Internet stock message boards even today, and you'll still see the Dendreon dead enders parrot the absurd conspiracy theories propagated by Overstock CEO Patrick Byrne and his crew of Deep Capture naked shorting bamboozlers. Dendreon was killed by mafia-connected hedge funds! It's the FDA's fault! If it wasn't for a small cabal of jealous prostate cancer doctors, Provenge would be a blockbuster!
Nonsense. Crushing debt killed Dendreon.
EP Vantage's Jacob Plieth:
When things are looking up, convertible debt can look highly attractive since – if things pan out – its future repayment looks trifling, and the only near-term pain is a relatively modest interest rate. Plenty of banks pitch this as “non-dilutive financing”, and many biotechs take the bait.
The key phrase, of course, is “if things pan out”; in biotech they rarely do. Development setbacks can take large chunks out of share prices, making the debt burden suddenly look large. At this point conversion often risks diluting equity holders excessively, while raising further equity puts even more pressure on the stock.
And this is how companies end up locked in a spiral of a falling share price and looming insolvency. And, if insolvency does come, the assets are usually sold off at fire-sale prices, with trade creditors, management payoffs and debt holders at the top of the heap, and equity holders at the bottom.
In short, debt financing sometimes works, but if it does the primary beneficiaries are the debt providers, and hardly ever the equity holders. The lesson seems to be not to fall into the temptation to start with.
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The concept of harnessing the power of the immune system to conquer cancer is not new. In fact, researchers have been thinking about how to do this for more than a century and have had very little success in implementing these concepts, until recently.
In 2010, the first cancer vaccine, Provenge, was approved for prostate cancer patients, and in 2011 a drug that inhibits key checkpoints of the immune system, Yervoy, was approved for patients with late-stage melanoma. Much of the excitement around immunotherapy is that it is one of few cancer treatments that can result in durable, complete remission of cancer.
Melanoma survivor Jeff Rowbottom, managing director of Kohlberg, Kravis, Roberts, said, “I found it pretty interesting that our immune system is the most effective way to cure cancer. Intuitively this seems to make a lot of sense, especially as a non-scientist.”
During a panel discussion at the 2013 Milken Institute Global Conference, panelists provided insight on why these therapies are now working when they had not been previously.
Suzanne Topalian, professor of surgery and oncology at Johns Hopkins University, and director of the melanoma program at the Sidney Kimmel Comprehensive Cancer Center, simply explained, “The technology has finally caught up with ideas that we have had over the past few decades about how to activate the immune system to fight cancer.”
Michael Giordano, senior vice president and head of development, oncology, and immunoscience at Bristol-Myers Squibb, added, “Immunotherapies have been around for a while, but they have undergone a renaissance as a result of a deeper understanding of the immune system.”
Marie Belldegrun, executive chairman of Kite Pharma, Inc. and director of the UCLA Institute of Urologic Oncology, underscored the point by explaining that the advancement of genetic engineering such that it has become simple, routine, and cost-effective, created a significant turning point that enabled scientists to really shed light on the complex inner-workings of the immune system. “We now understand all of the antennas and the GPS systems that the [immune] cells use to do their jobs.”
Moderator Louise Perkins, chief science officer of the Melanoma Research Alliance, pointed out that immune-based therapies are a form of personalized medicine; however, not necessarily in the way that the public normally thinks about personalized medicine in the context of targeting genetic mutations specific to the individual patient’s tumor. She explained that the immune system can target these genetic mutations specific to each patient, but the power of immunotherapy really lies in the fact that it is a living therapy that persists and can keep pace with new genetic mutations that occur in the tumor over time. This is important because tumors are very dynamic in how they respond to therapeutic stress. Tumors often become resistant to standard treatments by creating new genetic mutations that render treatments ineffective. The immune system can sense these changes in real time and adjust with the tumor to deter treatment evasion.
Panelists continued the discussion by highlighting what it takes for drugs like Yervoy and other immunotherapies to come to market. Giordano explained that, as a drug developer, first and foremost it is important to remember to keep the patient at the center of the need. Giordano also talked about the importance of collaborating across sectors – industry, government, and nonprofits – in order to efficiently and effectively bring medicines to patients. He stressed the role of patients and nonprofits to serve as honest brokers and push all stakeholders in the right direction to make sure that patients are kept at the center of the effort and that contributions from all stakeholders can be maximally leveraged.
Topalian added, “Nonprofits are becoming increasingly important to drive science forward, especially in the wake of sequestration."
She explained that as other funding sources are shrinking, philanthropy dollars will need to fill a very important funding gap to support cutting-edge ideas that traditional organizations perceive as too risky to put their dollars behind, but may come with high reward. She emphasized the point that taking educated, calculated risks in research can be a very good thing.
Finally, Giordano elegantly pointed out that the essence of what we need to do as a community in order to really meet the needs of patients is “Keep the patient at the center of the need and follow the science. If we follow the science then it will be good business; however, good business is not necessarily good science.”
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"How one scientist’s losing battle against his own cancer might save the rest of us."
I remain optimistic that this is the future of cancer treatment. Back in the early spring, I was approved for and underwent Provenge, an immunotherapy treatment for advanced prostate cancer. I mentioned "approved for" because this stuff is hideously expensive and insurance companies have very restrictive guidelines for approval. I am exceptionally lucky and have outstanding coverage, it was covered in full. The cost? Just shy of $100k... Many guys who get approval still face a co-pay of $20k. This is obscene...
Did it work? We really have no way of knowing other than how much longer I stay alive. There isn't a specific test for an immune response and it can be working even while the cancer remains active. A bit of a leap of faith but I felt it was worth it.
I just had a DEXA (dual-energy X-ray absorptiometry) scan this morning, an easy one, no radioactive injections or contrast medium… This one will be used to compare against my baseline bone density from early last year. The longer you’re on Lupron (my primary hormone suppression med), the greater the risk of Osteoporosis. I am essentially in permanent “manopause” since I have no testosterone. And for any of you who spend much time around me, you know that the other wonderful side effect is hot flashes. Lots of hot flashes…
Back to the waiting game. In a couple of weeks I need to do blood work in advance of my next Oncology exam. This one could be pretty important since it’s been a while due to having been going through the Provenge treatments. Before that I was getting blood work almost weekly as they monitored the progression in my PSA level. It’s been rising steadily (but in very small increments) since the end of last summer. That’s why we (I) decided to go for the Provenge. But the hard thing about Provenge is that it may not have any effect on PSA. It could be working great but my levels may continue to rise. Little hard to get your head around that…
And if my numbers are still going up, they will want me to consider the next level of hormone suppression. This one spooks me a bit since it involves shutting down my adrenal gland to turn off hormones that may be mimicking testosterone. I will have to actually take cortisone every day since you can’t live without that one.
The results of the DEXA may also come into play if I have suffered a significant loss of bone density. If that’s the case, yet another med may be added, Zometa. Dr. Deepak (my Oncologist) has already tried to talking me into it once before since in high doses, it may be useful in suppressing bony metastasis and pain (both of which I have). I said no last time because at that dosage level, there can be some major side effects. So we’ll see.
A lot of things swirling around in my head as the waiting continues.
