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Old 09-12-2010, 04:01 PM   #1
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Thumbs up Hormonal therapy as an option for THE initial therapy

Those of us who have experienced impressive success with hormonal therapy as our sole therapy for prostate cancer do not often recommend that approach to newly diagnosed patients, unless they have advanced cases. That may be about to change!

It's not that hormonal therapy has suddenly become curative (except in rare instances). It has not. It's not that likely substantial side effects with hormonal therapy have disappeared or become easily preventable. They have not. (It takes some effort.) It's not even that breakthrough new research has been published. That has not happened.

What has happened is that one of the doctors in one of the better-known practices specializing in prostate cancer, known for its long-term work in hormonal therapy (and other medical oncology approaches) has co-authored a book that was just published. In that book he presents hormonal therapy as a legitimate first line option for a wide variety of patients!

While his practice had previously helped lead patient education about hormonal therapy, especially about triple hormonal therapy with Proscar (finasteride) also used for maintenance, and had published research about their results, the doctors had not advocated hormonal therapy as a primary choice at the same level as radiation, surgery, cryosurgery, and combined therapy. Rather, hormonal therapy was more in the wings rather than on center stage: good for patients with advanced prostate cancer, or for patients with recurrences, or in support of other therapies, or for men who just could not stand the prospect of the possible side effects of the usual therapies. You can see that if you look at the long and detailed, highly informative section on hormonal therapy in "A Primer on Prostate Cancer--The Empowered Patient's Guide," by Dr. Stephen B. Strum and Donna Pogliano. Dr. Strum was the author's former partner before he semi-retired (and then co-authored the Primer - some retirement!).

I have now read the three key chapters in the new book that bear on hormonal therapy, and it is clear that the author is now presenting hormonal therapy as a reasonable and sound first therapy choice, except for men with low-risk disease for whom active surveillance is presented as the go-to option.

The doctor is Mark Scholz, MD, a medical oncologist in the Los Angeles area, and his co-author is one of his long-time patients, author Ralph H. Blum. Their book, just published on August 24, 2010, is "Invasion of the Prostate Snatchers", with the subtitle "No More Unnecessary Biopsies, Radical Treatment or Loss of Sexual Potency." (They clearly do see an important role for radical treatments, but they hope to decrease the number of unnecessary radical treatments with the likely side effect burdens of those treatments.)

Consider these statements near the beginning of Chapter 10, "TIP: Testosterone Inactivating Pharmaceuticals," page 95:

"Someday soon a nontoxic treatment for prostate cancer is going to come along.... The present reality, however, is that the potential side effects of surgery or radiation are intimidating. No one knows who will end up with irreversible impotence or incontinence. With surgery or radiation there is no going back. It's impossible to undo any harm that may have occurred. [Jim here: That's true but stretching it a bit as there are ways to minimize the harm for many of us.]

A MEDICINE TO TREAT PROSTATE CANCER?

What if there were a highly effective treatment with reversible side effects, a treatment that not only worked inside the prostate but also had anticancer effects covering the whole body? Believe it or not, there is such a treatment presently available--blockade of the male hormone testosterone...."


By now you may have already tripped over the terminology: "testosterone inactivating pharmaceuticals" in the chapter title. I find it awkward, and I'm sure it's confusing to new patients trying to sort out whether it means the same thing as the somewhat less intimidating phrase "androgen deprivation therapy" (widely used in published medical papers and texts) or the more familiar "hormonal therapy" or hormonal blockade therapy". All of these phrases mean virtually the same thing, though the phrase "hormonal therapy" is technically broader, covering not only androgen blockade but also estrogen drugs, for example. Nonetheless, the book is highly informative, and, with the exception of the phrase "testosterone inactivating pharmaceuticals," quite readable for the average patient.

I'll skip over the pedigree of that phrase, except to say that Dr. Scholz and colleagues use it in their published medical research paper. It's surely their choice for a paper they have "recently" submitted on the twelve-year results for 73 men who chose TIP as their primary therapy in their practice in the mid-90s. (It does not yet show up on PubMed.) Dr. Scholz describes the key findings on page 98: for this group of mostly intermediate-risk prostate cancer patients, 29% never needed more than a single course of TIP; 33% required periodic (intermittent) additional cycles of TIP to keep their PSA levels low (like me); 38% (28 men) elected one of the local, curative therapies at a later date. Of the latter patients, who had local therapy after an average of 5 1/2 years after the first cycle of TIP, only three relapsed, but with no metastases. All 73 men recovered their testosterone when TIP was stopped. While the authors don't state the average duration of TIP for the 73 men, from elsewhere and other papers it is likely about 18 months.

These statistics are pretty remarkable! However, if it were just 73 patients as the basis for advocating TIP as a primary therapy option, that's a thin foundation. However, the number is small because the authors wanted to give a long-term look at well-documented results. In the book, Dr. Scholz states that "Over the years we have seen hundreds of men with excellent responses to TIP."

Dr. Scholz is also well aware of the research published informally by a couple of his peers, Drs. Leibowitz and Tucker. Unfortunately he has had a sharp disagreement with Dr. Leibowitz, most likely over the standards for medical evidence, I believe, and the Leibowitz/Tucker results are not mentioned in "Invasion." Nonetheless, the Leibowitz/Tucker practice was the first to focus on triple hormonal blockade therapy (with finasteride also for maintenance) as a primary, sole therapy choice, and they published fairly long-term results in great detail for low-, intermediate-, and high-risk patients in a joint conference of medical groups in Orlando, Florida, in 2005.

Those results documented impressive success of triple blockade for all patients, but particularly for low-risk patients: virtually all low-risk patients achieved excellent, long-term control of their cancer and recovered from blockade side effects within several months (on average) after just a single course of blockade of thirteen months. I won't go into details here, but their practice, "Compassionate Oncology", published the results under the title "Update on Triple Androgen Blockade® followed by Proscar Maintenance".

Dr. Leibowitz really does have a good claim to being the first to trumpet triple, maintained blockade as a primary therapy for prostate cancer, but, unlike the Scholz group, his work was never published in a major medical journal, and, unfortunately, it never broke through as credible to the larger medical community.

However, with this new confidence expressed by Dr. Scholz, combined with the Leibowitz/Tucker work, and supported by informally reported similar success in Dr. Charles "Snuffy" Myers practice, it's looking like hormonal blockade as primary therapy has come of age.

This first post is already getting long, so I won't write about the important issue of typical side effects and how they are avoided or minimized. A number of us on the board have experienced some form of blockade, and we can chip in about our experiences.

In conclusion, I believe we are seeing the birth of hormonal therapy as a legitimate primary therapy option.

Jim

 
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