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Thursday, April 14, 2016

"Disruptive" solid tumor tx? Focused Ultrasound.

This STATnews report caught my eye recently.
How an obscure medical technology caught the eye of Joe Biden. And John Grisham
By REBECCA ROBBINS @rebeccadrobbins

CHARLOTTESVILLE, Va. — An obscure medical technique involving zapping a body part with converging beams of sound is finally getting some high-profile attention.

Focused ultrasound, as the procedure is known, is used commercially in the United States to treat just a few medical conditions, including uterine fibroids and prostate cancer. Just over two dozen hospitals and clinics across the country offer it. Hardly any insurers will pay for it.

But an irreverent, impatient, retired neurosurgeon has made it his mission to accelerate development of the treatment — and this week, he got an opportunity to do that in a big way when he was named to a panel advising Vice President Joe Biden on the national cancer moonshot initiative...

Kassell believes focused ultrasound has the potential to “play a real role” in advancing the moonshot’s goals, such as by boosting the effects of cancer immunotherapy or delivering chemotherapy in a more targeted manner. He believes it could treat many types of cancer, as well as other diseases like Parkinson’s and perhaps even Alzheimer’s.

“The problem,” Kassell said, “is that most people have never heard of focused ultrasound. So we need to get that visible.”...

He’s such a persuasive evangelist for focused ultrasound that he inspired best-selling legal novelist John Grisham — a personal friend — to write a book championing the technology’s potential, over the concerns of his publishers. It’s been ordered or downloaded more than 250,000 times since coming out in December...
Well, I downloaded and read the free book. A very quick read. About half of it comprised of photos and graphics.

...Paul has a problem. He has a tumor in the right frontal lobe of his brain, about the size of a hen’s egg. 

Looking back, the first symptom was a gradual decrease in his ability to concentrate at work. Naturally curious and active, he noticed an uncharacteristic tendency to procrastinate. At times he felt listless and tired. Then the headaches arrived, and with a fury. He blamed them on stress and took lots of ibuprofen. As he drove to work one morning, his vision became so blurred he stopped the car. Karen began to notice mood swings and a loss of patience with the kids. He grew more irritable, both at home and at the office. His boss chastised him for barking at a coworker. He quarreled with Karen over his dour moods and crankiness. She knew something was changing with her husband and urged him to see a doctor. He refused. 

On a Wednesday morning, as Paul is in the bathroom shaving, Karen hears a loud thump. She finds him on the floor, shaking in a full-blown grand mal seizure. She calls 911, and as she waits the seizure stops and he gradually awakens. He is confused, disoriented— doesn’t recognize Karen and doesn’t know where he is. The rescue squad arrives. Paul is loaded into an ambulance and taken to the hospital. In the emergency room, he is still drowsy and confused and complains of weakness on his left side. Upon examination, his left hand is very weak and he has difficulty lifting his left arm and leg. An MR scan reveals the tumor. 

He is admitted to the hospital and started on anticonvulsant medication to prevent further seizures, as well as steroids to decrease the swelling in his brain around the tumor. Paul and Karen are not shown the MR scan. A neurosurgeon is consulted...

Early Wednesday morning, one week after his seizure, they meet again with the neurosurgeon. The pathology report confirms their worst fears: glioblastoma, grade four. Although the tumor has been removed, it left behind microscopic portions that extend into the normal brain and cannot be surgically removed. These remnants of the tumor will almost certainly regrow, and must be treated with radiation and chemotherapy. When the tumor returns, there will be the likelihood of more surgery. With as much professional sympathy as possible, the doctor tells them that, according to statistics, Paul can expect to live 12 to 14 months. Occasionally a patient will live 5 to 10 years, but that’s uncommon. He offers his usual, “Hope for a miracle, but plan for the average.”...

Grisham, John (2016-01-19). The Tumor: A Non-Legal Thriller (Kindle Locations 69-150). Focused Ultrasound Foundation. Kindle Edition.
Glioblastoma. Ugh. I am reminded of this book I read and cited a while back.

Mr. Burrows' book is an eloquent cautionary tale about traversing the myriad dubious cancer tx options that come at you from every direction. He was also diagnosed with a glioblastoma. Highly, highly recommended book.
When I began telling family and friends, colleagues, clients and contacts about my inoperable, incurable brain tumour, and how it was going to one day kill me, there was lots of doubt. Actually, there was dissent. Not just the ‘oh, I can’t believe this is happening’ and ‘it just can’t be true’ type of dissent. There was actual, real disagreement with the facts. A friend of a friend cured their cancer by changing their diet. There’s this doctor in Canada or Germany or Ireland who does incredible things with brain tumours. I’ll pray for you and ask for healing. Think positive and you’ll live. Take this supplement and it’ll kill off the bad cells. Mix this herb with that tree’s sap and drink it five times a day. Stop eating wheat, dairy, meat, sugar. That celebrity had cancer and then it just went away overnight. Doctors aren’t always right. Let’s get you some experimental treatment. What about neurolinguistic programming? Watch this YouTube video. Read this article. Visit this website. Contact this charity. It’s the chemo that’ll kill you, not the tumour.   

Don’t give up.   
There’s always a chance.   
There’s always hope. 
It can’t do any harm. 
You never know unless you try it. 

Each of these suggestions was offered with love and concern. They were heartfelt responses to the statement for which there is no adequate response: ‘I have cancer.’ I do not blame anyone for offering their suggestions. Some were just a stab in the dark. Others truly believed their suggestions would help me. I’m grateful, however ludicrous some of them seemed. When friends and well-wishers offer a suggestion, a treatment or an approach to cancer, they’re doing so because they truly care and want to help. No one should be blamed for that. 

But there is a flip side. There are those in cancer circles who care less about cancer patients than they do about the money in their pockets. There are those who have built empires on selling treatments and diets that don’t work. There are those that hide or misinterpret evidence of tests that have failed to prove their treatment regime works. I was to find out all about them in the months that followed...

Burrows, Gideon (2015-09-01). This Book Won't Cure Your Cancer (Kindle Locations 43-59). Kindle Edition. 
The Alternative 
Paul was born in 1980, ten years too early. Had he been born in 1990 and diagnosed with a brain tumor at the age of 35, in 2025, his story could be rewritten as follows: 

That same Wednesday morning, Karen hears a crash in the bathroom, and she finds Paul on the floor in a grand mal seizure. He’s taken to the ER and admitted to the hospital. An MR scan is performed with molecular imaging, a more advanced scan than was available ten years earlier. 

Based on the scan, the neurosurgeon, with virtual certainty, makes a diagnosis of a glioblastoma and explains the prognosis and the treatment options, including focused ultrasound therapy. The size and location of Paul’s tumor make it amenable to treatment with focused ultrasound therapy, which is what the neurosurgeon recommends. He explains that the tumor in all probability cannot be cured and will return, but it can be controlled with repeated treatment, giving Paul more years with a high quality of life... [Grisham, op cit, Kindle Locations 206-214]
Interesting. Download the free Kindle book. It only takes about 20 minutes to read it. Worth your time.

A year ago I was coming to terms with my own post-biopsy prostate cancer dx, and just beginning the lengthy consideration of my tx options.

The phrase "focused ultrasound" never came up. Not once (neither from my urologist, nor in subsequent consults with three oncologists). It was "active surveillance," surgery, or radiation, period (I got the queasy feeling that my urologist wanted to cut on me, maybe work on his robotic prostatectomy chops).

Given the clinical particulars of my lesion, after my Stanford second opinion consult I chose the lengthy "Calypso focused IMRT" radiation regimen.

Well, while that ship has by now long sailed, I have to admit to lamenting not having been apprised of the "focused ultrasound" option. My Calypso beacons implant px did not go particularly well (and they are permanent), and I've now been dosed with nine weeks of daily ionizing radiation. The "informed consent" document I had to sign was explicit in setting forth the downstream long-term risk of iatrogenic secondary tumor development attributable to the rad tx. But, given my age (70) and the typical latency period of new tumor onset, the trade-off seemed rational, all things considered in context.

Nonetheless, I probably would have looked closely at the "FUS" tx. Assuming, of course, it would have been available to me, both in my service area (though it would only be a Virginia plane ride away worst case) and via my execrable BCBS/RI insuror.

I invite you to check them out. I will certainly be digging deeper.

I just downloaded and reviewed their latest available 501(c)(3) IRS 990 via Guidestar. Unremarkable. No dirt there. (Unlike per some other cases I've reviewed, LOL.)

A FUS TEDx talk...


Grisham makes note of some of the challenges.

Yeah, we're all familiar with these.

One (positively) "disruptive" aspect noted in the Grisham book: the FUS tx cost would've been about a quarter that of the late patient's surgery, radiation, and chemo. Cheaper and more effective? What's not to love?

Tangentially, I also think back to my late daughter, Sissy. In the spring of 1998 she underwent a last-ditch 24th hour px at Good Samaritan Hospital in L.A., "Gamma Knife Radiosurgery." In addition to her 11 lung mets, she'd developed a brain met that grew to nearly the size of a tennis ball.

The Gamma Knife px is not surgery and doesn't entail a knife. It involves the anchoring of a "helmet" comprised of 216 sealed cobalt gamma-emitter radionuclide sources via which to target and zap a tumor.

It did not work. Her brain lesion was by then too large for this px. We pretty much knew that going it. It was a "Hail Mary" ordered by her Brotman Attending, Dr. Mittleman. She died shortly thereafter.

Might FUS have worked, and saved or materially extended her life? While there's no point in dwelling wistfully on it, I cannot help but transiently wonder.

One place I always go to when looking for evidence of (or indications of a lack of) credibility is They have one scant mention of FUS.
Prostate Cancer Dilemmas: To Test or Not to Test, To Cut or Not to Cut
For the typical newly diagnosed patient the treatment options are surgery or radiation. There are other treatment options for advanced or metastatic cancer, including hormones and chemotherapy. New treatments being studied include cryosurgery and focused ultrasound...
Interesting. Thus far my post-IMRT prognosis looks pretty good, but should I encounter a "next time," I will certainly look at FUS if the dx is applicable.


U. Cal San Francisco has it. A BART ride away.

"MR-guided Focused Ultrasound Surgery (MRg-FUS) at UCSF"

Good page. Very informative.


John Grisham, in his "Tumor" preface:
Seven years ago, my friend and neighbor, Neal Kassell, gave a PowerPoint presentation on focused ultrasound therapy. Neal is a prominent neurosurgeon who’s spent his career drilling through skulls and making repairs to brains. During the PowerPoint, Neal, with great enthusiasm, explained that focused ultrasound therapy could one day alleviate the need for conventional brain surgery. Tumors would be destroyed using beams of ultrasound energy, and afterward the patient would walk out of the operating room and go home. Not only would the treatment be non-invasive, painless, quick, and relatively inexpensive, it could also save the patient’s life. 

Focused ultrasound therapy is still in its early stages, still experimental, but there is enough research to date to be very optimistic.

The brain is just the starting point. Tumors in the breast, prostate, pancreas, liver, kidneys, and bones could be treated on an out-patient basis. Neal loves to use the example of a man with prostate cancer undergoing focused ultrasound therapy, then driving himself back to the office for a few hours. Later, he goes home to celebrate his wedding anniversary with his wife. They share a champagne toast to growing old together.

This is not science fiction. Around the world, 50,000 men with prostate cancer have been treated with focused ultrasound. Over 22,000 women with uterine fibroids (benign tumors of the uterus) have been treated, thus avoiding hysterectomies and infertility. Clinical trials for tumors of the brain, breast, pancreas and liver, as well as Parkinson’s disease, arthritis, and hypertension are inching forward at over 225 research sites around the world...
As athenahealth CEO Jonathan Bush likes to say, "More Disruption, Please."


Also from STATnews, "Donald Trump’s failed vitamin venture becomes butt of ‘Daily Show’ jokes," by IKE SWETLITZ @ikeswetlitz


More to come...

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