New drug that enables your own cells to attack and kill cancer

This news today brings hope of a new way to fight all 

cancers. It's not a present wondercure, it could be 
years before it's been developed further and it 
becomes afordable to all, but it's a massive step in the 
right direction.

The new therapy turns a patient’s cells into a “living- 
drug,” and trains them to recognize and attack the 
disease. It is part of the rapidly growing field of immunotherapy that bolsters the immune system 
through drugs and other therapies and has, in some 
cases, led to long remissions and possibly even cures.

The Food and Drug Administration on Wednesday approved
the first-ever treatment that genetically alters a patient’s own
cells to fight cancer, a milestone that is expected to transform
treatment in the coming years.

The therapy, marketed as Kymriah and made by Novartis, was
approved for children and young adults for an aggressive type
of leukemia — B-cell acute lymphoblastic leukemia — that has
resisted standard treatment or relapsed. The F.D.A. called the
disease “devastating and deadly” and said the new treatment
fills an “unmet need.”

Novartis and other companies have been racing to develop
gene therapies for other types of cancers, and experts expect 
more approvals in the near future. Dr. Scott Gottlieb, the F.D.A. 
commissioner, said that more than 550 types of experimental
gene therapy were being studied.

There are drawbacks to the approach. Because Kymriah can
have life-threatening side effects, including dangerous drops
in blood pressure, the F.D.A. is requiring that hospitals and
doctors be specially trained and certified to administer it,
and that they stock a certain drug needed to quell severe
reactions.

Continue reading the main story

 Kymriah, which will be given to patients just once and must be
 made individually for each, will cost $475,000. Novartis said
 that if a patient does not respond within the first month after
 treatment, there will be no charge. The company also said it
 would provide financial help to families who were uninsured
 or underinsured.

Photo

Emily Whitehead, shown here in May, was near death at age 6 from leukemia and became the first pediatric patient to receive the experimental gene therapy. She is now 12 and has been in remission for more than five years. CreditChildren’s Hospital of Philadelphia, via Associated Press 

 

Discussing the high price during a telephone news conference, a
Novartis official noted that bone-marrow transplants, which
can cure some cases of leukemia, cost even more, from
$540,000 to $800,000.

About 600 children and young adults a year in the United States
would be candidates for the new treatment.

The approval was based largely on a trial in 63 severely ill
children and young adults who had a remission rate of 83
percent within three months — a high rate, given that relapsed
or treatment-resistant disease is often quickly fatal.

The treatment was originally developed by researchers at the
University of Pennsylvania and licensed to Novartis. It was
identified in previous reports as CAR-T cell therapy, CTL019
or tisagenlecleucel.

The first child to receive the therapy was Emily Whitehead, who
was 6 and near death from leukemia in 2012 when she was
treated, at the Children’s Hospital of Philadelphia. Now 12,
she has been free of leukemia for more than five years.

To customize Kymriah for individual patients, white blood cells
called T cells will be removed from a patient’s bloodstream at
an approved medical center, frozen, shipped to Novartis in
Morris Plains, N.J., for genetic engineering and multiplying,
frozen again and shipped back to the medical center to be
dripped into the patient. That processing is expected to take
22 days.

Novartis said the treatment would be available at an initial
network of 20 approved medical centers to be certified within
a month, a number that would be expanded to 32 by the end of
the year. Five centers will be ready to start extracting T cells 
from patients within three to five days, the company said.

Photo

An intravenous bag of Kymriah, which must be customized for individual patients. It is expected to cost $475,000 and can have potentially fatal side effects. 

Credit

Certification is being required because the revved-up T cells can
touch off an intense reaction, sometimes called a cytokine
storm, that can cause high fever, low blood pressure,
lung congestion, neurological problems and other life-
threatening complications. Medical staff members need
training to manage these reactions, and hospitals are being
told that before giving Kymriah to patients, they must be sure
that they have the drug needed to treat the problems,
tocilizumab, also called Actemra.

Dr. Kevin J. Curran, a pediatric oncologist at Memorial Sloan
Kettering Cancer Center in Manhattan, said his hospital was
“99 percent” of the way through the certification process, and
would soon be offering Kymriah.

“This is a big paradigm shift, using this living drug,” Dr. Curran
said. “It will provide a lot of hope. This is the beginning.”

He said he expected that eventually this type of treatment
would work for other, more common types of cancer, not just for
leukemia.

The F.D.A.’s approval of Kymriah ushers in “a new approach to
the treatment of cancer and other serious and life-threatening
diseases,” the agency said in a statement, noting that the new
therapy is “the first gene therapy available in the United States.”

Dr. Carl June, a leader in developing the treatment at the
University of Pennsylvania, recalled that in 2010, when tests
showed that the first patient was leukemia-free a month after
being treated, he and his colleagues did not believe it. They
ordered another biopsy to be sure.

“Now, I have to keep pinching myself to see that this happened,”
Dr. June said, his voice breaking with emotion. “It was so
improbable that this would ever be a commercially approved
therapy, and now it’s the first gene therapy approved in the
United States. It’s so different from all the pharmaceutical
models. I think the cancer world is forever changed.”

New technique for 3D visualization of prostate cancer tumors

Video: Targeted Prostate Biopsy Using MR-Ultrasound Fusion

 Webcast: Prostate Biopsy Using MR-Ultrasound Fusion

Suspicious areas seen on the MRI can be tracked and targeted during prostate biopsy

A new research study at UCLA aims to re-define prostate cancer significance through clinical validation of a tool which allows 3D visualization and tracking of the prostate. By fusing multi-parametric MRI (T2-weighted, diffusion-weighted imaging, dynamic contrast enhancement) with real-time ultrasound, suspicious areas seen on the MRI can be tracked and targeted during prostate biopsy. This research aims to improve currently available methods of cancer diagnosis.

Watch here: http://urology.ucla.edu/prostate-biopsy-video

Prostate Cancer Runs in Families

                               Andre                  Me                      Paul 

Prostate cancer runs in families, and my family gives no better example. My Dad died of it over 20 years ago. Thankfully, that was the reason I had regular checks. It landed on me 7 years ago, and then my brother Paul 4 years ago. We are both still survivors after surgery, but my brother Andre can only wait; will it pass him by? My son Kyle is now within the age group 40+ when he should be having regular PSA checks, but will he? I was diagnosed with no symptoms, my PSA was even within limits! My cancer was about to break out it was so advanced. I was a ticking bomb. I was lucky!
Don't forget, it's not how large your PSA is that gives the clue that it could be prostate cancer, it's the increase in your PSA over time. My PSA was 3.8 before surgery, well within limits, but my doctor spotted that it had grown from 1.1 to 3.8 in just 2 years. Know your PSA. Know it every year and write it down. Know that at least you didn't welcome this cancer in through your front door.

Advance in Brachytherapy

A new brachytherapy isotope, Cesium-131, could be a game-changer, a study indicates. Brachytherapy involves placing radioactive implants, or seeds, directly onto tumors to destroy cancer cells while limiting damage to healthy tissue.

IsoRay Medical markets the Cesium-131 brachytherapy that it developed as GammaTile. It is not only more cost-effective than other treatments, but also generates fewer side effects, researchers said.

Their study, “Long-Term Quality of Life in Prostate Cancer Patients Treated with Cesium-131,” was published in The International Journal of Radiation Oncology, Biology and Physics.

Scientists have refined brachytherapy many times since its introduction in 1901. Some experts see Cesium-131 as an optimal version because it is both fast-acting and has a shorter delivery time than other brachytherapies — about 30 days.

A key advantage of Cesium-131 is shorter recuperation periods, meaning patients can recover their urinary, bowel, and sexual functions quicker than with other brachytherapy solutions.

Ninety-five percent of GammaTile’s radiation is confined to the tumors it treats, and the rate of radiation injury is very low, IsoRay said.

The findings suggest that Cesium-131 brachytherapy offers patients an ability to maintain the quality of life they had before treatment better than other options.

“For far too long, patients have been treated for prostate cancer based on a medical professional’s familiarity [with a therapy] or, in some cases, due to far greater financial benefits to the physician,” Brian Moran, medical director of the Chicago Prostate Cancer Center, said in a press release. “This study reinforces that a new, patient-friendly treatment exists. Brachytherapy with Cesium-131 leverages the isotope’s short half-life to significantly reduce the duration of long-term symptoms and side effects.”

Discovery of new prostate cancer biomarkers could improve precision therapy

Mayo Clinic researchers have identified a new cause of treatment resistance in prostate cancer. Their discovery also suggests ways to improve prostate cancer therapy. The findings appear in Nature Medicine.

In the publication, the authors explain the role of mutations in the SPOP gene on the development of resistance to one class of drugs. SPOP mutations are the most frequent genetic changes seen in primary prostate cancer. These mutations play a central role in the development of resistance to drugs called BET-inhibitors.

BET, bromodomain and extra-terminal domain, inhibitors are drugs that prevent the action of BET proteins. These proteins help guide the abnormal growth of cancer cells.

As a therapy, BET-inhibitors are promising, but drug resistance often develops, says Haojie Huang, Ph.D., senior author and a molecular biologist within Mayo Clinic's Center for Biomedical Discovery. Prostate cancer is among the most diagnosed malignancies in the United States. It is also the third leading cause of cancer death in American men, according to the American Cancer Society. Because of this, says Dr. Huang, improving treatments for prostate cancer is an important public health goal.

In the publication, the authors report SPOP mutations stabilize BET proteins against the action of BET-inhibitors. By this action, the mutations also promote cancer cell proliferation, invasion, and survival.

"These findings have important implications for prostate cancer treatment because SPOP mutation or elevated BET protein expression can now be used as biomarkers to improve the outcome of BET inhibitor-oriented therapy of prostate cancer with SPOP mutation or BET protein overexpression," says Dr. Huang. Mutations in the SPOP gene can then be used to guide administration of anticancer drugs in patients with prostate cancer: The Nature Medicine publication presents four major discoveries:

• BET proteins (BRD2, BRD3, and BRD4) are true degradation substrates of SPOP.
• SPOP mutations cause elevation of BET proteins in prostate cancer patient specimens.
• Expression of SPOP mutants leads to BET-inhibitor resistance and activation the AKT-mTORC1 pathway that promotes cancer cell growth and survival.
• Co-administration of AKT inhibitors overcomes BET inhibitor resistance in SPOP-mutated prostate cancer. Mayo Clinic Ventures, the technology commercialization arm of Mayo Clinic, has a patent application in place for this promising prostate cancer biomarker and therapeutic technology.

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Story Source:

Materials provided by Mayo Clinic August 2017

The robot that could cure your prostate cancer

A guide to the other advances helping win the war against this disease feared by men

 Thirty men a day in the UK die of prostate cancer. It is a gloomy statistic – yet talk to experts in the field and the mood is anything but pessimistic. In fact, there is a sense that science is on the verge of turning the disease from one to be feared to little more than a chronic illness controlled with drugs, like asthma or diabetes.

Survival rates are better than ever: the number of deaths keeps falling and ten years after diagnosis, 84 per cent of men are still alive.

From more accurate screening and less invasive diagnostic techniques to robotic surgery and targeted drugs, huge advances in treatments also mean men are more likely to be cured, and less likely to be left impotent or incontinent – the big worries for most.

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Surgeon Christopher Ogden with the da Vinci Xi surgical robot that he uses to perform robotic prostatectomy at the Royal Marsden Hospital, London

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‘Soon this could be a disease that men routinely survive, and has little impact on their daily life,’ says Dr Iain Frame, research director at the charity Prostate Cancer UK.

But with advances in therapies comes new information for every man with prostate cancer and his loved ones to absorb – much of it complex. We spoke to Britain’s foremost experts, who between them have treated tens of thousands of men, about the new developments every patient should be aware of and the treatments that really do make a difference…

Christopher Ogden is a surgeon at the Royal Marsden Hospital in London

Christopher Ogden, a surgeon at the Royal Marsden Hospital in London, pioneered the use of robotic surgery for prostate cancer – treating more than 2,500 men with a technique that revolutionised the treatment of the disease. 

He says: ‘Although surgery might not be the first thing we offer men with prostate cancer, many will at some point need to have the gland removed. The operation is called a radical prostatectomy and it offers a cure in 95 per cent of cases.

‘Decades ago, the only option was open surgery – with the prostate removed through a long incision below the navel. Then came keyhole surgery, where instruments and a camera were inserted though several tiny cuts in the abdomen.

‘About 13 years ago, I was the first British surgeon to use the Da Vinci robot, which is a high-tech version of keyhole surgery, where instruments are held by a machine with robotic arms.

‘Back then it was seen as a bit outlandish. Now it’s the gold standard in surgery, with nearly 100 robots in the country, and hundreds more surgeons trained to use them.

‘The arms are controlled by the surgeon from a console next to the operating table. The procedure eliminates the risk of surgical error through hand tremors or shakes. And the video display in the console is highly magnified, which means we are better at avoiding damage to nearby nerves.

‘This means the risk of the complication feared most by men, erectile dysfunction, may be reduced.

‘The robot performs at least twice as well as the best surgeon in getting all cancer out in one go – reducing the need for repeat surgery, and greater risk of erectile dysfunction and incontinence.’

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Professor Roger Kirby is a consultant urologist and director of The Prostate Centre in London

Professor Roger Kirby, consultant urologist and director of The Prostate Centre in London, is a leading light in the field, having published more than 300 scientific papers on prostate tumours. He says:

‘Today, two-thirds of men with prostate cancer will never need to have surgery, and can instead undergo active surveillance – where regular checks are carried out to see if the tumour is progressing. If the cancer remains small and slow-growing, then there is no reason to operate.

‘Last year a study that tracked 1,600 men with prostate cancer for ten years found no difference in survival rates between men who had active surveillance, surgery or radiotherapy.

‘If they do need treatment, there are several options before surgery. Prostate tumours are very sensitive to testosterone, so we give men powerful hormone-blocking drugs which slow down cancer growth.

‘High-Intensity Focused Ultrasound [HIFU] – where a targeted blast of ultrasound is fired at the cancerous part of the prostate – destroys the tumour by heating it but leaves the rest of the prostate intact. But it's only offered on the NHS in clinical trials, and more research is needed before it can be more widely used.

‘Radiotherapy and chemotherapy also remain important treatment options – but robotic surgery may mean less so in the future.’

Nicholas James is Professor of Clinical Oncology at the Institute of Cancer and Genomic Sciences at the University of Birmingham

Nicholas James is Professor of Clinical Oncology at the Institute of Cancer and Genomic Sciences at the University of Birmingham, and chief investigator of the huge Cancer Research UK-funded STAMPEDE trial into treating aggressive prostate cancer. He says:

‘Prostate cancer is often in the news with stories of new drug developments, treatments, and tests. However, until a therapy is approved for use in the NHS, often the only way to access it is via a clinical trial.

‘I recommend men get themselves on to one if they can, and there are many being run by the NHS right now.

‘In a trial, all treatment must be done to impeccable standards to ensure the quality of the data.

‘This means that even patients who aren’t receiving the “new” drug or whatever is on trial still get a gold-standard level of quality when it comes to treatment.

‘If you are told there is a trial that isn’t suitable for you at the moment, then fine, but if your hospital simply doesn’t run trials, then I would try to look elsewhere for treatment. It is a badge of quality if a hospital is actively engaged in clinical trials.

‘One of the biggest recent treatment breakthroughs was discovered in the Cancer Research UK-funded STAMPEDE trial that I led.

‘There is also growing evidence from another British trial that doing an MRI of the prostate might spare some men the ordeal of a biopsy.

‘The scans also enable us to keep monitoring the patient more safely without them having to have a needle inserted into the prostate.

‘This means surveillance becomes safer, and more men will be able to avoid radiotherapy and surgery – in some cases totally, others for as long as possible.’

Dr Iain Frame is research director for the charity Prostate Cancer UK

Dr Iain Frame, research director for the charity Prostate Cancer UK, describes it's ambitious’ ten-year plan to halve mortality and bolster survival through better diagnosis and new treatments. He says:

‘Our main goal is to improve diagnoses, which will cut death rates by picking up cancers at an earlier stage. At the moment we are not very good at differentiating very aggressive tumours from the slow-growing ones that may never cause a problem.

‘So we are funding research looking at ways to tell them apart – in cancer blood tests that have been dubbed liquid biopsies.

‘Most middle-aged men will be familiar with prostate specific antigen or PSA testing. The newer tests being researched look for genetic material and other compounds in the blood that are produced by tumours, and can tell us about the cancer without us actually having to take solid samples.

‘Last year, we drew up a ten-year plan which has a key objective of halving halve the number of deaths to about 7,000 a year by 2026, and better diagnosis will help make this a reality. We think it is ambitious but achievable.’

Rock drummer Kenney Jones has played in The Faces and The Who 

Rock drummer Kenney Jones, 68, of iconic bands The Faces and The Who, was diagnosed in 2013. The father- of six, who lives in Surrey with wife Jayne, 59, is now cancer-free. He says:

‘I am passionate about talking about prostate cancer because I want men to catch it early, giving them a better chance of survival.

‘I was incredibly lucky to have been caught at the “late” end of early. The disease was still contained inside the prostate.

‘But looking back, I’d had symptoms for years. I blamed getting up two or three times a night on having a few glasses of wine in the evening. I also ignored the fact that my urine flow had slowed down.

‘I was offered a PSA test, a blood test that can detect problems with the prostate, while at my GP surgery for something else. I’d never heard of this test, but it saved my life. Just over a week later I was diagnosed with prostate cancer and discussing treatment options.

‘My biggest worry was whether the cancer had spread. Thankfully, it hadn’t – and I was offered brachytherapy, a type of radiotherapy.

‘This involved having 80 tiny titanium pellets inserted into my prostate to kill the tumour. They blast away at it for a few months and once they’ve done their job, they become inert and remain inside.

‘There were side effects – the radioactivity causes the prostate, bladder and the whole area to become inflamed. I couldn’t pee. It all calmed down after a few months and it worked. I am cancer-free and everything down there works fine.

‘All men need to talk about prostate cancer. It’s a killer – I lost my friend Alvin Stardust to it because he was diagnosed so late.

‘I have also warned my four sons to be vigilant – there were many men younger than me in hospital when I was there. This disease doesn’t discriminate.’

Don't fear THAT check...it won't hurt! 

By Dr Ellie Cannon  

Q) Does a test still involve THAT rather intimate examination?

A) A digital rectal examination is the normal way for a GP or specialist to examine a prostate. The gland is located in the pelvis, below the bladder, and can be examined by placing a finger into the rectum. It’s really not painful, and we do it all the time so you shouldn’t be embarrassed. The doctor can feel whether the prostate feels hard and irregular, which may be a sign of cancer. Urinary tract symptoms can also signal many far more common benign conditions, so an examination is an important way to distinguish between these.

Q) Is there anything I can do to reduce my risk?

A) Unlike other cancers, there are no ‘modifiable’ risk factors for prostate cancer – ones that you can improve yourself through lifestyle changes such as diet. It’s why screening tests and awareness is so important.

Q) If it’s not prostate cancer, what’s causing my symptoms?

A) You are far more likely to have a benign prostate condition than prostate cancer. Lower urinary tract symptoms such as waking at night to pass water, difficulties with flow and the increased need to go are common in men. These can be the signs of cancer but are also symptoms of benign prostate enlargement – a noncancerous condition treated with medication.

Q) Who needs to worry about prostate cancer?

A) A quarter of all new cancers in men are prostate, making it the most common male cancer – so really all men need to know about it. The average age of diagnosis is 72 and it is considered uncommon under the age of 50. Men from black Caribbean or African ancestry are at highest risk – and they are also more likely to have a more aggressive cancer. Your risk is increased by 2.5 times if your father had it.

Daily Mail publication August 2017