FOR OLDER BLACK MEN, A LIFESAVING PUSH FOR MORE PROSTATE CANCER TESTS

By Justin Wm. Moyer / The Washington Post

Posted Feb 3, 2019 at 10:35 AM Updated Feb 3, 2019 at 10:35 AM

WASHINGTON — African-American men are more likely than white men to develop and die of prostate cancer, and there is a debate about when they should be tested.

For Navin Shah and Vladimir Ioffe, a urologist and a radiation oncologist, respectively, in Prince George’s County, conversations between patients and doctors might not be enough to prevent illness. Sixty percent of their patients are African-American, and they recommend that every black man older than 50 be screened, while the federal government recommends only that the prostate test known as PSA screening be discussed with patients.

“I think we are not doing justice to African Americans if we do not screen them,” Shah said. “It is a very sad story.”

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Shah and Ioffe have data to support PSA screening in a recently published paper for Urology Times. Looking at tissue from nearly 2,900 biopsies, they found that after the U.S. Preventive Services Task Force — the federal agency that weighs in on the need for the tests — said routine screening was unnecessary in 2012, fewer biopsies were performed. But more of those biopsies revealed cancer, suggesting that some cases are being diagnosed later than they could have been.

“Despite a reduction in the total number of prostate biopsies by 30 percent, there was a 100 percent increase in the total number of positive prostate biopsies,” the study says — because, as Ioffe put it, when “men are not being screened, their cancer is progressing.”

“The main point of this whole thing is trying to advocate for high-risk men,” Ioffe said. “They need to be screened. Primary-care doctors shouldn’t be confused by the current recommendations.”

Discussing the need for PSA tests can set physicians against epidemiologists — or “number-crunchers,” as Ioffe called them. On one hand, prostate cancer doesn’t always kill. Testing every man could lead to a lot of unnecessary treatment — including invasive steps such as prostatectomy that can lead to side effects such as incontinence or erectile dysfunction.

According to this interpretation, Shah and Ioffe’s finding that fewer biopsies are being conducted is a good sign, and a higher proportion of biopsies showing cancer means that healthy men aren’t getting unnecessary tests.

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According to the National Institutes of Health, African-American men have a 15 percent chance of getting prostate cancer compared with white men’s 10 percent chance. Black men’s chance of dying is also higher — 4 percent among black men compared with 2 percent among white men.

Last month, researchers at the University of California-San Francisco studying 10,000 African-American prostate-cancer patients found that even those considered low-risk were twice as likely to die as patients in other demographic groups. The median age of black patients was also younger: 62 compared with 65.

William Powell, 63, was a few years into his retirement from the Social Security Administration when he was diagnosed with prostate cancer in 2016.

“I almost had a mental breakdown,” he said. “It was scary. Really, really scary.”

Powell, one of Ioffe’s patients, called his diagnosis and subsequent radiation treatment “an education.” One in four black men like him gets prostate cancer, he learned; many “don’t seek medical attention like they should.”

After his radiation treatment wrapped up last year, his count of prostate specific antigens, an indicator of cancer, is back to normal. Now, he is studying to become a minister and wants to use the pulpit to bring discussions about prostate cancer into the light. The disease is “kind of like a secret” in the black community, he said.

“People need to take this very seriously,” he said. “They really do. It will kill you.”

The U.S. Preventive Services Task Force guidelines, published in the Journal of the American Medical Association in May, say studying prostate cancer among black men should be a “national priority,” but the group was “not able to make a separate, specific recommendation on PSA-based screening.”

“Although it is possible that screening may offer greater benefits for African-American men compared with the general population, currently no direct evidence demonstrates whether this is true,” the guidelines said.

Alex Krist, the task force’s vice chair, said doctors don’t yet know which men with high PSA levels are truly at risk of dying of prostate cancer. If all black men are screened, there will be false positives and overtreatment, and black men — already underrepresented in data that the recommendations are based on — will suffer the consequences.

“We need to be thinking about both the benefits and the harms,” he said. “Maybe it’s not right to screen all African Americans.”″

Ioffe called the guidelines “ambivalent and lukewarm.”

“It means that as far as the task force is concerned, you can either screen or not,” he said. “In contrast to this, we are saying that screening should be clearly recommended and endorsed for high-risk men.”

Daniel J. George, an oncologist at Duke University who reviewed Shah and Ioffe’s paper, said worries about overtreatment are understandable. But he said the paper, while preliminary four years after the task force’s policy change, showed that such concerns were “not a reason not to screen.”

“We may be diagnosing patients later in their disease course,” he said. “That’s the concern I would have with a less-aggressive cancer-screening policy.”

Shah, meanwhile, said the task force’s recommendations weren’t enough. Everybody has a right to know their diagnosis, he said.

“Black people are suffering,” he said. “That’s a fact.”

https://www.dispatch.com/news/20190203/for-older-black-men-lifesaving-push-for-more-prostate-cancer-tests

HOW DOES PROSTATE CANCER AFFECT SEX?

Thursday 13 December 2018 

Reviewed by Daniel Murrell, MD 

People who are having or have had treatment for prostate cancer sometimes have problems with sex. These include a loss of interest in sex, inability to get an erection, and fertility issues.

Prostate cancer, or cancer of the prostate gland, is a disease in which cells in the prostate tissue divide uncontrollably, forming a lump, or tumor. When the tumor grows large enough, it can block the urethra, which is the tube that carries urine from the bladder to leave the body.

In rare cases, prostate cancer may cause erection difficulties, but it does not usually affect sexual function.

However, the overall experience of cancer, including its effects on the reproductive system and its treatment, which may include radiation therapy, surgery, or hormone therapy, can cause problems.

Prostate cancer is the most common non-skin cancer in men in the United States. It affects around 13 in every 100 American men, according to the Centers for Disease Control and Prevention (CDC).

In this article, we explain how prostate cancer can affect sex and provide some tips on how to maintain a healthy sex life during this time.

Psychological factors

The psychological effect of have prostate cancer

The psychological effect of a prostate cancer diagnosis can add to stress about sexual performance.

It is not unusual to feel anxious and depressed following a cancer diagnosis and during treatment. Anxiety can also lead to relationship stress.

Prostate cancer causes several physical changes that can affect a person’s sexual confidence. These may include:

  • bowel problems and urine leakage
  • difficulty getting an erection
  • reduced semen production
  • reduced fertility

These issues can affect sexual desire and performance.

If the cancer is slow-growing and in the early stages, a doctor may recommend monitoring the disease instead of active treatment. This option is known as watchful waiting.

Monitoring does not have side effects that cause sex problems, although anxiety may persist, and the person may still have less interest in sex as a result. Counseling may help them overcome this.

Some might worry that they have a sexually transmitted infection (STI), but prostate cancer is not an STI, and a person cannot pass it to another person through sex or by any other means.

Effects of surgery

Sometimes, surgery is necessary to remove cancerous tissue or the entire prostate gland.

Surgery carries the risk of erectile dysfunction.

Nerves that help control an erection run close to the prostate gland. During surgery, the surgeon will try to protect the nerves from damage while treating the nearby prostate gland.

Nerve-sparing prostatectomy and a biopsy are two options that can help reduce the risk.

Nerve-sparing prostatectomy aims to preserve the nerves that control erections. However, there is the risk that the procedure will not eliminate cancer and that some of the tumor may remain.

Nerve-sparing surgery is not always possible. Whether or not it is a viable treatment option depends on the location and severity of prostate cancer.

A biopsy can help a doctor determine if cancer is present on only one side of the prostate. If this is the case, surgery may spare the nerves on the other side. Having a biopsy for prostate cancer does not appear to increase the risk of erectile dysfunction, according to 2012 research.

Cryotherapy is a less invasive procedure in which doctors use probes to freeze prostate cancer cells. However, there is also a risk of nerve damage with this type of treatment.

Radiation therapy

Radiation therapy kills cancer cells, but it can also affect the surrounding healthy tissue and possibly the rest of the body too.

Radiation therapy for the prostate can result in some loss of prostate function.

A more focused type of radiation therapy called brachytherapy may have a lower risk. This treatment involves implanting radioactive seeds into the prostate, and it is less likely to affect other parts of the body.

Hormonal therapy

Androgens, such as testosterone, are hormones that are necessary for male reproductive and sexual function, but they also encourage the growth of cancer cells in a person with prostate cancer.

One way of treating prostate cancer is to block or reduce the production and use of these hormones. It might be possible to do this with the use of various types of drug or by surgically removing one or both testicles.

However, hormonal therapy can also have some side effects, including the risk of erection problems, loss of libido, and reduced fertility.

Androgen deprivation therapy (ADT) is a hormone treatment for prostate cancer, but there is a high risk of sexual dysfunction afterward. One expert, writing for the 2015 American Society of Clinical Oncology meeting, noted that after 3–4 months of use, irreversible damage may occur to the erectile tissue of the penis.

However, some men continue to be sexually active while using ADT. One option is to use the treatment intermittently. However, it can still take up to a year for testosterone to return to normal levels.

Fertility problems

Different cancer treatments, including medications, chemotherapy, radiation therapy, and hormone therapy, can affect fertility.

Sperm production may fall or stop with radiation treatment. It usually comes back again afterward, although the individual may still produce a smaller quantity of sperm.

Even with a smaller amount of sperm, the person may still be fertile.

For those who wish to have children in the future, one option is to store sperm in a sperm bank before starting prostate treatment.

If the treatment results in infertility and the individual wishes to have children, doctors can use stored sperm for artificial insemination or in vitro fertilization (IVF).

Tips for maintaining a healthy sex life

If loss of sexual function occurs after prostate cancer treatment, several options can help a person find pleasure in sex again or return to normal sexual function.

Researchers and counselors offer advice to those who wish to pursue an active sex life during and after prostate cancer.

Here are some of their tips.

  • Manage expectations
  • Experiment with nonsexual intimacy.
  • Experimenting with nonsexual intimacy is one way to reduce anxiety over sexual performance during treatment for prostate cancer.

One choice to make is whether to pursue an active sex life or if the individual and their partner are happy to pursue new forms of intimacy.

This could involve experimenting with:

  • massage
  • new ways of touching
  • vibrators and other aids
  • the use of videos

Those in a relationship may find that their partner is happy to enjoy nonsexual intimacy.

A counselor can offer advice on alternative options. It is important to talk to a partner about what is happening and to discuss the alternatives. Good communication can lead to mutual trust and understanding, and this can help people to overcome fears and concerns in both partners.

Make time

Set aside time for physical stimulation. It may take extra physical and mental stimulation to get and sustain an erection.

Penile rehabilitation

A number of treatments can help a person achieve an erection, including:

  • oral drugs, such as avanafil (Spedra), sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra)
  • cream to apply to the penis, such as alprostadil (Vitaros)
  • other drugs that come in injection or pellet form
  • vacuum pumps that can draw blood into the penis before sex
  • an inflatable implant may be an option if medications or other treatments are not effective

Urine leakage

Placing a tension ring at the base of the penis may help reduce the risk of leakage.

Dry orgasm

Treatment for prostate cancer might mean that the person can have an erection but is not able to produce semen. As a result, they may experience a dry orgasm. Sex counselors generally advise that this may not matter very much. Some people learn to enjoy a dry orgasm.

For gay and bisexual men

A partner who is usually insertive, or top, during sex may want to consider changing to receive anal penetration, as sex may be difficult without a full erection.

In the case of a prostatectomy, a partner who usually receives penetration may find that sex is less pleasurable, as the prostate gland usually contributes to the sensation.

For trans women

Trans women who doctors assigned a male gender at birth will still have a prostate gland. They should have regular checks to ensure that the prostate remains healthy.

For single people

A person who is not in an established relationship may be uncomfortable with the changes in their sexual function at this time. It may be worth them waiting until they feel comfortable with their new sexuality before starting a new relationship.

Give it time

A loss of interest in sex may occur due to fatigue and other problems relating to prostate cancer and treatment. This disinterest can improve or disappear over time.

Talk

Open communication with a partner makes it easier to agree on expectations and share concerns. In some cases, a lower sex drive will not bother the partner. Others may enjoy finding new ways to be intimate.

Keep healthy

Keeping healthy through exercise may increase the chances of returning to an active sex life.

Getting enough exercise may help boost a person’s sex life. Studies show that people with prostate cancer who exercise are more likely to return to an active sex life.

However, there is no evidence that exercise reduces erectile dysfunction.

The number of people whom erectile dysfunction persistently affects after prostate cancer surgery varies widely.

Factors influencing the likelihood of issues include age and general health before the operation.

Does sex affect the risk of prostate cancer?

In 2016, a study that appeared in European Urology looked at whether frequent ejaculation protects against prostate cancer.

The investigation involved almost 32,000 men and looked to build on previous research, which had found that more regular ejaculation seemed to lower prostate cancer risk.

This new research also concluded that ejaculating more often lowered the chances of prostate cancer.

However, the authors called for further research because other factors, aside from ejaculation, could account for the results. They could not confirm that ejaculation protects against prostate cancer.

One theory, which is known as prostate stagnation, suggests that ejaculating less often allows potentially cancer-causing secretions to build up.

IMMUNO-ONCOLOGY SUFFERED A SETBACK IN 2018. What’s Next? Checkpoint inhibitors remain top sellers, but it wasn’t all rosy news this year.

Shannon Jones

Todd Campbell

Dec 18, 2018 

PD-1 checkpoint inhibitors are among the most successful and widely used cancer drugs in the world, but they’re not perfect medicines. Many people fail to respond to them or relapse after taking them, so studies have begun that team next-generation drugs with them to try to improve results. Unfortunately, optimism for combination approaches was dealt a big blow in 2018 when Incyte‘s ( HYPERLINK “https://www.fool.com/quote/nasdaq/incyte/incy” NASDAQ:INCY) trial of its IDO inhibitor alongside PD-1s failed.

In this clip from The Motley Fool’s  HYPERLINK “https://www.fool.com/podcasts/industry-focus/” Industry Focus: Healthcare, analyst Shannon Jones and Todd Campbell review the performance of PD-1s in 2018 and offer up thoughts on their future.

A full transcript follows the video.

This video was recorded on Dec. 12, 2018.

Shannon Jones: We’re going to talk about the leaders of the immuno-oncology front, specifically leaders who are producing a kind of drug called checkpoint inhibitors. These PD-1s continue to dominate, but as you describe it, Todd, there have been cracks in the armor. The next key is combination therapies. How do you get them working together?

Todd Campbell: Right. Immuno-oncology has been the big story of this decade. The launch of PD-1 drugs, Bristol Myers‘ Opdivo, Merck‘s Keytruda, they’ve revolutionized how we attack certain cancers like melanoma and lung cancer. But, now that they’re being so widely used, we are starting to see that people do relapse after receiving these therapies, some people don’t respond to them, maybe there are more side effects than we initially thought to their use. So, you’ve got a bunch of different companies who’ve gone out and said, “How can we improve upon these PD-1 drugs?” So, they’re running combination trial therapies, where they’re taking their drugs in development and using them alongside Opdivo and Keytruda and some of these others in that same class of drugs.

The hope had been that that would be a slam dunk. You take these drugs, they have mechanism of action X, you match them up with the anti-PD-1s that have mechanism of action Y, and sure enough, it all works perfectly. More people ended up responding for longer periods.

Unfortunately, some of that enthusiasm got tempered earlier this year. That was because Incyte had been doing a combination study matching up its IDO inhibitor with a PD-1 inhibitor, and unfortunately, when the trial results came in, that combo failed to outperform PD-1 use alone. That really threw a big monkey wrench in the concept of, will combination therapies actually improve upon the therapy or not?

Jones: Todd, I would dare say that that Phase III trial failure with Incyte’s drug was probably the biggest pipeline failure, just because there was so much hype leading into that Phase III readout. Everyone said, “OK, these checkpoint inhibitors, we know that they work in some patients, and for those that do, you see some impressive results. But if we can start to combine with an IDO inhibitor… ” There are other combinations that have been tested and haven’t really proven them out. But, there was so much hype leading into this Phase III study. I think this was probably the biggest heartbreak for many of us that love this space. Yeah, a lot of chip in the armor when it comes to PD-1s. Definitely something to keep an eye on. Some of the hype related to these combination therapies has been tempered moving into 2018, and it’ll probably continue to be so for 2019, as well.

Campbell: I mean, there are 1,500 clinical trials still ongoing for combination therapies with PD-1s. 1,500. Which is crazy. It’s up from 216 in 2016. PD-1s are going to remain the mainstay. If you look at Opdivo and Keytruda, the two top-selling ones, if you combine their sales together, they did almost $4 billion in sales last quarter. If you look at estimates, PD-1s could be $30 billion drugs by 2025. I think PD-1s will remain a mainstay, but for investors heading into 2019, reign in a little bit of your optimism for any trial readouts that are combination-oriented.

https://www.fool.com/investing/2018/12/18/immuno-oncology-suffered-a-setback-in-2018-whats-n.aspx

STUDY FINDS 3 in 4 AMERICANS UNAWARE EARLY PROSTATE CANCER DOESN’T HAVE NOTICEABLE SYMPTOMS

October 3, 2018

Ines Martins, PhD 

There is still a significant lack of understanding about prostate cancer and its symptoms among people in the U.S., even though more than three million American men are diagnosed with the disease every year, an awareness report from the Prostate Cancer Foundation (PCF) shows.

According to the report, “PCF 3P Report 2018: Public Perception of Prostate Cancer,” nearly three in four Americans (69%) are unaware that early-stage prostate cancer does not present noticeable symptoms, and fewer than one-third (28%) know that men could receive screening with a simple blood test.

“The PCF 3P Report illustrates the profound need for more prostate cancer health education and awareness,” Jonathan W. Simons, MD, president and CEO of the Prostate Cancer Foundation, said in a press release.

“Men need to understand that if they are in an at-risk group or over 50, they should be discussing prostate cancer screening options with their primary care physician as one in nine of them will be diagnosed. This is critical information that will help save men’s lives,” Simons said.

To understand how the public perceives prostate cancer, the PCF surveyed more than 2,000 adult men and women across the U.S. Participants were ages 18 and older, including millennials — ages 21 to 37 — gen-Xers, ages 38 to 53 — and baby boomers – ages 54 to 73.

Most men with early prostate cancer don’t experience any symptoms of the disease. Unless patients undergo frequent screening, the disease may go undetectable for many years. When it is diagnosed at later stages, the cancer is more aggressive and difficult to treat.

However, only 31% of Americans correctly said there are no noticeable symptoms for early-stage prostate cancer, and even though that is true, 42% said that symptoms are one of the top three reasons to get screened, followed by risk factors and a recommendation.

Current screening guidelines recommend that men should begin regular screenings when they turn 50 or if they have a high risk for the disease — those with a family history of the prostate cancer and men of African-American descent.

Screening is done through a test that measures the levels of prostate-specific antigen (PSA) in the blood, and should be based on a shared clinical decision between a patient and their healthcare provider.

But the report showed a significant lack of awareness about prostate cancer screening, with only 42% of men having discussed screening with their doctor, and only 28% who know that screening starts with a blood test.

Of note, 68% of men said they would be screened if they could receive a blood test instead of a physical examination.

Because most men think screening involves a physical examination like digital rectal exams, they point to embarrassment, being uncomfortable, and fear of diagnosis as the top three reasons for not getting screened.

Another troubling observation was that minorities, including African-American men, were less likely to have been screened. African-Americans are 74% more likely to develop prostate cancer than men of any other ethnicity, and are 2.4 times more likely to die from the disease than Caucasians.

Also, only 40% of participants was aware of a genetic link between prostate and breast cancer, and only 12% believe that BRCA — the most important gene in breast cancer — is also related to prostate cancer.

Millennials were found to be the most underinformed group, with one in five thinking that women could get prostate cancer.

STUDY SHOWS PROMISE FOR FUTURE PROSTATE CANCER TREATMENT

James Ives, MPsych

Feb 4 2019

A new ‘seek-and-destroy’ gene therapeutic system could have the potential to treat prostate cancer in the future, after it halted the majority of tumors in laboratory models at the University of Strathclyde and the Beatson Institute.

The system was used against two types of prostate tumor, causing 70% of one type and 50% of the other to vanish over a period of one month.These results are a promising start for the system as it continues its progress towards the clinic.

Prostate cancer is the fourth most widespread cancer in the world, the second most common in men and the most commonplace in Europe and North America. It causes the death of 300,000 patients worldwide each year and its incidence has continually increased over the last two decades.

The research has been published in the journal Drug Delivery. It involved researchers from Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde’s Department of Pure and Applied Chemistry and the Cancer Research UK Beatson Institute in Glasgow.

Dr Christine Dufès, a Senior Lecturer in Strathclyde Institute of Pharmacy and Biomedical Sciences, led the research. She said: “Although some treatments, including chemotherapy and radiotherapy, can be effective against localized tumors, there is still no effective treatment for patients whose cancer recurs or spreads. This means that new therapeutic approaches are urgently needed for these patients.

“Gene therapy could be highly promising for the treatment of prostate cancer, but its use is currently limited by the lack of delivery systems which can selectively deliver the therapeutic genes to the tumors without adverse side effects for healthy tissues.

“To address this, we develop a new ‘seek-and-destroy’ nanomedicine linked to an iron-carrying protein called lactoferrin, whose receptors are found in large amounts in many cancers. The results show that it is highly promising for the treatment of prostate cancer by gene therapy.”

The research was carried out on two prostate cancer cell lines, PC-3 and DU145, in laboratory settings.

The intravenous administration of the nanomedicine treatment resulted in the complete disappearance of 70% of the PC-3 tumors and half of the DU145 prostate tumors over one month.

The research was funded by Worldwide Cancer Research – formerly known as AICR.

Dr Matthew Lam, Science Communications Manager at Worldwide Cancer Research said: “We are delighted to see that this research is making the advances that could one day see gene therapy used to treat prostate cancer patients in the clinic. The clever chemistry employed in this study to enable the delivery of the treatment right at the heart of the tumor is a promising step forward.

“Our thanks goes to the brilliant supporters of Worldwide Cancer Research, whose generous donations have made this research possible.”

https://www.news-medical.net/news/20190204/Study-shows-promise-for-future-prostate-cancer-treatment.aspx

Top 10 Immuno-Oncology Stories of 2018

January 2, 2019 

by Patricia Inacio, PhD

No. 10 – “Early Data Supports Phase 3 Trial of Pegilodecakin as Possible Treatment for Advanced Pancreatic Cancer”

The immunotherapy candidate pegilodecakin (AM0010), in combination with FOLFOX chemotherapy, was found safe for the treatment of advanced pancreatic cancer in the ongoing SEQUOIA Phase 3 trial (NCT02923921). The study is recruiting up to 566 participants whose tumors have progressed after first-line chemotherapy. It hopes to demonstrate that ARMO Biosciences‘s pegilodecakin plus chemo is better than chemo alone at extending patients’ lives. Updated results are expected by 2020, and if positive, may support the treatment’s approval in the U.S.

No. 9 – “‘Switchable’ CAR T-cell Therapy Kills Advanced Pancreatic Cancer Cells in Mice, Study Reports”

Another promising immunotherapy, called “switchable” CAR T-cell immunotherapy, was able to eliminate cancer in mice whose tumors came from cells of people with advanced pancreatic cancer, including cancer cells that had moved to distant organs. Unlike traditional CAR T-cell approaches, where immune cells target a specific region of a particular cancer protein, “switchable” CAR T-cells use adapter molecules (also known as antibody switches) that help them target multiple regions of a single protein, or even another cancer protein, if patients develop resistance. This also makes the treatment extremely safe, as researchers are able to stop the treatment if required.

No. 8 – “Keytruda-Epacadostat Combo Fails Primary Goal in Phase 3 Trial for Melanoma, Companies Announce”

A setback in the search for more effective therapies against melanoma was reported with the cessation of a Phase 3 clinical trial evaluating Keytruda (pembrolizumab) and epacadostat in metastatic melanoma patients. The KEYNOTE-252 (NCT02752074) trial failed to demonstrate that a combination of these two immunotherapies is better than Keytruda alone at stopping cancer progression, and a benefit in overall survival was not expected.

No. 7 – “New Guidelines Aim to Help Doctors Recognize, Manage Side Effects of Immune Checkpoint Inhibitors”

While the therapeutic potential of immune checkpoint inhibitors — a type of immunotherapy that restores the immune system’s ability to attack and destroy cancer cells — is increasingly recognized, the therapy comes with associated risks, such as the increased likelihood of the immune system attacking a patient’s own tissues. In an effort to help clinicians recognize the side effects early and deliver prompt treatment, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) developed a set of guidelines regarding how to assess and manage the side effects associated with immune checkpoint inhibitors.

No. 6 – “Immunotherapy Candidate M7824 Effective in Advanced Lung Cancer Patients, Phase 1 Trial Shows“

M7824, a treatment developed by EMD Serono for patients with advanced non-small cell lung cancer (NSCLC) who failed first-line chemotherapy, shrank tumors in 25% of patients in a Phase 1 trial (NCT02517398). The treatment has a dual mechanism, blocking the immune checkpoint molecule PD-L1 and trapping the immunosuppressive molecule TGF-beta. Aiming to enroll about 587 patients, the trial is recruiting at sites in the U.S., U.K, Canada, Australia, Europe, Korea, Taiwan, and Japan.

No. 5 – “Keytruda Slows Liver Cancer Progression in Phase 2 Trial“

While the Keytruda-ecapadostat combination failed to improve the outcomes of metastatic melanoma patients, the immune checkpoint inhibitor alone showed promising clinical benefit among those with advanced hepatocellular carcinoma — the most common form of liver cancer. The ongoing KEYNOTE-224 Phase 2 trial (NCT02702414) tested Keytruda as a second-line treatment and showed that 16.3% of patients responded to treatment, and 61.5% had their disease stabilized. But only 1% of patients had their cancer eradicated.

No. 4 – “New Dosing Schedule Allows Patients to Receive Opdivo Every Four Weeks“

Earlier last year, a new dosing scheduled of the immune checkpoint inhibitor Opdivo (nivolumab) was approved in the U.S. for several cancers, allowing it to be offered every four weeks. Opdivo was already approved as a 240 mg dose given every two weeks, but a 480 mg dose, given in a four-week schedule, was found comparable in terms of safety and efficacy. The approval also allows both regimens to be given in 30-minute infusions, cutting previous infusion time by half.

No. 3 – “Cancer Cells Can Flood Bloodstream with Protein ‘Warriors’ Against Immune Response, Study Finds“

In addition to suppressing local immune responses by producing the PD-L1 immune checkpoint protein, cancer cells can also dampen systemic anti-tumor immunity through the release into the bloodstream of small vesicles armed with this molecule. While PD-1 inhibition with Keytruda reversed this effect in most patients, those with high blood levels of such vesicles had worse responses, possibly because of overly exhausted T-cells. The findings suggest that vesicle-associated PD-L1 in the blood could be used as a biomarker to identify patients most likely to respond to anti-PD-1/PD-L1 therapies.

No. 2 – “FDA Approves Opdivo for Certain Patients with Advanced Small Cell Lung Cancer“

2018 marked the first approval of an immunotherapy for metastatic small cell lung cancer (SCLC) patients who failed platinum-based chemotherapy and at least one other line of treatment. Bristol-Myers Squibb’s Opdivo became the first new medication for these patients in nearly 20 years after 12% of patients in a Phase 1/2 clinical trial responded to the treatment, regardless of their PD-L1 levels — a biomarker of response to Opdivo. Responses in CheckMate-032 (NCT01928394) lasted a median of 17.9 months, with some reaching up to 42 months. The accelerated approval is now contingent upon verification of clinical benefit in additional trials.

No. 1 – “Keytruda Beats Chemo at Increasing NSCLC Patients’ Survival, Phase 3 Trial Shows“

In a year where immunotherapy revealed such promise in lung cancer patients, our most-read story reported that Keytruda beats chemotherapy when given as a first-line treatment to NSCLC patients whose tumors are positive for the PD-L1 factor. The KEYNOTE-042 Phase 3 trial (NCT02220894) included patients with locally advanced or metastatic NSCLC and found that Keytruda significantly extended their lives compared to standard platinum-based chemotherapy. The treatment is being reviewed by the U.S. Food and Drug Administration and a decision is expected this month.

IDENTIFYING THE RISK FACTORS FOR PROSTATE CANCER AND HOW NEW DEVELOPMENTS MAY HELP

by Daniel Dupuis

There are a number of risk factors of varying severity that can increase or decrease the odds that a man may contract prostate cancer. Recent efforts and initiatives, however, may help provide guidance and resources to help reduce the incidence of prostate cancer and work toward more effective treatment options. There are some substantial developments that may offer very effective treatment options and may even offer solutions that can mitigate the horrific side effects that are inherent to almost all cancer therapies. 

Prostate Cancer Risk Factors

A risk factor is anything that affects your chance of getting a disease such as cancer. Different cancers have different risk factors. Some risk factors, for example a person’s age or family history certainly cannot be changed, while others, such as diet can be modified. 

But having a risk factor, or even several, does not mean that you will get the disease. Many people with one or more risk factors never get cancer, while others who get cancer may have no evident risk factors.

One key observation, however, is that a more rigorous testing regimen should be followed if one has more than a few risk factors.

Age

Prostate cancer is rare in men younger than 40, but the chance of having prostate cancer rises rapidly after age 50. About 6 in 10 cases of prostate cancer are found in men older than 65.

No one can make themselves younger, but the need for more frequent testing increases every year. Additionally, if one is aware that they have elevated risk factors it would be wise to be tested on an annual basis.

New Developments

A new screening tool for prostate cancer has been shown to offer better accuracy than the test currently used by most physicians in the United States. The new test, called the 4Kscore™ test (OPKO Lab), offers various advantages over the more commonly used prostate specific antigen (PSA) blood test.

The new test improves on these common issues with the PSA blood test:

Isn’t specific to cancer; detects a variety of prostate issues

Doesn’t account for a natural tendency for PSA levels to rise with age

The current method for measuring PSA levels has led to a number of false positives in a number of men, which has led them to undergo unnecessary biopsies. The U.S. Preventive Service Task Force gave PSA screening a grade of D in 2012. They said the harm it brings outweighs the benefits.

The new 4Kscore™ test does not replace the current PSA test, but is a follow-up to a positive PSA. It can reduce biopsies, that are uncomfortable and may lead to infection, by 30 to 50%.

Race/Ethnicity

Prostate cancer occurs more often in African-American men and in Caribbean men of African ancestry than in men of other races. African-American men are also more than twice as likely to die of prostate cancer as white men. Prostate cancer occurs less often in Asian-American and Hispanic/Latino men than in non-Hispanic whites. The reasons for these racial and ethnic differences are not clear.

This does not mean that Asian-Americans or Hispanics/Latino or Caucasian men should consider foregoing testing; it simply means that African Americans need to maintain a more rigorous testing regimen.

A New Study for African American Men

There has been a recent launch of an initiative that will try to ascertain why African American men are more likely to get, and die, from prostate cancer. It will be the largest study of its kind. It is backed by the National Cancer Institute and aims to enroll 10,000 study subjects. There is, of course, no cost to the participants; in fact, they will all receive a nominal payment of $50. 

Simply search for “RESPOND study and prostate cancer.” 

Family history

Prostate cancer seems to run in families, which suggests that in some cases there may be an inherited or genetic marker that may be categorized as a risk factor. Having a father or brother with prostate cancer more than doubles a man’s risk of developing this disease. (The risk is higher for men who have a brother with the disease than for those who have a father with it.) The risk is much higher for men with several affected relatives, particularly if their relatives were young when the cancer was found.

This simply means that individuals that fit this profile should have more frequent testing.

Diet

The exact role of diet in prostate cancer is not clear, but several factors have been studied.

Men who eat a lot of red meat or high-fat dairy products appear to have a slightly higher chance of getting prostate cancer. These men also tend to eat fewer fruits and vegetables. Doctors aren’t sure which of these factors is responsible for raising the risk. It may explain the low incidence of cancer in Asian men.

Some studies have suggested that men who consume a lot of calcium (through food or supplements) may have a higher risk of developing prostate cancer. Dairy foods (which are often high in calcium) might also increase risk. 

Research, however, does indicate that some foods may decrease your chance of contracting prostate cancer. 

Tomatoes. Tomatoes are high in lycopene, which could have a protective effect against prostate, lung, and stomach cancers. Multiple studies suggest that high levels of lycopene in the blood are linked with a lower risk of prostate cancer and may even help slow the spread of cancerous cells. Cooked tomatoes have a higher concentration of lycopene than raw.

Fruits. Diets high in fruits and vegetables have been shown to protect against many cancers. Lycopene-containing fruits including guava, papaya, and watermelon are recommended. Some research suggests that pectin — a common fiber found in apples, apricots, plums, and citrus fruits and used as a thickener in many jams and marmalades — may reduce the number of cancerous cells by as much as 40 percent. 

Vegetables. A new study from the University of Colorado finds a high-fiber diet rich in vegetables might be why Asian men develop prostate cancer so infrequently compared to Western men. Additionally, researchers have reported that fiber-rich eating could slow the progression of the disease. Other studies have found broccoli and cauliflower to be especially effective in reducing cancer risk because cruciferous veggies slow the growth of cancer cells in the body. 

Medications in Development

Aneustat Shows Promise as a Non-Toxic Drug for Prostate Cancer

Aneustat is an immunotherapy that is truly groundbreaking. It is taken orally and offers substantial efficacy,yet has a negligible side effect profile and presents no known safety risks. It is a multivalent, multifunctional platform drug. It is identified as a platform drug because it has been subject to studies that pair it with a number of currently utilized medications for prostate cancer. Studies indicate that it can significantly increase efficacy, while redicing side effects, and even more importantly, drug resistance. Combination therapy has become an increasingly popular option and Aneustat has been proven to be effective as both a stand-alone medication and as a component of combination therapy while being paired with numerous cancer drugs.

Aneustat is scheduled to begin a phase 3 study in collaboration with Johns Hopkins that will focus on Aneustat with enzalutimide for post-surgical, radiation recurrent prostate cancer, while another study at the Tisch Cancer Center at Mt. Sinai will examine Aneustat in combination with docataxel for metastatic castration resistant prostate cancer. 

Darolutamide

Darolutamide (developmental code names ODM-201, BAY-1841788) is a nonsteroidal antiandrogen (NSAA) – specifically, a selective antagonist of the androgen receptor (AR) – which is under development by Orion and Bayer HealthCare for the treatment of advanced, castration-resistant prostate cancer. 

It is an oral medication and appears to to neglibly cross the blood-brain barrier. This is beneficial due to the reduced risk of seizures and other central side effects. Another advantage is that it does not seem to increase testosterone levels in mice or humans. 

The results of a recent study will soon be published, and early indications are that it compares favorably with enzalutamide (Xtandi) and apalutamide (Erleada), yet may have a more favorable side effect profile. 

VISION Study

A new global phase 3 clinical research study in men with progressive metastatic castration-resistant prostate cancer (mCRPC), called the VISION study, will evaluate the effectiveness and safety of the investigational drug Lu-PSMA-617, in combination with the best standard of care, versus patients treated with best standard of care alone. This research is being conducted by physicians in approximately 80 institutions throughout the US, Canada, and Europe and will include approximately 750 men who are eligible for the trial.

New Combination Therapy 

Pfizer and Astellas have announced that a recent study has indicated that the addition of enzalutamide to standard androgen deprivation (ADT) has led to improved outcomes in men with metastatic, hormone-sensitive prostate cancer (mHSPC). This is the first time that a “second-line” form of androgen deprivation has been shown to have meaningful efficacy in the treatment of any form of hormone-sensitive (as opposed to castration-resistant) prostate cancer.

NEW DRUGS ON THE HORIZON 2019

by Daniel Dupuis

There are a number of new medications in development that offer help for patients suffering from a number of different diseases.

Cancer research, much like last year, is prominent among both small biotech firms, in addition to large pharmaceutical companies. The main focus is on how they might maintain or increase efficacy, while hoping to mitigate life-altering side effects and/or safety concerns.

Many other sectors have also seen some major breakthroughs, among them ALS, Multiple Systems Atrophy, complicated urinary tract infections and chronic migraines.

This list includes some major developments in oncology drug development, in addition to a new treatment for plaque psoriasis and a promising formulation for Alzheimer’s disease. 

Talazoparib For Breast Cancer

Talazoparib is a new medication from Pfizer that is currently in phase 3 trials that offers some hope for women with advanced stage breast cancer (with the BRCA1 and BRCA2 gene mutation). The BRCA gene mutations are common among aggressive breast and ovarian cancers.

Patients that took part in the study lived longer without their cancer progressing by an average of three months more than women treated with standard chemotherapy. While three months may seem to be an incremental change, it is a substantial period of time relevant to improvements within the cancer sector. There are many drugs that have been approved in the past that have improved life expectancy by periods of time that are measured in days, rather than weeks.

In the current trial, researchers found that the women who were randomly selected to receive talazoparib had a higher response rate to treatment than women who received standard chemotherapy: 63 percent versus 27 percent. 

The drug does, however, have side effects. Among women receiving talazoparib, 55 percent had blood disorders, mostly anemia, compared with 38 percent of those receiving standard chemotherapy. 

In addition, 32 percent of the women receiving talazoparib had other side effects, which is only slightly less than the rate of 38 percent for those in the trial that were on standard chemotherapy.

New Drug from Galera Therapeutics Reduces Effects of Radiation

Within the oncology sector, there are a number of approaches to mitigating the life-altering side effects and safety risks associated with cancer therapies, which includes the many immuno-therapies and combination drugs that are currently under investigation. 

Galera Therapeutics has pursued a novel approach to helping reduce a prominent side effect of radiation therapy. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419 for the reduction of the duration, incidence and severity of mouth lesions induced by radiotherapy for head and neck cancer. 

Results from Galera’s 223-patient, double blind, randomized, placebo-controlled Phase 2b clinical trial demonstrated GC4419’s ability to dramatically reduce the duration of mouth lesions from 19 days to 1.5 days (92 percent), the incidence of lesions through completion of radiation by 34 percent and the severity by 47 percent. It also indicated that GC4419 increased tumor response to radiation therapym while preventing toxicity in normal tissue. Mouth lesions are one of the most commonly cited side effects among people under radiotherapy.

While mouth lesions are its lead indication, GC4419 is also being studied in combination with SBRT for its anti-tumor effect in a Phase 1/2 trial of patients with locally advanced pancreatic cancer.

Aneustat Is a True Breakthrough Medication for Prostate Cancer

Aneustat is an immunotherapy that is truly groundbreaking. It is taken orally and offers substantial efficacy, yet has a negligible side effect profile and presents no known safety risks. It is a multivalent, multifunctional platform drug. It is identified as a platform drug because it has been subject to studies that pair it with a number of currently utilized medications for prostate cancer. Studies indicate that it can significantly increase efficacy, while redicing side effects, and even more importantly, drug resistance. Combination therapy has become an increasingly popular option and Aneustat has been proven to be effective as both a stand-alone medication and as a component of combination therapy while being paired with numerous cancer drugs.

Aneustat is scheduled to begin a phase 3 study in collaboration with Johns Hopkins that will focus on Aneustat with enzalutimide for post-surgical, radiation recurrent prostate cancer, while another study at the Tisch Cancer Center at Mt. Sinai will examine Aneustat in combination with docataxel for metastatic castration resistant prostate cancer. 

New Alzheimer’s Drug Slows Memory Loss in Early Trial Results

The long, discouraging quest for a medication that works to treat Alzheimer’s disease reached a potentially promising milestone. For the first time in a large clinical trial, a drug was able to both reduce the plaques in the brains of patients and slow the progression of dementia.

The drug, currently known as BAN2401, is a result of a cooperative initiative of Eisai, a Japanese company, and Biogen, based in Cambridge, Mass. Eisai is the maker of Aricept, which is one of the few drugs that can help slow early memory decline, but which is effective for only about six to nine months, while Biogen is the maker of another Alzheimer’s treatment, aducanumab, that has shown early promise in a small Phase 1 trial in both reducing amyloid and slowing cognitive decline.

More extensive trials will be needed to know if the new drug is truly effective, but if the results, presented recently at the Alzheimer’s Association International Conference in Chicago, are borne out, the drug may be the first to successfully attack both the brain changes and the symptoms of Alzheimer’s.

Aside from a couple of medications that can slow memory decline for a few months, there is no effective treatment for Alzheimer’s, which affects about 44 million people worldwide, including 5.5 million Americans. It is estimated that those numbers will triple by 2050.

Realistic goals for the current treatment of Alzheimer’s are not focused on cognitive improvement, but instead are merely demonstrating that a drug might slow the progression of the disease. On a battery of cognitive and functional tests measuring memory and skills like planning and reasoning, the performance of the high-dose BAN2401 group declined at a rate that was 30 percent slower than the rate of decline in the placebo group.

Risankizumab Offers New Hope for People with Psoriasis

There is no shortage of drugs used to treat autoimmune conditions. Indeed, two drugs in this class, Humira® and Enbrel®, are currently first and second in overall spending for all medications in the U.S.

Risankizumab is currently being evaluated by the FDA for the treatment of plaque psoriasis, an autoimmune disease. Risankizumab has demonstrated greater efficacy in reducing psoriasis symptoms in clinical trials vs. the currently available medications.

Study participant’s lesions improved by 90%, while also offering complete clearance among some of the subjects. 82% of patients had a 90% clearance rate, while 49% reported 100% clearance.

Looking forward, risankizumab is also being studied for other autoimmune conditions, such as Crohn’s disease and ulcerative colitis.

A NEW STUDY FOCUSES ON A BREAKTHROUGH IMMUNO-ONCOLOGY DRUG COMBINATION

by Daniel Dupuis

A number of immuno-therapies formulations for the treatment of cancer have been developed in a quest to extend patient survival rates, while also mitigating life-altering side effects and safety concerns. While no current or proposed drug can make this claim, a recently published study that was featured in the British Journal of Cancer provides data that indicates that the initial promise of immunotherapies has been realized. 

Previous studies have demonstrated that Aneustat™ is not only effective as a stand-alone oncology therapy, but can also best be described as a “foundational” drug for combination cancer therapy. Aneustat™ has been paired in studies with a wide array of oncology medications that have been recognized as standard-of-care therapies and the results have consistently demonstrated that the addition of Aneustat™ offers dramatically improved outcomes and reduced drug resistance, thereby, expanding the therapeutic window.

A recently published study, Treatment with docetaxel in combination with Aneustat leads to potent inhibition of metastasis in a patient-derived xenograft model of advanced prostate cancer,Qu, et al.,1 11/doi:10,1038/bjc.2017,474, appears in the British Journal of Oncology and assesses the therapeutic advantages of combining Aneustat™ with docetaxel for advanced stage prostate cancer. 

The study utilizes the patient-derived cancer tissue xenograft mode, which is the preferred methodology of the National Cancer Institute. 

Docetaxel + Aneustat™ markedly inhibited C4-2 cell migration and LTL-313H lung micro-metastasis/kidney invasion. This drug combination downregulated expression of cancer driver genes such as FOzM1 (and FOXM1-target genes). 

Aneustat™ has been clinically proven to boost the immune system to kill cancer cells through aptosis, in addition to regulating the metabolic system (tumor microenvironment) to stop proliferation while therapeutically affecting 1750 cancer related genes.

These results confirm earlier results by the same researcher that demonstrated that Aneustat™ alone was more effective than docetaxel for tumor shrinkage and inhibition of cancer cell growth. The combination of docetaxel and Aneustat™, however, was superior to either drug as a single agent.

The significance of this study is considerable in that it not only demonstrates improved efficacy, but offers a combination therapy that is also safer, while reducing the debilitating side effects common to oncology medications. 

This study is a part of a series of studies that demonstrate that Anuestat™ has improved the overall efficacy of a wide array of medications known to be accepted as first-line therapies for prostate cancer, including enzalutamide, bicalutamide, abiraterone and apalutamide. Of even greater significance, however, is that Aneustat™ has been proven to be effective against tumors that have already been deemed to be resistant to these medications. This indicates that the various combination therapies will be viable for a longer period of time than any single agent.

More than 1 in 10 men will be diagnosed with prostate cancer at some point in their lives, and 1 in 41 will die of the disease; making it the second leading cause of cancer death in American men, according to the American Cancer Society. Additionally, a recent report states that while the incidence of most cancers is in decline, late stage prostate cancer has risen since 2015. 

Aneustat™ in combination with docetaxel is a subject of continuing trials and it may be a potential candidate for Fast Track approval by the FDA. This conclusion is based on the FDA giving added weight to formulations that can effectively alter key biomarkers (a key component of the approval of Keytruda for new indications).  Aneustat™ is non-toxic, with a negligible side effect profile (minor nausea) and no apparent safety risks. As a multi-target immuno-therapy it can prevent, rather than be a contributing factor, to the onset of co-morbidities.

This recent study confirms that Aneustat™ is a foundational drug that can be combined with numerous standard of care medications that can improve overall efficacy, while reducing side effects and safety concerns and mitigate the inherent drug resistance associated with current oncology medications.

Aneustat™ was developed by Omnitura that is scheduled for an IPO in 2019.