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Thursday, July 4, 2019

Risk of dementia rises with prostate cancer hormone-blocking therapy

Prostate cancer patients who received hormone-lowering therapy were at higher risk of developing dementia and Alzheimer’s disease later on than men who didn’t get this treatment, a large U.S. study finds.
Researchers who followed nearly 155,000 men with prostate cancer found that overall, those given so-called androgen-deprivation therapy were at a 20% higher risk of being diagnosed with dementia and at 14% higher risk of an Alzheimer’s diagnosis in the next 10 years. The risk continued to rise with increasing doses of androgen-deprivation drugs.
The results suggest that in cases where the prostate cancer is localized, androgen-deprivation therapy may not be a good choice, said the study’s lead author, Ravishankar Jayadevappa, a research associate professor in the department of medicine at the University of Pennsylvania’s Perelman School of Medicine in Philadelphia.
Even in patients at high risk, there needs to be a discussion about the elevated risk of dementia and Alzheimer’s disease during long-term follow-up, Jayadevappa said.
The most common androgens found in the male body are testosterone and dihydrotestosterone (DHT). According to the American Cancer Society, doctors may choose to prescribe androgen-lowering therapy because it can result in slower growth – or even shrinkage – of prostate tumors.
Studies on the cognitive impacts of androgen-deprivation therapy have had mixed results, Jayadevappa and his colleagues note in JAMA Network Open.
In an attempt to arrive at a more definitive result, the researchers pored over data from a National Cancer Institute database that collects information on cancer incidence, treatment and mortality from 18 sites, encompassing 28% of the U.S. population, and links it with Medicare data.

The researchers focused on men who were aged 66 and older and diagnosed with localized or advanced prostate cancer between 1996 and 2003. The men were followed until 2013, so all had at least 10 years of follow-up. Out of 154,089 men in the study, 62,330 received androgen deprivation therapy within two years of their diagnosis.
The study team found that 13.1% of men who got hormone-lowering therapy and 9.4% of those who didn’t were diagnosed with Alzheimer’s disease during the follow-up period. Similarly, 21.6% of those who got androgen deprivation and 15.8% of those who didn’t were diagnosed with other forms of dementia.
Greater exposure was also tied to greater risk: Men who got one to four doses of androgen deprivation therapy had a 19% higher risk for Alzheimer’s or dementia, while those who had eight or more doses had a 24% higher risk of developing Alzheimer’s and a 21% higher risk of developing dementia.
Dr. Catherine Marshall welcomed the new study. “We know there are many negative side effects of ADT (androgen-deprivation therapy), including many long-term side effects,” said Marshall, an assistant professor at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland. “While this question of a link between ADT and Alzheimer’s disease and dementia has been explored before, this is quite possibly the largest study to address this issue. Because of that, it adds important information about the risk of Alzheimer’s disease and dementia for men being treated.”
Studies like this one are very important because “our clinical trials are not always as long as this study and may not capture the long-term consequences of these treatments,” Marshall said in an email. “Delaying the start of ADT until the disease is more advanced may be a reasonable option for many men and would help to ultimately shorten the total duration of treatment.”
The new study is very interesting and “it may lead to prevention trials for Alzheimer’s disease,” said Dr. Oscar Lopez, director of the University of Pittsburgh Alzheimer Disease Research Center in Pennsylvania.

But there are some caveats, Lopez said in an email. “The use of a Medicare database to determine the presence of Alzheimer’s disease is a limitation since the mild cases are usually not captured by these types of registries,” he said.
SOURCE: bit.ly/2XpGjIp JAMA Network Open, online July 3, 2019.
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Sports playbook helps doctors predict cancer patient outcomes

In this season of global soccer competitions and hotly contested political primaries, bookies and pundits are scouring every evolving scrap of information and sifting through mountains of data in an effort to predict the outcome of the next game or election. These predictions can change on a dime, however, based on a player’s poor pass or a candidate’s stellar debate performance.
Statisticians refer to the technique of incorporating a variety of continuously generated information—who is on the bench, who was injured in the first half of the match, who polled well in Iowa yesterday—as calculating in-game win probability, and it’s been used for decades to predict the outcome of ongoing sports matches or elections.
Now researchers at the Stanford University School of Medicine have taken a page from this playbook to generate more accurate prognoses for . They’ve done so by designing a computer algorithm that can integrate many different types of predictive data—including a tumor’s response to treatment and the amount of cancer DNA circulating in a patient’s blood during therapy—to generate a single, dynamic risk assessment at any point in time during a patient’s course of treatment. Such an advance could be deeply meaningful for patients and their doctors.
“When we care for our patients, we are walking on eggshells for a profound period of time while we try to determine whether the cancer is truly gone, or if it is likely to return,” said associate professor of medicine Ash Alizadeh, MD, Ph.D. “And patients are wondering ‘Should I be planning to attend my child’s wedding next summer, or should I prioritize making my will?’ We are trying to come up with a better way to predict at any point during a patient’s course of treatment what their outcome is likely to be.”
Surprisingly, the researchers have also found that the approach, which they’ve termed CIRI for Continuous Individualized Risk Index, may also help doctors to pinpoint people who might benefit from early, more aggressive treatments as well as those who are likely to be cured by standard methods.
The study will be published online July 4 in Cell. Alizadeh, a Stanford Health Care oncologist who specializes in treating patients with blood cancers, shares senior authorship with associate professor of radiation oncology Maxmilian Diehn, MD, Ph.D. Instructor of medicine David Kurtz, MD, Ph.D., and postdoctoral scholars Mohammad Esfahani, Ph.D., and Florian Scherer, MD, are the lead authors.
Getting a more complete picture
The researchers began their study by looking at people previously diagnosed with diffuse large B-cell lymphoma, which is the most common blood cancer in the United States. Although nearly two-thirds of adults with DLBCL are cured with standard treatment protocols, the remaining third will likely die from the disease.
When a DLBCL patient is diagnosed, clinicians like Alizadeh, Diehn and Kurtz assess the initial symptoms, the cell type from which the cancer originated and the size and location of the tumor after the first imaging scan to generate an initial prognosis. More recently, clinicians have also been able to assess the amount of tumor DNA circulating in a patient’s blood after the first one or two rounds of therapy to determine how the tumor is responding and estimate a patient’s overall risk of succumbing to their disease.
But each of these situations gives a risk based on a snapshot in time rather than aggregating all the data available to generate a single, dynamic risk assessment that can be updated throughout the course of a patient’s treatment.
“What we’re doing now is somewhat like trying to predict the outcome of a basketball game by tuning in at halftime to check the score, or by watching only the tipoff,” Diehn said, “when in reality we know that there are any number of things that could have happened during the first half that we aren’t taking into account. We wanted to learn if it’s best to look at the latest information available about a patient, the earliest information we gathered, or whether it’s best to aggregate all of this data over many time points.”
Alizadeh and his colleagues gathered data on more than 2,500 DLBCL patients from 11 previously published studies for whom the three most common predictors of prognosis were available. They used the data to train a computer algorithm to recognize patterns and combinations likely to affect whether a patient lived for at least 24 months after seemingly successful treatment without experiencing a recurrence of their disease. They also included information from 132 patients for whom data about circulating tumor DNA levels were available prior to and after the first and second rounds of treatment.
“Our standard methods of predicting prognoses in these patients are not that accurate,” Kurtz said. “Using standard baseline variables it becomes almost a crystal ball exercise. If a perfectly accurate test has a score of 1, and a test that assigns patients randomly to one of two groups has a score of 0.5—essentially a coin toss—our current methods score at about 0.6. But CIRI’s score was around 0.8. Not perfect, but markedly better than we’ve done in the past.”
Identifying better treatment options
The researchers next tested CIRI’s performance on data from previously published panels of people with a common leukemia and another on breast cancer patients. Although the prognostic indicators varied for each disease, they found that, by serially integrating the predictive information over time, CIRI outperformed the standard methods. Furthermore, it suggested that it might be useful to identify patients who might need more aggressive intervention within one or two rounds of rather than waiting to see if the disease recurs.
“What I didn’t expect was that aggregating all this information through time may also be predictive,” Alizadeh said. “It might tell us ‘you’re going down the wrong path with this therapy, and this other therapy might be better.’ Now we have a mathematical model that might help us identify subsets of  who are unlikely to do well with standard treatments.”
The researchers are next planning to test CIRI’s predictive capabilities in people recently diagnosed with aggressive lymphoma.
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Journal information: Cell
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5 Plant-Based Meat Makers That Could Give Beyond Meat A Run For Its Money

Beyond Meat Inc BYND 1.23%‘s stellar run since its Wall Street debut on May 2 has turned the spotlight on plant-based meat companies.
Plant-based meat products are substitutes that mimic the properties of actual meat, and therefore look and taste like meat. The telling proof for the popularity of these products is Beyond Meat’s recently released results, which revealed a 215% jump in first-quarter net sales.
The lucrative market opportunity is likely to allure more and more players.
The following are companies that are bracing to make a name for themselves in the up-and-coming market for plant-based meat products.

Tyson Foods

Tyson Foods, Inc. TSN 1.08% announced in mid-June that it has introduced the first plant-based and blended products under the brand name “Raised & Rooted,” marking its foray into the alternative protein segment.
The company announced plans to roll out its initial products — plant-based nuggets as well as blended burgers and a beef-plant combo product — at several of its major retail customers.

Nestle

Swiss food giant Nestle NSRGY 0.02% revealed on April 2 plans to launch 100% plant-based burgers in Europe and the U.S., with the U.S. launch planned for fall.
The company said the burgers don’t compromise on flavor, texture and cooking experience.
“We believe this trend is here to stay, as consumers look at different ways to enjoy and balance their protein intake and lower the environmental footprint of their diets,” the company said in the release.

ConAgra

Conagra Brands Inc CAG 5.96%, which recently reported disappointing quarterly results, is eyeing an opportunity in the space through the Gardein brand, which came into its stable through its 2018 Pinnacle Foods acquisition. The brand has a presence in food service and a strong market positioning in plant-based meat alternatives at the retail level.
The company quantified the market opportunity for plant-based meat alternatives at $30 billion in the U.S. alone.

Impossible Foods

Based in Redwood, California and founded in 2011, privately held Impossible Foods develops plant-based substitutes for meat and dairy products. It launched its flagship product, the Impossible Burger, in 2016, and also makes plant-based sausage products.

Hormel Foods

Hormel Foods Corp HRL 1.33% recently said at the Deutsche Bank dbAccess Global Conference that it has been working on meat substitutes in multiple channels over the past several years.
The company has introduced the Fuse burger, which is a blend of meat and some plant-based items. One of its food service subsidiaries is working on a plant-based pizza topping.
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FDA Places Unum’s Early Stage Cancer Drug Trial On Clinical Hold

Unum Therapeutics Inc UMRX 3.2% shares were under pressure Wednesday following a clinical trial update provided by the company late Tuesday.

What Happened

The FDA has imposed a clinical hold on the Phase 1 ATTCK-20-2 trial that evaluated ACTR087 in combination with Roche Holdings AG Basel ADR RHHBY 0.25%‘s rituximab following lymphodepleting chemotherapy with fludarabine and cyclophosphamide in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma.
A clinical hold is an order issued by the FDA to delay an ongoing clinical trial or altogether suspend it; enrolled patients may not be given the investigational drug and new patient enrollment is halted.
The FDA action comes after Unum submitted a safety report regarding one patient in cohort 3 of the trial who experienced serious adverse events that included Grade 3 neurotoxicity, cytomegalovirus infection and Grade 4 respiratory distress.

Why It’s Important

Unum, which provides curative T-cell therapies to treat a broad range of cancer patients, went public in May 2018.
Since closing at $12.90, a 24% premium over its IPO price of $12, the stock has lost much of its value.
In its S-1 filing ahead of the IPO, Unum disclosed two deaths in its ACTR087 trial, with one resulting from enterococcal sepsis related to the investigational drug and another from unrelated sepsis.
The company said it has deprioritized its onetime lead product candidate ACTR087 and is now focusing on its new ACTR construct ACTR707 in combination with rituximab for the same indication.

What’s Next

Unum said the FDA has agreed that patients who previously received ACTR087 and have clinical responses may continue to receive rituximab infusions, with continued monitoring for adverse events.
The company said it will work closely with the FDA to further review these events and report data from the ATTCK-20-2 trial at the end of 2019.
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Kellogg Rallies As Columnist Reviews MorningStar Farms Grillers Veg Burger

Kellogg K 6.27% shares rallied after a MarketWatch columnist shared why he thinks, “Kellogg is sitting on a ‘fake meat’ gold mine bigger than Beyond Meat,” adding that MorningStar Grillers’ vegetarian burgers are better than Beyond Meat’s BYND 1.23% Beyond Burgers.
MarketWatch columnist Brett Arends points out that Morningstar Farms is a division of Kellogg and produces vegetarian food. This means Kellogg owns the largest single “fake meat” operation.
MorningStar’s “Grillers” vegetarian burgers, according to Arends, are “way better than Beyond Meat’s, Beyond Burgers.”
The MorningStar Grillers are mainly made of soy. Arends makes the point that anyone watching the stock market, reading the news or watching the news knows there’s a sudden Wall Street mania for so-called “fake meat” burgers. Beyond Meat shares skyrocketed sixfold since its IPO two months ago.
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Blood pressure drug linked with increased risk of diverticulosis

This condition causes small bulges or pouches to appear in the lining of the intestine. Particularly affecting the elderly (as many as 65 per cent of over 85s may be affected), diverticulosis can in some cases can lead to a medical emergency if the pouches become infected or burst.
The new early-stage research finding comes from a team of scientists led by Imperial College London, who investigated the effectiveness and side effects of three common blood pressure medications: ACE-inhibitors, beta-blockers and .
High blood pressure affects one in ten adults across the globe, and increases the risk of heart attack and stroke. The most common treatments for high blood pressure are  and medications.
However, despite the three main medications being taken by millions, investigating their potential side effects (as well as studying their effectiveness for treating other diseases), can be difficult and often involves lengthy and expensive clinical trials.
To overcome this problem, the research team, led by Imperial’s School of Public Health, used  to study the effects of the drugs.
By investigating versions of genes that mimic the effects of these drugs, the team were able to study the drugs’ effectiveness—and their potential .
First, the researchers, who published their work in the journal Circulation, identified the proteins targeted by the drugs, and which help lower blood pressure. Next, they analysed genetic data from around 750,000 people and identified the so-called genetic variants that code for these proteins.
The team, who included researchers from LMU Munich, then studied whether these gene variants—which cause increased production of these proteins—were linked to an increased or decreased risk of other diseases.
The good news was that, as expected, these so-called genetic variants (which coded for proteins involved in lowering blood pressure) were linked to lower heart disease and stroke risk.
However after assessing the risk of around 900 different diseases—using data from the UK Biobank study—the team found that the versions of genes related to the effects of a particular type of calcium channel blocker—the non-dihydropyridine class, were linked to an increased the risk of a bowel condition called diverticulosis.
The team compared their findings with further , and supported the potential link with an increased risk of the bowel condition.
The link now needs further investigation with larger trials, explains Dr. Dipender Gill, co-lead author of the research from Imperial’s School of Public Health: “This is the first time that this class of blood pressure drug has been associated with diverticulosis. We’re not sure of the underlying mechanism—although it may relate to effects on the function of intestine muscles, which perform contractions to transport food through the gut.”
Dr. Joanna Tzoulaki, senior author from Imperial’s School of Public Health added: “The study of genetic variants that mimic the effect of drugs is evolving as a powerful concept to help prioritise clinical trials and design clinical trials more likely to be successful”.
Dr. Gill cautions the findings should not change current prescribing guidelines and that people should not stop taking their medication unless first consulting their doctor.
He added: “These findings should not change clinical practice, but instead should act as a catalyst for further research.”
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Journal information: Circulation
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Vermont places 92 percent tax on E-cigarettes

A  92 percent tax on electronic cigarettes took effect in Vermont on Monday as the state tries to reduce young people’s use of the devices.
That rate means that e-cigarettes will now cost about the same as combustible cigarettes, CBS News reported.
The e-cigarette tax increase bill was sponsored by State Rep. George Till, who said it will help keep the products out of the hands of young people. “We know the group that is most sensitive to price is teenager,” he told CBS News. “And we know that these companies are going out of their way to get kids addicted.”
Two other measures meant to reduce youth smoking also took effect in Vermont on Monday. One raised the legal age for buying and using cigarettes, e-cigarettes, and tobacco products to 21 from 18, and the other restricts retail and online sales of tobacco and related products, CBS News reported. Just last week, San Francisco became the first U.S. city to ban the sale, distribution, and manufacturing of  products.
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More information: CBS News Article
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