Drug combination therapy for estrogen-receptor–positive breast cancer passes critical step for worldwide approval

Building on earlier clinical trials, UCLA researchers have confirmed that the "breakthrough" drug palbociclib when used in combination with the traditional hormonal therapy letrozole delays progression of advanced breast cancer significantly and without the harsh side effects seen in some women prescribed letrozole alone.

The study, published online in the New England Journal of Medicine, is the phase 3 study following phase 1 and phase 2 clinical trials that led to the U.S. Food and Drug Administration approval of palbociclib in early 2015. Palbociclib was also approved in Europe for the first time earlier this month based on these results. In 2013, after women in a clinical study led by UCLA researchers showed a dramatic improvement, the FDA granted palbociclib "breakthrough therapy" status, allowing it to be fast-tracked for approval.

The drug combination is the first and only treatment for women with estrogen-receptor-positive breast cancer to show such significant results in a randomized phase 3 trial. Dr. Richard Finn and Dr. Dennis Slamon of the UCLA Jonsson Comprehensive Cancer Center led the laboratory studies and previous trials and are co-authors of the study.

"These results are a truly meaningful advancement for women in this patient population," said Finn, who is also an associate professor of medicine in the David Geffen School of Medicine at UCLA. "The results of the phase 3 study will support the full approval of palbociclib in the United States and around the world."

Palbociclib (marketed as IBRANCE by Pfizer, Inc.) is known as the first new drug that in combination with hormonal therapy has proven to be very effective in post-menopausal women with estrogen receptor-positive breast cancer. The ER+/HER2- subgroup represents the largest proportion of breast cancer cases and is traditionally treated with therapies, like tamoxifen or letrozole, that target the hormone receptor pathway. Palbociclib, which was developed by Pfizer Inc., prevents cells from dividing by targeting a key family of proteins (CDK4/6) responsible for cell growth.

Led by Finn and Slamon, an international team of investigators from 17 countries analyzed 666 women with advanced ER+/HER2- breast cancer. The people were treated with a combination of palbociclib and letrozole and had not received prior systemic therapy for their cancer. The results of the new study confirmed the previous findings of the multi-year phase 1 and phase 2 trials, which showed a significant increase in the time it took the cancer to progress compared to letrozole alone.

The phase 2 trial also demonstrated that survival without side effects nearly doubled -- 20.2 months for women who received palbociclib plus letrozole compared to 10.2 months in patients who received letrozole alone -- representing a 42 percent reduction in the risk of disease progression. The new phase 3 trial further confirmed these findings.

"The results from both studies are really remarkable for the degree of benefit they provide in slowing the growth of estrogen-receptor positive breast cancer," said Slamon, director of the Revlon/UCLA Women's Cancer Research Program and director of clinical and translational research at the Jonsson Cancer Center. "The drug combination is very well tolerated and without the side effects of traditional chemotherapy, such as infections, nausea and significant hair loss."

Palbociclib is the first CDK 4/6 treatment to be approved for cancer treatment and provides proof of concept that targeting this pathway is important for the treatment of women with ER+ breast cancer. The researchers said the phase 3 findings will open the door to further studies in breast cancer and other diseases.

Besides leading the clinical development, the initial scientific observation that drove the development of palbociclib and other CDK 4/6 inhibitors in breast cancer came out of work from the UCLA Translational Oncology Research Laboratories under the direction of Finn and Slamon.

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Being Socially Active Linked to Lower Dementia Risk

People who are socially engaged are exercising cognitive skills such as memory and language, which may help them to develop cognitive reserve - while it may not stop their brains from changing, cognitive reserve could help people cope better with the effects of age and delay any symptoms of dementia," said senior author. 

The research,  used data from the "Whitehall II" study, tracking 10,228 participants who had been asked on six occasions between 1985 and 2013 about their frequency of social contact with friends and relatives. 

The same participants also completed cognitive testing from 1997 onwards, and researchers referred to the study participants' electronic health records up until 2017 to see if they were ever diagnosed with dementia. 

For the analysis, the research team focused on the relationships between social contact at age 50, 60 and 70, and subsequent incidence of dementia, and whether social contact was linked to cognitive decline, after accounting for other factors such as education, employment, marital status and socioeconomic status. 

The researchers found that increased social contact at age 60 is associated with a significantly lower risk of developing dementia later in life. 

The analysis showed that someone who saw friends almost daily at age 60 was 12 per cent less likely to develop dementia than someone who only saw one or two friends every few months. 

They found similarly strong associations between social contact at ages 50 and 70 and subsequent dementia. 

"Spending more time with friends could also be good for mental well-being, and may correlate with being physically active, both of which can also reduce the risk of developing dementia," he added.

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Aerobic exercises may boost cognitive skills, delay Alzheimer’s

Engaging in aerobic exercises such as spinning, running, walking may be three times more effective than other types of exercise in delaying the risk of Alzheimer’s disease as well as improving cognitive function in older adults, a study has found.

Alzheimer’s disease — the most common form of dementia — is a brain disorder that destroys memory and thinking skills over time in older adults. There is presently no cure for the condition, though treatment options are available.

The findings, showed that older adults at risk for or who have Alzheimer’s, who did aerobic exercise by itself experienced a three times greater level of improvement in their ability to think and make decisions than those who participated in combined aerobic training and strength training exercises.
Older adults in the non-exercise group faced declines in cognitive function.

However, those who exercised showed small improvements in cognitive function no matter what type of exercise they did, the researchers said.

Geriatrics experts have for long suggested that exercising can improve brain health in older adults.
The World Health Organization (WHO) has recommended that older adults perform 150 minutes a week of moderate exercise (such as brisk walking), 75 minutes a week of vigorous aerobic training, or a combination of the two types.

The WHO also suggested older adults perform muscle-strengthening exercises on at least two or more days a week.

For the study,  the team reviewed 19 studies involving 1,145 older adults that examined the effect of an exercise training programme on cognitive function in the elderly at risk for or diagnosed with Alzheimer’s.

Of the participants, in their mid-to late 70s, 65 per cent were at risk for Alzheimer’s and 35 per cent had been diagnosed with Alzheimer’s.

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Paracetamol during pregnancy may delay daughters’ language skills

Women who consume acetaminophen — also known as paracetamol and widely used to reduce a high fever or relieve pain — during early pregnancy are six times more likely to see delay in their daughters’ language skills, warns a new study.

Acetaminophen is the active ingredient in Tylenol and hundreds of over-the-counter and prescription medicines.

The maternal intake of acetaminophen saw a reduction in the intelligence quotient level along with increasing language delay, defined as the use of lesser than 50 words, by the kids.

The communication delay affected boys at the same time, but was more prevalent among the girls, the study showed.

“Given the prevalence of prenatal acetaminophen use and the importance of language development, our findings, if replicated, suggest that pregnant women should limit their use of this analgesic during pregnancy,” said a Professor.

“It’s important for us to look at language development because it has shown to be predictive of other neurodevelopmental problems in children,” the Prof. added.

The study,  examined 754 women, who were in eight-13 weeks of pregnancy.

Researchers asked participants to report the number of acetaminophen tablets they had taken between conception and enrollment, and tested the acetaminophen concentration in their urine at enrollment.

Both the number of tablets and concentration in urine were associated with a significant increase in language delay in girls, with a slight decrease in boys.

Previous studies have found that the over exposure to the pain relieving drug during pregnancy also damages the fertility of the daughters.

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Removing old cells from joints can delay onset of osteoarthritis

Good news, a study has found that selective removal of old cells, senescent cells (SnCs) from joints can significantly delay the onset of osteoarthritis. The team presented a novel pharmacologic candidate that alleviates age-related degenerative joint conditions, such as osteoarthritis (OA) by selectively destroying SnCs.
 
Their findings suggested that the selective removal of old cells from joints could reduce the development of post-traumatic OA and allow new cartilage to grow and repair joints. This breakthrough research was done recently by some researchers.

Senescent cells (SnCs) accumulate with age in many vertebrate tissues and are present at sites of age-related pathlogy. Although these cells play an essential role in wound healing and injury repair, they may also promote cancer incidence in tissues. For instance, in articular joints, such as the knee and cartilage tissue, SnCs often are not cleared from the area after injury, thereby contributing to OA development.

To test the idea that SnCs might play a causative role in OA, they took both younger and older mice and cut their anterior cruciate ligaments (ACL) to mimic injury. They, then, administered injections of an experimental drug, named UBX0101 to selectively remove SnCs after anterior cruciate ligament transection (ACLT) surgery.

Indeed, the research team reported that aged mice did not exhibit signs of cartilage regeneration after treatment with UBX0101 injections, The researchers noted that their findings provide new insights into therapies targeting SnCs for the treatment of trauma and age-related degenerative joint disease. The research appeared in a medical journal.

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Researchers discover rescue protein that delays cell death

A team of researchers has discovered a rescue protein that delays the cell death and can offer a treatment for cancer, neurodegeneration and infection.

The study was published in journal Cell.The team has discovered how a set of proteins delays the "executioner" machinery that kills damaged or infected cells in a process called necroptosis.

The scientists believe these finding may have wide clinical implications if researchers can develop drugs to control the cellular rescue machinery.

Rescue treatments that prevent necroptosis in transplanted organs could reduce injury to the transplant caused by lack of oxygen, researchers said.

Drugs to rescue cells from necroptosis could also help prevent injuries to tissue deprived of blood by heart attack and stroke. In such cases, restoring blood flow and oxygenation triggers inflammation that kills tissue.

The scientists said cell-rescuing drugs could also thwart cancer spread by protecting blood vessel cells from being killed by tumor cells.

Tumor cells escape the bloodstream to spread in the body by killing blood vessels. Blocking the rescue machinery might also prove useful in treating cancers, by enhancing death of cancer cells by necroptosis.

In treating neurodegenerative disorders such as ALS--also known as Lou Gehrig`s Disease--activating the rescue machinery could help prevent death of brain cells.

In treating viral infections such as influenza, rescue treatment could extend the life of cells infected by the virus, so that the body`s immune system would be more strongly alerted to fight the infection.

Scientists knew that the "executioner" in necroptosis was a protein called MLKL.When MLKL is activated by the necroptosis machinery, it triggers a piercing of the plasma membrane surrounding the cell, ultimately killing it.

However, the scientists discovered how cells could survive necroptosis.Researchers showed the plasma membrane could repair itself by forming "bubbles" of broken plasma membrane that would shed from the cell to repair the holes.

Experiments showed the set of proteins called ESCRT-III was responsible for forming the repair bubbles. The research also revealed that ESCRT-III delayed or prevented necroptosis by repairing breaks in the plasma membrane.

The delay gave the dying cells time to release signals to alert surrounding cells to the presence of a viral infection.The investigators also discovered that activating MLKL is not a point of no return for cell survival, and that ESCRT-III could resuscitate damaged cells.In experiments relevant to transplantation, the researchers measured levels of activated MLKL protein in tissue samples from kidneys used in transplants.

Such cells experience stress during the transplantations, and researchers suspected the cells would show signs of necroptosis.The scientists found that although MLKL was activated in the kidney cells after transplantation, the cells did not die, and this protection correlated with an increase in the levels of the ESCRT-III machinery necessary for rescue of cells with active MLKL.

Douglas Green, Ph.D., chair of the St. Jude Department of Immunology emphasized that the current findings are only "suggestive" at this point, because the experiments were done in cell cultures and tissue samples. Further studies are needed to establish that the rescue machinery functions in whole organs.

The research by Green and his colleagues will also aim at discovering the biological signals regulating ESCRT-III, to enable more precise control of the rescue machinery."Those studies could yield drugs to regulate the rescue process," Green said.

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