MicroRNAs: circulating biomarkers for the early detection of imperceptible cancers via biosensor and machine-learning advances
New Drug Approved For Common Type Of Breast Cancer Recurrence
Oct. 14, 2024 – A new breast cancer drug has received quick federal approval after a clinical trial showed it could more than double the time before a common type of breast cancer recurrence worsens.
The FDA approved Itovebi for people with hormone-sensitive breast cancer that returned while or after taking endocrine therapy, such as the medicine tamoxifen. Itovebi is only approved for people who have a genetic mutation called PIK3CA and whose cancer type is HER2-negative. (HER2 refers to a protein that can affect cancer growth.)
Along with its approval of the new drug, the FDA approved a genetic test called FoundationOne Liquid CDx as an option to identify people with the PIK3CA mutation. The mutation occurs in 40% of breast cancers that are hormone-sensitive and HER2-negative.
One of the researchers from the clinical trial for Itovebi called the drug "a new standard in how PIK3CA-mutated breast cancers are treated."
"The PI3K pathway plays a pivotal role in disease progression and has been challenging to target," Komal Jhaveri, MD, a breast oncologist and clinical director for drug development at Memorial Sloan Kettering Cancer Center, said in a news release from drugmaker Genentech.
Itovebi's generic name is inavolisib, and it is approved to be taken along with already approved treatments for this type of breast cancer recurrence, which are the drugs Ibrance and Faslodex. Their generic names are palbociclib and fulvestrant, respectively.
In the clinical trial of 325 people, those who took the three drugs averaged 15 months before their cancer spread or they died of the disease (a measure known as progression-free survival). People in the study who took only Ibrance and Faslodex averaged just over 7 months of progression-free survival, the FDA reported in its approval. The agency noted that full data is not yet available, but early numbers suggest the addition of Itovebi may help people ultimately live longer.
Itovebi is taken as a daily tablet. The FDA approval detailed that the most common adverse reactions affected 20% or fewer people in the study and included laboratory test abnormalities, inflammation of the mouth or lips, diarrhea, fatigue, nausea, rash, decreased appetite, COVID-19 infection, and headache. The drug's label also includes a warning about a risk of hyperglycemia, or high blood sugar.
Discovery Of MicroRNA May Change The Fight Against Cancer
The 2024 Nobel Prize in Medicine was awarded on Monday, October 7 to two American scientists for their discovery of microRNA – a previously unknown type of genetic switch that could lead to significant medical breakthroughs.
Despite the development of several treatments and tests using microRNAs against cancer, heart disease, viruses, and other illnesses, none have yet reached patients.
Furthermore, when Nobel laureates Victor Ambros and Gary Ruvkun unveiled their discovery decades ago, it attracted little attention, as many thought it was just "something weird about worms," as University of Cambridge geneticist Eric Miska put it.
Messenger RNA and gene regulationEvery cell in the human body contains the same set of instructions called DNA. Some cells become brain cells, while others develop into muscles.
So, how do cells determine their specific roles? The relevant parts of the DNA instructions are highlighted through a process known as gene regulation.
Ribonucleic acid (RNA) typically serves as a messenger, conveying instructions from DNA to proteins – the building blocks of life that transform cells into brains or muscles.
Miska provided the example of the messenger RNA vaccines deployed against COVID-19 during the pandemic, which introduce a message with new instructions to build proteins that block viruses.
Discovery of microRNAHowever, the two new Nobel winners, Ambros and Ruvkun, discovered an entirely new type of gene regulator that had previously been overlooked by science.
Rather than acting as messengers that relay information, microRNAs function as switches to turn other genes on or off.
"This was a whole new level of control that we had totally missed," said Miska, who has worked on microRNA for two decades, including with the new Nobel laureates.
"The discovery of microRNAs brought an additional level of complexity by revealing that regions that were thought to be non-coding play a role in gene regulation," added French researcher Benoit Ballester.
The critical role of microRNAIn the 1980s, Ambros and Ruvkun were working separately on how genes interact in one-millimeter-long roundworms called C. Elegans.
When they compared their research, it led to the discovery of microRNA. Ambros published the finding in a 1993 paper.
"Nobody really paid much attention," Miska said, explaining that most scientists at the time thought it only applied to worms.
Then, in 2000, Ruvkun published research showing that microRNA is present throughout the animal kingdom, including in humans and even some viruses.
"This was not just something weird that worms do, but in fact all animals and plants are totally dependent for development and normal function on them," Miska said.
MicroRNA regulates hundreds of genesIt is now believed that more than a thousand genes that respond to microRNAs exist in the human body.
Many new treatments and tests using microRNA are undergoing trials, but none have been widely made available yet.
"Though there are no very clear applications available yet in microRNAs, understanding them, knowing that they exist, understanding their counter-regulatory networks, is always the first step," said Gunilla Karlsson Hedestam, a scientist at Karolinska Institute.
Hope in the fight against cancerMicroRNAs are particularly promising for fighting cancer because some of these switches "act as a tumor suppressor, so they put a brake on cells dividing inappropriately," Miska explained.
Others, meanwhile, induce "cells to divide, which can lead to cancer," he added.
Since many viruses use microRNAs, several antiviral drugs are at various stages of development, including one for hepatitis C.
However, one complicating factor has been that microRNAs can be unstable.
Scientists also hope they can be used as a test called a "biomarker," which could reveal, for example, what type of cancer a patient might have.
According to Miska, microRNAs could also be involved in the evolution of our species. "It seems very likely that microRNAs have important roles in why the human brain is different from the brains of other primates," he said.
Although studying human brains is challenging, Miska hopes that future research will provide more insights into how microRNAs contribute to the complex structure and functions of both human bodies and brains.
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Mom Diagnosed With Two Types Of Cancer In One Breast Shares Her Story: 'Thankful I Listened To My Body'
Morgen Chesonis-Gonzalez was shocked to get the very rare diagnosis — and now advocates for others to get early screenings
In June 2020, Morgen Chesonis-Gonzalez, then 47, decided to push off her annual mammogram. Everything had always come back fine on previous ones. But about a month later, she felt a persistent pain, and a lump about the size of a tennis ball under her arm pit.
She rescheduled her mammogram for July, and in August, she learned she had two types of breast cancer in her right breast.
"That was a surprise," says her breast surgical oncologist, Dr. Starr Mautner, 41, at Miami Cancer Institute, part of Baptist Health South Florida. "It is very rare."
While being diagnosed with two types of cancer is very rare, it wasn't unheard of, Chesonis-Gonzalez remembers her doctors telling her — and that made her feel better.
Courtesy of Morgen Chesonis-Gonzalez
Chesonis-Gonzalez now wants to share her own story to help others in the same position feel less alone — and to encourage people to schedule screenings early.
"I'm thankful that I listened to my body and was brave to make the appointments and to follow through," says Chesonis-Gonzalez, a clinical art therapist who works with school children in Miami. "If I had waited a year, it would've been catastrophic. It could have been so much worse."
Chesonis-Gonzalez was officially diagnosed on August 20, 2020. She had two different types of cancer in her right breast: One was a triple negative, extremely aggressive, fast-moving tumor, and the other was a smaller, estrogen-positive tumor that was very very small and only detected via the breast MRI.
Courtesy of Morgen Chesonis-Gonzalez
Dr. Mautner says her biggest concern was treating the more aggressive tumor. Starting in September 2020, Chesonis-Gonzalez had six months of what her doctor describes as a "very harsh" chemotherapy, known as "the red devil."
"It's not an easy treatment at all," Dr. Mautner says.
But it worked: It shrunk the tumor.
While the cancer was only in one breast, for peace of mind, Chesonis-Gonzalez decided to have a double mastectomy on February 10, 2021.
"I wrote a goodbye letter to my breasts, thanking them for nursing my children, and being a part of me — but now they're trying to kill me, so we have to stop," she says.
Courtesy of Morgen Chesonis-Gonzalez
After the surgery, she needed two months of physical therapy, just to be able to lift her arms above her head, so she could receive the 28 rounds of daily radiation. Her body needed the next six months to heal from the scarring, blistering and radiation damage. Then she was able to have breast reconstruction surgery.
Treatment was physically and mentally grueling, she says. To help her get through the worst days, she says she'd remind herself, "I want to see my grandkids. I want to meet them. This is what I want."
Her son and daughter, who were 13 and 11 when she was diagnosed four years ago, also had a difficult time with their mom's treatment.
"They really suffered," she says. "I think breast cancer is horrible any time, but at a non-COVID time, relatives can come. They can go and spend the night at a friend's house. They could have people hang out and go to movies. We could not. We were on house arrest, basically. They had nowhere else to go except to see me go through all of this."
Courtesy of Morgen Chesonis-Gonzalez
Together, the family had "cat therapy" sessions where they rotated cuddling their three pet cats.
On days when she had chemo, her husband, Gerardo Gonzales Vedo, 52, would pick up pizza and they would all watch Stranger Things. "To have some bit of joy," she says. And together they laughed, a lot.
When she lost her hair from the chemo, her son started calling her "Master Oogway," the bald tortoise from Kung Fu Panda. "You develop a gallows humor as a survival skill," she says.
Her daughter took a photograph of her mother's bald head that she titled, "Survivor." She won a local art contest with the picture.
Courtesy of Morgen Chesonis-Gonzalez
"My mantra was 'Better every day,'" she says.
In August, she celebrated her four-year mark of being cancer-free. Her doctor says her prognosis is excellent. She takes daily medication to prevent a recurrence. She practices mindfulness, meditates and she and her husband go for walks at 5:30 a.M. Before she goes to work. She cut back on red meat, and eats more fruits and vegetables.
She joined a dragon boat paddling group composed of other breast cancer survivors called SOS Save our Sisters; everyone on the team has gone through a similar journey.
Courtesy of Morgen Chesonis-Gonzalez
"Keep moving forward," she says. "If you're a woman, and you happen to be a mom, everybody else's needs are met before your own. And I need to try and change that, not only for myself, but also advocate for that too. Because if we're not around for our children, then that's tragic."
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