Health
Some cancer patients could avoid surgery with innovative new therapy
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An experimental drug has shown promise in fighting a hard-to-treat form of bladder cancer known as BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC).
BCG (Bacillus Calmette-Guérin) is an immunotherapy drug that is often the first-line treatment for certain early-stage bladder cancers.
The new drug, TAR-200 — which was evaluated in a trial sponsored and conducted by Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson — may offer a less invasive alternative to bladder removal surgery.
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TAR-200 is a small, drug-releasing device placed directly into the bladder through a simple outpatient procedure, without general anesthesia, according to the study press release.
Once inserted, it slowly releases the chemotherapy drug gemcitabine over several weeks.
Researchers say the new bladder-inserted device could spare patients from losing their bladder entirely. (iStock)
“Traditionally, these patients have had very limited treatment options. This new therapy is the most effective one reported to date for the most common form of bladder cancer,” said study lead Sia Daneshmand, M.D., director of urologic oncology with Keck Medicine of USC, in a press release.
“The findings of the clinical trial are a breakthrough in how certain types of bladder cancer might be treated, leading to improved outcomes and saved lives.”
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Bladder cancer is the fourth most common cancer in men and the 11th most common cancer in women.
According to the Urology Care Foundation, non-muscle-invasive bladder cancer is found in the tissue that lines the inner surface of the bladder.
“Bladder cancer is one of the 10 most common cancers worldwide, yet treatment options have remained largely unchanged for over 40 years.”
High-risk NMIBC carries a greater chance of coming back after treatment. This study aimed to find an option for patients whose cancer recurred even after standard therapy.
“The standard treatment plan for these patients was surgery to remove the bladder and surrounding tissue and organs, which has many health risks and may negatively impact patients’ quality of life,” said Daneshmand.
This new therapy could eventually allow some patients to avoid that procedure.
Trial results showed that many patients stayed cancer-free for more than two years. (iStock)
All participants in the study had high-risk NMIBC that did not respond to the standard immunotherapy drug BCG. The study was split into multiple groups who tested different combinations of drugs and treatment methods.
In one group, patients received TAR-200 once every three weeks for about six months, followed by maintenance treatments every 12 weeks for up to two years.
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Among 85 patients in this group, 82.4% showed no detectable signs of cancer after treatment. In that group, 52.9% remained cancer-free at one year, and many stayed cancer-free for more than two years without needing additional therapy.
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In another group of patients with a less aggressive type of early-stage bladder cancer, early disease-free survival rates were 85.3% at six months and 81.1% at nine months. Overall, 94% were able to keep their bladders.
The clinical trial results were published earlier this year in the Journal of Clinical Oncology.
The TAR-200 device delivers gemcitabine directly to the bladder, keeping the drug where it’s needed most. (iStock)
The researchers emphasized that this is still mid-stage (Phase 2b) data. Longer-term, larger trials and regulatory reviews are still needed before the treatment could become standard care.
“Because the study didn’t include a traditional comparison (no randomized control arm), we can’t definitively say how TAR-200 stacks up against other treatments in a fair head-to-head way,” the researchers wrote.
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Patients in this study are a specific subset (BCG-unresponsive and eligible for bladder preservation) and may not represent all bladder-cancer cases.
“Also, follow-up time remains relatively short and the number of patients modest, meaning we don’t yet know how long the benefits will last or how they apply to larger, more diverse groups of people,” the researchers added.
Health
Your bedroom temperature could be putting your heart in serious danger, study warns
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The temperature of the bedroom at night could affect heart health — particularly in older adults.
Heat places extra demands on the cardiovascular system, according to lead study author Dr. Fergus O’Connor from Griffith University in Queensland, Australia.
When the human body is exposed to heat, its reaction is to work harder to try and circulate blood to the skin surface for cooling, he noted.
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“However, when the heart works harder and for longer, it creates stress and limits our capacity to recover from the previous day’s heat exposure,” O’Connor stated in a press release.
Researchers aimed to understand how real-world bedroom temperatures affected older adults.
When the heart works harder and for longer, it creates stress and limits its capacity to recover from the previous day’s heat exposure. (iStock)
The team followed 47 adults living in southeast Queensland averaging 72 years of age.
While many sleep observations are conducted in special clinics, this was a “free-living” study, meaning the participants carried on with their normal activities and sleep schedules.
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Scientists monitored the participants throughout an entire Australian summer, from December to March. Each person wore a high-tech fitness tracker to monitor their heart rate from 9 p.m. to 7 a.m., according to the release.
While many sleep observations are conducted in special sleep clinics, this was a “free-living” study, meaning the group carried on with their normal activities and sleep schedules. (iStock)
Sensors were then placed directly in participants’ bedrooms to record the temperatures, monitoring over 14,000 nighttime hours of sleep in total.
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The temperature at which the heart began to show signs of disruption was a little more than 75 degrees Fahrenheit.
Between 75 and 79 degrees Fahrenheit, the odds of a “clinically relevant” drop in heart recovery rose by 40%, the researchers found.
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Between 79 and 82 degrees Fahrenheit, the odds doubled. Above 82, the risk was nearly triple compared to cooler rooms.
Between 75 and 79 degrees Fahrenheit, the odds of a “clinically relevant” drop in heart recovery rose by 40%. (iStock)
“For individuals aged 65 years and over, maintaining overnight bedroom temperatures at 24 C (75.2 F) reduced the likelihood of experiencing heightened stress responses during sleep,” O’Connor said.
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While the study shows a strong link between heat and heart stress, its observational design means that it doesn’t definitively prove heat is the only cause, the researchers acknowledged.
As the study only focused on older adults in Australia, it may not apply to other populations.
“When the heart works harder and for longer, it creates stress and limits our capacity to recover from the previous day’s heat exposure.”
Also, while the wearable devices are advanced, they are not as precise as the medical-grade ECGs used in clinical settings.
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O’Connor emphasized a gap in temperature guidance — while there are guidelines for maximum daytime indoor temperature, there are no equivalent recommendations for nighttime conditions.
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The study was published in the journal BMC Medicine.
Health
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Health
Family pleads for kidney donor as teen’s health declines: ‘We need help’
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A New Jersey family is desperately seeking a living donor to save Thaddeus Giansanti, an eighth-grader who was born with kidney disease.
Thaddeus has had multiple surgeries throughout his 13 years, including one to remove a kidney as a baby.
Despite his struggles, he has remained positive and optimistic, his parents shared with Fox News Digital.
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“His remaining kidney is now failing,” said his father, Carlo Giansanti. “We are not a match, so now we’re asking for help from the community.”
The family first found out about their son’s kidney disease before he was born, when an ultrasound detected a potential issue.
Christa DeMark and Carlo Giansanti are pictured with their son Thaddeus, who has battled kidney disease his entire life. (Christa DeMark)
“It was nothing alarming at that point — it looked like he had extra fluid when he was born,” Thaddeus’ mother, Christa DeMark, told Fox News Digital. “Everything seemed normal, but right before we were leaving, they noticed an elevated creatinine number (a measure of kidney function in blood tests) that led to us being in touch with nephrology.”
She added, “There was something wrong with the ureters (tubes that carry urine from the kidneys to the bladder) and the formation of the kidneys.”
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Thaddeus spent an extended period of time in the NICU, where he had multiple procedures. Before he was even 5 months old, he underwent a left nephrectomy to remove his left kidney.
His remaining kidney was diagnosed with chronic kidney disease, which has required lifelong medications.
“He’s been with nephrology and nephrologists his entire life, and up until last year, everything’s been stable, but that’s been slowly changing,” DeMark said. “He’s getting bigger, and it’s been putting more stress on his remaining kidney.”
Thaddeus, now 13, has had multiple surgeries throughout his life, including one to remove his kidney as a baby. (Christa DeMark)
Doctors informed the family that their best course of action would be to find a living donor.
“Everything’s been sped up based on his bloodwork lately,” DeMark said. “So it’s looking like we need something quicker than we thought, which is why we’re looking for living donors.”
“It has pushed us to rely on faith in a way that’s very palpable — we are just coming together as a family and taking each day as it comes.”
If Thaddeus does not receive a kidney transplant within a couple of weeks, he will need to be put on dialysis, according to his doctors.
“It’s obviously been challenging for him,” DeMark said. “He’s dealing with it very well, but these are difficult situations we’re navigating.”
His parents describe Thaddeus as a smart, outgoing boy — a straight-A student who was recently awarded multiple scholarships for next year, when he will become a high-school freshman.
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Thaddeus is very athletic and enjoys playing soccer, golfing and fencing. He also plays piano and often volunteers in his community, including being an altar server and working with the local food pantry.
“He loves his family, and loves doing things with his family,” DeMark said. “He’s just a great kid.”
The boy’s remaining kidney is failing, and his family is asking the community to help find a life-saving donor. (Christa DeMark)
Thaddeus’ parents said they have not shared much about their son’s medical condition until now. “We wanted Thad to just be the bright, happy person that he is, so we’ve minimized it for years,” DeMark said.
But in the last couple of weeks, as their son’s condition has become more dire, they have started to speak out about their situation.
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“We never expected to have such an outpouring of people who cared or people trying to help — it’s been incredibly humbling,” DeMark said.
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“It has pushed us to rely on faith in a way that’s very palpable — we are just coming together as a family and taking each day as it comes,” she went on. “We are remaining hopeful because we know there’s a solution to this problem. We just need help.”
“The miracle Thad needs right now is people who have the ability to step up,” his mother said. “He is a great kid, a kind kid.” (Christa DeMark)
To be considered for the donation program, kidney donors must be 45 or younger, have a BMI under 30 and match Thaddeus’ O blood type.
For those who are considering becoming donors, DeMark emphasized that it entails a laparoscopic procedure with a “fairly quick” healing process that is covered by their insurance, not the donor’s.
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“The miracle Thad needs right now is people who have the ability to step up,” she added. “He is a great kid, a kind kid.”
Those interested in being considered as a donor can complete this Kidney Transplant Living Donor Questionnaire.
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