BCG

Inexpensive combo-chemotherapy found to be better tolerated than BCG for common bladder cancer

Posted by

0


An on-going, worldwide shortage of bacillus Calmette-Guérin (BCG) means that many patients with a common and serious type of bladder cancer have limited access to this effective standard of care treatment. But, for the first time in almost 50 years, there appears to be a viable treatment alternative.

A new study from the University of Iowa finds that a safe, inexpensive combo-chemotherapy is better tolerated than BCG and is better at preventing high-grade cancer recurrence in patients with non-muscle invasive bladder cancer (NMIBC).

Bladder cancer is the sixth most common cancer in the U.S., and NMIBC accounts for about 75% of bladder cancer cases. High-risk NMIBC has a significant risk of both recurrence and progression. Typical treatment for high-risk NMIBC involves surgical removal of the tumor followed by treatment with BCG.

The new approach, which was developed by Michael O’Donnell, MD, at the University of Iowa over 10 years ago, replaces BCG with a combination of two inexpensive, readily available chemotherapy drugs-;gemcitabine and docetaxel (gem/doce). Based on this pioneering research from the UI, other major cancer centers have increasingly adopted this regimen, as well. Most recently, a UI study published in 2022 showed that 82% of patients with high-risk NMIBC who were treated with gem/doce instead of BCG remained cancer-free two years after treatment.

With that earlier study we showed that patients with untreated non-muscle invasive bladder cancer who received gem/doce had excellent safety and efficacy outcomes that were on par with historical outcomes of BCG. This was novel and impactful as it provides the first highly effective and accessible alternative to BCG, for which none previously existed. However, one limitation in that study was there was no direct comparison to the standard of care treatment-;BCG.”

Vignesh Packiam, MD, clinical assistant professor of urology with UI Health Care

With the new study, published Feb. 28 in JAMA Network Open, Packiam, O’Donnell and their UI colleagues address that limitation by retrospectively comparing outcomes of 312 patients who received either gem/doce or BCG over a 10-year period at UI Hospitals & Clinics.

The study found that gem/doce provided better recurrence-free survival in patients with high-risk NMIBC compared to BCG, and fewer patients who received gem/doce therapy discontinued their treatment compared to patients who receive

“The results were very promising,” says Packiam, who also is a member of UI Holden Comprehensive Cancer Center. “We believe this new study will have an immediate impact as it shows stronger evidence for using gem/doce for patients with newly diagnosed non-muscle invasive bladder cancer, for whom there is no alternative option due to the BCG shortage.”

The findings also provide valuable support for the phase 3 BRIDGE trial, a prospective multi-institutional randomized controlled trial that was recently activated and that will be the definitive trial for gem/doce compared to BCG for NMIBC.

In addition to Packiam and O’Donnell, the UI team included first author Ian McElree, a medical student at the UI Carver College of Medicine, as well as Ryan L. Steinberg, MD, and Sarah Mott.

The study was funded in part by grants from the National Cancer Institute and the John and Carol Walter Family Foundation.

Source:

University of Iowa Health Care

TB vaccine ‘could help prevent MS’

Posted by

0


MRI brain scan showing multiple sclerosis lesions


Related Stories

An anti-tuberculosis vaccine could prevent multiple sclerosis, early research suggests.

A small-scale study by researchers at the Sapienza University of Rome has raised hopes that the disease can be warded off when early symptoms appear.

More research is needed before the BCG vaccine can be trialled on MS patients.

The MS Society said the chance to take a safe and effective preventative treatment after a first MS-like attack would be a huge step forward.

MS is a disease affecting nerves in the brain and spinal cord, causing problems with muscle movement, balance and vision.

Early signs include numbness, vision difficulties or problems with balance.

BCG vaccine

  • Bacillus Calmette-Guerin (BCG) is a live vaccine made up of a weakened strain of Mycobacterium bovis, a bacterium that causes tuberculosis (TB) in cattle
  • The bacteria are altered so that they do not cause a TB infection, but stimulate the body’s immune system to make it resistant to the disease
  • The vaccine has existed for 80 years and is one of the most widely used of all current vaccines, reaching more than 80% of newborns and infants in countries where it is part of the national childhood immunisation programme

About half of people with a first episode of symptoms go on to develop MS within two years, while 10% have no more problems.

In the study, published in the journalNeurology, Italian researchers gave 33 people who had early signs of MS an injection of BCG vaccine.

The other 40 individuals in the study were given a placebo.

After five years, 30% of those who received the placebo had not developed MS, compared with 58% of those vaccinated.

“These results are promising, but much more research needs to be done to learn more about the safety and long-term effects of this live vaccine,” said study leader Dr Giovanni Ristori.

“Doctors should not start using this vaccine to treat MS or clinically isolated syndrome.”

Dr Susan Kohlhaas, head of biomedical research at the MS Society, said it was a small but interesting study.

“It’s really encouraging to see positive results from this small trial, but they’ll need validating in larger and longer-term studies before we know if the BCG vaccination can reduce the risk of someone developing MS.

“Ultimately, the chance to take a safe and effective preventative treatment after a first MS-like attack would be a huge step forward.”

The findings add weight to a theory that exposure to infections early in life might reduce the risk of diseases such as MS by stimulating the body’s immune system.

Dr Dennis Bourdette, of Oregon Health and Science University in Portland, US, said the research suggested “BCG could prove to be a ‘safe, inexpensive, and handy’ treatment for MS”.

He wrote in an accompanying editorial in Neurology: “The theory is that exposure to certain infections early in life might reduce the risk of these diseases by inducing the body to develop a protective immunity.”