sSometimes numbers tell a story, but sometimes they obscure a story. According to the latest figures from the National Cancer Institute, the death rate for people diagnosed with bladder cancer has barely budged over the past 30 years. But experts treating the disease tell a different, more optimistic story — and credit much of it to an increase in clinical trials. “In just the past five or six years, there has been a great deal of work researching new treatments Bladder cancer patients“We’re seeing unprecedented responses to some of these new drugs,” says Dr. Stephen Burjian, MD, professor and chief of urology at the Mayo Clinic in Rochester, Minn.
Some of the greatest advances in treating bladder cancer have involved a class of drugs called immune checkpoint inhibitors. They shift the activity of a person’s immune system in ways that help them fight cancer cells. “These were typical changes,” Burjian says. “The way we treat bladder cancer is different than it was just five years ago.”
Others in his field tell a similar story. For people with metastatic and non-metastatic bladder cancer, the past half decade has seen the introduction of dozens of promising new treatments. Some were revolutionary, while others led to incremental but significant improvements in care. In each case, these developments relied on clinical trials and the people involved in them.
“Clinical trials are the way we got here,” says Dr. Guru Sunpavdi, director of the Bladder Cancer Program at Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School in Boston. “All of the new drugs that we’ve introduced that have changed outcomes for bladder cancer patients — it all came from clinical trials.”
Clinical trials are carefully designed research studies, conducted in a medical setting, that help experts identify new or better ways to prevent, diagnose, or treat disease. “Participation in a trial is often the only way to gain access to new and promising drugs, or treatment alternatives that may be better than standards of care,” Sonbavdi explains.
Although nearly every type of cancer is the subject of ongoing research, he says bladder cancer may be one of the hottest areas for clinical trial work. Part of that is due to the spread of cancer. Bladder cancer is the sixth most common cancer in the United States, with more than 80,000 new cases diagnosed annually. But there is another factor, which is that until recently, decades have passed without major breakthroughs Bladder cancer treatment. “We’ve had some chemotherapy, but this was a cancer in which we didn’t see a lot of advances until about five years ago,” Sonbavdi says.
Like Borgian, he highlights the game-changing impact that immune checkpoint inhibitors have had on bladder cancer treatment. This and other advances have led to an explosion of new research — and with it, more people are needed to participate in clinical trials.
Unfortunately, this need is not met. says Dr. Ashish Kamat, MD, professor of urological oncology and director of bladder cancer research at the University of MD Anderson Cancer Center in Houston. “To get reliable results, trials need a lot of patients, and until we have more participation it will be difficult to move the needle as much as we would like.”
How do you find clinical trials?
Part of the problem, Cammat says, is that many people with bladder cancer may not realize they qualify to participate in a clinical trial. Cancer clinicians—particularly those not affiliated with major research institutions—often fail to present these opportunities with their patients. “I gave educational talks to patient groups, and people came up to me and said they had no idea this option even existed,” he says. “In some cases, they ended up coming to Houston and participating.”
He recommends that patients bring up the subject themselves; Just asking your doctor if clinical trials are worth exploring could be enough to get the ball rolling. Also, websites such as ClinicalTrials.gov, maintained by the US National Library of Medicine, provide up-to-date information about current research trials. You can easily search for clinical trials that actively attract participants in your state or city. Meanwhile, most health systems and major research institutions maintain their own patient-facing websites that display clinical trial information. For example, MD Anderson, Dana Farber, and the Mayo Clinic provide these online resources.
Not everyone with bladder cancer will be a good candidate for a clinical trial. For some, the current standard of care may provide the most effective treatment for disease. “For a patient with low-grade bladder cancer, resection” — that is, surgical removal of the tumor — “has a very high cure rate,” Kamat says. “For this patient, it may not be advisable to participate [in a trial] Because the standard of care is very effective.”
On the other hand, being diagnosed with metastatic bladder cancer — that is, cancer that has spread to other parts of the body — may make the prospect of a trial more attractive. “Unfortunately for patients in this area, current treatments do not provide long-term long-term survival,” he says. Clinical trials may provide their best chance of beating averages. It may also provide alternatives to invasive procedures. Among people with non-muscle-invasive bladder cancer — a group that makes up about 75% to 80% of new bladder cancer patients — some don’t respond well to current medications, Camat says. In these patients, the bladder usually must be surgically removed. “This is an invasive, life-altering procedure, and clinical trials may provide another option,” he says. Of course each case is different and needs to be evaluated by the patient’s physician.
Some may be hesitant to sign up for what is essentially an experience. But Clinical trials They are tightly regulated to ensure that participants are not exposed to undue risks. Dana-Farber’s Sonpavde says clinical trials almost always build on previous work indicating that the intervention – that is, a new treatment or something else being studied – is at least not excessively risky compared to the current standard of care, and that there is evidence that it may be useful. “Once you do the trial, you already have basic research showing that the intervention is promising,” he says. There is always some element of risk. But with that risk comes the potential reward of getting new and better cancer treatment care, he says.
What does participating in a clinical trial look like
Let’s say you and your care team have Identified a clinical trial It can be appropriate. You will then meet with someone involved in the experience who will make sure that you understand exactly what the experience entails. You’ll get a comprehensive explanation of the study design, as well as any potential risks or drawbacks.
If you decide you want to proceed – that is, if you give your informed consent – you will likely go through some sort of screening process to make sure you meet the criteria for the trial. This may include additional tests — scans, biopsies, blood tests — in addition to checking your medical records. “Sometimes we start doing these assessments and something comes out that makes the patient ineligible,” Sonbavdi says. For example, your cancer’s genetic makeup may not fit the study guidelines, or you may be taking medications that would interfere with treatment. But if the screening process goes well, the study will likely start soon – usually within one to three weeks.
It’s important to highlight that in many clinical trials, some people don’t get the new drug or treatment. In other words, they are part of a ‘control’ group that will help the study team assess whether the new intervention provides a benefit. “Overall, the trial will compare a new treatment to a standard of care treatment,” Sunbavdi explains. In other words, even if you don’t get the new treatment, you’ll generally be no worse than if you didn’t sign up.
Another benefit of participating in clinical research is that in some cases – whether you are getting the new intervention or a control intervention – the cost of treatment will be covered by the trial. Outside of clinical trials, some high-end drugs may cost thousands of dollars — or they may not be available at all.
On the other hand, clinical trials will not usually cover the cost of accommodation or transportation for those participating. This can be a major drawback for those who do not live in cities or near research institutions. Also, participants are not usually compensated.
what is happening now
Almost every aspect of bladder cancer is now the focus of clinical research. But many areas are the subject of particularly keen interest.
Burjian says new treatments for non-muscle-invasive bladder cancer are one of the most active areas of research. He recently led a trial that looked at something called adenovirus vector therapy. “This involves infusing the new drug into the bladder to stimulate the immune system to attack the bladder cancer,” he says. His experiment found promising results, and his group is now recruiting participants for some related experiments. Meanwhile, Bordjian says a lot of current research is looking at new and improved ways to deliver effective treatments. For example, some trials are examining drug delivery mechanisms that are deregulated over time, which may offer advantages over standard intravenous injections. “We are looking for better ways to administer medications to reduce the risk of toxicity,” he says.
Another area of bladder cancer research focuses on personalized treatments for metastatic cancers. These precise drugs can be directed to specific targets on tumors. Burjian mentions some new classes of therapies designed to target specific genetic mutations within a person’s cancer cells. “We’re starting to target treatments to those tumors, and that’s another change that’s moving the field forward,” he says.
change the story
The National Cancer Institute estimates that this year alone, more than 80,000 people will be diagnosed with bladder cancer. More than 17,000 people diagnosed with bladder cancer will not live until 2023. Improving these numbers will depend on the clinical trials and the people who participate in them.
“The only way we can make more progress is for patients to get involved in this work,” Sunpavdi says. Again, not everyone will be a good fit, and participating in the experience may carry some risks. But you lose very little – and gain a lot – by exploring your options with your care team.
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