clinical trials for bladder cancer | Health Advice

sSometimes numbers tell a story, but sometimes they obscure one. According to the latest data from the National Cancer Institute, the death rate for people with bladder cancer has hardly decreased during the past 30 years. But experts who treat the disease tell a different and more optimistic story—and they attribute an increase in clinical trials to it. “Over the past five or six years, a lot of work has been done on new treatments for patients with bladder cancer, and we’re seeing unprecedented response with some of these new drugs,” said Dr. Stephen A. Burjian, professor and chair of the department of urology at Mayo Clinic in Rochester, Minn.

Some of the biggest advances in the treatment of bladder cancer involve a class of drugs called immune checkpoint inhibitors. They change the activity of a person’s immune system in a way that helps them fight cancer cells. “These paradigms are changing,” Burjian says. “The way we treat bladder cancer is different than it was just five years ago.”

Others in his area tell a similar story. For people with both metastatic and non-metastatic bladder cancer, the past half decade has seen the introduction of dozens of promising new treatments. Some have been revolutionary, while others have led to incremental but significant improvements in care. In each case, these progress are dependent on clinical trials and the people who participate in them.

“Clinical trials are kind of how we got here,” says Dr. Guru Sonpawde, director of the Bladder Cancer Program at the Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School in Boston. “All the new drugs that we’re coming up with that have changed the outcomes for patients with bladder cancer — 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 a disease. “Participating in a trial is often the only way to gain access to new and promising drugs, or therapeutic options that may be superior to the standard of care,” explains Sonpavde.

Although all types of cancer are the subject of ongoing research, he says bladder cancer may be one of the hottest areas for clinical-trial work. Part of this is due to the prevalence of cancer; Bladder cancer is the sixth most common cancer in the US, with more than 80,000 new cases diagnosed annually. But another factor is that, until recently, decades had passed without major breakthroughs in bladder cancer treatment. “We had some chemotherapy, but this was a cancer in which we didn’t see much progress until about five years ago,” says Sonpawde.

Like Burjian, he highlights the game-changing effect that inhibitors of immune checkpoints have on the treatment of bladder cancer. This and other advances have sparked an explosion in new research—and with it, the need for more people to participate in clinical trials.

Unfortunately, this need is not being met. Dr Ashish Kamat, an Endowed Professor of Urologic Oncology and Director of Bladder Cancer Research, says, “There are so many drugs and treatments being discovered in this area that in some cases there has not been enough patient participation to validate study results. ” MD Anderson Cancer Center in Houston. “To get reliable results, trials require a lot of patients, and until we have more involvement, it will be difficult to move the needle as much as we want.”

How to Find Clinical Trials

Part of the problem, Kamat says, is that many people with bladder cancer may not know they are eligible to participate in a clinical trial. Cancer doctors—especially those not affiliated with major research institutions—often fail to bring these opportunities with their patients. “I’ve given educational talks to patient groups, and people have come up to me saying they didn’t know this option existed,” he says. “In some cases they have fled to Houston.”

He recommends that patients discuss the matter themselves; Just asking your doctor whether clinical trials worth exploring may be enough to get the ball rolling. Also, websites such as clinicaltrial.gov, which is 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 are actively recruiting participants in your home state or city. Meanwhile, most major health systems and research institutions maintain their own patient-facing sites containing clinical trial information. For example, MD Anderson, Dana-Farber and the Mayo Clinic provide these online resources.

Not everyone diagnosed 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 the disease. “For a patient who has low-grade bladder cancer, a resection”—that is, surgical removal of the tumor—”has a very high cure rate,” says Kamat. “For this patient, it may not be appropriate to participate [in a trial] Because the standard of care is so effective.”

On the other hand, the prognosis for people with metastatic bladder cancer — that is, a cancer that has spread to other parts of the body — may make the prospect of a test more attractive. “Unfortunately for patients in this location, current treatments are not providing durable long-term survival,” he says. Clinical trials can provide your best chance to beat the average. They may also provide alternatives to invasive procedures. Kamat says that among people with non-muscle-invasive bladder cancer — a group that makes up about 75% to 80% of new bladder cancers — some don’t respond well to current medications. These patients should normally have their bladder removed surgically. “This is a life-changing invasive procedure, and clinical trials may provide another option,” he says. Of course, every case is different and should be evaluated by the patient’s physician.

Some may be hesitant to sign up for what is essentially an experiment. But clinical trials are strictly regulated to ensure that those who participate are not exposed to undue risks. Dana-Farber’s Sonpawde says clinical trials are always built on a foundation of prior work that suggests an intervention—that is, a new treatment or other study being conducted—at least compared to the current standard of care. Less is not overly risky, and there is evidence that it can be beneficial. “Once a trial is in place, you already have basic research showing that the intervention is promising,” he says. There is always some element of risk. But with this risk comes the potential reward of gaining access to new and better cancer care, he says.

Read more: Latest breakthroughs that could help bladder cancer patients

What it’s like to participate in a clinical trial

Let’s say you and your care team have identified a clinical trial that might be a good fit. You will next meet with someone involved in the test who will make sure you understand exactly what is involved in the experiment. You will find a full explanation of the study design as well as any potential risks or drawbacks.

If you decide you want to go ahead—that is, if you give your informed consent—you may need to go through some sort of screening process to make sure you meet the criteria for the test. This may include additional tests – scans, biopsies, blood tests – as well as checking your medical records. “Sometimes we start doing these evaluations and something comes up that makes the patient ineligible,” Sonpawde says. For example, the genetic makeup of your cancer may not ultimately meet the study guidelines, or you may be taking drugs that will interfere with treatment. But if the screening goes well, you’ll probably start studying sooner—usually within one to three weeks.

It is important to highlight that, in many clinical trials, some people do not receive a new drug or new treatment. In other words, they are part of a “control” group that will help the study team assess whether the new intervention provides benefits. “Typically, the trial will compare the new treatment to the standard-of-care treatment,” explains Sonpavde. In other words, even if you don’t get new treatment, you generally won’t get any worse if you didn’t enroll.

Another benefit of participating in clinical research is that in some cases — whether you’re receiving a new intervention or a control intervention — the cost of your treatment will be covered by the trial. Outside of a clinical-trial setting, some cutting-edge drugs will cost thousands of dollars—or they may not be available at all.

On the other hand, clinical trials will usually not cover the cost of the participants’ stay or transportation. This can be a major deterrent for those who do not live in cities or near research institutes. In addition, participants are usually not compensated.

Read more: Cancer care is changing, so patients no longer feel like a number

What is happening now

Almost every aspect of bladder cancer is now a focus of clinical research. But several areas are of particular intense interest.

Burjian says novel 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 adenoviral vector therapy. “This involves inserting a novel drug into the bladder to stimulate the immune system to attack the bladder cancer,” he says. His trial yielded promising results, and his group is now recruiting participants for some related trials. In the meantime, Bourgen says a lot of current research is looking at new and better ways to deliver effective treatments. For example, some trials are examining time-released delivery mechanisms for drugs, which may confer advantages over standard intravenous injections. “We are looking at better ways to administer drugs to reduce the risk of toxicity,” he says.

Another hot area of ​​bladder cancer research is focusing on personalized therapies for metastatic cancer. These precision drugs can be directed at specific targets identified on the tumor. Burjian mentions a few new classes of therapy that are designed to target specific genetic mutations within a person’s cancer cells. “We’re starting to target therapies for those tumors, and this is another step-ahead change,” he says.

story change

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 with bladder cancer just won’t live to see 2023. Improving these figures will depend on clinical trials and the people who participate in them.

“The only way we can move forward is to get patients to take part in this work,” says Sonpavde. Again, not everyone will be a good fit, and participating in the test can carry some risks. But you lose little — and stand to gain a lot — by exploring your options with your care team.

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