Clinical trials for kidney cancer: What you need to know

Ifortunately, in most cases, Kidney cancer is caught before spreading to other parts of the body. For these patients, treatment usually includes nephrectomy, which is the surgical removal of one or both kidneys. The goal of surgery is to prevent the cancer from spreading. Unfortunately, many people who undergo nephrectomy for disease have a high risk—between 20% and 50%, according to recent estimates—of eventually developing metastatic cancer.

Until recently, there was not much a person’s care team could do in this situation to prevent the cancer from coming back. Reliably effective “adjuvant” immunotherapies—something added to surgery to prevent the cancer from returning—have yet to be identified. But in 2021, New England Journal of Medicine publish the results of a Groundbreaking clinical trial. The trial involved about 1,000 people who underwent nephrectomy with a high risk of cancer recurrence. About half of the people took the placebo drug, while the other half took a kidney cancer drug called pembrolizumab. Pembrolizumab is an immune checkpoint inhibitor—an immunotherapy drug that stimulates the immune system to fight cancer cells. After two years of follow-up, trial participants taking the immunotherapy drug were less likely to have a cancer recurrence than those taking a placebo. A few months later, the U.S. Food and Drug Administration (FDA) approved pembrolizumab as an adjuvant treatment.

“This is a win-win situation,” said Dr. Toni Choueiri, one of the leaders of that trial and director of the Lank Genital Cancer Center at the Dana-Farber Cancer Institute in Boston. profit. Not only do trial participants benefit from the drug, but the trial’s findings help expand the medical community’s knowledge of the disease and its arsenal.

Clinical trials like the Choueiri-led event is happening all the time around the country. They are a necessary step—and often the final step—in the development of new drugs to treat kidney cancer. But they don’t always involve drugs. Clinical trials are also used to test the effectiveness of new surgical techniques, new diagnostic procedures, and anything else that can improve the lives of people with kidney cancer. While some trials create new ground, others test for small changes to existing standards of care—such as increasing or decreasing drug doses or changing the way side effects are managed. side effects of treatment. In any case, the results of one trial help shape the treatment of people with kidney cancer, and therefore their importance cannot be overstated.

Here, Choueiri and other kidney cancer experts detail the latest developments in the trial landscape. They also explain who is eligible to participate in a clinical trial, how to enroll in a trial, and how the trial has helped revolutionize the field of kidney cancer drugs.

Mapping the current test context

Kidney cancer does not respond well to conventional cancer treatments, such as radiation therapy or standard chemotherapy. As recently as 2005, only one drug—an immunotherapy drug called interleukin-2—was approved by the FDA to treat kidney cancer.

Thankfully, the situation today is much different. “We currently have more than a dozen FDA-approved drugs, and each drug has been approved and is ready for use thanks to the following guidelines,” said Dr. James Brugarolas, director of the Kidney Cancer Program at Texas Southwestern University. randomized clinical trial. Medical Center in Dallas.

Brugarolas is engaged in translational research, which aims to bring scientific discoveries made in the laboratory or in animal models into the field of human medicine. Some of his recent studies are related to a transcription factor called HIF-2. Transcription factor is basically a protein molecule that controls gene activity, and HIF-2 regulates genes that influence kidney cancer tumor growth. For many years, there has been speculation that blocking the action of HIF-2 might prevent or slow the growth of kidney cancer. However, due to the unusual structure of HIF-2, conventional drugs cannot bind to it. Brugarolas said HIF-2 is essentially “uncontrollable”. But a few years ago, researchers at UT Southwestern identified a flaw in the HIF-2 protein that could be exploited with specially designed drugs. Brugarolas helped develop those drugs, called HIF-2 inhibitors, and a series of clinical trials have demonstrated that they are effective for certain types of kidney cancer. “Very few cancer drugs target transcription factors, so this is a new paradigm,” he said.

Brugarolas notes that clinical trials of HIF-2 inhibitors are ongoing, and similar trials are looking at many other new drug treatments. Like other forms of cancer, kidney cancer is not really a disease, he said. It would be more accurate to call it a family of related cancers with diverse features. Some of his other work, including clinical trials he leads, has looked at these characteristics to determine how certain groups of patients will respond to certain therapies.

While some clinical trials test groundbreaking new treatments, others involve new existing drugs. Eric Jonasch, a kidney cancer specialist and professor of internal genital oncology at MD Anderson Cancer Center in Houston, says this type of “combination therapy” is a special area. active in kidney cancer research. Several combinations have received FDA approval. “Multiple combinations are being worked on, and not only dual but triple combinations.”

Not all experimental work involves drug treatment. “There have been advances in surgical techniques, such as robotic surgery,” says Jonasch. A specialized type of radiation therapy is another promising area of ​​research. “The ability to focus radiation while minimizing side damage has been significantly improved,” he said. Radiation may offer improvements over broader “systemic” treatments for people with metastatic kidney cancer. He adds: “It can even treat kidney tumors on its own without surgery.

The benefits of all this testing are substantial—and quantifiable. “Kidney cancer is a disease where maybe 15 years ago, a person diagnosed with stage 4 had only a year to live, and now the average is almost five years,” says Choueiri. The next decade is sure to bring more dramatic improvements in the lives and longevity of people with kidney cancer. But to get there, clinical trials need participants.

Read more: Coping with the side effects of kidney cancer treatment

Benefits of participating in a clinical trial

The exact risks and rewards of participating in a clinical trial will vary from one patient—and the trial—to the next. But in general, experts say there are two compelling reasons for people with kidney cancer to participate in this type of medical research.

“First, participating in a trial can give patients the opportunity to access therapies they may not otherwise have access to,” says Jonasch. In nearly all cases, the costs of these therapies – which can be substantial – will be covered by the companies or organizations conducting the trials.

For those who might be nervous about trying an experimental treatment, Jonasch says every clinical trial must be approved by a review board — an unaffiliated group of experts that scrutinizes the trial. recommended to ensure that participants are not exposed to undue risk. “Due to the way ethics boards work these days, chances are you’ll get something equal to or superior to standard care,” he said. Research in Journal of the National Cancer Institute have found that people with cancer who participate in clinical trials tend to do slightly better than those who do not. Especially for people with terminal cancer with a poor prognosis, participating in the trial could be beneficial, that study found.

It’s no exaggeration to say that participating in a clinical trial means the difference between life and death for some participants. “I have a lot of patients participating in small molecule drug clinical trials. [drugs] or immunotherapies, if they had received the standard of care back then, they would not be alive now,” Choueiri said.

Another benefit of participating in the trial is the impact its findings have on the cancer community. “You’re expanding our knowledge of this disease, and you’re helping to develop therapies that may benefit other patients,” says Jonasch.

One of the tragedies of cancer is that, in many cases, it robs a person of all the good that a person could have done had their life not been interrupted or cut short by the disease. “For many patients, their lives have been dramatically ruined by cancer, and they can appreciate the opportunity to help others with similar conditions,” says Brugarolas.

Read more: Latest breakthroughs could improve kidney cancer treatment

How to join a clinical trial

The first step, says Choueiri, is to ask your care team if you might be a good candidate for a clinical trial. A referral from a doctor or oncologist is the most common way to sign up for a trial.

However, you may also have to do some small research on your own. “The entire field of cancer, not just kidney cancer, is expanding at a rate that makes it difficult to know everything that is going on,” Choueiri said. If you are not being treated at a large research hospital or health system, your care team may not be aware of trials that could benefit you.

There are many ways to find tests on your own. “Go to,” suggests Jonasch. This is a comprehensive database of ongoing clinical trials in the United States and other parts of the world. You can search for it based on your cancer type and location, and it can help you find tests worth telling your doctor about.

Jonasch also recommends connecting with organizations that advocate for kidney cancer patients, such as the Kidney Cancer Society and the International Kidney Cancer Alliance, to inquire about clinical trials. “These groups can be a tremendous resource for navigating these waters,” he said.

Finally, he said, there is a particularly strong need for greater experimental participation by people of color, who are not always appropriately represented in this work. He blamed accessibility and recruitment problems for these shortcomings. “We’re still not getting it right, but there are efforts underway to make sure we’re reaching communities that may not otherwise have access to clinical trials,” he said. “It is extremely important that we have a diversity of representation to ensure we understand the impact across all patient groups.”

Clearly, there’s a lot going on in the kidney cancer testing space. It is certain that more breakouts may soon follow.

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