In 2019, the National Cancer Institute (NCI) revealed that a group of researchers has launched a clinical trial to examine an immunotherapy drug in patients who have been diagnosed with both cancer and autoimmune diseases, such as lupus, rheumatoid arthritis, or type 1 diabetes.
Immunotherapy drugs improve the ability of the immune system to recognize and attack tumor cells. In recent years, immunotherapy treatments have benefited a growing number of men and women, including patients with advanced cancers.
However, doctors have not uncovered whether immunotherapy is completely safe and effective for those who have both an autoimmune disease and cancer because such patients have been excluded from most clinical trials of immunotherapy drugs.
In this post, we will explore the clinical trial that’s making the future of immunotherapy brighter for everyone, especially to people with autoimmune diseases.
Why Clinical Trials Refuse People With Both Cancer and Autoimmune Diseases
According to Dr. Hussein Tawbi of the University of Texas MD Anderson Cancer Center and one of the head investigators for the new trial, an overactive immune system is the main reason why scientists and medical researchers have excluded many people with both autoimmune diseases and cancer from hundreds of clinical trials testing the efficacy of immunotherapy drugs.
For medical professionals who treat patients with both diseases, the general lack of information on the effects of immunotherapy in people with cancer and autoimmune diseases has caused a clinical conundrum. Many doctors have been hesitating to use immunotherapy drugs in patients with autoimmune diseases because they do not have substantial evidence supporting the safety of such drugs when introduced to a patient with multiple sclerosis, Sjögren syndrome, and other autoimmune diseases. “There is no guidance on how to handle these cases,” says Tawbi.
Improving the Future of Immunotherapy in People With Autoimmune Diseases
The objectives of the new clinical trial, which NCI is sponsoring, include:
- To help researchers understand the benefits of immunotherapy in cancer patients with autoimmune diseases
- To identify the potential risks of immunotherapy treatments in patients with both cancer and autoimmune diseases
The clinical trial could also provide more information on the biology of autoimmune diseases, which may help scientists explore new treatments.
“This study is the first of its kind,” Dr. Tawbi proudly announces. What the researchers unveil may allow medical professionals to extend the promise of immunotherapy in a safer manner to those who have an existing autoimmune disease and a malignant disorder.
About 10 to 30 percent of cancer patients have an autoimmune disease, reveals Dr. Elad Sharon of NCI’s Cancer Therapy Evaluation Program and a leading contributor to the study. As such, the results of the trial could change the future of thousands, if not millions, of patients.
Releasing the Immune System’s Brakes
Autoimmune diseases occur when the immune system “malfunctions” and begins to attack the body’s healthy tissues.
Immunotherapy drugs work by “releasing the brakes” on the human immune system, which then allows immune cells to detect and kill tumor cells. However, some doctors have been concerned about stimulating the immune system to fight cancer in people with autoimmune diseases, as it may “unleash the wrath of autoimmunity,” leading to potentially severe complications.
The Clinical Trial: Participants, Tests, and More
To put a rest to such concerns, the new clinical trial will involve 260 people who have advanced cancer and autoimmune disease, including systemic sclerosis, dermatomyositis, rheumatoid arthritis, inflammatory bowel disease, lupus, multiple sclerosis, Sjögren’s syndrome, and Crohn’s disease.
Each participant will receive nivolumab (Opdivo), an immune checkpoint inhibitor that the Food and Drug Administration (FDA) approved for treating a number of malignant diseases, including lymphoma, lung cancer, kidney cancer, liver cancer, and bladder cancer, among others.
To ascertain the safety of the immunotherapy drug, the researchers will monitor participants for any sudden emergence of “flares” or severe autoimmune symptoms. Moreover, the researchers will analyze the drug’s overall effectiveness by tracking each patient’s response to the treatment, how long each patient survives without their cancer and autoimmune diseases progressing, and how long the patients survive.
The Source of Hope for a Promising Tomorrow
One of the many reasons for doing this trial is that immunotherapy, in general, has cured many patients with advanced or metastatic cancer, evident in New Hope Unlimited’s survivor success stories. Many of these featured patients are thriving today because of effective immunotherapy treatments.
“If we can learn how to use immunotherapy to treat people with both cancer and autoimmune diseases, then we could offer these patients potentially curative therapy,” says Tawbi.
Immunotherapy Already Works for Some Patients With Both Diseases
In the United States, even though no clinical trial has tested immunotherapy in people with both cancer and autoimmune disease, some physicians have shared their experiences in treating such patients with immunotherapy.
For instance, a series of case reports in medical journals suggest that patients with cancer and autoimmune diseases may respond to immunotherapy treatments positively and the same as patients without an autoimmune disease.
Patients with stimulated immune systems may experience more immune-related side effects as one would expect. Still, a patient who experiences such side effects can respond to immune checkpoint inhibitors, explained Dr. Alexandra Drakaki of the David Geffen School of Medicine at the University of California, Los Angeles.
“We hope to learn more about this from the new NCI-sponsored clinical trial,” she added.
Patients Simply Want to Survive
Dr. Drakaki has incorporated immunotherapy drugs to treat some of her patients with metastatic cancer and autoimmune disease outside of a clinical trial, and most of the immune-related side effects have been manageable, she said.
Her patients have been willing to accept the possible risks of worsening autoimmune symptoms in exchange for promising cancer treatment results. These patients, she noted, were generally in good health and had “well-controlled” autoimmune diseases.
My patients, “they just want to be alive. They don’t care if their autoimmune symptoms are going to get worse temporarily,” she stressed.
The Bottom Line
Ultimately, although many patients have already benefited from immunotherapy treatments, the ongoing research hopes to better understand the mechanisms that cause treatment-related side effects in cancer patients with autoimmune diseases. The findings could eventually lead to new therapies for people with both cancer and autoimmune conditions.
Is Cancer Immunotherapy Right for You?
New Hope Unlimited gives you easy access to world-class doctors and immunotherapy experts. To determine your candidacy for immunotherapy treatments, call 480-666-1403 now to schedule a consultation. Harnessing the body’s natural defenses might be the solution you’ve long been seeking.