ATLANTA — "Immunotherapy operates on this very simple principle: a patient's cancer can be eradicated if we can just instruct the immune system to eradicate it," said Ryan Sullivan, MD, associate director of the melanoma program at Massachusetts General Hospital in Boston. "But for patients with autoimmune disease, it comes with a catch."
Immunotherapy helps a patient's immune system locate and destroy tumor cells, he explained here at the American College of Rheumatology 2019 Annual Meeting. But for patients without a normal immune system — those with rheumatoid arthritis, for example, or Crohn's disease — immunotherapy could supercharge existing problems in the immune system, causing severe adverse effects that could worsen symptoms.
It is a cold reality that has left thousands of patients with autoimmune disease and cancer out of the many clinical trials of immunotherapy. And although some cancer centers are offering immunotherapy to these patients, it is not a formal guideline, and oncologists often do so only when no other options are available.
"These drugs are really amazing; they help a lot of people," Sullivan told Medscape Medical News. "But there is a very large group of people that they are not helping because we haven't studied the toxicity they might present to people with autoimmune disease."
So earlier this year, the National Cancer Institute (NCI) launched a phase 1 clinical trial to evaluate how effective nivolumab is for the treatment of cancer in patients with autoimmune disorders, said Sullivan's copresenter, Elad Sharon, MD, senior investigator and medical officer of the cancer therapy evaluation program at the NCI.
Clinical Trial in Autoimmune Disorders
Study participants have different autoimmune diseases — including dermatomyositis, rheumatoid arthritis, lupus, ulcerative colitis, Crohn's disease, multiple sclerosis, and Sjogren's syndrome — at different levels of severity.
The researchers hope to build a repository of blood samples and, if possible, tumor samples from this patient population to create a scientific resource that will increase the understanding of cancer and autoimmune disease and be used to test treatment options, Sharon said.
"Can patients with autoimmune diseases be treated with immunotherapies?" he asked. "Can patients be retreated with these therapies to mitigate the risk?"
"So far we have zero protocols for answering these questions," he told Medscape Medical News.
Between 10% and 30% of all cancer patients have an autoimmune disease, said Hussein Tawbi, MD, PhD, director of melanoma clinical research and early drug development at the University of Texas M.D. Anderson Cancer Center in Houston, who is one of the lead NCI trial investigators.
"And not only are these people excluded from immunotherapy treatment, because nobody dares to treat them, they are at a higher risk of developing cancer to start with," Tawbi explained, because they "are often on chronic immune suppression therapy."
"That's what we really had been thinking about," he told Medscape Medical News. "Can we do this in a very controlled and measured way, and really identify what the toxicities are, how much is the risk, and how you need to handle it to treat side effects as they arise?"
"You have people who are — with autoimmune disease — unfortunately immune to themselves," he said.
We have cancer therapy that is very safe and effective for average patients, he pointed out. "It's really hard to tell someone, 'I'm not going to give you this drug I have on the shelf that can cure you because I'm afraid I'm going to hurt you.' This study should help us start to understand how to better manage those patients."
Initial results from the trial, designed with help from rheumatology experts at Johns Hopkins University Medicine in Baltimore, should be available in about 2 years, Tawbi said.
American College of Rheumatology (ACR) 2019 Annual Meeting. Presented November 10, 2019.
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Cite this: The Trick of Treating Cancer in Autoimmune Diseases - Medscape - Nov 22, 2019.