Powerful cancer immunotherapy may be safe for some patients with underlying rheumatologic disease, a small study indicates.
Uma Thanarajasingam, MD, PhD, from the Mayo Clinic in Rochester, Minnesota, and colleagues, published their findings online January 24 in Arthritis and Rheumatology.
The researchers found that when patients with rheumatalogic diseases who later were diagnosed with cancer were prescribed immune checkpoint inhibitors (ICIs), only 38% had a flare of their disease or severe immune-related adverse effects (IRAEs) and were not at greater risk for such complications than were people in the general population.
The most common IRAEs are mild cutaneous or gastrointestinal symptoms, and the rate of severe IRAEs with a single ICI is less than 2% in the general population, according to the paper.
“Based on our observations, immune checkpoint inhibitor therapy should be considered in select patients with pre-existing rheumatologic disease,” Dr Thanarajasingam said in a news release. “However, there is an immediate and pressing need for prospective, and ideally multi-center trials to study rheumatic patients who go on to need immune checkpoint inhibitor therapy – both to better understand their safety profile in this under-studied patient group, as well as elucidate risk.”
The team reviewed medical records to identify all patients who received immune checkpoint inhibitor therapy who had preexisting rheumatologic disease at Mayo Clinic, Rochester, Minnesota, between 2011 and 2016 (about 5200).
Sixteen patients were identified (81% women; median age, 68.5 years). The most common rheumatologic diseases were rheumatoid arthritis, polymyalgia rheumatica, Sjögren’s syndrome, and systemic lupus erythematosus. The most common cancer was malignant melanoma, followed by pulmonary malignancies and non-Hodgkin lymphoma. Six patients (38%) had an IRAE or flare of their rheumatologic disease, and for two of them, effects were mild. All responded well to glucocorticoids and therapy discontinuation.
David Pisetsky, MD, PhD, professor of medicine and immunology at Duke University Medical Center in Durham, North Carolina, noted that the study had limitations, including being very small and retrospective and potentially having selection bias, but told Medscape Medical News the findings were “encouraging.”
He said about ICIs, which were introduced in 2011, “this is going to be one of the biggest things in cancer.”
This study is one of the first to show that the immunotherapy may at least not hurt cancer patients with preexisting rheumatologic or autoimmune disease, he said.
Immune checkpoint therapy trials initially excluded patients with underlying rheumatologic diseases for fear that the drugs would worsen their condition.
This article’s findings indicate that if someone with preexisting rheumatologic disease “had advanced malignancy, that is not a reason to withhold this therapy,” Dr Pisetsky said.
These kinds of studies are just starting to come out because the first approvals for ICIs were limited in the forms of cancer that would be treated, he added. Now tests for wider use are happening, and larger trials will shed light on who can and should get them and who should not because the risk would be too great, he said.
Dr Pisetsky added, “To me, this is encouraging that we’re not going to significantly worsen these rheumatic diseases in the short term, and patients who have malignancy and a rheumatic disease can certainly be considered” for ICIs.
One unanswered question is that if a patient has a problem after taking an ICI, it is hard to determine what caused it. Patients getting this therapy have already been on many other therapies, Dr Pisetsky notes, so it is hard to separate out the effect of the ICIs alone.
He noted that most cancer therapies are associated with adverse effects.
“In the setting of advanced malignancy,” Dr Pisetsky said, “we understand that the risk and benefit tradeoff has to be different than for someone who does not have these morbidities.”
In a future study he would like to see it tested with more rheumatic conditions to see if there are some that would be made much worse by these drugs.
The authors agree that larger, prospective studies will be necessary to validate the findings and establish evidence-based guidelines so IRAEs can be properly identified and rated.
Dr Thanarajasingam serves on the advisory board of Bristol-Myers Squibb, which makes some of the cancer immunotherapies. The remaining authors and Dr Pisetsky have disclosed no relevant financial relationships.
Arthritis Rheumatol. Published online January 24, 2018. Abstract
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