Toxicities Associated with Immunotherapy Warrant ‘Very High Level of Suspicion’
Since 2011, the FDA has approved six immune checkpoint inhibitors designed to reverse the course of multiple cancers.
Those approvals — along with oncologists’ willingness to combine immunotherapies — has led to more durable responses among patients with cancer.
However, many oncologists say the toxicities associated with immunotherapies, especially those used in combination, pose a greater risk to patients than often reported in clinical trials funded by the pharmaceutical companies that develop and distribute these drugs.
“A lot of physicians grew up in the era of chemotherapy and targeted therapy, and now immunotherapy comes along and everyone is excited,” Igor Puzanov, MD, MSCI, FACP, director of early phase clinical trials and chief of melanoma at Roswell Park Cancer Institute, told HemOnc Today. “Clinicians want to provide these immunotherapies to their patients but, at the same time, they need to get the help to manage the new toxicities. These drugs are good and they are saving lives, so we must figure it out.”
Toxicities from combination immunotherapy can range from skin rashes, mucositis and diarrhea to colitis, sepsis, hypothyroidism, hyperthyroidism, pneumonitis, myocarditis, arrhythmia, type 1 diabetes and hypophysitis. These can occur within weeks after initiation.
“These side effects can happen and, when they happen, they can be severe and lethal,” Ryan J. Sullivan, MD, assistant professor of medicine at Harvard Medical School and assistant professor of hematology/oncology at Massachusetts General Hospital, told HemOnc Today. “Even when we’re using single-agent PD-1 inhibitors, we need to be vigilant at diagnosing immune-related toxicities and managing them early as opposed to waiting to begin actively pursuing a diagnosis and therapy. The earlier you identify the toxicity, the better the management.”
David M. Waterhouse, MD, MPH, Co-Director of Research at OHC agrees. “They are correct to cite that prompt recognition of side effects and early recognition is very important. They are also correct that combining therapies is proving more challenging than many anticipated. That said, the IO drugs offer incredible promise. The drugs we have now are the model T’s and we have to allow time to move the bar further, which is another reason why clinical trials are so important.”
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