The American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) recently developed a set of guidelines to serve as recommendations to clinicians regarding how to assess and manage the side effects associated with immune checkpoint inhibitors.
They were published in The Journal of Clinical Oncology, under the title “The Management of Immune-related Adverse Events in Patients Treated with Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline and NCCN Guidelines® for Management of Immunotherapy-Related Toxicities.”
“With rapidly increasing use of immune checkpoint inhibitors, it is imperative that clinicians are knowledgeable about their unique toxicity profiles,” Clifford A. Hurdis, MD, chief executive officer of ASCO, said in a press release. “These new guidelines from ASCO and NCCN will help our community continue to provide the highest quality of care to all patients as they incorporate these agents into routine care.”
The guidelines recommend that cancer patients:
- with mild toxicities (grade 1) — except for some neurologic and hematologic toxicities — continue with treatment
- with moderate toxicities (grade 2), temporarily stop use of checkpoint inhibitors until lab work or symptoms show the reaction is mild or better; corticosteroids can be a replacement therapy
- with severe toxicity (grade 3), be managed with high-dose corticosteroids for at least six weeks; extreme caution is advised when restarting immunotherapy, if the treating physician decides to try such treatment again
- with evidence of very severe cases of toxicity (grade 4), immediately and permanently stop use the checkpoint inhibitor
Specific recommendations are given, depending on the affected organ.
These guidelines are specific to immune checkpoint inhibitors, the groups said, and are not applicable to other types of immunotherapy. An educational video accompanies their publication, created for patients and caregivers.
Immune checkpoint inhibitors are a type of immunotherapy, relatively new, that bolster the immune system’s response to “an invader” so as to attack and destroy cancer cells. But side effects associated with this therapy can involve multiple organs, and can be severe and irreversible. Because use of immune checkpoint inhibitors is relatively recent, doctors are not necessarily highly experienced in recognizing and treating such side effects.
Common side effects of immune checkpoint inhibitors include rash, diarrhea, low thyroid hormone, and fatigue. But known side effects extend to inflammation of the lung, intestines or liver, hormonal abnormalities, and kidney, heart, or neurologic problems.
“If you take the brakes off the immune system and allow it to attack cancer, it may also attack the healthy tissue in a patient’s body,” said John Thompson, MD, co-director of the Seattle Cancer Care Alliance Melanoma Clinic, Fred Hutchinson Cancer Research Center, and a co-chair of the panel that developed the ASCO guideline. “Fortunately, most of the side effects are reversible, but early recognition and proper treatment are critical.”
Immune checkpoint inhibitors approved by the U.S. Food and Drug Administration (FDA) to help patients with a variety of cancers include Opdivo (nivolumab), Yervoy (ipilimumab), Keytruda (pembrolizumab), Bavencio (avelumab), and Tecentriq (atezolizumab).
“While novel immunotherapies allow for life-extending therapy for selected forms of cancer, their success is associated with potentially substantial toxicity,” said Robert W. Carlson, MD, chief executive officer of NCCN. “These side effects are different from other forms of anticancer therapy and require rapid and appropriate recognition and treatment.”
The guidelines were developed with input from multidisciplinary panels composed of experts in such fields as medical oncology, pulmonology, hematology, neurology, emergency medicine, and included patient advocates, the release notes. The recommendations are based on a systematic review of literature and an informal consensus process with the panels.