Immune checkpoint inhibitors are associated with similar survival outcomes among patients with advanced non–small-cell lung cancer (NSCLC), regardless of a patient’s history of autoimmune disorders, according to a retrospective study. Such patients are typically excluded from clinical trials. Overall frequency of adverse events was similar between the two groups, but a secondary analysis revealed higher rates of some adverse events in patients with active autoimmune disease, suggesting caution in this group. The analysis of outcomes (abstract 110) was presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago.
ASCO Expert David Graham, MD, of the Levine Cancer Institute in Charlotte, North Carolina, told Cancer Network, “Given the mechanism of action, we have worried that we could cause more difficulties for patients with autoimmune disorders than the benefits they would obtain. These data give credence that a population of patients with lung cancer and a history of autoimmune disorders may be able to receive the important benefits of immunotherapy. In the end, short of situations [like] active Crohn’s or inflammatory bowel disease, we can consider these patients as candidates for these important therapies.”
The researchers retrospectively analyzed data from ASCO’S CancerLinQ database that included 2,425 patients with advanced NSCLC who had at least one dose of an immune checkpoint inhibitor in 2 or more visits. Patients were considered to have an active autoimmune disease if there was evidence of a condition in the year prior to initiating immune checkpoint inhibitors, based on ICD-9/ICD-10 codes or use of therapies like systemic steroids.
Ninety-four percent of patients received PD-1 inhibitors; 22.1% of those patients had evidence of active autoimmune disease.
Twenty-two percent of patients had an active autoimmune disorder. The median overall survival was 12.4 months in all patients, 12.8 months in patients with no autoimmune disease, and 11.5 months in those with autoimmune disease (P = .13). There was no significant difference between patients with autoimmune disease and those without autoimmune disease in time to treatment discontinuation (P = .13), time to next treatment (P = .63), or real-world progression-free survival (P = .74).
The overall frequency of adverse events was similar between the two groups, but the researchers did note an increase in adverse events in the autoimmune disease group, including endocrine (4.9% vs 3.2%), gastrointestinal (8.9% vs 7.6%), and blood disorders (3.8% vs 2.4%).
“If they have active disease, particularly if they are on corticosteroid therapy, I would avoid immunotherapy completely. Mainly, I’m thinking of patients with active inflammatory bowel disease, sarcoid, etc. Otherwise, I would discuss it with the patient using a lot of warnings that we might have to stop things short if they run into trouble. If the patient is agreeable, I would go ahead,” said Graham.