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Immune-Related Toxic Effects and Treatment Outcomes in Patients With Cancer and Autoimmune Diseases Receiving Immune Checkpoint Inhibitor Therapy


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In a single-institution retrospective cohort study reported in JAMA Oncology, Han et al found that patients with autoimmune diseases had similar outcomes with immune checkpoint inhibitor (ICI) therapy for solid tumors as those without autoimmune diseases, with occurrence vs no occurrence of autoimmune disease flare or immune-related adverse events in such patients being associated with improved outcomes. Patients with active autoimmune diseases had poorer outcomes.  

Study Details

The study included data from 1,822 patients with 18 types of solid tumors diagnosed from January 2015 to December 2018 who received ICI treatment with PD-1/PD-L1 inhibitor monotherapy or combination therapy at Memorial Sloan Kettering Cancer Center. A total of 147 patients (8.1%) had autoimmune diseases, most commonly psoriasis (n = 38) and rheumatoid arthritis (n = 18); of these, 25 patients (16.9%) had active autoimmune disease requiring systemic immunosuppression at ICI initiation. No significant differences in baseline characteristics were identified between the autoimmune disease and non–autoimmune disease groups.

The findings of this cohort study suggest that safety and efficacy of ICIs are similar between patients with cancer with and without concurrent autoimmune disease diagnoses. Immune-associated toxic effects in patients with autoimmune diseases appear to be associated with superior immunotherapy efficacy, with the caveat that patients with active autoimmune disease had poorer outcomes.
— Han et al

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Key Findings

Rates of objective response (28.6% vs 25.7%, P = .43) and overall survival (hazard ratio [HR] = 0.95, 95% confidence interval [CI] = 0.76–1.17, P = .61) did not significantly differ between the total autoimmune disease group vs the non–autoimmune disease group.

Among the 147 patients with autoimmune diseases, 87 (59.1%) had ICI toxicity, consisting of disease flare (worsening of autoimmune disease) in 20 (13.6%), immune-related adverse events in 45 (30.6%), and both in 22 (14.9%). Among 42 patients with disease flare, 34 (81%) had grade 1 or 2 and 8 (19%) had grade 3 toxicity; 14 (33%) required immunosuppressive treatment. Among 67 patients with immune-related adverse events, 51 (76%) had grade 1 or 2, 13 (19%) had grade 3, and 2 (3%) had grade 4 toxicity; of a total of 106 immune-related adverse events, 40 (37.7%) were treated with immunosuppression. Disease flare was more common in patients with active vs nonactive autoimmune diseases (60.0% vs 22.1%, P < .001).

Patients with autoimmune diseases who experienced disease flare or immune-related adverse events (toxic effects) had a higher objective response rate vs those who did not (42.5% vs 8.3%, P < .001). On multivariate analysis including toxic effects as a time-varying covariate, patients with autoimmune diseases who experienced toxic effects had significantly improved overall survival compared with those without or who had not yet experienced toxic effects (HR = 0.55, 95% CI = 0.32­–0.95, P = .03).

Patients with active autoimmune diseases had a similar objective response rate vs those with nonactive autoimmune diseases (24.0% vs 29.5%, P = .64), but significantly poorer overall survival (HR = 2.81, 95% CI = 1.41­–5.58, P = .003).

The investigators concluded, “The findings of this cohort study suggest that safety and efficacy of ICIs are similar between patients with cancer with and without concurrent autoimmune disease diagnoses. Immune-associated toxic effects in patients with autoimmune diseases appear to be associated with superior immunotherapy efficacy, with the caveat that patients with active autoimmune disease had poorer outcomes.”

Luc Morris, MD, MSc, of the Department of Surgery, Memorial Sloan Kettering Cancer Center, is the corresponding author for the JAMA Oncology article.  

Disclosure: The study was supported by Fundación Alfonso Martín, National Institutes of Health, National Cancer Institute, and others. For full disclosures of the study authors, visit jamanetwork.com.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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