Immune check-point inhibitors (ICPi) are routinely used in cancer treatment in the United Kingdom and are associated with immune-related adverse events (irAE). Most patients with autoimmune disease (AID) are often excluded from clinical trials investigating ICPi, due to hypothetical increased risks of AID flare or severe irAE, but these risks have never been conclusively verified. We present experience using ICPi at a UK tertiary cancer centre, comparing the irAE profile and efficacy in patients with pre-existing AID to those without.
This was a single centre retrospective analysis of electronic records of solid tumour patients who received treatment with an ICPi from January 2017 to December 2020. From a total of 562 patients, 15 had pre-existing AID. These were compared to those without AID in a 1:3 matched cohort for tumour-type and treatment.
The AID cohort had inflammatory bowel disease (N=5), psoriasis (N=3), rheumatoid arthritis (N=2), polymyalgia rheumatica (N=2), autoimmune endocrinopathies (N=4), lupus (N=1) and sarcoidosis (N=1). 3 patients had 2 co-existing AID. All 15 patients had well controlled AID. 9 were on hormone replacement, immunosuppressive (prednisolone <10mg, n=2, mesalazine, n=1), or topical agents. 6 were not on AID treatment. The table below lists patient demographics, irAE and outcomes. 3 out of 15 AID patients had irAE possibly linked to their underlying AID (1 psoriasis, 1 RA, 1 colitis; no G3 or higher). No significant differences were found in the number of G3 or higher irAE, treatment discontinuation due to irAE, response to treatment, or survival between cohorts. Patient demographics, irAE and outcomes
No AID (n=45) AID (n=15) P-value Tumour type 0.9698 Gynaecological 3 1 Colorectal 6 2 Head & neck 3 1 Merkel cell 3 1 Urothelial 6 2 Non-small cell lung 24 8 Immunotherapy agent >0.9999 Atezolizumab 3 1 Pembrolizumab 27 9 Durvalumab 3 1 Nivolumab 6 2 Ipilimumab and nivolumab 6 2 Treated under clinical trial 0.8686 Yes 13 4 No 32 11 Total number of irAEs 0.5691 0 21 9 1 17 5 2 7 1 Grade 3-5 irAEs 0.42 Grade 3 or 4 8 1 Grade 5 1 0 Best response 0.1044 Stable disease 5 1 Mixed response 5 1 Complete or partial response 18 5 Progressive disease 14 4
Exacerbation of pre-existing AID was infrequent and did not result in severe toxicity. Patients with well-controlled AID could be considered for entry in clinical trials involving ICPi.
The authors.
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All authors have declared no conflicts of interest.