@article{2999633, title = "Real-world safety and efficacy data of immunotherapy in patients with cancer and autoimmune disease: the experience of the Hellenic Cooperative Oncology Group", author = "Fountzilas, E. and Lampaki, S. and Koliou, G.-A. and Koumarianou, A. and Levva, S. and Vagionas, A. and Christopoulou, A. and Laloysis, A. and Psyrri, A. and Binas, I. and Mountzios, G. and Kentepozidis, N. and Kotsakis, A. and Saloustros, E. and Boutis, A. and Nikolaidi, A. and Fountzilas, G. and Georgoulias, V. and Chrysanthidis, M. and Kotteas, E. and Vo, H. and Tsiatas, M. and Res, E. and Linardou, H. and Daoussis, D. and Bompolaki, I. and Andreadou, A. and Papaxoinis, G. and Spyratos, D. and Gogas, H. and Syrigos, K.N. and Bafaloukos, D.", journal = "Cancer Immunology, Immunotherapy", year = "2022", volume = "71", number = "2", pages = "327-337", publisher = "Springer Science and Business Media Deutschland GmbH", issn = "0340-7004, 1432-0851", doi = "10.1007/s00262-021-02985-6", keywords = "adult; aged; autoimmune disease; female; follow up; human; immunology; immunotherapy; male; middle aged; mortality; neoplasm; pathology; prognosis; retrospective study; survival rate; very elderly, Adult; Aged; Aged, 80 and over; Autoimmune Diseases; Female; Follow-Up Studies; Humans; Immune Checkpoint Inhibitors; Immunotherapy; Male; Middle Aged; Neoplasms; Prognosis; Retrospective Studies; Survival Rate", abstract = "Background: Data on the safety and efficacy of immune checkpoint inhibitors (ICI) in patients with concurrent autoimmune diseases (AID) are limited. Methods: We performed a retrospective multicenter review of medical records of patients with cancer and underlying AID who received ICI. The primary endpoint was progression-free survival (PFS). Results: Among 123 patients with pre-existing AID who received ICI, the majority had been diagnosed with non-small cell lung cancer (NSCLC, 68.3%) and melanoma (14.6%). Most patients had a rheumatologic (43.9%), or an endocrine disorder (21.1%). Overall, 74 (60.2%) patients experienced an immune-related adverse event (irAE) after ICI initiation, AID flare (25.2%), or new irAE (35%). Frequent irAEs included thyroiditis, dermatitis and colitis. ICI was permanently discontinued due to unacceptable (8.1%) or fatal (0.8%) toxicity. In patients with NSCLC, corticosteroid treatment at the initiation of immunotherapy was associated with poor PFS (HR = 2.78, 95% CI 1.40–5.50, p = 0.003). The occurrence of irAE was associated with increased PFS (HR = 0.48, 95% CI 0.25–0.92, p = 0.026). Both parameters maintained their independent prognostic significance. Conclusions: ICI in patients with cancer and pre-existing AID is associated with manageable toxicity that infrequently requires treatment discontinuation. However, since severe AID flare might occur, expected ICI efficacy and toxicity must be balanced. Clinical trial identifier: NCT04805099. © 2021, The Author(s)." }