TY - JOUR TI - Real-world safety and efficacy data of immunotherapy in patients with cancer and autoimmune disease: the experience of the Hellenic Cooperative Oncology Group AU - Fountzilas, E. AU - Lampaki, S. AU - Koliou, G.-A. AU - Koumarianou, A. AU - Levva, S. AU - Vagionas, A. AU - Christopoulou, A. AU - Laloysis, A. AU - Psyrri, A. AU - Binas, I. AU - Mountzios, G. AU - Kentepozidis, N. AU - Kotsakis, A. AU - Saloustros, E. AU - Boutis, A. AU - Nikolaidi, A. AU - Fountzilas, G. AU - Georgoulias, V. AU - Chrysanthidis, M. AU - Kotteas, E. AU - Vo, H. AU - Tsiatas, M. AU - Res, E. AU - Linardou, H. AU - Daoussis, D. AU - Bompolaki, I. AU - Andreadou, A. AU - Papaxoinis, G. AU - Spyratos, D. AU - Gogas, H. AU - Syrigos, K.N. AU - Bafaloukos, D. JO - Cancer Immunology, Immunotherapy PY - 2022 VL - 71 TODO - 2 SP - 327-337 PB - Springer Science and Business Media Deutschland GmbH SN - 0340-7004, 1432-0851 TODO - 10.1007/s00262-021-02985-6 TODO - 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 TODO - 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). ER -