Real-world safety and efficacy data of immunotherapy in patients with cancer and autoimmune disease: the experience of the Hellenic Cooperative Oncology Group
Elena Fountzilas, Sofia Lampaki, Georgia-Angeliki Koliou, Anna Koumarianou, Sofia Levva, Anastasios Vagionas, Athina Christopoulou, Athanasios Laloysis, Amanda Psyrri, Ioannis Binas, Giannis Mountzios, Nikolaos Kentepozidis, Α. Kotsakis, Emmanouil Saloustros, Anastasios Boutis, Adamantia Nikolaidi, George Fountzilas, Vassilis Georgoulias, Miltiadis Chrysanthidis, Ηλίας Κοττέας, Henry Hiep Vo, Marinos Tsiatas, Eleni Res, Helena Linardou, Dimitrios Daoussis, Iliada Bompolaki, Anna Andreadou, George Papaxoinis, Dionisiοs Spyratos, Helen Gogas, Konstantinos N. Syrigos, Dimitrios Bafaloukos
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.