Abstract

Immune related adverse events (irAEs) have been reported to associate with efficacy of immunotherapy. However, no consistent association has been verified. The objective of this study is to further explore whether the appearance of irAEs after treatment with immune checkpoint inhibitors (ICIs) is associated with survival benefit in patients with advanced non-small cell lung cancer (aNSCLC). This is a single center retrospective cohort study of patients undergoing ICI therapy for recurrent or metastatic NSCLC during March 2015 to August 2019. Patients received ≥1 dose of ICIs and had ≥2 clinical visits were eligible for inclusion. Clinical data on patient characteristics, irAEs occurrence, and survival outcomes were abstracted from the electronic medical record of patients (LinkDoc database). The irAEs were graded (CTCAE v4.0) as per physician according to their daily clinical practice. Survival outcomes were estimated by using the Kaplan-Meier methods and compared with the Log-rank test. Among 277 patients, most were male (72.2%) and smokers (73.3%). Median patient age was 60 (IQR: 54-67) years. Majority of tumors (83.4%) were stage IV and adenocarcinoma (61.7%) was the most common subtype. A total of 248 (89.5%) patients experienced AE (22.7% ≥ grade 3). IrAEs was observed in 51 (18.4%) patients (5.8% ≥ grade 3). The most common irAEs included hypothyroidism (3.4%), anemia (2.7%), leukopenia (1.7%), neutropenia (1.6%), fatigue (1.6%), thrombocytopenia (1.2%), and gastrointestinal disorders (1.0%). The median progression free survival (PFS) and overall survival (OS) of the patients were 6.8 (95%CI: 5.8, 8.3) and 21.5 (95%CI: 15.9, 52.4) months, respectively. As for the line of therapy, the median OS was 21.5 (15.9, NE) months in the first line patients and 18.2 (15.8, NE) months in the second line or above group. Meanwhile, the corresponding median PFS were 12.1 (5.7, 21.5) and 6.0 (5.3, 8.3) months, respectively. However, no prognostic significance of irAE incidence was observed with respect to either OS (P=0.6894) or PFS (P=0.7609) of the patients. The development of irAEs did not appear to associate with better survival of our aNSCLC patients during ICI therapy. Future studies are still needed to clarify it further.

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