Abstract 1114P
Background
Based on convincing results from randomized controlled trials (RCTs), Immune-checkpoint inhibitors (ICI) are increasingly used as standard therapy in real-life clinical settings. However, real-life patients differ clinically from RCT populations, which might affect chance of obtaining long-term survival. Currently, only sparse data on long-term outcome for real-life patients with advanced non-small cell lung cancer (NSCLC) treated with ICI exist.
Methods
Data from four Danish centers including 729 patients with advanced NSCLC receiving monotherapy with ICI was obtained. Retrospective data during September 2015-October 2018 (n=566) and prospective data during April 2018-April 2021 (n=163). Data-cutoff was set at April 1st 2022. Data on baseline characteristics of age, sex, programmed death-ligand 1 (PD-L1), comorbidity, performance status, body mass index, organ metastases, known autoimmunity, and Khorana score were registered. Kaplan-Meier estimates and log-rank test were used for survival analyses and Cox regression for determination of prognostic factors.
Results
Median time of follow-up (FU) was 48.7 months (IQR 37.2-54.3). For 9% of patients a full two year ICI course was completed. Median overall survival (OS) in first line treatment was 20.4 months (IQR 8.5-45.0) compared to 11.4 months (IQR 4.6-27.1) in ≥ 2nd line (HR 1.48, 95%CI 1.25-1.75). Estimated probability of OS was 30% at 3 years, 23% at 4 years, and 13% at 5 years in first line compared to 17%, 13%, and 11% in ≥ 2nd line, respectively. Factors, which were statistically significant in favor of longer OS in the multivariate analysis were female sex, age < 75 years, PD-L1 ≥ 50%, performance status < 2, no liver- and bone metastases, and Khorana score < 2.
Conclusions
Compared to RCTs, long-term OS and progresion free survival rates seem lower in real-life patients, which may in part be attributable to more patients over 75 years and/or more patients with PS > 1. Besides PD-L1 < 50%, a baseline Khorana score ≥ 2, male sex, liver- and bone metastases were factors associated with impaired survival. Indeed, the promising flattening of both the OS and PFS curves indicate that a subset of real-life patients also obtain long-term remission.
Clinical trial identification
NCT03870464.
Editorial acknowledgement
Legal entity responsible for the study
Birgitte Bjornhart, Mette Mouritzen.
Funding
Region of Southern Denmark, Department of Oncology, Odense University Hospital.
Disclosure
M. Pohl: Financial Interests, Personal and Institutional, Invited Speaker, lectures and consultancy: AstraZeneca, BMS, MSD, Pfizer, Roche. All other authors have declared no conflicts of interest.