Effect and Tolerability of Immunotherapy in Patients with NSCLC with or without Brain Metastasis

SIMPLE SUMMARY: Immune checkpoint inhibitors (ICIs) are increasingly used in the treatment of non-small cell lung cancer (NSCLC). Most randomized clinical trials have excluded patients with brain metastasis (BM), and real-life patients with NSCLC who receive ICIs are not routinely scanned with magnetic resonance imaging (MR-C) of the brain prior to ICI. This means that there are no prospective data available on the prevalence of BM or on the rate of intracranial response (ICR) attributable to ICIs. To evaluate this along with the impact of BM on quality of life and overall survival, we used MR-C as a screening tool in 159 ICI-eligible patients with advanced NSCLC prior to first ICI. At the time of ICI initiation, 28% of patients had BM. Of those who received ICI without additional early local radiotherapy or surgery, 50% had intracranial response at their first MR-C assessment. Long-term survival of patients with BM was comparable to those without. ABSTRACT: Sparse data exist on immune checkpoint inhibition (ICI) in NSCLC patients with brain metastasis (BM), especially for those with no local therapy (LT) (whole brain radiation therapy (WBRT), stereotactic RT (SRT) or neurosurgery) preceding ICI. Our aims were to investigate the prevalence of BM, rate of intracranial response (ICR), and survival and quality of life (QoL) in real-life patients with advanced NSCLC undergoing palliative ICI. This was a prospective non-randomized study (NCT03870464) with magnetic resonance imaging of the brain (MR-C) performed at baseline resulting in a clinical decision to administer LT or not. ICR evaluation (MR-C) at week 8–9 (mRECIST criteria) for group A (LT) and group B (untreated) was assessed. Change in QoL was assessed using EQ-5D-5L. Of 159 included patients, 45 (28%) had baseline BM. Median follow-up was 23.2 months (IQR 16.4–30.2). Of patients in group A (21) and B (16), 16/37 (43%) had symptomatic BM. ICR was 8/21, 38% (complete or partial response) for group A versus 8/16, 50% for group B. No statistical difference in median overall survival of patients with BM (group A: 12.3 (5.2-NR), group B: 20.5 months (4.9-NR)) and without (22.4 months (95% 16.2–26.3)) was obtained. Baseline QoL was comparable regardless of BM, but an improved QoL (at week 9) was found in those without BM. Patients with NSCLC and BM receiving ICI had long-term survival comparable to those without BM.