P09.24 Real-World Data in Non-Small Cell Lung Cancer Treated with Checkpoint Inhibitors in a Latin American Institution

Abstract

While randomized clinical trials (RCT) are the gold standard to determine the effectiveness of cancer therapy, their strict eligibility criteria do not match the conditions that we see in our clinical practice, especially for non-small cell lung cancer (NSCLC) patients. Real-world data (RWD) provides complementary information on use and clinical outcomes. Here we analyzed real-world outcomes of metastatic NSCLC patients treated with checkpoint inhibitors. Retrospective analysis of advanced NSCLC treated with PD-1/PD-L1 inhibitors in a private cancer center at Lima-Peru (Oncosalud-AUNA) from 2015 to 2019. Epidemiological, clinical and pathological data were collected from electronic medical records. Efficacy was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The Kaplan-Meier method was used to estimate the survival curves, and the influence of different factors on progression-free survival (PFS) and overall-survival (OS) was determined by the log-rank test. The Cox model was used to calculate the hazard ratios. 82 patients were included. Median age at diagnosis was 65 years (range 38-92y); most patients were males (61%), never smokers (62.2%) and had a status performance of 1 (77.8%) or 2 (14.8%). Adenocarcinoma was the most common histological type (84.1%). PDL1 status was negative or unknown for 61% of patients; between 1 and 49% for 19.5%; and ≥50% for 19.5%. 8 patients were EGFR positive. Patients received a PD-1/PD-L1 inhibitors alone or in combination with chemotherapy in 68.3% and 31.7% of the cases, respectively; in either first (48.8%), second (35.4%) or third/later (15.9%) line of treatment. For the complete cohort, the objective response rate (ORR) was 36.6% an 19.5% of patients achieved stable disease. With a median follow-up time of 18.4 months, median PFS was 5 months and median OS was 10.7 months. Duration of response (DoR) was 17.3 months (95% CI 10.29 – 24.38). The type of response was significantly associated with PFS (p<0.01) and OS (p<0.01) (Fig 1). Age, sex, smoking status, histology, PDL1 expression, EGFR status, line of therapy and use in combination or not with chemotherapy, did not appear to impact OS. Status performance of 2-3 vs 0-1 doubled the chances of dying (HR 2.18; 95%CI [1.10-4.32], p=0.025). This analysis suggests that OS in real-world patients is similar to that reported in RCT. Likewise, the subset of responders obtains durable benefit. The lack of difference in OS according to the evaluated clinicopathologic characteristics suggests benefit of PD-1 inhibitors in a wide spectrum of multitreated patients with metastatic NSCLC. Results from this study confirm those obtained in RCT and demonstrate their applicability to a Latin American real-world setting.