The efficacy and safety of continuous intravenous infusion of rh-endostatin combined with platinum-based doublet chemotherapy for advanced non-small-cell lung cancer

Abstract Background Platinum-based doublet chemotherapy is the current standard first-line treatment for patients with driver-gene-negative advanced non-small-cell lung cancer (NSCLC). However, its recurrence rate is relatively high. Accumulating evidence suggests that the addition of antiangiogenic agents to platinum-based chemotherapy can improve the survival outcomes for NSCLC patients. However, the optimal administration protocol for intravenous recombinant human endostatin (rh-endostatin), an antiangiogenic agent, remains uncertain at present. Aim This study aims to investigate the efficacy and safety of 5-d continuous intravenous infusion of rh-endostatin in combination with chemotherapy for patients with advanced NSCLC. The predictive biomarkers for this treatment regimen were further probed. Methods This prospective, single-arm multicenter study enrolled a total of 48 patients with advanced NSCLC who were histologically or cytologically confirmed but had not received any prior treatment from February 2021 to July 2022. Prior to chemotherapy, the patients received a continuous intravenous infusion of rh-endostatin (210mg) over a period of 120 hours, using an infusion pump. The chemotherapy regimen consisted of platinum in combination with either pemetrexed or paclitaxel, administered in cycles of 21 days. The primary endpoint of the study was progression-free survival (PFS), and the secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and assessment of adverse events (AEs). Results The median PFS (mPFS) was 6.7 months, the median OS (mOS) was 12.1 months, the ORR was 52.1%, and the DCR was 79.2%. The most common adverse effects were leukopenia (52.1%), anemia (33.3%) and thrombocytopenia (20.8%). These toxicities were deemed acceptable and manageable. In addition, we observed a correlation between higher serum carcinoembryonic antigen (CEA) levels and shorter PFS and OS. Conclusions The combination of a 5-day continuous intravenous infusion of rh-endostatin with chemotherapy demonstrated both safety and efficacy for the treatment of advanced NSCLC. Additionally, we found that baseline serum levels of CEA may serve as a predictor of the efficacy of rh-endostatin plus chemotherapy in NSCLC patients.