Effectiveness and safety of recombinant human endostatin injection plus immune checkpoint inhibitors for non-small cell lung cancer: a single-centered, retrospective study

To evaluate the clinical effectiveness and safety of recombinant human endostatin (rh-Endo) injection plus immune checkpoint inhibitor (ICI) treatment of non-small cell lung cancer (NSCLC) treatment. We collected the medical records and follow-up data of inoperable NSCLC patients who received the corresponding anti-tumor treatment for at least 4 cycles and were discharged from our hospital from January 2021 to January 2023 for a retrospective analysis. According to the treatment methods, they were assigned to rh-Endo+ICIs (Endostatin+ICIs) and ICIs groups. Rh-Endo injection was administered at 210 mg each time via continuous chemotherapy pump infusion for 3 days, once every 3 weeks. The use of ICIs followed the instructions. Neither rh-Endo injection nor ICIs were allowed to be administered at a reduced dose. Therapeutic efficacy was compared between groups, tumor biomarkers, health status, and life quality were observed, and the occurrence of adverse reactions was documented. Progression-free survival (PFS) and overall survival (OS) during patient follow-up (2 years) were tracked. In this study, 114 eligible cases were included, with 73 receiving ICIs+rh-Endo. The disease control rate (DCR) of the ICIs and Endostatin+ICIs groups was 46.35% and 75.34% (P=0.002), respectively. Both cohorts exhibited reduced serum cytokeratin 19 fragment (CYFRA21-1), squamous cell carcinoma antigen (SCCA), carbohydrate antigen 50 (CA50) after three cycles of treatment, especially in the Endostatin+ICIs group (P