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<0.05). Endostatin+ICIs also contributed to better health status and life quality in patients compared to ICIs. The Endostatin+ICIs group displayed longer mean PFS (10.6 months vs. 6.8 months) and mean OS (17.6 months vs. 8.3 months) than the ICIs group. The results indicated that rh-Endo injection plus ICIs showesno significantly difference compare to ICIs alone in the adverse reaction rate, shows superior efficacy in improving clinical efficacy, significantly prolonging PFS and OS, and boosting patients' health status and quality of life.