Abstract Background Although PD-1/PD-L1 inhibitors have revolutionized advanced non-small cell lung cancer (NSCLC) treatment, systemic administration is limited by suboptimal local drug concentrations in tumors and the occurrence of immune-related adverse events (irAEs). This study innovatively evaluated, for the first time, the efficacy and safety of local administration of PD-1 inhibitors via bronchial artery infusion (BAI) for the treatment of NSCLC. Methods This single-center prospective cohort study enrolled a total of 47 patients with advanced NSCLC (stage IIIB-IV) who were EGFR and ALK wild-type and exhibited poor response following 2 to 4 cycles of standard treatment. Patients were divided into BAI (n = 23) and Venous (n = 24) groups based on the route of PD-1 inhibitor administration. Both groups received PD-1 inhibitors combined with platinum-based chemotherapy. The primary endpoints of the study was progression-free survival (PFS), and the secondary endpoints were objective response rates(ORR), disease control rates (DCR), overal survival (OS) and safety. Results At 6-month follow-up, the BAI group exhibited significantly higher ORR (47.8% vs. 16.7%, P = 0.026) and DCR (73.9% vs. 41.6%, P = 0.014) compared to the Venous group. Median PFS was significantly prolonged in the BAI cohort (11.1 vs. 6.6 months; HR = 0.372, 95% CI: 0.150-0.919; P = 0.030), with a trend toward improved OS (17.9 vs. 15.2 months, P = 0.085). Multivariate analysis identified BAI administration (HR = 0.372, P = 0.032) and younger age (HR = 2.838, P = 0.039) as independent predictors of prolonged PFS. No grade 3-4 treatment-related adverse events were observed in either group of patients. Immune-related pneumonia (grade 1-2) occurred in 4.3% of patients in the BAI group and 4.2% in the venous group. Due to the limited sample size, a statistical comparison between groups was not performed. All adverse events were manageable with appropriate supportive treatment. Conclusion BAI administration of PD-1 inhibitors significantly enhances therapeutic efficacy in advanced NSCLC, yielding prolonged PFS and higher ORR and DCR compared to the Venous group, without increasing severe toxicity.The following figure illustrated the efficacy evaluation of two patients who underwent immunotherapy and chemotherapy via BAI. This abstract is funded by: None
Zhou et al. (Fri,) studied this question.