Efficacy and safety of bronchial arterial chemoembolization in combination with tislelizumab for non-small cell lung cancer: a phase II study

This study was designed to assess the efficacy and safety of bronchial arterial chemoembolization (BACE) combined with tislelizumab for stage III-IV non-small cell lung cancer (NSCLC). In a single-arm, phase II study (NCT05058560), stage III-IV NSCLC patients who refused or were ineligible to receive standard treatments were enrolled. Patients received BACE followed by 200 mg tislelizumab every 3 weeks until disease progression, intolerable toxicities, or discontinuation determined by the investigators. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety, and quality of life (QoL). Thirty patients (median age, 67 years, 24 male) were enrolled in this study between December 2021 and August 2022. The median follow-up was 23 (95% confidence interval [CI], 21.5-24.5) months. At the data cutoff (March 1, 2024), the median PFS was 10.5 (95%CI, 7.8-13.2) months and the median OS was 15.0 (95%CI, 8.2-21.8) months. Of the 30 patients, 1 patient (3.3%) achieved complete response (CR).17 patients (56.7%) showed partial response (PR), 6 (20.0%) had stable disease (SD), and 6 patients (20.0%) had progressive disease (PD). The ORR was 60.0% (18 of 30 patients) and the DCR was 80.0% (24 of 30patients). The expression rate of PD-L1, tumor feeding arteries and previous treatment history were prognostic factors for PFS and OS. No grade 3 or higher treatment-related adverse events (TRAEs) occurred. Common grade 2 TRAEs were nausea, fever, and cough. QoL improved significantly after 1 cycle of treatment compared with baseline, including global quality of life, physical functioning, and emotional functioning. In conclusion, BACE with tislelizumab is a safe, feasible and efective palliative treatment option for stage III-IV NSCLC patients.