Efficacy and safety of bronchial arterial chemoembolization (BACE) in combination with tislelizumab for non-small cell lung cancer (NSCLC): A phase II study.

person Xuhua Duan The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China info_outline Xuhua Duan, Hao Li, Donglin Kuang, Mengfan Zhang, Wenze Xu, Chao Liang, Jiacheng Wang, Daqian Han, Jianzhuang Ren

Authors person Xuhua Duan The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China info_outline Xuhua Duan, Hao Li, Donglin Kuang, Mengfan Zhang, Wenze Xu, Chao Liang, Jiacheng Wang, Daqian Han, Jianzhuang Ren Organizations The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China Abstract Disclosures Research Funding No funding sources reported Background: Bronchial artery chemoembolization (BACE) and immune checkpoint inhibitors (ICIs) are important therapy for NSCLC. The short-term benefit from BACE is considerable while the long-term survival benefits from ICIs is remarkable. This trial is designed to determine the efficacy and safety of immunotherapy with tislelizumab in addition to BACE in stage III-Ⅳ NSCLC patients (pts) who failed, refused or ineligible to receive standard treatments. Methods: 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). Results: Thirty patients were enrolled in this study between December 2021 and August 2022. The median follow-up was 12 (range, 1.5-12) months. At the data cutoff (August 31, 2023), the median PFS was 10.5 (95% confidence interval [CI], 7.8-13.2) months and the median OS was not reached. The 3 -, 6 -, and 12-month ORR were 63.3% (95%CI, 43.9%-80.1%), 56.7% (95%CI, 37.4%-74.5%), and 30.4% (95%CI, 13.2%-52.9%), respectively. The DCR at 3 months was 80% (95%CI, 61.4%-92.3%), at 6 months was 76.7% (95%CI, 57.7%-90.1%), and at 12 months was 47.8% (95%CI, 26.8%-69.4%). The expression rate of PD-L1, tumor feeding arteries, and the application times of tislelizumab were prognostic factors for PFS. 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. Conclusions: The study demonstrated promising efficacy and manageable safety profiles of BACE plus tislelizumab for advanced NSCLC patients, indicating a potential and effective treatment option for this population. Clinical trial information: NCT05058560.

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