Efficacy of argon-helium cryoablation combined with PD-1 inhibitors in non-small cell lung cancer.

BACKGROUND AND PURPOSE: This study aimed to evaluate the efficacy and safety of argon-helium cryoablation combined with Programmed Death-1 (PD-1) inhibitors versus PD-1 inhibitors plus chemotherapy in treating non-small cell lung cancer (NSCLC). Patient/material and methods: In this single-center, open-label, randomized controlled trial, 60 NSCLC patients treated between December 2020 and December 2023 were enrolled. Patients were randomly assigned (1:1) to either a study group (argon-helium cryoablation + PD-1 inhibitor, n = 30) or a control group (PD-1 inhibitor + chemotherapy, n = 30). Allocation was concealed using sequentially numbered, opaque, sealed envelopes (SNOSE). Primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary endpoints included short-term efficacy - objective response rate (ORR), disease control rate (DCR) - immune function changes (CD4+, CD8+, CD4+/CD8+), and adverse reactions, assessed after four cycles and during a 1-year follow-up. RESULTS: ORR and DCR were higher in the study group (ORR: 73.33% vs. 53.33%; DCR: 90.00% vs. 83.33%), though not statistically significant (P > 0.05). Baseline immune parameters were similar. After four cycles, the study group showed statistically significantly higher CD4+ and CD4+/CD8+ ratios, and lower CD8+ levels (all P < 0.001). Adverse reactions were comparable between groups (P > 0.05). At 1-year follow-up, the PFS rate was 63.3% vs. 43.3%. The study group had a statistically significantly better OS (median not reached vs. 10.3 months, P = 0.003) and longer median PFS (9.6 vs. 8.3 months, P = 0.005). INTERPRETATION: Argon-helium cryoablation combined with PD-1 inhibitors statistically significantly improved OS, PFS and immune function in NSCLC patients, offering a promising alternative to standard therapy.