Background This study aimed to evaluate the real-world treatment pattern and effectiveness of first-line treatment with paclitaxel liposome-based chemotherapy plus immunotherapy among Chinese patients with unresectable advanced non-small cell lung cancer (NSCLC).

Methods The data for this study were sourced from the ‘Efficacy and Safety of Immunotherapy in NSCLC Patients: A Multi-Center Observational Study’ project within the real-world lung cancer database initiative launched by the Lung Cancer Special Committee of the China Medical Education Association, with a specific focus on the use of paclitaxel liposome plus immunotherapy. Patient data was drawn from an online hospital platform. The study conducted a retrospective review of clinical data from unresectable advanced NSCLC patients who underwent first-line treatment with paclitaxel liposome-based chemotherapy and immunotherapy in seven Chinese hospitals between April 2020 and January 2023. The primary outcome was progression-free survival (PFS), with objective response rate (ORR) and safety as secondary outcomes. Survival analysis was carried out using the Kaplan-Meier method, with univariate analysis using the Log rank test, and multivariate analysis employing the Cox proportional hazard model.

Results Among the 100 patients with unresectable advanced NSCLC who received first-line treatment with paclitaxel liposome-based chemotherapy plus immunotherapy, 98 were male, and 2 were female. Of all patients, 85 (85%) were squamous cell carcinoma, 4 (4%) were adenocarcinoma, and 11 (11%) were NSCLC where specific pathological subtypes were not recorded. In terms of TNM staging, 37 patients were at stages IIIB-IIIC (37%), and 63 at stage IV (63%). The median cycle for first-line paclitaxel liposome-based chemotherapy and immunotherapy was 4. Immunotherapy agents used included tislelizumab (n=60), pembrolizumab (n=19), sintilimab (n=14), camrelizumab (n=4), durvalumab (n=2), and toripalimab (n=1). 98% of patients were co-administered platinum, with 91 receiving carboplatin, 4 receiving nedaplatin, and 3 receiving cisplatin. Out of the 78 patients evaluated for effectiveness, 4 achieved a complete response, 43 demonstrated a partial response, 28 had stable disease, and 3 experienced progressive disease. The overall ORR was 60.2%, and the disease control rate was 91.5%. The median PFS was 11 months (range: 8.9 to 16.8 months). Multivariate analysis identified age and TNM stage as independent risk factors for PFS (P<0.05), with patients aged = 64 or at TNM stage III having better PFS. The most common adverse events included bone marrow suppression, gastrointestinal reactions, and liver function abnormalities.

Conclusions Paclitaxel liposome-based chemotherapy plus immunotherapy demonstrated substantial effectiveness and safety for advanced NSCLC in the real-world setting.

Ethics Approval This study was approved by the Medical Ethics Committee of Yinchuan Internet Hospital (HLWYJ-2022–006), and all patients signed electronic informed consent.