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May 16, 2026Open Access

Real-world effectiveness of first-line immunotherapy with or without chemotherapy versus chemotherapy alone in advanced non-small cell lung cancer

LLLihua LiShanxi Provincial Cancer Hospital JDJuan DuShanxi Provincial Cancer Hospital JYJing YangShanxi Provincial Cancer Hospital

Key Points

This study aims to evaluate the real-world effectiveness of first-line immunotherapy with or without chemotherapy compared to chemotherapy alone in advanced non-small cell lung cancer (NSCLC).
Collected data from 401 patients with stage IV NSCLC treated between January 2019 and December 2021.
Evaluated overall survival using Kaplan-Meier curves and Cox proportional hazards models for subgroup analyses.
Analysis included comparison of domestically and internationally developed PD-1 inhibitors.
Median overall survival was significantly longer in the ICIs with or without chemotherapy group (22.0 months) versus chemotherapy alone (14.0 months, p < 0.0001).
In a propensity score-matched cohort of 236 patients, ICIs group retained significantly longer overall survival compared to chemotherapy alone.
No significant overall survival difference was found between domestically developed PD-1 inhibitors and pembrolizumab (p = 0.28).

Abstract

This real-world retrospective study evaluated the effectiveness of first-line immunotherapy with or without chemotherapy compared with chemotherapy alone in patients with advanced non-small cell lung cancer (NSCLC). It also explored survival outcomes associated with domestically developed and internationally developed PD-1 inhibitors in China. Methods Data were collected from 401 patients with stage IV NSCLC treated at Shanxi Province Cancer Hospital between January 2019 and December 2021, including 248 in the chemotherapy group and 153 in the immune checkpoint inhibitors (ICIs) with or without chemotherapy group. The primary outcome was overall survival (OS). Kaplan-Meier curves and log-rank tests were used to evaluate survival differences, and Cox proportional hazards models were employed for subgroup analyses. Results The median OS was significantly longer in the ICIs with or without chemotherapy group than in the chemotherapy group (22.0 months vs. 14.0 months, p 0.0001). In a propensity score-matched cohort of 236 patients, ICIs with or without chemotherapy remained associated with significantly longer OS than chemotherapy alone. Exploratory subgroup analyses suggested potential heterogeneity in the survival benefit associated with ICIs-based treatment according to BMI, pre-existing pulmonary disease, smoking status, and T stage; however, these findings should be interpreted cautiously given the limited sample sizes within some subgroups. Concomitant corticosteroid use was associated with shorter OS (median 20.0 vs. 26.0 months, p = 0.036), while antibiotic and proton pump inhibitor use showed non-significant trends toward reduced survival. No significant OS difference was observed between domestically developed ICIs (camrelizumab, sintilimab, tislelizumab) and the internationally developed agent pembrolizumab (median 22.0 vs. 24.0 months, p = 0.28). Conclusion First-line immunotherapy with or without chemotherapy significantly improves survival compared with chemotherapy alone in advanced NSCLC. No statistically significant difference in overall survival was observed between domestically developed PD-1 inhibitors and pembrolizumab in this cohort; however, this comparison should be interpreted cautiously given the limited sample size, particularly in the internationally developed ICIs group.

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