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. 2025 Aug 13:16:1562458.
doi: 10.3389/fimmu.2025.1562458. eCollection 2025.

Efficacy and safety of first-line chemotherapy combined with immune checkpoint inhibitors for extensive-stage small cell lung cancer patients: a real-world propensity score matching study

Bin Jia #  1 , Chenyi Zhou #  1 , Fei Zhao  2 , Xiaoru Song  2 , Yuan Ding  2 , Xiyin Wang  1 , Boying Wu  1 , Huina Wang  2 , Quanman Hu  1   2 , Shuaiyin Chen  2
Affiliations

Efficacy and safety of first-line chemotherapy combined with immune checkpoint inhibitors for extensive-stage small cell lung cancer patients: a real-world propensity score matching study

Bin Jia et al. Front Immunol. .

Abstract

Background: extensive-stage small cell lung cancer (ES-SCLC) were the majority of SCLC patients. Recently the combination of chemotherapy with immune checkpoint inhibitors (ICIs) have emerged as the new first-line treatment standard for ES-SCLC. However, the specific patient populations that are most likely to benefit from this treatment remains to be clearly identified making the establishment of baseline biomarkers critical.

Methods: We recruited ES-SCLC patients who were treated at the First Affiliated Hospital of Zhengzhou University and conducted a propensity score-matched analysis (PSM). And used the Kaplan-Meier (K-M) method and Cox proportional hazards regression to compare the survival outcomes. In addition, univariate and multivariate COX regression analyses were conducted to identify predictors.

Results: After-PSM, chemotherapy group had a longer median overall survival (mOS) of 15.23 months (95%CI: 14.00-17.87) and hazard ratio (HR) of 0.576 (95% confidence interval (CI): 0.404-0.821), P=0.002), and the median progression free survival (mPFS) in the chemotherapy group was shorter: 6.05months (95%CI: 4.33-7.87), HR=0.707 (95%CI: 0.526 -0.950, P=0.021) compared to before PSM. Multivariate analysis confirmed that Eastern Cooperative Oncology Group performance status (ECOG PS) =1 (HR: 2.36, 95% CI: 1.38-4.03, P=0.002) and brain metastases (HR: 2.08, 95% CI: 1.05-4.14, P=0.038) were independent prognostic factors for PFS, and only systemic inflammation response index (SIRI)> 2.63 (HR: 0.06, 95% CI: 0.01-0.29, P<0.001) was an independent prognostic factor for OS.

Conclusion: our findings indicate that incorporating ICIs into first-line chemotherapy significantly improves PFS and OS in ES-SCLC patients, while maintaining safety. Moreover, poor ECOG PS, brain metastases, and high SIRI at baseline may serve as valuable prognostic indicators for disease progression and survival in ES-SCLC patients undergoing first-line chemotherapy plus ICIs. It is worth noting that these findings should be interpreted as hypothesis-generating, not definitive clinical conclusions.

Keywords: COX; ES-SCLC; ICIs; PSM; chemotherapy; prognostic.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Diagram of the patient’s selection process. SCLC, Small cell lung cancer; ES, extensive-stage; ICIs, immune checkpoint inhibitors.
Figure 2
Figure 2
Survival outcomes of chemotherapy/chemotherapy +ICIs. (A) Kaplan-Meier curves of OS stratified by chemotherapy/chemotherapy +ICIs; (B) Kaplan-Meier curves of PFS stratified by chemotherapy/chemotherapy +ICIs; (C) Forest plot of subgroup analysis of OS; (D) Forest plot of subgroup analysis of PFS; OS, overall survival; PFS, progression free survival; SCLC, Small cell lung cancer; ICIs, immune checkpoint inhibitors; HR, hazard ratio; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status.
Figure 3
Figure 3
Survival outcomes of chemotherapy/chemotherapy +ICIs after PSM. (A) Kaplan-Meier curves of OS stratified by chemotherapy/chemotherapy +ICIs after PSM; (B) Kaplan-Meier curves of PFS stratified by chemotherapy/chemotherapy +ICIs after PSM; OS, overall survival; PFS, progression free survival; PSM, propensity score matching; ICIs, immune checkpoint inhibitors; HR, hazard ratio; CI, confidence interval.
Figure 4
Figure 4
Tumor response and treatment-related AEs in all ES-SCLC patients. (A) Tumor response in all ES-SCLC patients. (B) Treatment-related AEs in all ES-SCLC patients. (C) irAEs in all ES-SCLC patients (D) irAEs in chemotherapy group and chemotherapy plus ICIs group ES, extensive-stage; AEs, adverse events; ICIs, immune checkpoint inhibitors; PR, partial response; SD, stable disease; ORR, objective response rate; DCR, disease control rate; PD-1, programmed cell death protein 1; PDL -1, programmed cell death ligand 1. irAEs, immune-related adverse events.
Figure 5
Figure 5
Survival outcomes of different ICIs (PD-1/PDL-1) (A) Kaplan-Meier curves of OS stratified by different ICIs (PD-1/PDL-1); (B) Kaplan-Meier curves of PFS stratified by different ICIs (PD-1/PDL-1); OS, overall survival; PFS, progression free survival; ICIs, immune checkpoint inhibitors. HR, hazard ratio; CI, confidence interval; PD-1, programmed cell death protein 1; PDL-1, programmed cell death ligand 1.
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