Real-World Outcomes of First-Line Pembrolizumab Monotherapy in Metastatic NSCLC with High PD-L1 Expression (TPS ≥ 50%): A Multicenter Study from Serbia
<b>Background:</b> Pembrolizumab monotherapy is the standard first-line treatment for metastatic non-small cell lung cancer (NSCLC) patients whose tumors express a PD-L1 tumor proportion score (TPS) of ≥50%. However, real-world data regarding its effectiveness outside of clinical trials,...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-05-01
|
| Series: | Biomedicines |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2227-9059/13/5/1175 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849711886414643200 |
|---|---|
| author | Filip Marković Mihailo Stjepanović Milan Rančić Marina Cekić Milica Kontić |
| author_facet | Filip Marković Mihailo Stjepanović Milan Rančić Marina Cekić Milica Kontić |
| author_sort | Filip Marković |
| collection | DOAJ |
| description | <b>Background:</b> Pembrolizumab monotherapy is the standard first-line treatment for metastatic non-small cell lung cancer (NSCLC) patients whose tumors express a PD-L1 tumor proportion score (TPS) of ≥50%. However, real-world data regarding its effectiveness outside of clinical trials, particularly in Eastern European populations, are limited. <b>Methods:</b> We conducted a retrospective, multicenter study including 225 patients with metastatic NSCLC and PD-L1 TPS ≥ 50% who received first-line pembrolizumab monotherapy in Serbia between 2019 and 2022. Patient demographics, clinical characteristics, and treatment outcomes were collected. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method, and multivariable Cox proportional hazards regression was performed to identify predictors of outcomes. <b>Results:</b> The median PFS was 9.7 months (95% CI: 7.979–11.421), and the median OS was 17.0 months (95% CI: 12.813–20.187) at a median follow-up of 18.1 months. The overall response rate (ORR) was 36.4%, and the disease control rate (DCR) was 73.4%. Multivariable analysis identified good performance status (ECOG PS 0–1), PD-L1 TPS ≥ 90%, and the occurrence of immune-related adverse events (irAEs) as independent predictors of improved PFS and OS. <b>Conclusions:</b> Our study highlights the efficacy and safety of first-line pembrolizumab monotherapy in a real-world Serbian population with metastatic NSCLC and high PD-L1 expression. Furthermore, it confirms the prognostic value of ECOG PS, high PD-L1 expression, and the development of irAEs in predicting favorable clinical outcomes. |
| format | Article |
| id | doaj-art-cefb99aed96b43daa0af995c72927ae6 |
| institution | DOAJ |
| issn | 2227-9059 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Biomedicines |
| spelling | doaj-art-cefb99aed96b43daa0af995c72927ae62025-08-20T03:14:30ZengMDPI AGBiomedicines2227-90592025-05-01135117510.3390/biomedicines13051175Real-World Outcomes of First-Line Pembrolizumab Monotherapy in Metastatic NSCLC with High PD-L1 Expression (TPS ≥ 50%): A Multicenter Study from SerbiaFilip Marković0Mihailo Stjepanović1Milan Rančić2Marina Cekić3Milica Kontić4Clinic for Pulmonology, University Clinical Centre of Serbia, 11000 Belgrade, SerbiaClinic for Pulmonology, University Clinical Centre of Serbia, 11000 Belgrade, SerbiaPulmonary Diseases Clinic, University Clinical Center Nis, 18000 Nis, SerbiaPulmonary Diseases Clinic, University Clinical Center Nis, 18000 Nis, SerbiaClinic for Pulmonology, University Clinical Centre of Serbia, 11000 Belgrade, Serbia<b>Background:</b> Pembrolizumab monotherapy is the standard first-line treatment for metastatic non-small cell lung cancer (NSCLC) patients whose tumors express a PD-L1 tumor proportion score (TPS) of ≥50%. However, real-world data regarding its effectiveness outside of clinical trials, particularly in Eastern European populations, are limited. <b>Methods:</b> We conducted a retrospective, multicenter study including 225 patients with metastatic NSCLC and PD-L1 TPS ≥ 50% who received first-line pembrolizumab monotherapy in Serbia between 2019 and 2022. Patient demographics, clinical characteristics, and treatment outcomes were collected. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method, and multivariable Cox proportional hazards regression was performed to identify predictors of outcomes. <b>Results:</b> The median PFS was 9.7 months (95% CI: 7.979–11.421), and the median OS was 17.0 months (95% CI: 12.813–20.187) at a median follow-up of 18.1 months. The overall response rate (ORR) was 36.4%, and the disease control rate (DCR) was 73.4%. Multivariable analysis identified good performance status (ECOG PS 0–1), PD-L1 TPS ≥ 90%, and the occurrence of immune-related adverse events (irAEs) as independent predictors of improved PFS and OS. <b>Conclusions:</b> Our study highlights the efficacy and safety of first-line pembrolizumab monotherapy in a real-world Serbian population with metastatic NSCLC and high PD-L1 expression. Furthermore, it confirms the prognostic value of ECOG PS, high PD-L1 expression, and the development of irAEs in predicting favorable clinical outcomes.https://www.mdpi.com/2227-9059/13/5/1175first-linehigh PD-L1 expressionimmune check-point inhibitorsnon-small cell lung cancerpembrolizumabpredictive factors |
| spellingShingle | Filip Marković Mihailo Stjepanović Milan Rančić Marina Cekić Milica Kontić Real-World Outcomes of First-Line Pembrolizumab Monotherapy in Metastatic NSCLC with High PD-L1 Expression (TPS ≥ 50%): A Multicenter Study from Serbia Biomedicines first-line high PD-L1 expression immune check-point inhibitors non-small cell lung cancer pembrolizumab predictive factors |
| title | Real-World Outcomes of First-Line Pembrolizumab Monotherapy in Metastatic NSCLC with High PD-L1 Expression (TPS ≥ 50%): A Multicenter Study from Serbia |
| title_full | Real-World Outcomes of First-Line Pembrolizumab Monotherapy in Metastatic NSCLC with High PD-L1 Expression (TPS ≥ 50%): A Multicenter Study from Serbia |
| title_fullStr | Real-World Outcomes of First-Line Pembrolizumab Monotherapy in Metastatic NSCLC with High PD-L1 Expression (TPS ≥ 50%): A Multicenter Study from Serbia |
| title_full_unstemmed | Real-World Outcomes of First-Line Pembrolizumab Monotherapy in Metastatic NSCLC with High PD-L1 Expression (TPS ≥ 50%): A Multicenter Study from Serbia |
| title_short | Real-World Outcomes of First-Line Pembrolizumab Monotherapy in Metastatic NSCLC with High PD-L1 Expression (TPS ≥ 50%): A Multicenter Study from Serbia |
| title_sort | real world outcomes of first line pembrolizumab monotherapy in metastatic nsclc with high pd l1 expression tps ≥ 50 a multicenter study from serbia |
| topic | first-line high PD-L1 expression immune check-point inhibitors non-small cell lung cancer pembrolizumab predictive factors |
| url | https://www.mdpi.com/2227-9059/13/5/1175 |
| work_keys_str_mv | AT filipmarkovic realworldoutcomesoffirstlinepembrolizumabmonotherapyinmetastaticnsclcwithhighpdl1expressiontps50amulticenterstudyfromserbia AT mihailostjepanovic realworldoutcomesoffirstlinepembrolizumabmonotherapyinmetastaticnsclcwithhighpdl1expressiontps50amulticenterstudyfromserbia AT milanrancic realworldoutcomesoffirstlinepembrolizumabmonotherapyinmetastaticnsclcwithhighpdl1expressiontps50amulticenterstudyfromserbia AT marinacekic realworldoutcomesoffirstlinepembrolizumabmonotherapyinmetastaticnsclcwithhighpdl1expressiontps50amulticenterstudyfromserbia AT milicakontic realworldoutcomesoffirstlinepembrolizumabmonotherapyinmetastaticnsclcwithhighpdl1expressiontps50amulticenterstudyfromserbia |