The Efficacy of First-Line Pembrolizumab Monotherapy in Patients with Metastatic NSCLC Aged ≥70 Years with High PD-L1 (TPS ≥ 50%) Expression: A Multicenter Real-World Study
Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Patients
2.2. Ethics Approval
2.3. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
6. Limitations
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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N = 381 | N (%) | ||
---|---|---|---|
Mean age at treatment start (range) [years] | 66.21 (35–90) | ||
Aged ≥70 years | |||
Yes | 149 (39.1) | ||
No | 232 (60.8) | ||
Patients ≥ 70 (N = 149) | Patients < 70 (N = 232) | p value | |
Sex | 0.54 | ||
Male | 84 (56.4%) | 138 (59.5%) | |
Female | 65 (43.6%) | 94 (40.5%) | |
Smoking status | 0.01 | ||
Current or former | 123 (84.5%) | 220 (94.8%) | |
Never | 26 (15.5%) | 12 (5.2%) | |
ECOG PS | 0.35 | ||
0–1 | 123 (82.5%) | 180 (77.6%) | |
≥2 | 26 (17.5%) | 52 (22.4%) | |
Histology | 0.88 | ||
Non-squamous | 114 (76.5%) | 179 (77.3%) | |
Squamous | 35 (23.5%) | 53 (22.8%) | |
PD-L1 status | 0.37 | ||
50–79% | 72 (48.3%) | 123 (53%) | |
80–100% | 77 (51.7%) | 109 (47%) | |
CNS metastasis at baseline | 0.07 | ||
Yes | 23 (15.4%) | 53 (22.8%) | |
No | 126 (84.6%) | 179 (77.2) | |
Radiotherapy | 0.52 | ||
Yes | 38 (25.5%) | 66 (28.5%) | |
No | 111 (74.5) | 166 (71.5%) | |
PD as per RECIST | |||
Yes | 215 (56.4) | ||
Received systemic treatment in 2nd line of therapy | 36 (16.7) | ||
Did not receive systemic treatment in 2nd line of therapy | 179 (83.3) | ||
No | 166 (43.6) | ||
Best response to pembrolizumab (RECIST) | |||
PD | 101 (26.6) | ||
SD | 141 (37.0) | ||
PR | 127 (33.3) | ||
CR | 12 (3.1) | ||
Real-world DCR | 279 (73.4) | ||
Real-world ORR | 138 (36.4) | ||
Median ToT (95% confidence interval) [months] | 14.0 (10.5–17.5) | ||
Median overall survival (95% confidence interval) [months] | 22.63 (16.7–28.6) |
Discontinuation Reason | <70 Years (n = 167) | ≥70 Years (n = 102) |
---|---|---|
Disease progression | 129 (77.2%) | 86 (84.3%) |
High-grade irAEs | 22 (13.2%) | 9 (8.8%) |
Decline in ECOG PS/comorbidities | 16 (9.6%) | 7 (6.9%) |
Age ≥70 Years (N = 149)-N (%) | Age <70 Years (N = 232)-N (%) | |
---|---|---|
CR | 6 (4.0%) | 6 (2.6%) |
PR | 53 (35.6%) | 74 (31.9%) |
SD | 51 (34.2%) | 91 (39.2%) |
PD | 39 (26.2%) | 61 (26.3%) |
Univariate Regression Analysis | Multivariate Regression Analysis | |||||
---|---|---|---|---|---|---|
HR | 95% CI | p | HR | 95% CI | p | |
Radiotherapy (yes vs. no) | 0.677 | 0.423–1.143 | 0.134 | |||
Sex (male vs. female) | 1.393 | 0.926–2.094 | 0.111 | |||
Histology (non-squamous vs. squamous) | 1.085 | 0.707–1.665 | 0.708 | |||
Smoking status (current or former smoker vs. never-smoker) | 0.581 | 0.327–0.991 | 0.048 | 0.645 | 0.379–1.098 | 0.108 |
PD-L1 (50–79 vs. 80%+) | 0.979 | 0.648–1.480 | 0.920 | |||
ECOG PS (0–1 vs. ≥2) | 2.364 | 1.445–3.867 | 0.001 | 2.266 | 1.380–3.720 | 0.001 |
CNS mets (yes vs. no) | 1.024 | 0.568–1.847 | 0.937 |
Univariate Regression Analysis | Multivariate Regression Analysis | |||||
---|---|---|---|---|---|---|
HR | 95% CI | p | HR | 95% CI | p | |
Radiotherapy (yes vs. no) | 0.685 | 0.416–1.214 | 0.134 | |||
Sex (male vs. female) | 1.308 | 0.834–2.051 | 0.242 | |||
Histology (non-squamous vs. squamous) | 1.050 | 0.610–1.805 | 0.861 | |||
Smoking status (current or former smoker vs. never-smoker) | 0.538 | 0.311–0.931 | 0.027 | 1.104 | 0.8–1.524 | 0.546 |
PD-L1 (50–79 vs. 80%+) | 0.992 | 0.644–1.530 | 0.973 | |||
ECOG PS (0–1 vs. ≥2) | 2.867 | 1.718–4.782 | 0.001 | 2.789 | 1.659–4.690 | 0.001 |
CNS mets (yes vs. no) | 1.189 | 0.638–2.216 | 0.585 |
Patients Receiving Second-Line Systemic Therapy Following PD as per RECIST (N = 215; 100%) | ||
---|---|---|
Yes (N = 36; 16.7%) | No (N = 179; 83.3%) | |
Age < 70 years | 26 (12%) | 83 (38.6%) |
Age ≥ 70 years | 10 (4.6%) | 96 (44.4%) |
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Marković, F.; Hochmair, M.; Müser, N.; Fabikan, H.; Rodriguez, V.M.; Janzic, U.; Stjepanović, M.; Kontić, M. The Efficacy of First-Line Pembrolizumab Monotherapy in Patients with Metastatic NSCLC Aged ≥70 Years with High PD-L1 (TPS ≥ 50%) Expression: A Multicenter Real-World Study. Cancers 2025, 17, 2190. https://doi.org/10.3390/cancers17132190
Marković F, Hochmair M, Müser N, Fabikan H, Rodriguez VM, Janzic U, Stjepanović M, Kontić M. The Efficacy of First-Line Pembrolizumab Monotherapy in Patients with Metastatic NSCLC Aged ≥70 Years with High PD-L1 (TPS ≥ 50%) Expression: A Multicenter Real-World Study. Cancers. 2025; 17(13):2190. https://doi.org/10.3390/cancers17132190
Chicago/Turabian StyleMarković, Filip, Maximilian Hochmair, Nino Müser, Hannah Fabikan, Vania Mikaela Rodriguez, Urska Janzic, Mihailo Stjepanović, and Milica Kontić. 2025. "The Efficacy of First-Line Pembrolizumab Monotherapy in Patients with Metastatic NSCLC Aged ≥70 Years with High PD-L1 (TPS ≥ 50%) Expression: A Multicenter Real-World Study" Cancers 17, no. 13: 2190. https://doi.org/10.3390/cancers17132190
APA StyleMarković, F., Hochmair, M., Müser, N., Fabikan, H., Rodriguez, V. M., Janzic, U., Stjepanović, M., & Kontić, M. (2025). The Efficacy of First-Line Pembrolizumab Monotherapy in Patients with Metastatic NSCLC Aged ≥70 Years with High PD-L1 (TPS ≥ 50%) Expression: A Multicenter Real-World Study. Cancers, 17(13), 2190. https://doi.org/10.3390/cancers17132190