Abstract
Purpose
Although immune-checkpoint inhibitors have become a new therapeutic option for recurrent/metastatic non-small cell lung cancers (R/M-NSCLC), its clinical benefit in the real-world is still unclear.
Methods
We investigated 1181 Korean patients with programmed death-1 ligand 1 (PD-L1)-positive [tumor proportion score (TPS) ≥ 10% by the SP263 assay or ≥ 50% by the 22C3 assay] R/M-NSCLC treated with pembrolizumab or nivolumab after failure of platinum-based chemotherapy.
Results
The median age was 67 years, 13% of patients had ECOG-PS ≥ 2, and 27% were never-smokers. Adenocarcinoma was predominant (61%) and 18.1% harbored an EGFR activating mutation or ALK rearrangement. Pembrolizumab and nivolumab were administered to 51.3% and 48.7, respectively, and 42% received them beyond the third-line chemotherapy. Objective response rate (ORR) was 28.6%. Pembrolizumab group showed numerically higher ORR (30.7%) than the nivolumab group (26.4%), but it was comparable with that of the nivolumab group having PD-L1 TPS ≥ 50% (32.4%). Median progression-free survival (PFS) and overall survival (OS) were 2.9 (95% CI 0–27.9) and 10.7 months (95% CI 0–28.2), respectively. In multivariable analysis, concordance of TPS ≥ 50% in both PD-L1 assays and the development of immune-related adverse events (irAEs) were two significant predictors of better ORR, PFS, and OS. EGFR mutation could also predict significantly worse OS outcomes.
Conclusion
The real-world benefit of later-line anti-PD1 antibodies was comparable to clinical trials in patients with R/M-NSCLC, although patients generally were more heavily pretreated and had poorer ECOG-PS. Concordantly high PD-L1 TPS ≥ 50% and development of irAE could independently predict better treatment outcomes, while EGFR mutation negatively affected OS.
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Acknowledgements
Current multicenter research was initiated and supported by the collaboration from Health Insurance Review and Assessment Service of Korea (201812072D200) and by the Korean Cancer Study Group (KCSG LU19-05). And this work was supported by Konkuk University Medical Center Research Grant 2018. Lastly, we would like to thank Editage (www.editage.co.kr) for English language editing.
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LSK SMO gave a core assistance in data collection and developing a raw registry, which was thoroughly guided by JHP and JHK. GLR and HA made a final dataset, and made all statistical analyses for the study. JHP reviewed the literature, interpreted the data analysis, and mainly drafted the article. JHK initially inspired and motivated the concept of present study, who finally reviewed and confirmed the final version to be published. All co-authors listed equally contributed to enrollment of patients as expert medical oncologists or pulmonologists of lung cancer, and they all read and approved the final article.
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Park, J.H., You, G.L., Ahn, MJ. et al. Real-world outcomes of anti-PD1 antibodies in platinum-refractory, PD-L1-positive recurrent and/or metastatic non-small cell lung cancer, and its potential practical predictors: first report from Korean Cancer Study Group LU19-05. J Cancer Res Clin Oncol 147, 2459–2469 (2021). https://doi.org/10.1007/s00432-021-03527-4
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DOI: https://doi.org/10.1007/s00432-021-03527-4