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Öğe Concordance of PD-L1 expression and CD8+ TIL intensity between NSCLC and synchronous brain metastases(Assoc Basic Medical Sci Federation Bosnia & Herzegovina Sarajevo, 2020) Batur, Sebnem; Dulger, Onur; Durak, Sermin; Yumuk, Perran Fulden; Caglar, Hale Basak; Bozkurtlar, Emine; Bozkurt, SuheylaProgrammed death-ligand 1 (PD-L1) is suggested to be a predictive biomarker in non-small-cell lung carcinoma (NSCLC). However, the differential expression of PD-L1 in primary lung tumor vs. synchronous metastases, especially brain metastasis (BM), remains unclear. This study assessed the concordance of PD-L1 expression on tumor cells and tumor-infiltrating lymphocytes (TILs) and CD8(+) TIL intensity between primary lung tumors and synchronous BMs from 24 NSCLC patients. PD-L1, CD3, and CD8 positivity was determined by immunohistochemistry (IHC). PD-L1 scoring was based on the proportion of tumor cells with membranous expression of PD-L1 and the cutoff values <1%, 1-49%, >= 50%. CD3 and CD8 positivity in TILs was evaluated semi-quantitatively and the proportion of CD3+/CD8(+)TILs was determined. PD-L1 expression on tumor cells and TILs was evaluated in relation to CD3+/CD8(+)TIL proportions and the intensity of CD8(+)TILs between the paired primary lung and BM tissues. In the primary lung tumors, PD-L1 positivity was observed in 25%, 37.5%, and 37.5% cases for the cutoff values <1%, 1-49%, >= 50% respectively. PD-L1 expression on tumor cells was strongly correlated between the paired primary lung and BM tissues, in all cutoff groups. However, PD-L1 expression on TILs and the proportion of CD3+/CD8(+)TILs were not strongly correlated in all three groups between the paired primary lung tumors and BMs. The intensity of CD8(+)TILs was concordant in only 54.16% of the paired primary lung tumors and BMs. This study showed a high concordance of PD-L1 expression in neoplastic cells between primary NSCLC and synchronous BMs.Öğe Health-related quality of life for pembrolizumab (pembro) plus ipilimumab (ipi) versus pembro plus placebo in patients with metastatic NSCLC with PD-L1 tumor proportion score ? 50%: KEYNOTE-598.(Lippincott Williams & Wilkins, 2021) Sendur, Mehmet Nahit; Reck, Martin; Rodriguez-Abreu, Delvys; Park, Keunchil; Lee, Dae Ho; Cicin, Irfan; Yumuk, Perran Fulden[Abstract Not Available]Öğe Pembrolizumab Plus Ipilimumab or Placebo for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ? 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study(Lippincott Williams & Wilkins, 2021) Boyer, Michael; Sendur, Mehmet A. N.; Rodriguez-Abreu, Delvys; Park, Keunchil; Lee, Dae Ho; Cicin, Irfan; Yumuk, Perran FuldenPURPOSE Pembrolizumab monotherapy is standard first-line therapy for metastatic non-small-cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1) tumor proportion score (TPS) >= 50% without actionable driver mutations. It is not known whether adding ipilimumab to pembrolizumab improves efficacy over pembrolizumab alone in this population. METHODS In the randomized, double-blind, phase III KEYNOTE-598 trial (ClinicalTrials.gov identifier: ), eligible patients with previously untreated metastatic NSCLC with PD-L1 TPS >= 50% and no sensitizing EGFR or ALK aberrations were randomly allocated 1:1 to ipilimumab 1 mg/kg or placebo every 6 weeks for up to 18 doses; all participants received pembrolizumab 200 mg every 3 weeks for up to 35 doses. Primary end points were overall survival and progression-free survival. RESULTS Of the 568 participants, 284 were randomly allocated to each group. Median overall survival was 21.4 months for pembrolizumab-ipilimumab versus 21.9 months for pembrolizumab-placebo (hazard ratio, 1.08; 95% CI, 0.85 to 1.37; P = .74). Median progression-free survival was 8.2 months for pembrolizumab-ipilimumab versus 8.4 months for pembrolizumab-placebo (hazard ratio, 1.06; 95% CI, 0.86 to 1.30; P = .72). Grade 3-5 adverse events occurred in 62.4% of pembrolizumab-ipilimumab recipients versus 50.2% of pembrolizumab-placebo recipients and led to death in 13.1% versus 7.5%. The external data and safety monitoring committee recommended that the study be stopped for futility and that participants discontinue ipilimumab and placebo. CONCLUSION Adding ipilimumab to pembrolizumab does not improve efficacy and is associated with greater toxicity than pembrolizumab monotherapy as first-line treatment for metastatic NSCLC with PD-L1 TPS >= 50% and no targetable EGFR or ALK aberrations. These data do not support use of pembrolizumab-ipilimumab in place of pembrolizumab monotherapy in this population. (C) 2021 by American Society of Clinical Oncology