Abstract
BackgroundImmune checkpoint inhibitors have been rapidly adopted for therapy of advanced non–small-cell lung cancer (aNSCLC) based on clinical trial findings. Our aim was to examine outcomes in United States oncology practice settings for patients prescribed pembrolizumab monotherapy for previously treated, programmed death ligand-1 (PD-L1)–expressing aNSCLC, thus clinically similar to patients in the KEYNOTE-010 trial. Patients and MethodsThis retrospective observational study used a nationally representative database to identify adult patients with histologically confirmed aNSCLC and PD-L1 tumor proportion score (TPS) ≥ 1% previously treated with platinum-containing chemotherapy (and appropriate tyrosine kinase inhibitor if nonsquamous aNSCLC with EGFR/ALK genomic tumor aberration). Eligible patients initiated pembrolizumab monotherapy from January 1, 2016, to November 29, 2018; data cutoff was May 31, 2019. The Kaplan-Meier method was used to estimate real-world time on treatment (rwToT) and overall survival (OS). ResultsThe 349 eligible patients included 199 (57%) men; the median age was 68 years (range, 37-84 years); 70 (25%) of 278 patients with known performance status had Eastern Cooperative Oncology Group score ≥ 2. The median patient follow-up was 8.1 months (range, 1 day to 39.2 months). The median rwToT was 4.9 months (95% confidence interval [CI], 3.7-5.8 months) overall and 5.8 months (95% CI, 4.2-6.6 months) for the TPS ≥ 50% cohort (n = 218). The median OS was 13.8 months (95% CI, 11.0-16.5 months) and 16.5 months (95% CI, 13.7-22.0 months) overall and for TPS ≥ 50%, respectively; 12-month survival rates were 54% and 60%, respectively. ConclusionPatients treated at oncology practices with pembrolizumab monotherapy for previously treated PD-L1–expressing aNSCLC experienced rwToT and OS similar to treatment duration and OS in phase III clinical trial settings.
Highlights
Randomized controlled trials (RCTs) are designed with high internal validity to deliver reliable efficacy and safety data via strict patient selection criteria, random treatment assignment, close monitoring, and well-defined follow-up.[1]
We further identified patients in the database ! 18 years old who initiated pembrolizumab monotherapy from January 1, 2016, to November 29, 2018, for histologically confirmed, PD-L1eexpressing (TPS ! 1%) advanced nonesmall-cell lung cancer (NSCLC) who were previously treated with platinum-containing chemotherapy and, if nonsquamous NSCLC with EGFR sensitizing mutation or ALK gene rearrangement, prior therapy with an appropriate tyrosine kinase inhibitor (TKI)
The other 15 tumors were noted as having positive PD-L1 expression but lacked a recorded PD-L1 tumor proportion score (TPS) level; they were included in the overall TPS ! 1% population but could not be assigned to the TPS ! 50% or TPS 1% to 49% cohort
Summary
Randomized controlled trials (RCTs) are designed with high internal validity to deliver reliable efficacy and safety data via strict patient selection criteria, random treatment assignment, close monitoring, and well-defined follow-up.[1]. Immune checkpoint inhibitors of programmed death protein-1 (PD-1) have been rapidly adopted in clinical practice for treating advanced nonesmall-cell lung cancer (NSCLC)[2,6,7,8] on the basis of RCT results published within the past 5 years.[9,10,11,12,13] Results of the CheckMate 057/017 and KEYNOTE-010 trials established the efficacy of nivolumab and pembrolizumab monotherapy, respectively, as compared with docetaxel, for previously treated advanced NSCLC,[9,10,11] with patient eligibility in KEYNOTE-010 limited to those with tumors expressing PD ligand-1 1%).[11,14,15] real-world data are needed to understand the outcomes of pembrolizumab therapy for advanced NSCLC as prescribed in routine practice.[1,16] Pembrolizumab was first approved by the United States (US) Food and Drug Administration (FDA) in early October 2015 for treating patients with PD-L1eexpressing advanced NSCLC that had progressed after other treatments Immune checkpoint inhibitors of programmed death protein-1 (PD-1) have been rapidly adopted in clinical practice for treating advanced nonesmall-cell lung cancer (NSCLC)[2,6,7,8] on the basis of RCT results published within the past 5 years.[9,10,11,12,13] Results of the CheckMate 057/017 and KEYNOTE-010 trials established the efficacy of nivolumab and pembrolizumab monotherapy, respectively, as compared with docetaxel, for previously treated advanced NSCLC,[9,10,11] with patient eligibility in KEYNOTE-010 limited to those with tumors expressing PD ligand-1 (PD-L1 tumor proportion score [TPS] ! 1%).[11,14,15] real-world data are needed to understand the outcomes of pembrolizumab therapy for advanced NSCLC as prescribed in routine practice.[1,16] Pembrolizumab was first approved by the United States (US) Food and Drug Administration (FDA) in early October 2015 for treating patients with PD-L1eexpressing advanced NSCLC that had progressed after other treatments
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