scholarly journals Outcomes to first-line pembrolizumab in patients with PD-L1-high (≥50%) non–small cell lung cancer and a poor performance status

2020 ◽  
Vol 8 (2) ◽  
pp. e001007 ◽  
Author(s):  
Joao V Alessi ◽  
Biagio Ricciuti ◽  
Elizabeth Jiménez-Aguilar ◽  
Fangxin Hong ◽  
Zihan Wei ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Clinical Outcomes ◽  
Systemic Therapy ◽  
Performance Status ◽  
Small Cell ◽  
Second Line ◽  
Small Cell Lung ◽  
First Line ◽  
Ecog Ps

BackgroundPatients with non–small cell lung cancer (NSCLC) and a poor Eastern Cooperative Oncology Group Performance Status (ECOG PS) have been excluded from phase III immunotherapy clinical trials. We sought to evaluate clinical outcomes to first-line pembrolizumab in patients with advanced NSCLC, a PD-L1 Tumor Proportion Score (TPS) of ≥50%, and an ECOG PS of 2.MethodsWe performed a multicenter retrospective analysis of patients with metastatic NSCLC and a PD-L1 TPS of ≥50% (negative for genomic alterations in EGFR and ALK) who received treatment with first-line pembrolizumab. Clinical outcomes were compared in patients based on ECOG PS.ResultsAmong the 234 patients, 83.3% (n=195) had an ECOG PS of 0 or 1, and 16.7% (n=39) had an ECOG PS of 2. The baseline clinicopathological characteristics were balanced between the ECOG PS 0–1 vs 2 groups in terms of age, sex, tobacco use, histology, KRAS mutation status, presence of other potentially targetable driver mutations (BRAF, MET, HER2, RET), presence of brain metastases, and PD-L1 TPS distribution. Compared with patients with an ECOG PS of 0 or 1, patients with an ECOG PS of 2 had a significantly lower objective response rate (43.1% vs 25.6%; p=0.04), a numerically shorter median progression-free survival (6.6 months vs 4.0 months; HR 0.70 (95% CI 0.47 to 1.06); p=0.09), and a significantly shorter median overall survival (20.3 months vs 7.4 months; HR 0.42 (95% CI 0.26 to 0.68); p<0.001). On disease progression, patients with an ECOG PS of 2 were significantly less likely to receive second-line systemic therapy compared with patients with an ECOG PS of 0–1 (65% vs 22.2%, p=0.001).ConclusionsA subset of patients with NSCLC and an ECOG PS of 2 can respond to first-line pembrolizumab. However, clinical outcomes in this population are often poor and use of second-line systemic therapy is infrequent.

Outcomes to first-line pembrolizumab in patients with PD-L1-high (≥50%) non-small-cell lung cancer and a poor performance status.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9568-9568
Author(s):  
Joao Victor Machado Alessi ◽  
Biagio Ricciuti ◽  
Elizabeth Jimenez Aguilar ◽  
Fangxin Hong ◽  
Zihan Wei ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Clinical Outcomes ◽  
Systemic Therapy ◽  
Performance Status ◽  
Small Cell ◽  
Second Line ◽  
Small Cell Lung ◽  
First Line ◽  
Ecog Ps

9568 Background: Patients with non-small cell lung cancer (NSCLC) and a poor Eastern Cooperative Oncology Group performance status (ECOG PS) have been excluded from immunotherapy clinical trials. We sought to evaluate clinical outcomes to first-line pembrolizumab in patients with advanced NSCLC, a PD-L1 tumor proportion score (TPS) of ≥50%, and an ECOG PS of 2. Methods: We performed a multicenter retrospective analysis of patients with metastatic NSCLC and a PD-L1 tumor proportion score (TPS) of ≥50% (negative for genomic alterations in EGFR and ALK) who received treatment with first-line commercial pembrolizumab. Clinical outcomes were compared in patients based on ECOG PS. Results: Among 234 patients, 83.3% (N = 195) had an ECOG PS of 0 or 1, and 16.7% (N = 39) had an ECOG PS of 2. The baseline clinicopathological characteristics were balanced between the ECOG PS 0-1 vs 2 groups in terms of age, sex, tobacco use, histology, KRAS mutation status, presence of other potentially targetable driver mutations ( BRAF, MET, HER2, RET), history of central nervous system (CNS) disease, and PD-L1 TPS distribution. Compared to patients with an ECOG PS of 0-1, patients with an ECOG PS of 2 had a significantly lower objective response rate (ORR 43.1% vs 25.6%; P = 0.04), a numerically shorter median progression free survival (mPFS 6.6 months vs 4.0 months; P = 0.09), and a significantly shorter median overall survival (mOS 20.3 months vs 7.4 months; P < 0.001). Upon disease progression, patients with an ECOG PS of 2 were significantly less likely to receive second-line systemic therapy compared to patients with an ECOG PS of 0-1 (55.5% vs 14.3%, P < 0.001). Conclusions: Although a subset of patients with an ECOG PS of 2 can respond first-line pembrolizumab, clinical outcomes in this population are poor, and use of second-line systemic therapy is infrequent.

scholarly journals Influence of Performance Status on the Effectiveness of Pembrolizumab Monotherapy in First-Line for Advanced Non-Small-Cell Lung Cancer: Results in a Real-World Population

Biology ◽  
2021 ◽  
Vol 10 (9) ◽  
pp. 890
Author(s):  
Rocío Jiménez Jiménez Galán ◽  
Elena Prado-Mel ◽  
María Antonia Pérez-Moreno ◽  
Estefanía Caballano-Infantes ◽  
Sandra Flores Moreno
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Performance Status ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Ecog Ps

The KEYNOTE-024 clinical trial showed promising results for pembrolizumab in the first-line of treatment of advanced non-small-cell lung cancer (NSCLC). However, the profile of patients in real-world practice differs from those included in this clinical trial. Here, an observational single-center retrospective study was performed through a comparative analysis of clinical outcomes after pembrolizumab therapy according to the Eastern Cooperative Oncology Group Stage Performance Status (ECOG PS). Moreover, univariate and multivariate analyses were carried out to detect prognostic factors. In our cohort, 63.7% of patients had an ECOG PS of 0–1. Regarding response rate, 31.8% of patients had a partial response (PR), 19.3% had stable disease (SD) and 23.9% had progression disease. On the other hand, patients with ECOG PS ≥ 2 showed a significantly lower rate of PR and SD to pembrolizumab than patients with a PS of 0–1. The rate of response, median overall survival (OS) and progression-free survival (PFS) were significantly higher in patients with ECOG PS 0–1 than in those with ECOG PS ≥ 2. In the current study, we found ECOG PS as the only independent predictor of OS and PFS. Due to the ECOG PS scale being a subjective parameter, other tools are needed to identify treatment effectiveness to each patient.

scholarly journals Treatment Patterns and Overall Survival Associated with First-Line Systemic Therapy for Patients with Advanced Non-Small Cell Lung Cancer

2017 ◽  
Vol 23 (2) ◽  
pp. 195-205 ◽  
Author(s):  
Michele M. Spence ◽  
Rita L. Hui ◽  
Jennifer T. Chang ◽  
Joanne E. Schottinger ◽  
Mirta Millares ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Systemic Therapy ◽  
Treatment Patterns ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line

scholarly journals 562 Real-world assessment of current treatment patterns and clinical outcomes among patients with EGFR and ALK wild type non-small cell lung cancer (NSCLC) in the US

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A591-A591
Author(s):  
Lyudmila Bazhenova ◽  
Jonathan Kish ◽  
Beilei Cai ◽  
Nydia Caro ◽  
Bruce Feinberg
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Clinical Outcomes ◽  
Treatment Patterns ◽  
Small Cell ◽  
Wild Type ◽  
Small Cell Lung ◽  
First Line ◽  
The Us ◽  
Nsclc Patients

BackgroundTreatment for advanced non-small cell lung cancer (NSCLC) has dramatically advanced in the past 5 years with the advent of immunotherapy (IO). This study sought to describe treatment patterns and clinical outcomes in a representative sample of NSCLC patients.MethodsPatients were identified by physicians from a voluntary sample of community practices across the US. Stage IIIB/IV NSCLC patients with EGFR/ALK wild-type initiating any first-line (1L) systemic therapy between 01/01/2016 and 12/31/2019 with at least 2 months of follow-up (unless deceased) were included, and were followed until November 2020. Sampling quotas included 250 patients who initiated 1L in 2016/2017 and 250 patients who did so in 2018/2019. Best tumor response was collected from patient charts during each line of therapy (LOT). Progression-free survival (PFS) and overall survival (OS) were calculated from initiation of 1L by Kaplan-Meier method. Baseline characteristics and clinical outcomes are described and presented by treatment regimen received.ResultsOf 500 submitted patients, 497 were included post QA/QC. Across all patients, mean age at 1L initiation was 65 years, 57.3% were male, 92.9% had stage IV disease, and 68.6% were ECOG-OS 0/1 (Table 1). Overall, 60.2% (n=299), 33.2% (n=165), and 6.6% (n=33) received 1, 2, or =3 LOTs during the study period. Most common 1L regimens (%) were platinum-doublet chemotherapy plus IO (PDC+IO) (40.6%), PDC (29.4%), IO monotherapy (20.7%), PDC+bevacizumab (6.2%); while most common 2L regimens were IO monotherapy (42.4%), single-agent chemotherapy (SAC) (18.2%), SAC+VEGF inhibitor (15.7%), PDC (8.1%), and PDC+bevacizumab (5.6%). Over 90% of pts who received IO monotherapy had PD-L1 >50%. Moving from 2016/2017 to 2018/2019, utilization of 1L PDC declined from 45.0% to 13.7% while utilization of 1L PDC+IO increased from 27.3% to 54.0%. Among those who received only one LOT (n=299), 44.5% were still on 1L, 14.0% stopped receiving 1L, and 41.5% were deceased. Overall response rates were 67.3%, 35.6%, 60.2%, and 61.3% for 1L PDC+IO, PDC, IO monotherapy, and PDC+bevacizumab, respectively (Table 1). First-line median PFS/OS (months) was 15.6/26.5, 5.3/13.7, 17.8/NR, and 10.8/18.6, respectively for PDC+IO, PDC, IO monotherapy, and PDC+bevacizumab (table 1).Abstract 562 Table 1ConclusionsData from 2016 to 2020 was used provide a contemporary assessment of treatment patterns among EGFR/ALK wild-type NSCLC patients. Although 1L treatment utilization shifted to IO-based regimens in recent years, 41.5% of patients did not survive to receive second-line therapy, 1L PFS did not exceed 1.5 years, and median OS remained limited across all 1L treatment groups.Ethics ApprovalOn August 20, 2020, Western Institutional Review Board (WIRB) approved a request for a waiver of authorization for use and disclosure of protected health information (PHI) for this research. The study is exempt under 45 CFR § 46.104(d)(4).

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