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2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 113-113
Brian Yoon ◽  
Dilhan Weeraratne ◽  
Yull Edwin Arriaga ◽  
Hu Huang ◽  
Travis John Osterman

113 Background: Over the past decade, genomic testing has become standard of care for metastatic non-small cell lung cancer (NSCLC). These tests qualify patients for additional anti-cancer therapies and should be performed in all patients. Small scale studies at the institutional level have revealed that there may be disparities in genomic testing in NSCLC and not all patients may have similar access to care. In this study, we use the IBM Explorys Electronic Health Record (EHR) database to conduct a nationwide retrospective, observational study to understand how gender, race, insurance type, and spoken language impacts the rate of genomic testing in metastatic NSCLC patients. Methods: From Jan 1st, 2015 to Dec 31st, 2020, the IBM Explorys EHR database comprised 128,119 lung cancer patients using the SNOMED-CT concept of Primary Malignant Neoplasm of the Lung (CID 93880001). As structured staging information was not available, metastatic NSCLC patients were imputed by removing patients who received thoracic surgeries (presumably stage I or II) and those who received radiation therapy (presumably stage III). Following imputation, 120,470 patients with metastatic NSCLC were queried for testing for EGFR, ALK, ROS1, and/or RET. Odds ratios and chi-squared tests were computed for gender, race, insurance type, and spoken language comparing patients that received genomics testing to those who did not. Results: Genomic testing was taken significantly more by male patients (OR: 1.35, p<0.0001), and by Caucasian patients (OR: 1.39, p<0.0001). Compared to the public insurance plans, the genomic testing was significantly more in patients with private insurance plans (OR: 2.48, p<0.0001) and self-pay patients (OR: 2.84, p<0.0001). Patients speaking English as their first language significantly less likely took genomic testing (OR: 0.81, p<0.05). Conclusions: This study aims to identify gaps in health disparities in gender, race/ethnicity, and insurance type for genomic testing that should be standard practice. Future investigation and attention to this issue appears necessary to begin moving from documenting disparities, to understanding them, and ultimately to reducing them.[Table: see text]

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 135-135
Ryan S. Chiang ◽  
Michael Glover ◽  
Gavin Hui ◽  
Aakash Desai ◽  
Heather A. Wakelee ◽  

135 Background: Black patients have a disproportionately high incidence and mortality from lung cancer. Despite the importance of clinical trials, there continue to be significant racial disparities in recruitment for pivotal registration studies. In 2016, the FDA recommended reporting racial enrollment with a minimum of 5 categories (White, Black, Asian, American Indian or Alaskan Native [AIAN] and Native Hawaiian or Pacific Islander [NHPI]). The International Committee of Medical Journal Editors also recommend reporting race and ethnicity. We evaluated race reporting and representation in registration trials for thoracic cancers. Methods: We reviewed the FDA website and identified all new drug licensing indications in thoracic malignancies (small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC) and mesothelioma) from 2006 to 2020. NSCLC was further classified as EGFR+, ALK+, other mutation and NOS (no driver mutation). Clinical trials cited on the licensing label for market authorization were recorded and the corresponding registration trial publication was identified. If race was unreported or underreported (defined as ≤3 groups) in the licensing study, then additional information was obtained from clinicaltrials.gov. We calculated the proportion of registration trials meeting FDA criteria and the proportion of each racial group in trials. Results: From 2006-2020, we identified 55 new licensing indications, involving 26 unique drugs; 5 approvals in SCLC, 49 approvals in NSCLC and 1 in mesothelioma. Prior to the FDA race reporting guidelines, 33% (6/18) of registration studies did not meet FDA requirements. This improved to 27% (10/37) after the guideline introduction. Overall 29,545 patients participated in thoracic registration trials; 66% White, 22% Asian, 2% Black, <1% AIAN, <1% NHPI, 1% other or multiple races and 9% unknown. Table shows race distribution by cancer subtype. Conclusions: Although improving, a substantial number of registrational clinical trials in thoracic oncology still do not report race per FDA guidance. In addition, Black individuals are disproportionately under-represented in registration trials. Greater efforts are needed for the inclusion of Black patients and other minorities in clinical trials.[Table: see text]

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 62-62
Chetan Vakkalagadda ◽  
Bijal Desai ◽  
Nisha Anjali Mohindra ◽  
Sheetal Mehta Kircher

62 Background: The Oncology Care Model (OCM) is a Center for Medicare and Medicaid Innovation (CMMI) alternative payment model designed to enhance value in cancer care. Based on a practice’s historical performance, the model predicts a target price for a 6-month episode of care and adjusts for factors such as age, modality received, geographic location, trend factor, and receipt of a novel therapy. Practices are incentivized to reduce costs of care, allowing for a performance based payment if the total cost of care is below the predicted OCM target price. At our OCM practice, when compared to other malignancy types, lung cancer has disproportionately failed to meet the OCM target. The purpose of our review was to explore the contribution of systemic therapy to total cost within the OCM model for lung cancer episodes. Methods: We reviewed claims and clinical data for the OCM Performance Period 6 (PP6), which corresponds to episodes beginning between 1/2/19-7/1/19 and ending between 7/2/19-12/31/19, for all OCM lung cancer episodes at Northwestern Medical Group. Results: 142 patients were identified with non-small cell (n = 128, 91%) and small cell lung cancer (n = 14, 9%). Patients received a PD1 inhibitor either alone or in combination with chemotherapy (n = 87), tyrosine kinase inhibitors (n = 18), both a PD1 inhibitor and a TKI (n = 2), or chemotherapy alone (n = 35). All systemic therapy use was deemed guideline compliant. 46 patients (33%) had at least 1 cancer-related hospital admission during the episode. 19 patients (13.4%) died during the OCM performance period. 39/142 (27.5%) of patients’ episode costs achieved the OCM target. Among the 103 patients whose total costs exceeded the target, drug costs alone exceeded the target in 67 (65%). Drug costs alone exceeded the total target in 59% (n = 63/107) of those who received PD1 inhibitor or TKI therapy and 11.4% (4/35) of those who received chemotherapy alone. 94% (n = 63/67) of patients for whom drug costs alone exceeded the OCM target received anti-PD1 therapy or a TKI. Conclusions: Drug cost alone exceeded the total target in the majority of OCM lung cancer episodes that did not achieve savings, highlighting the dominant role drugs play in the OCM model. With targeted therapy and immunotherapy already the standard of care in metastatic non-small cell lung cancer, and gaining a foothold in earlier stages of disease, accounting for these therapies in the OCM target price methodology will be critical for oncology practices to be successful within such value-based payment models.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 244-244
Stephanie Ossowski ◽  
Elad Neeman ◽  
Charles Borden ◽  
Amy Ying Ju Lin ◽  
Raymond Liu

244 Background: Next generation sequencing (NGS) is a crucial component of evaluation of newly diagnosed patients with metastatic non-small cell lung cancer (NSCLC) to determine appropriate first line treatment. Delays in NGS can lead to psychologic distress for patients and can affect choices in first line therapy, especially for patients with underlying targetable mutations. While more data is needed to benchmark turnaround time for NGS results, guidelines and expert consensus suggest time from diagnosis to treatment should be 15 days and turnaround time for genomic testing 10-14 days. This study was aimed at reducing time to NGS results in a large integrated health care system. Methods: Through the ASCO Quality Training Program, we reviewed electronic medical records of 25 patients with newly diagnosed, untreated metastatic NSCLC from 12/2018 to 9/2020 and determined number of days from pathological diagnosis to NGS results. We reviewed process maps for oncology, pathology, the internal data management division, and a genomic testing company to determine factors leading to significant preventable delays. Since 11/2020, we created an automated weekly report using CoPath to identify new pathological diagnoses of potential metastatic NSCLC. The oncology department reviewed these cases weekly and NGS orders were placed for patients with metastatic NSCLC. Eleven additional patients with newly diagnosed metastatic NSCLC were included in the prospective cohort. Results: Demographic characteristics are noted in Table. Our intervention reduced median time from pathological diagnosis to NGS results from 24 to 19 days. Median time from biopsy results to NGS order was reduced from 7 to 1 day. Time from specimen being sent from pathology to NGS vendor was a median of 6 days in both cohorts. Total time from pathological diagnosis to appropriate treatment was reduced from a median of 33 to 25 days. Conclusions: Delays in time to NGS results can be reduced by improved communication between departments and simple, automated interventions to ensure results are efficiently released to an oncologist. Additional Plan-Do-Study-Act cycles are currently being developed to further reduce time from biopsy results to NGS results. [Table: see text]

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 59-59
Woojung Lee ◽  
Scott Spencer ◽  
Josh John Carlson ◽  
Tam Dinh ◽  
Victoria Dayer ◽  

59 Background: The use of comprehensive genomic profiling (CGP) in cancer patients could lead to additional enrollment in clinical trials that study novel genetic biomarkers, potentially reducing treatment costs for payers and improving health outcomes for patients. Our objective was to estimate the number of additional clinical trials in which patients with non-small cell lung cancer (NSCLC) could potentially enroll due to the use of CGP vs. a comparator panel of 50 genes or less. Methods: Clinical trials in NSCLC that started between 2015 - 2020 were identified from the Aggregate Analysis of ClinicalTrials.gov (AACT) database. Trials with unknown status or study sites outside the United States only were excluded. We abstracted information on required genetic alterations based on the study eligibility criteria. We calculated the incremental number of trials available to patients due to results generated by CGP (FoundationOne CDx, 324 genes) vs. a commercially available comparator panel that was 50 genes or less (Oncomine Dx Target Test, 23 genes) by phase and calendar year. The additional trials were characterized by disease severity, type of therapy, and setting. Results: Enrollment eligibility was dependent on genetic variant status in 35% (250/709) of all identified NSCLC trials. There were 29 (248 vs. 219) additional clinical trials available to patients through the use of CGP, 12% of all gene-specific trials for NSCLC. We identified 45 uses of genetic markers in the 29 additional clinical trials. The most frequent genetic marker in the incremental trials was microsatellite instability, accounting for 44% of all identified markers (20/45). The incremental number of trials available to patients due to the use of CGP did not vary significantly over time but varied by phase – most of the additional clinical trials were in phase 1 or 2 (28/29, 97%). Most of the incremental trials were in metastatic disease (22/29, 76%) and were conducted in academic or advanced community settings (18/29, 62%). The most frequently studied type of intervention in these studies was targeted monotherapy (8/29, 28%), followed by immuno-monotherapy (7/29, 24%). Conclusions: Clinical trials in NSCLC initiated over the past 5 years have consistently included CGP-specific genes or markers in eligibility criteria. Patients with NSCLC have the potential to benefit from the use of CGP as compared to smaller gene panels through improved access to clinical trials.[Table: see text]

2021 ◽  
Vol 11 (1) ◽  
Chie Morita ◽  
Tatsuya Yoshida ◽  
Masayuki Shirasawa ◽  
Ken Masuda ◽  
Yuji Matsumoto ◽  

AbstractEpidermal growth factor receptor (EGFR) exon 20 insertion mutations (Exon20ins) account for 4–12% of all EGFR mutations in non-small cell lung cancer (NSCLC) patients. Data on the differences in clinical characteristics between patients with Exon20ins and major mutations (M-mut) such as exon 19 deletion and L858R are limited. We retrospectively reviewed advanced NSCLC patients with EGFR mutations, who were treated with systemic therapy between January 2011 and December 2019. We identified 23 patients with Exon20ins and 534 patients with M-mut. In Exon20ins patients, the median age was 60 (range 27–88) years, and females and never-smokers were predominant. Clinical characteristics were similar in the two groups. In Exon20ins patients, 17 patients received platinum doublet as first-line therapy, and the overall response rate (ORR) and median progression-free survival (mPFS) were 11.8% and 8.9 months. Additionally, seven patients received conventional EGFR-tyrosine kinase inhibitors (TKIs), and eight patients anti-PD-1 antibodies in any-line therapy. ORR and mPFS of EGFR-TKIs and anti-PD-1 antibodies were 0%, 2.2 months and 25%, 3.1 months, respectively. Overall survival was significantly shorter in Exon20ins patients than in M-mut patients (29.3 vs. 43.4 months, p = 0.04). The clinical outcomes in Exon20ins patients were not satisfactory compared to M-mut patients.

Fu Du ◽  
Xin Qi ◽  
Aotong Zhang ◽  
Fanfan Sui ◽  
Xuemin Wang ◽  

AbstractPD-L1 is abnormally regulated in many cancers and is critical for immune escape. Fully understanding the regulation of PD-L1 expression is vital for improving the clinical efficacy of relevant anticancer agents. TGF-β plays an important role in the low reactivity of PD-1/PD-L1 antibody immunotherapy. However, it is not very clear whether and how TGF-β affects PD-L1 expression. In the present study, we show that TGF-β upregulates the expression of the transcriptional coactivator MRTF-A in non-small-cell lung cancer cells, which subsequently interacts with NF-κB/p65 rather than SRF to facilitate the binding of NF-κB/p65 to the PDL1 promoter, thereby activating the transcription and expression of PD-L1. This leads to the immune escape of NSCLC cells. This process is dependent on the activation of the TGF-β signaling pathway. In vivo, inhibition of MRTF-A effectively suppresses the growth of lung tumor syngrafts with enrichment of NK and T cells in tumor tissue. Our study defines a new signaling pathway that regulates the transcription and expression of PD-L1 upon TGF-β treatment, which may have a significant impact on research into the application of immunotherapy in treating lung cancer.

2021 ◽  
Vol 2021 ◽  
pp. 1-16
Jiahang Song ◽  
Shuming Zhang ◽  
Yuanyuan Sun ◽  
Junjie Gu ◽  
Ziqi Ye ◽  

Purpose. Radiotherapy resistance is now recognized as the major obstacle to the effective therapeutic management of non-small-cell lung cancer (NSCLC). As a single biomarker has limited effect in stratifying NSCLC patients, this research aimed to identify long non-coding RNAs (lncRNAs) correlated with radiotherapy response to ameliorate forecast of NSCLC prognosis. Methods. In a cohort of NSCLC patients with radiotherapy history (n = 96) from TCGA, genetic data of lncRNA expression profiling were performed. To identify radioresponse-related lncRNA sets which dysregulated significantly between radiosensitive (RS) and radioresistant (RR) groups, differential expression analysis was carried out. Cox relative regression was implemented to set up a radioresponse-related risk model. Moreover, we adopted survival analysis to measure the predictive potentiality of the prognosis model. Results. Four radioresponse-related lncRNAs (CASC19, LINC01977, LINC02471, and MAGI2-AS3) were screened to create a prognostic signature. Then, we described a lncRNA signature-based regulatory network and explored the correlation of the immune microenvironment and the signature. Additionally, in vitro assays uncovered inhibition of LINC01977 weakened radioresistance of NSCLC cells. Conclusion. We provided a novel radioresponse-related lncRNAs signature with excellent clinical potency for an effective prognostic forecast of patients.

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