scholarly journals Comprehensive Genomic Profiling Facilitates Implementation of the National Comprehensive Cancer Network Guidelines for Lung Cancer Biomarker Testing and Identifies Patients Who May Benefit From Enrollment in Mechanism‐Driven Clinical Trials

2016 ◽  
Vol 21 (6) ◽  
pp. 684-691 ◽  
Author(s):  
James H. Suh ◽  
Adrienne Johnson ◽  
Lee Albacker ◽  
Kai Wang ◽  
Juliann Chmielecki ◽  
...  
2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 59-59
Author(s):  
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]


2015 ◽  
Vol 4 (2) ◽  
pp. 87-95
Author(s):  
Elena Vigliar ◽  
Umberto Malapelle ◽  
Claudio Bellevicine ◽  
Giancarlo Troncone

2020 ◽  
Vol 9 (3) ◽  
pp. 887-897
Author(s):  
Erik Thunnissen ◽  
Birgit Weynand ◽  
Dalma Udovicic-Gagula ◽  
Luka Brcic ◽  
Malgorzata Szolkowska ◽  
...  

2019 ◽  
Vol 14 (10) ◽  
pp. S1004-S1005
Author(s):  
J. Martin Lopez ◽  
L. Aduz Alexandre ◽  
S. Gatius Caldero ◽  
A. Navarro Gonzales ◽  
P. Saiz Lopez ◽  
...  

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e20515-e20515 ◽  
Author(s):  
Bijal Shah-Manek ◽  
Chitra Karki ◽  
Sarah Whitmire ◽  
Long Ha ◽  
Samantha Martino ◽  
...  

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21727-e21727
Author(s):  
Ani K John ◽  
Baiyu Yang ◽  
Roma Shah

e21727 Background: Identification of molecular alterations can provide essential information to guide personalized treatment selection for advanced non-small cell lung cancer (aNSCLC) patients. However, in routine oncology practice, not all eligible patients receive biomarker testing and receive treatment according to the testing results following the National Comprehensive Cancer Network (NCCN) guideline. We aim to examine the impact of adherence to guideline-recommended therapy on the duration of treatment in a real-world setting. Methods: Patients diagnosed with non-squamous aNSCLC (stage IIIB and above) and received the first-line of therapy (FLOT) between 2011 and 2019 from the nationwide Flatiron Health electronic health record-derived de-identified database were included in this analysis. Adherence was defined as using any NCCN guideline-recommended FLOT consistent with a patient’s biomarker testing results (EGFR, ALK, ROS1, BRAF and PD-L1) assessed up to 90 days before and/or 14 days after the FLOT start date. Non-adherence was defined as not receiving guideline-recommended FLOT based on the above-mentioned biomarker results, or patients treated without evidence of biomarker testing. Median time to treatment discontinuation (TTD) of FLOT was calculated using Kaplan-Meier analysis. Unadjusted and adjusted Cox proportional hazards regression models were used to evaluate the association between guideline adherence and TTD. Results: A total of 17,137 eligible patients were included (67.5% adherent, 32.5% non-adherent). Mean age at diagnosis was 67 years (SD: 10 years). The majority of patients (92%) received care at a community clinic, and 73% reported having insurance plans. Overall, 87.2% had discontinuation of FLOT, including 84.9% in the adherent group and 92.0% in the non-adherent group. The median TTD was 155 days (95% CI 153-159) in the adherent group and 128 days (95% CI 125-132) in the non-adherent group. Adherent patients had a lower risk of FLOT discontinuation in the unadjusted analysis (hazard ratio [HR] 0.78, 95% CI 0.76-0.81), which remained significant after adjusting for potential confounders including age at FLOT start, sex, history of smoking, and stage at initial diagnosis (HR 0.76, 95% CI 0.74-0.79). Conclusions: Among non-squamous aNSCLC patients, the majority of patients were adherent to NCCN guidelines. Adherence was associated with lower risk of discontinuation and longer duration of FLOT.


2021 ◽  
pp. jclinpath-2020-207280
Author(s):  
Clara Salas ◽  
Javier Martín-López ◽  
Antonio Martínez-Pozo ◽  
Teresa Hernández-Iglesias ◽  
David Carcedo ◽  
...  

AimThe aim of this study was to describe the testing rate and frequency of molecular alterations observed in the Lung Cancer Biomarker Testing Registry (LungPath).MethodsA descriptive study of NSCLC biomarker determinations collected from March 2018 to January 2019, from 38 Spanish hospitals, was carried out. Only adenocarcinoma and not otherwise specified histologies were included for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1) and programmed death ligand-1 (PD-L1) expression. The testing rate and the positivity rate were calculated. Multivariate logistic regression was used to explore the joint relationship between independent explanatory factors and both testing and positivity rates. Two models were adjusted: one with sample type and histology as independent factors, and the other adding the testing rate or the positivity rate of the other biomarkers.Results3226 patient samples were analysed, where EGFR, ALK, ROS1 and PD-L1 information was collected (a total of 12 904 determinations). Overall, 9118 (71.4%) determinations were finally assessed. EGFR (91.4%) and ALK (80.1%) were the mainly tested biomarkers. Positivity rates for EGFR, ALK, ROS1 and PD-L1 were 13.6%, 3.4%, 2.0% and 49.2%, respectively. Multivariate models showed a lower testing rate for ALK in surgical pieces, fine-needle aspiration or other types of samples versus biopsies.ConclusionsDespite the high testing rate in EGFR and ALK in NSCLC, the real-world evidence obtained from the LungPath demonstrates that ROS1 and PD-L1 were not determined in a significant portion of patients. LungPath provides crucial information to improve the coverage in molecular testing in lung cancer, to monitor the positivity rate and the introduction of new biomarker testing in clinical practice.


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