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Barriers to non-small cell lung cancer trial eligibility.

ABSTRACT: Introduction:Cancer clinical trial (CCT) enrollment is low potentially threatening the generalizability of trial results and expedited regulatory approvals. We assessed whether type of initial patient appointment for non-small cell lung cancer (NSCLC) is associated with CCT eligibility. Methods:Using a patient-to-accrual framework, we conducted a quasi-retrospective cohort pilot study at Sidney Kimmel Comprehensive Cancer Center (SKCCC), Baltimore, Maryland. 153 NSCLC patients new to SKCCC were categorized based on type of initial appointment: patients diagnosed or treated and patients seen for a consultation. CCT eligibility was determined by comparing eligibility criteria for each open trial to the electronic medical record (EMR) of each patient at every office visit occurring within 6-months of initial visit. Results:We found no association between type of initial appointment and CCT eligibility (OR, 1.15; 95% CI, 0.49-2.73). Analyses did suggest current smokers were less likely to be eligible for trials compared to never smokers (OR, 0.15; 95% CI, 0.03-0.64), and stage 4 patients with second line therapy or greater were more likely to be eligible than stage 1 or 2 patients (OR, 5.18; 95% CI, 1.08-24.75). Additional analyses suggested most current smokers and stage 1 or 2 patients had trials available but were still ineligible. Conclusions:SKCCC has a diverse portfolio of trials available for NSCLC patients and should consider research strategies to re-examine eligibility criteria for future trials to ensure increased enrollment of current smokers and stage 1 or 2 patients. We could not confirm whether type of initial visit was related to eligibility.

SUBMITTER: Hardesty JJ

PROVIDER: S-EPMC5898521 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Barriers to non-small cell lung cancer trial eligibility.

Hardesty Jeffrey J JJ Kanarek Norma F NF

Contemporary clinical trials communications 20171124

<h4>Introduction</h4>Cancer clinical trial (CCT) enrollment is low potentially threatening the generalizability of trial results and expedited regulatory approvals. We assessed whether type of initial patient appointment for non-small cell lung cancer (NSCLC) is associated with CCT eligibility.<h4>Methods</h4>Using a patient-to-accrual framework, we conducted a quasi-retrospective cohort pilot study at Sidney Kimmel Comprehensive Cancer Center (SKCCC), Baltimore, Maryland. 153 NSCLC patients new ...[more]

PMID: 29696224

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Project description:Purpose Prospectively identifying who will benefit from adjuvant chemotherapy (ACT) would improve clinical decisions for individual non-small-cell lung cancer (NSCLC) patients. Most current molecular signatures for lung cancer are prognostic only and provide limited information with regard to the functional importance of the genes selected. In this study, we aim to develop and validate a functional gene set that predicts the clinical benefit of ACT in NSCLC. Experimental Design An 18-hub-gene prognosis signature was developed through a systems biology approach using a large NSCLC dataset from the Director’s Challenge Consortium. The prognostic value of this signature was tested in NSCLC patients from UT Lung SPORE cohort and additional five public datasets. The 18-hub-gene set was then integrated with genome-wide functional (RNAi) data and genetic aberration data to derive a 12-gene predictive signature for ACT benefit in NSCLC. Results We showed that the 18-hub-gene set can robustly predict the prognosis of patients with adenocarcinoma in all validation datasets across four microarray platforms. The refined 12-gene functional set was successfully validated in two independent datasets. The predicted benefit group showed significant improvement in survival after ACT (JBR.10 clinical trial data: hazard ratio=0.36, p=0.038; UT Lung SPORE data: hazard ratio=0.34, p=0.017), while the predicted non-benefit group showed no survival improvement. Conclusions This is the first study to integrate genetic aberration, genome-wide RNAi functional data, and mRNA expression data to identify a functional gene set that is predictive for ACT benefits. This 12-gene predictive signature has been validated in two independent NSCLC cohorts. Patients were eligible to enter the study if they underwent curative resection for NSCLC at MD Anderson Cancer Center between December 1996 and June 2007, and patients with radiation therapy were excluded from the study. All tissue samples were obtained by surgical resection from patients who had provided written informed consent. Tissues were stored at −140°C after being snap frozen in liquid nitrogen. Serial sectioning of each sample was used to histologically evaluate tumor and malignant cells content before RNA extraction. The primary tumor tissues from 176 patients were selected randomly from similar samples in the UT Lung SPORE tumor collection based on stringent, predefined quality control procedures before any data analysis, including the presence of ≥70% tumor tissue and ≥50% malignant cells in the frozen tissue used for RNA extraction. In this cohort, 133 patients are adenocarcinomas (ADCs) and 43 patients are squamous cell carcinomas (SCCs); 49 patients received ACT (mainly Carboplatin plus Taxanes) and 127 patients did not receive ACT.

Project description:Background: While precision medicines targeting genetic mutations and alterations in non-small cell lung cancer (NSCLC) have been available since 2010, their adoption into clinical practice has been slow. Evidence suggests that a number of barriers, such as insufficient clinician knowledge, a need for training of test providers, or a lack of specific clinical guidelines, may slow the implementation of precision in general. However, little attention has been given to the barriers to providing precision medicines in NSCLC. The purpose of this protocol is to outline the design for a qualitative interview study to identify the barriers and facilitators to the provision of precision medicines for NSCLC. Methods: This study will use semi-structured interviews with clinicians (n=10), test providers (n=10), and service commissioners (n=10) to identify the perceived barriers and facilitators to providing historical, current, and future precision medicines in NSCLC. Participants will be identified through mailing list advertisements and snowball sampling. Recruitment will continue until data saturation, indicated by no new themes arising from the data. Interviews will be conducted by telephone to facilitate geographical diversity. The qualitative data will be analysed using a framework analysis with themes anticipated to relate to; relevant barriers to providing precision medicines, the impact of different barriers on medicine provision, changes in the ability to provide precision medicines over time, and strategies to facilitate the provision of precision medicines. Ethics: This study has been approved by the University of Manchester Proportionate Review Research Ethics Committee (Reference number: 2017-1885-3619). Written consent will be obtained from all participants. Conclusion: This study is the first to explore the barriers and facilitators to providing precision medicines for NSCLC in the English NHS. The findings will inform strategies to improve the implementation of future precision medicines. These findings will be disseminated in peer-reviewed publications and national and international conferences.

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Barriers to non-small cell lung cancer trial eligibility.

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Barriers to non-small cell lung cancer trial eligibility.

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