المؤلفون: Vaidya, Riha, Unger, Joseph M., Qian, Lu, Minichiello, Katherine, Herbst, Roy S., Gandara, David R., Neal, Joel W., Leal, Ticiana A., Patel, Jyoti D., Dragnev, Konstantin H., Waqar, Saiama N., Edelman, Martin J., Sigal, Ellen V., Adam, Stacey J., Malik, Shakun, Blanke, Charles D., LeBlanc, Michael L., Kelly, Karen, Gray, Jhanelle E., Redman, Mary W.

المصدر: JCO Precision Oncology; 9/7/2023, p1-13, 13p

مصطلحات موضوعية: LUNG cancer, NON-small-cell lung carcinoma, OLDER patients, INDIVIDUALIZED medicine

مستخلص: PURPOSE: Lung Cancer Master Protocol (Lung-MAP), a public-private partnership, established infrastructure for conducting a biomarker-driven master protocol in molecularly targeted therapies. We compared characteristics of patients enrolled in Lung-MAP with those of patients in advanced non–small-cell lung cancer (NSCLC) trials to examine if master protocols improve trial access. METHODS: We examined patients enrolled in Lung-MAP (2014-2020) according to sociodemographic characteristics. Proportions for characteristics were compared with those for a set of advanced NSCLC trials (2001-2020) and the US advanced NSCLC population using SEER registry data (2014-2018). Characteristics of patients enrolled in Lung-MAP treatment substudies were examined in subgroup analysis. Two-sided tests of proportions at an alpha of.01 were used for all comparisons. RESULTS: A total of 3,556 patients enrolled in Lung-MAP were compared with 2,215 patients enrolled in other NSCLC studies. Patients enrolled in Lung-MAP were more likely to be 65 years and older (57.2% v 46.3%; P <.0001), from rural areas (17.3% v 14.4%; P =.004), and from socioeconomically deprived neighborhoods (42.2% v 36.7%, P <.0001), but less likely to be female (38.6% v 47.2%; P <.0001), Asian (2.8% v 5.1%; P <.0001), or Hispanic (2.4% v 3.8%; P =.003). Among patients younger than 65 years, Lung-MAP enrolled more patients using Medicaid/no insurance (27.6% v 17.8%; P <.0001). Compared with the US advanced NSCLC population, Lung-MAP under represented patients 65 years and older (57.2% v 69.8%; P <.0001), females (38.6% v 46.0%; P <.0001), and racial or ethnic minorities (14.8% v 21.5%; P <.0001). CONCLUSION: Master protocols may improve access to trials using novel therapeutics for older patients and socioeconomically vulnerable patients compared with conventional trials, but specific patient exclusion criteria influenced demographic composition. Further research examining participation barriers for under represented racial or ethnic minorities in precision medicine clinical trials is warranted. Precision medicine master protocols conducted as a public-private partnership may improve trial access for patients. [ABSTRACT FROM AUTHOR]

: Copyright of JCO Precision Oncology is the property of American Society of Clinical Oncology and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

المؤلفون: Lee, Shing M., Fan, Weijia, Wang, Aijin, Vaidya, Riha, Redman, Mary W., Gettinger, Scott N., Bazhenova, Lyudmila, Herbst, Roy S., Hershman, Dawn L., Unger, Joseph M.

المصدر: JCO Clinical Cancer Informatics; 4/21/2023, Vol. 7, p1-13, 13p

مصطلحات موضوعية: CLINICAL trials, IMMUNOTHERAPY, NON-small-cell lung carcinoma, TOXICITY testing, CARDIOTOXICITY, HEART, PROGRESSION-free survival, GRAPHICAL modeling (Statistics)

مستخلص: PURPOSE: Clinical trial adverse event (AE) data are increasingly complex and high-dimensional, especially for trials evaluating novel targeted agents and immunotherapies. Standard approaches to summarize and analyze AEs remain generally tabular, failing to describe the nature of AEs. Novel dynamic and data visualization methods are needed to enable a more comprehensive assessment of the overall toxicity profile of treatments. METHODS: We developed methods for visualizing the numerous categorizations and types of AEs along with a dynamic approach to better reflect its highly dimensional nature without sacrificing the reporting of rare events. Circular plots displaying the proportion of maximal-grade AEs by system organ classes (SOCs) and butterfly plots displaying the proportion of AEs by severity for each AE term were developed to enable comparisons of AE patterns by treatment arm. These approaches were applied to a randomized phase III trial (S1400I; ClinicalTrials.gov identifier: NCT02785952) comparing nivolumab with nivolumab plus ipilimumab in patients with stage IV squamous non–small-cell lung cancer. RESULTS: Our visualizations revealed that patients randomly assigned to nivolumab and ipilimumab had higher rates of grade 3 or higher AEs compared with nivolumab alone for several SOCs, including musculoskeletal (5.6% v 0.8%), skin (5.6% v 0.8%), vascular (5.6% v 1.6%), and cardiac (4% v 1.6%) toxicities. They also suggested a pattern of higher prevalence of moderate GI and endocrine toxicities and showed that although the rates of cardiac and neurologic toxicities were similar, the types of events were discordant. CONCLUSION: The graphical approaches we proposed enable a more comprehensive and intuitive evaluation of toxicity types by treatment groups, which is not apparent in tabular and descriptive reporting methods. [ABSTRACT FROM AUTHOR]

: Copyright of JCO Clinical Cancer Informatics is the property of American Society of Clinical Oncology and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)