Identifying the initiation of a new line of therapy for metastatic lung, breast, and colorectal cancer in real-world data: a scoping review

Identifying the initiation of a new line of therapy for metastatic lung, breast, and colorectal cancer in real-world data: a scoping review | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL Pharmacoepidemiology and Drug Safety This is a preprint and has not been peer reviewed. Data may be preliminary. 24 November 2025 V1 Latest version Share on Identifying the initiation of a new line of therapy for metastatic lung, breast, and colorectal cancer in real-world data: a scoping review Authors : Oluwadamilola ONASANYA 0000-0001-9774-8119 [email protected] , Seyed Hamidreza Mahmoudpour , Benjamin A. Bates 0000-0002-1221-4028 , Irene M. Shui , Geoffrey Liu , Eng Hooi Tan , Yi-Hsin Yang , … Show All … , Maribel Salas , Joseph Fadare 0000-0002-5641-1402 , Dimitri Bennett , Paula Drummond 0000-0002-4639-7424 , Ju-Young Shin 0000-0003-1010-7525 , Sonia Guleria 0000-0003-1230-3968 , Jocelyn Wang R , Manila Hada , Hélène Denis , Soko Setoguchi , Ilse Truter , Luciane Lopes 0000-0002-3684-3275 , and Ruth Wangia Dixon Show Fewer Authors Info & Affiliations https://doi.org/10.22541/au.176396448.83473491/v1 Published Pharmacoepidemiology and Drug Safety Version of record Peer review timeline 299 views 127 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Purpose: This study aimed to identify and synthesize published algorithms for identifying the initiation of a new line of therapy (LOT) for metastatic lung, breast, and colorectal cancer in real-world data (RWD). Methods: We conducted a scoping review of published, English-language studies describing algorithms for identifying any LOTs with systemic anti-cancer therapy (SACT) for either non-metastatic or metastatic lung, breast or colorectal cancer in RWD between January 1, 2014, and April 29, 2024. Dual reviewers independently screened titles, abstracts and full-text articles with disagreements resolved by a third reviewer. Data were extracted, categorized, synthesized, and summarized in narrative and tabular formats. Results: The review identified 25 studies, mainly from the U.S. (64%). Electronic health/medical records (EHRs) were the most frequently utilized (72%) RWD source. Twenty-four studies (96%) described RWD algorithms for identifying the initiation of a new LOT for metastatic lung, breast, or colorectal cancer. In 23 studies, algorithms required observing a new, adjuvant, SACT after an ‘incident’ metastatic diagnosis code, which had been preceded by a metastasis-free lookback period of varied duration. Three studies’ algorithms required observation of the completion of non-metastatic LOTs before initiation of a new LOT for metastatic cancer. Three studies validated their algorithms. Conclusions: Different algorithms are being used to identify LOT initiation for metastatic cancer. Most algorithms require an incident diagnosis of metastasis before considering subsequent SACT as newly initiated LOT for metastatic cancer. However, definitions of metastasis onset, and gap duration to therapy initiation, vary. Supplementary Material File (pds-25-0999-file001.docx) Download 307.63 KB File (pds-25-0999-file002.pptx) Download 49.91 KB File (pds-25-0999-file003.pptx) Download 40.31 KB Information & Authors Information Version history V1 Version 1 24 November 2025 Peer review timeline Published Pharmacoepidemiology and Drug Safety Version of Record 27 Apr 2026 Published Copyright This work is licensed under a Non Exclusive No Reuse License. Collection Pharmacoepidemiology and Drug Safety Keywords algorithms frameworks line of therapy lot observational studies oncology scoping review Authors Affiliations Oluwadamilola ONASANYA 0000-0001-9774-8119 [email protected] Carelon Research Inc View all articles by this author Seyed Hamidreza Mahmoudpour Merck Healthcare KGaA View all articles by this author Benjamin A. Bates 0000-0002-1221-4028 Rutgers University Camden University College View all articles by this author Irene M. Shui Merck & Co Inc View all articles by this author Geoffrey Liu University of Toronto Dalla Lana School of Public Health View all articles by this author Eng Hooi Tan University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences View all articles by this author Yi-Hsin Yang National Health Research Institutes View all articles by this author Maribel Salas Bayer Corporation View all articles by this author Joseph Fadare 0000-0002-5641-1402 Ekiti State University College of Medicine View all articles by this author Dimitri Bennett Takeda Development Center Americas Inc View all articles by this author Paula Drummond 0000-0002-4639-7424 Fundacao Ezequiel Dias View all articles by this author Ju-Young Shin 0000-0003-1010-7525 Sungkyunkwan University School of Pharmacy View all articles by this author Sonia Guleria 0000-0003-1230-3968 Parexel Sweden AB View all articles by this author Jocelyn Wang R Janssen Research and Development LLC View all articles by this author Manila Hada Merck & Co Inc Upper Gwynedd View all articles by this author Hélène Denis HEVA SAS View all articles by this author Soko Setoguchi Rutgers Robert Wood Johnson Medical School Department of Medicine View all articles by this author Ilse Truter Nelson Mandela University Faculty of Health Sciences View all articles by this author Luciane Lopes 0000-0002-3684-3275 Universidade de Sorocaba View all articles by this author Ruth Wangia Dixon Carelon Research Inc View all articles by this author Metrics & Citations Metrics Article Usage 299 views 127 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Oluwadamilola ONASANYA, Seyed Hamidreza Mahmoudpour, Benjamin A. Bates, et al. Identifying the initiation of a new line of therapy for metastatic lung, breast, and colorectal cancer in real-world data: a scoping review. Authorea . 24 November 2025. DOI: https://doi.org/10.22541/au.176396448.83473491/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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