{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T08:06:57Z","timestamp":1753862817806,"version":"3.41.2"},"reference-count":33,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,5,2]],"date-time":"2024-05-02T00:00:00Z","timestamp":1714608000000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>This study aims to evaluate published clinical trials of ramucirumab to assess the risk\/benefit profile and burden over time for patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The burden of oncologic drug development on patients paired with increasing clinical trial failure rates emphasizes the need for reform of drug development. Identifying and addressing patterns of excess burden can guide policy, ensure evidence\u2010based protections for trial participants, and improve medical decision\u2010making.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>On May 25, 2023 a literature search was performed on Pubmed\/MEDLINE, Embase, Cochrane CENTRAL, and ClinicalTrials.gov for clinical trials using ramucirumab as monotherapy or in combination with other interventions for cancer treatment. Authors screened titles and abstracts for potential inclusion in a masked, duplicate fashion. Following data screening, data was extracted in a masked, duplicate fashion. Trials were classified as positive when meeting their primary endpoint and safety, negative or indeterminate.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Ramucirumab was initially approved for gastric cancer but has since been tested in 20 cancers outside of its FDA approved indications. In our analysis of ramucirumab trials, there were a total of 10,936 participants and 10,303 adverse events reported. Gains in overall survival and progression\u2010free survival for patients were 1.5 and 1.2 months, respectively. FDA\u2010approved indications have reported more positive outcomes in comparison to off\u2010label indications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We found that FDA\u2010approved indications for ramucirumab had better efficacy outcomes than non\u2010approved indications. However, a concerning number of adverse events were observed across all trials assessed. Participants in ramucirumab randomized controlled trials saw meager gains in overall survival when evaluated against a comparison group. Clinicians should carefully weigh the risks associated with ramucirumab therapy given its toxicity burden and poor survival gains.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.7130","type":"journal-article","created":{"date-parts":[[2024,5,3]],"date-time":"2024-05-03T06:30:14Z","timestamp":1714717814000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Assessing patient risk, benefit, and outcomes in drug development: A decade of ramucirumab clinical trials"],"prefix":"10.1002","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1358-5119","authenticated-orcid":false,"given":"Adam","family":"Khan","sequence":"first","affiliation":[{"name":"Office of Medical Student Research Oklahoma State University Center for Health Sciences  Tulsa Oklahoma USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hassan","family":"Khan","sequence":"additional","affiliation":[{"name":"Office of Medical Student Research Oklahoma State University Center for Health Sciences  Tulsa Oklahoma USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Griffin K.","family":"Hughes","sequence":"additional","affiliation":[{"name":"Office of Medical Student Research Oklahoma State University Center for Health Sciences  Tulsa Oklahoma USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chase","family":"Ladd","sequence":"additional","affiliation":[{"name":"Office of Medical Student Research Oklahoma State University Center for Health Sciences  Tulsa Oklahoma USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1447-3832","authenticated-orcid":false,"given":"Ryan","family":"McIntire","sequence":"additional","affiliation":[{"name":"Office of Medical Student Research Oklahoma State University Center for Health Sciences  Tulsa Oklahoma USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brooke","family":"Gardner","sequence":"additional","affiliation":[{"name":"Office of Medical Student Research Oklahoma State University Center for Health Sciences  Tulsa Oklahoma USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andriana M.","family":"Pe\u00f1a","sequence":"additional","affiliation":[{"name":"Office of Medical Student Research Oklahoma State University Center for Health Sciences  Tulsa Oklahoma USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abigail","family":"Schoutko","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Oklahoma State University Center for Health Sciences  Tulsa Oklahoma USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jordan","family":"Tuia","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics University of California San Francisco  San Francisco California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kirstien","family":"Minley","sequence":"additional","affiliation":[{"name":"Office of Medical Student Research Oklahoma State University Center for Health Sciences  Tulsa Oklahoma USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7876-3978","authenticated-orcid":false,"given":"Alyson","family":"Haslam","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics University of California San Francisco  San Francisco California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vinay","family":"Prasad","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics University of California San Francisco  San Francisco California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matt","family":"Vassar","sequence":"additional","affiliation":[{"name":"Office of Medical Student Research Oklahoma State University Center for Health Sciences  Tulsa Oklahoma USA"},{"name":"Department of Psychiatry and Behavioral Sciences Oklahoma State University Center for Health Sciences  Tulsa Oklahoma USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,5,2]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"Stomach cancer \u2010 statistics.Cancer.Net. 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