Fosnetupitant for long-delayed chemotherapy-induced nausea and vomiting in oxaliplatin-based regimens: A prospective observational study (LODEC-N)

Fosnetupitant for long-delayed chemotherapy-induced nausea and vomiting in oxaliplatin-based regimens: A prospective observational study (LODEC-N) | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Fosnetupitant for long-delayed chemotherapy-induced nausea and vomiting in oxaliplatin-based regimens: A prospective observational study (LODEC-N) Yohei Iimura, Hirotoshi Iihara, Takeshi Aoyama, Toshinobu Hayashi, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9148601/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 7 You are reading this latest preprint version Abstract Purpose An exploratory analysis of the phase III CONSOLE study indicated that the triplet antiemetic regimen including fosnetupitant (FosNTP) may be effective across extended overall period (0–168 h) for highly emetogenic chemotherapy-induced nausea and vomiting (CINV); however, its impact during the long-delayed phase (> 168 h) remains unclear. This study aimed to prospectively explore the benefits of FosNTPs in preventing CINV beyond 168 h in patients undergoing oxaliplatin-based chemotherapy. Methods This single-center, single-arm, prospective observational study recruited patients scheduled to receive oxaliplatin-based chemotherapy. The primary endpoint was the long-delayed (120–336 h) complete control (CC) rate. Key secondary endpoints included the long-delayed complete response (CR) rate and the overall (0–336 h) CC, CR, and total control (TC) rates. Relative risks for emetogenic events were assessed using a logistic regression model. Results The analysis included 100 patients. Most eligible patients received CapeOX (oxaliplatin + capecitabine) (92.0%). The long-delayed CC rate was 76.3%. The long-delayed CR and TC rates were 84.7% and 75.4%, respectively. Risk factors for CINV in participants who did not achieve CC during the long-delayed phase included age (odds ratio 0.954 [95% confidence interval 0.909–0.998]), female sex (8.808 [2.446–41.992]), and history of motion sickness (5.050 [1.118–27.548]). Conclusion The triplet regimen involving FosNTP demonstrated sufficient efficacy in preventing CINV in patients receiving oxaliplatin-based chemotherapy, including during the long-delayed phase. However, participants with high emetic risk factors—such as younger age, female sex, or a history of motion sickness—continued to experience suboptimal control. Trial registration number and date of registration : jRCT1030230130 fosnetupitant long-delayed CINV chemotherapy oxaliplatin antiemetics Full Text Additional Declarations Competing interest reported. Hirotoshi Iihara served as a consultant for Astellas Pharma Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., and Taiho Pharmaceutical Co., Ltd. Hirotoshi Iihara received lecture fees from Astellas Pharma Co., Ltd.; AstraZeneca plc; Chugai Pharmaceutical Co., Ltd.; Daiichi Sankyo Co., Ltd.; Eli Lilly and Company; Nippon Kayaku Co., Ltd.; Ohara Pharmaceutical Co., Ltd.; Sawai Pharmaceutical Co., Ltd.; Taiho Pharmaceutical Co., Ltd.; and Yakult Honsha Co., Ltd. Yohei Iimura, Takeshi Aoyama, Toshinobu Hayashi, Masaaki Ishibashi, Chieko Sasuga, Naoki Furukawa, Eri Anzai, Yuki Ijichi, and Seiichiro Kuroda have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 23 Apr, 2026 Reviewers agreed at journal 13 Apr, 2026 Reviewers agreed at journal 26 Mar, 2026 Reviewers invited by journal 19 Mar, 2026 Editor assigned by journal 19 Mar, 2026 Submission checks completed at journal 19 Mar, 2026 First submitted to journal 17 Mar, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9148601","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":609855001,"identity":"5ddbb5d6-8269-47de-b39e-1900d5befd6f","order_by":0,"name":"Yohei Iimura","email":"data:image/png;base64,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","orcid":"","institution":"The University of Tokyo","correspondingAuthor":true,"prefix":"","firstName":"Yohei","middleName":"","lastName":"Iimura","suffix":""},{"id":609855002,"identity":"45c85650-050d-4127-bf72-a6288140a3dc","order_by":1,"name":"Hirotoshi Iihara","email":"","orcid":"","institution":"Gifu University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Hirotoshi","middleName":"","lastName":"Iihara","suffix":""},{"id":609855003,"identity":"34e7d96c-713e-428c-b10f-0780240d05bb","order_by":2,"name":"Takeshi Aoyama","email":"","orcid":"","institution":"Japanese Foundation for Cancer","correspondingAuthor":false,"prefix":"","firstName":"Takeshi","middleName":"","lastName":"Aoyama","suffix":""},{"id":609855004,"identity":"e5bf72af-5f68-4c94-95a6-7cbda0532e14","order_by":3,"name":"Toshinobu Hayashi","email":"","orcid":"","institution":"Fukuoka University","correspondingAuthor":false,"prefix":"","firstName":"Toshinobu","middleName":"","lastName":"Hayashi","suffix":""},{"id":609855005,"identity":"59d7feb9-c991-4b43-8f0f-d45112c13881","order_by":4,"name":"Masaaki Ishibashi","email":"","orcid":"","institution":"The University of Tokyo","correspondingAuthor":false,"prefix":"","firstName":"Masaaki","middleName":"","lastName":"Ishibashi","suffix":""},{"id":609855006,"identity":"77a0549a-d01f-45a4-90a0-3b87076cbdee","order_by":5,"name":"Chieko Sasuga","email":"","orcid":"","institution":"The University of Tokyo","correspondingAuthor":false,"prefix":"","firstName":"Chieko","middleName":"","lastName":"Sasuga","suffix":""},{"id":609855007,"identity":"31e30c30-d340-460d-91ed-9d9a71173a37","order_by":6,"name":"Naoki Furukawa","email":"","orcid":"","institution":"The University of Tokyo","correspondingAuthor":false,"prefix":"","firstName":"Naoki","middleName":"","lastName":"Furukawa","suffix":""},{"id":609855008,"identity":"ce1a8f92-6732-4a5f-9ce9-962e2ecf5798","order_by":7,"name":"Eri Anzai","email":"","orcid":"","institution":"The University of Tokyo","correspondingAuthor":false,"prefix":"","firstName":"Eri","middleName":"","lastName":"Anzai","suffix":""},{"id":609855009,"identity":"ce47e425-c3a0-461a-9862-53091def975b","order_by":8,"name":"Yuki Ijichi","email":"","orcid":"","institution":"The University of Tokyo","correspondingAuthor":false,"prefix":"","firstName":"Yuki","middleName":"","lastName":"Ijichi","suffix":""},{"id":609855010,"identity":"6a26beb7-63af-4d33-b4bf-77dc6f97b89f","order_by":9,"name":"Seiichiro Kuroda","email":"","orcid":"","institution":"The University of Tokyo","correspondingAuthor":false,"prefix":"","firstName":"Seiichiro","middleName":"","lastName":"Kuroda","suffix":""}],"badges":[],"createdAt":"2026-03-17 12:08:30","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9148601/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9148601/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":105564457,"identity":"7d42e283-df3c-425d-b31b-7d9cf333c7d1","added_by":"auto","created_at":"2026-03-27 12:49:38","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":534173,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9148601/v1_covered_1da60726-300c-4521-9299-b38ff45f9dc4.pdf"}],"financialInterests":"Competing interest reported. Hirotoshi Iihara served as a consultant for Astellas Pharma Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., and Taiho Pharmaceutical Co., Ltd. Hirotoshi Iihara received lecture fees from Astellas Pharma Co., Ltd.; AstraZeneca plc; Chugai Pharmaceutical Co., Ltd.; Daiichi Sankyo Co., Ltd.; Eli Lilly and Company; Nippon Kayaku Co., Ltd.; Ohara Pharmaceutical Co., Ltd.; Sawai Pharmaceutical Co., Ltd.; Taiho Pharmaceutical Co., Ltd.; and Yakult Honsha Co., Ltd. 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This study aimed to prospectively explore the benefits of FosNTPs in preventing CINV beyond 168 h in patients undergoing oxaliplatin-based chemotherapy.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis single-center, single-arm, prospective observational study recruited patients scheduled to receive oxaliplatin-based chemotherapy. The primary endpoint was the long-delayed (120–336 h) complete control (CC) rate. Key secondary endpoints included the long-delayed complete response (CR) rate and the overall (0–336 h) CC, CR, and total control (TC) rates. Relative risks for emetogenic events were assessed using a logistic regression model.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe analysis included 100 patients. Most eligible patients received CapeOX (oxaliplatin + capecitabine) (92.0%). The long-delayed CC rate was 76.3%. 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