{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T09:55:08Z","timestamp":1790848508875,"version":"4.1.0"},"reference-count":20,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2022,1,19]],"date-time":"2022-01-19T00:00:00Z","timestamp":1642550400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009954","name":"Taiho Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009954","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2022,4,15]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND<\/jats:title>\n                    <jats:p>Fosnetupitant (FosNTP), an intravenous neurokinin 1 receptor antagonist, demonstrated a favorable safety profile with a potentially low risk of injection site reactions (ISRs) and promising antiemetic efficacy in patients receiving cisplatin\u2010based highly emetogenic chemotherapy in a previous phase 2 study. We conducted a randomized, double\u2010blind safety study to evaluate the safety profile of FosNTP, including ISRs, in patients receiving doxorubicin\u2010cyclophosphamide or epirubicin\u2010cyclophosphamide (AC\/EC) chemotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>Patients scheduled to receive AC\/EC were randomized 1:1 to receive 235\u00a0mg of FosNTP or 150\u00a0mg of fosaprepitant (FosAPR), both in combination with 0.75\u00a0mg of intravenous palonosetron and 9.9\u00a0mg of dexamethasone on day 1. The stratification factors were age category (&lt;55 vs \u226555\u00a0years) and study site. The primary end point was the incidence of treatment\u2010related adverse events (TRAEs) with FosNTP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Overall, 102 patients were randomized to FosNTP (n\u00a0=\u00a052) or FosAPR (n\u00a0=\u00a050), and all were treated with the study drug and evaluated for safety. The primary end point, the incidence of TRAEs, was similar with FosNTP (21.2%; 95% confidence interval [CI], 11.1%\u201034.7%) and FosAPR (22.0%; 95% CI, 11.5%\u201036.0%), with any\u2010cause ISRs observed in 5.8% and 26.0% of patients, respectively, and treatment\u2010related ISRs observed in 0% and 10.0%, respectively. The overall (0\u2010120 hour) complete response (defined as no emetic event and no rescue medication) rate, standardized by age category in the full analysis set, was 45.9% (23 of 51 patients) with FosNTP and 51.3% (25 of 49 patients) with FosAPR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>FosNTP demonstrated a favorable safety profile with a very low risk of ISRs in the AC\/EC setting.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cncr.34088","type":"journal-article","created":{"date-parts":[[2022,1,19]],"date-time":"2022-01-19T16:54:07Z","timestamp":1642611247000},"page":"1692-1698","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["A phase 3 safety study of fosnetupitant as an antiemetic in patients receiving anthracycline and cyclophosphamide: CONSOLE\u2010BC"],"prefix":"10.1002","volume":"128","author":[{"given":"Kazuo","family":"Matsuura","sequence":"first","affiliation":[{"name":"Department of Breast Oncology Saitama Medical University International Medical Center Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junji","family":"Tsurutani","sequence":"additional","affiliation":[{"name":"Advanced Cancer Translational Research Institute Showa University Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Inoue","sequence":"additional","affiliation":[{"name":"Department of Breast Oncology Saitama Cancer Center Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Tanabe","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Toranomon Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuhiko","family":"Taira","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Sagara Hospital Kagoshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaoru","family":"Kubota","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine and Oncology Graduate School of Medicine Nippon Medical School Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohide","family":"Tamura","sequence":"additional","affiliation":[{"name":"Thoracic Center St. Luke's International Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8893-9519","authenticated-orcid":false,"given":"Toshiaki","family":"Saeki","sequence":"additional","affiliation":[{"name":"Department of Breast Oncology Saitama Medical University International Medical Center Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,1,19]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw270"},{"key":"e_1_2_9_3_1","volume-title":"Clinical Practice Guidelines in Oncology: Antiemesis. Version 1","author":"National Comprehensive Cancer Network","year":"2021"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.74.4789"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10147-020-01818-3"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-013-2089-8"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.2147\/CMAR.S93620"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.7150\/jca.7706"},{"key":"e_1_2_9_9_1","first-page":"379","article-title":"Differential impact of fosaprepitant on infusion site adverse events between cisplatin\u2010 and anthracycline\u2010based chemotherapy regimens","volume":"35","author":"Fujii T","year":"2015","journal-title":"Anticancer Res"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-014-2326-9"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.3892\/mco.2016.769"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mds541"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-013-2106-y"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.32429"},{"key":"e_1_2_9_15_1","unstructured":"Highlights of prescribing information. AKYNZEO\u00ae (netupitant and palonosetron) capsules for oral use. AKYNZEO\u00ae (fosnetupitant and palonosetron) for injection for intravenous use. US Food and Drug Administration. Accessed June 3 2021.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/210493s000lbl.pdf"},{"key":"e_1_2_9_16_1","unstructured":"Summary of product characteristics. Akynzeo 300 mg\/0.5 mg hard capsules. Akynzeo 235 mg\/0.25 mg powder for concentrate for solution for infusion. European Medicines Agency. Accessed June 3 2021.https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/akynzeo\u2010epar\u2010product\u2010information_en.pdf"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-013-2201-2"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2019-0527"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/cam4.2979"},{"key":"e_1_2_9_20_1","doi-asserted-by":"crossref","unstructured":"ShiraishiY HataA&InuiNet al. A phase III randomized double\u2010blind multicenter active control study of fosnetupitant for the prevention of chemotherapy\u2010induced nausea and vomiting (CINV) in patients receiving cisplatin based highly emetogenic chemotherapy (HEC): CONSOLE study [abstract 12099]. Abstract presented at: Annual Meeting of the American Society of Clinical Oncology; June 4\u20108 2021; Chicago IL.","DOI":"10.1200\/JCO.2021.39.15_suppl.12099"},{"key":"e_1_2_9_21_1","unstructured":"Highlights of prescribing information. EMEND (fosaprepitant) for injection for intravenous use. US Food and Drug Administration. Accessed June 3 2021.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022023s019lbl.pdf"}],"container-title":["Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cncr.34088","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cncr.34088","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cncr.34088","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T13:47:08Z","timestamp":1760276828000},"score":1,"resource":{"primary":{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/10.1002\/cncr.34088"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1,19]]},"references-count":20,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2022,4,15]]}},"alternative-id":["10.1002\/cncr.34088"],"URL":"https:\/\/doi.org\/10.1002\/cncr.34088","archive":["Portico"],"relation":{},"ISSN":["0008-543X","1097-0142"],"issn-type":[{"value":"0008-543X","type":"print"},{"value":"1097-0142","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,1,19]]},"assertion":[{"value":"2021-10-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-12-13","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-01-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}