{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T21:53:49Z","timestamp":1784238829797,"version":"3.55.0"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2023,6,7]],"date-time":"2023-06-07T00:00:00Z","timestamp":1686096000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UG1CA189823"],"award-info":[{"award-number":["UG1CA189823"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R01CA225647"],"award-info":[{"award-number":["R01CA225647"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UG1CA190140"],"award-info":[{"award-number":["UG1CA190140"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UG1CA232760"],"award-info":[{"award-number":["UG1CA232760"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UG1CA233163"],"award-info":[{"award-number":["UG1CA233163"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,8,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Purpose<\/jats:title>\n                  <jats:p>A protocol was developed to evaluate the value of an NK-1 receptor antagonist for preventing nausea and vomiting resulting from highly emetogenic chemotherapy when an olanzapine-based antiemetogenic regimen was used.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Materials and Methods<\/jats:title>\n                  <jats:p>A221602, a prospective double-blind, placebo-controlled clinical trial, was developed to compare 2 \u00adolanzapine-containing antiemetic regimens, one with an NK-1 receptor antagonist (aprepitant or fosaprepitant) and one without. Trial patients had a malignant disease for which they received intravenous highly emetogenic chemotherapy (single day cisplatin \u2265 70 mg\/m2 or doxorubicin plus cyclophosphamide on 1 day). Patients on both arms received commonly administered doses of a 5-HT3 receptor antagonist, dexamethasone, and olanzapine. Additionally, patients were randomized to receive an NK-1 receptor antagonist (fosaprepitant 150 mg IV or aprepitant 130 mg IV) or a corresponding placebo. The primary objective was to compare the proportion of patients with no nausea for 5 days following chemotherapy between the 2 study arms. This trial was designed to test for the noninferiority of deleting the NK-1 receptor antagonist, with noninferiority defined as a decrease in freedom from nausea by less than 10%.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 690 patients were entered on this trial, 50% on each arm. The proportion of patients without nausea for the complete 5-day study period was 7.4% lower (upper limit of the one-sided 95% confidence interval was 13.5%) in the arm without an NK-1 receptor antagonist compared with the arm with an NK-1 receptor antagonist.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>This trial did not provide sufficient evidence to support that deletion of the NK-1 receptor antagonist was as good as keeping it, as a part of a 4-drug antiemetic regimen for highly emetogenic chemotherapy (ClinicalTrials.gov Identifier: NCT03578081).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyad140","type":"journal-article","created":{"date-parts":[[2023,6,8]],"date-time":"2023-06-08T00:33:56Z","timestamp":1686184436000},"page":"722-729","source":"Crossref","is-referenced-by-count":3,"title":["Olanzapine With or Without Fosaprepitant for Preventing Chemotherapy Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: A Phase III Randomized, Double-Blind, Placebo-Controlled Trial (ALLIANCE A221602)"],"prefix":"10.1093","volume":"28","author":[{"given":"Rudolph M","family":"Navari","sequence":"first","affiliation":[{"name":"Department of Hematology Oncology, Simon Williamson Clinic , Birmingham, AL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Le-Rademacher","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Management Center, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrice","family":"Smieliauskas","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, Wayne State University , Detroit, MI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn J","family":"Ruddy","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"James Saphner","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, Aurora Cancer Care , Green Bay, WI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heshan","family":"Liu","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Management Center, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Harlos","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Management Center, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adedayo A","family":"Onitilo","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, Marshfield Clinic-Weston Center , Marshfield, WI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karthik","family":"Giridhar","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Mayo Clinic , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Preet","family":"Paul Singh","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, Springfield Clinic, Heartland NCORP , Springfield, IL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pavan S","family":"Reddy","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, Cancer Center of Kansas , Wichita, KS , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Selina","family":"Chow","sequence":"additional","affiliation":[{"name":"Alliance Protocol Operations Office, University of Chicago , Chicago, IL , 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