Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type

dc.contributor.authorWeinstein, Cindy
dc.contributor.authorJordan, Karin
dc.contributor.authorGreen, Stuart
dc.contributor.authorKhanani, Saleem
dc.contributor.authorBeckford-Brathwaite, Elizabeth
dc.contributor.authorVallejos, Waldimir
dc.contributor.authorPong, Annpey
dc.contributor.authorNoga, Stephen J.
dc.contributor.authorRapoport, Bernardo Leon
dc.date.accessioned2020-12-23T06:28:05Z
dc.date.available2020-12-23T06:28:05Z
dc.date.issued2020-09
dc.descriptionAdditional file 1. List of Independent Ethics Committees (IECs).en_ZA
dc.description.abstractBACKGROUND: Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25–120 h after chemotherapy initiation), compared with a 3-day control regimen (ClinicalTrials.gov, NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers). METHODS: Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)–based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0–120 h and 0–24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed. RESULTS: CR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/ colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2–22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well tolerated in all cancer subgroups. CONCLUSIONS: This post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type.en_ZA
dc.description.departmentImmunologyen_ZA
dc.description.librarianpm2020en_ZA
dc.description.sponsorshipMerck Sharp & Dohme Corpen_ZA
dc.description.urihttp://www.biomedcentral.com/bmccanceren_ZA
dc.identifier.citationWeinstein, C., Jordan, K., Green, S. et al. 2020, 'Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type', BMC Cancer, vol. 20, no. 1, art. 918, pp. 1-10.en_ZA
dc.identifier.issn1471-2407 (online)
dc.identifier.other10.1186/s12885-020-07259-5
dc.identifier.urihttp://hdl.handle.net/2263/77477
dc.language.isoenen_ZA
dc.publisherBioMed Centralen_ZA
dc.rights© The Author(s). 2020 Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License.en_ZA
dc.subjectChemotherapy-induced nausea and vomiting (CINV)en_ZA
dc.subjectFosaprepitanten_ZA
dc.subjectGastrointestinal canceren_ZA
dc.subjectLung canceren_ZA
dc.subjectBreast canceren_ZA
dc.subjectGynecologic canceren_ZA
dc.titleSingle-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer typeen_ZA
dc.typeArticleen_ZA

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