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Randomized, Placebo-Controlled, Phase III Trial of Fosaprepitant, Ondansetron, Dexamethasone (FOND) Versus FOND Plus Olanzapine (FOND-O) for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Hematologic Malignancies Receiving Highly Emetogenic Chemotherapy and Hematopoietic Cell Transplantation Regimens: The FOND-O Trial

•Chemotherapy-induced nausea/vomiting (CINV) is common after HCT despite triplet prophylaxis.•This is the first study to evaluate adding olanzapine to triplet prophylaxis for highly emetogenic chemotherapy (HCT for hematology and HCT patients.•Olanzapine + triplet prophylaxis improved clinical outco...

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Published in:Biology of blood and marrow transplantation 2018-10, Vol.24 (10), p.2065-2071
Main Authors: Clemmons, Amber B., Orr, Julianne, Andrick, Benjamin, Gandhi, Arpita, Sportes, Claude, DeRemer, David
Format: Article
Language:English
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Summary:•Chemotherapy-induced nausea/vomiting (CINV) is common after HCT despite triplet prophylaxis.•This is the first study to evaluate adding olanzapine to triplet prophylaxis for highly emetogenic chemotherapy (HCT for hematology and HCT patients.•Olanzapine + triplet prophylaxis improved clinical outcomes versus triplet prophylaxis alone in HCT patients. Evidence supports olanzapine for prophylaxis of chemotherapy-induced nausea/vomiting (CINV) for highly emetogenic chemotherapy; however, most studies focus on solid malignancies and single-day regimens. A randomized, double-blinded, placebo-controlled trial was conducted to compare the addition of olanzapine to triplet therapy (fosaprepitant, ondansetron, dexamethasone [FOND-O]) versus triplet therapy alone (FOND) in preventing CINV in hematology patients receiving single-day and multiple-day highly emetogenic chemotherapy and hematopoietic cell transplant (HCT) regimens (NCT02635984). The primary objective of this study was to compare complete response (CR; no emesis and minimal nausea,
ISSN:1083-8791
1523-6536
DOI:10.1016/j.bbmt.2018.06.005