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Title: Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-emetogenic chemotherapy
Authors: Suthinee Ithimakin
Pathra Theeratrakul
Apirom Laocharoenkiat
Akarin Nimmannit
Charuwan Akewanlop
Nopadol Soparattanapaisarn
Sirisopa Techawattanawanna
Krittiya Korphaisarn
Pongwut Danchaivijitr
Faculty of Medicine, Siriraj Hospital, Mahidol University
Keywords: Medicine
Issue Date: 1-Jan-2020
Citation: Supportive Care in Cancer. (2020)
Abstract: © 2020, Springer-Verlag GmbH Germany, part of Springer Nature. Purpose: We assessed the efficacy of aprepitant (APR) or 10 or 5 mg OLN (OLN10 or OLN5) plus ondansetron and dexamethasone for chemotherapy-induced nausea/vomiting (CINV) prophylaxis in patients receiving high-emetogenic chemotherapy (HEC). Methods: Patients who received doxorubicin + cyclophosphamide or cisplatin were given intravenous ondansetron and dexamethasone prior to chemotherapy and oral dexamethasone on days 2–4 and randomized 1:1:1 to receive APR125 on day 1 and APR80 on days 2–3 or OLN10 or OLN5 on days 1–4. Matched placebo controls were used. The primary endpoint was no nausea in ≤ 120 h. Secondary endpoints included CINV severity, complete response (CR) rate, adverse effects (AE), and quality of life. Results: Of 141 patients, 104 received AC and 37 received cisplatin. The no-nausea rates were 33% (APR), 43.2% (OLN10; p = 0.24), and 37% (OLN5; p = 0.87). Grades 2–4 nausea were experienced by fewer patients for OLN10 than for APR (24–120 h, 8.7% vs. 27.7%, respectively; p = 0.02; overall period, 19.6% vs. 40.4%, respectively; p = 0.03). The median visual analog scale nausea score from 24 to 120 h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03). The degrees of vomiting, CR, and AE were similar between the APR and OLN10 groups. CINV was similar between the OLN5 and APR groups. Conclusions: Nausea was less severe for OLN10 than for APR in patients receiving HEC, but other measures were similar. CINV prevention efficacy was comparable between OLN5 and APR.
ISSN: 14337339
Appears in Collections:Scopus 2020

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