Publication: 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
Issued Date
2020-01-01
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ISSN
14337339
09414355
09414355
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2-s2.0-85081034214
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Mahidol University
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SCOPUS
Bibliographic Citation
Supportive Care in Cancer. (2020)
Suggested Citation
Suthinee Ithimakin, Pathra Theeratrakul, Apirom Laocharoenkiat, Akarin Nimmannit, Charuwan Akewanlop, Nopadol Soparattanapaisarn, Sirisopa Techawattanawanna, Krittiya Korphaisarn, Pongwut Danchaivijitr 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. Supportive Care in Cancer. (2020). doi:10.1007/s00520-020-05380-6 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/53805
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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
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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.