Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus
- PDF / 346,764 Bytes
- 8 Pages / 595.276 x 790.866 pts Page_size
- 27 Downloads / 213 Views
ORIGINAL ARTICLE
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 Suthinee Ithimakin 1 & Pathra Theeratrakul 1 & Apirom Laocharoenkiat 2 & Akarin Nimmannit 3 & Charuwan Akewanlop 1 & Nopadol Soparattanapaisarn 1 & Sirisopa Techawattanawanna 1 & Krittiya Korphaisarn 1 & Pongwut Danchaivijitr 1 Received: 23 January 2020 / Accepted: 24 February 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract 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. Keywords Aprepitant . Nausea . Olanzapine . Chemotherapy-induced emesis
Introduction
* Suthinee Ithimakin [email protected] 1
Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand
2
Pharmacy Department, Siriraj Hospital, Mahidol University, Bangkok, Thailand
3
Department of Research, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
Chemotherapy-induced nausea and vomiting (CINV) is one of the most feared adverse effects (AE). As a result, patients occasionally deny accepting crucial chemotherapy for fear of nausea/vomiting. Some patients experience severe vomiting or prolonged nausea, which may be a cause of anticipatory emesis in subsequent cycles. High-emetogenic chemotherapy (HEC), including cisplatin at a dose ≥ 50 mg/m2 or doxorubicin pl
Data Loading...
