A double-blind randomized phase II dose-finding study of olanzapine 10 mg or 5 mg for the prophylaxis of emesis induced by highly emetogenic cisplatin-based chemotherapy

• Published in: International journal of clinical oncology 2018-04, Vol.23 (2), p.382-388
• Main Authors: Yanai, Takako, Iwasa, Satoru, Hashimoto, Hironobu, Ohyanagi, Fumiyoshi, Takiguchi, Tomomi, Takeda, Koji, Nakao, Masahiko, Sakai, Hiroshi, Nakayama, Toshiaki, Minato, Koichi, Arai, Takahiro, Suzuki, Kenichi, Shimada, Yasuhiro, Nagashima, Kengo, Terakado, Hiroyuki, Yamamoto, Noboru
• Format: Article
• Language: English
• Subjects: Antipsychotics; Cancer Research; Chemotherapy; Cisplatin; Clinical trials; Dexamethasone; Double-blind studies; Drug therapy; Medicine; Medicine & Public Health; Nausea; Olanzapine; Oncology; Original Article; Patients; Prophylaxis; Solid tumors; Surgical Oncology; Vomiting
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-017-1200-4

Purpose The aim of this phase II study was to evaluate the efficacy and safety of two doses (10 and 5 mg) of olanzapine in combination with standard antiemetic treatment (aprepitant, palonosetron, and dexamethasone) for patients receiving highly emetogenic chemotherapy (HEC). Methods A multi-institutional, double-blind, randomized phase II, dose-finding study of olanzapine was performed in patients with a malignant solid tumor who were receiving HEC with cisplatin (≥ 50 mg/m 2 ). Patients were randomly assigned either olanzapine 10 or 5 mg orally on days 1–4, combined with standard antiemetic treatment. The primary endpoint was a complete response (CR; no emesis and no use of rescue medications) in the delayed phase (24–120 h after the start of cisplatin treatment). Results 153 patients were randomized to the 10 mg group ( n  = 76) or the 5 mg group ( n  = 77). The CR rate in the delayed phase was 77.6% (80% CI: 70.3–83.8, P  = 0.01) in the 10 mg group and 85.7% (80% CI: 79.2–90.7, P