• Isseki Maeda, Eriko Satomi, Daisuke Kiuchi, Kaoru Nishijima, Yoshinobu Matsuda, Akihiro Tokoro, Keita Tagami, Yoshihisa Matsumoto, Akemi Naito, Tatsuya Morita, Satoru Iwase, Phase-R N/V Study Group, Hiroyuki Otani, Takuya Odagiri, Hiroaki Watanabe, Masanori Mori, Yosuke Matsuda, Hiroka Nagaoka, Meiko Mayuzumi, Yoshiaki Kanai, Nobuhiro Sakamoto, and Keisuke Ariyoshi.
• Department of Palliative Care, Senri-Chuo Hospital, Toyonaka, Osaka, Japan. isseki.maeda@gmail.com.
• Support Care Cancer. 2021 Oct 1; 29 (10): 5831-5838.

PurposeTo examine the safety, effectiveness, and patient-perceived benefit of treatment with olanzapine for nausea and vomiting (N/V) in patients with advanced cancer.MethodsWe conducted a multicenter prospective observational study in a tertiary care setting (Trial registration number: UMIN000020493, date of registration: 2016/1/12). We measured the following: average nausea in the last 24 h using a Numeric Rating Scale (NRS: range 0-10) at baseline and day 2, patient-perceived treatment benefit (based on a 5-point verbal scale), and adverse events (AEs; using the Common Terminology Criteria for Adverse Events version 4).ResultsThe 85 participants (45% men) had a mean age of 58.7±15.8 years. Major causes of N/V were opioids (44%) and chemotherapy (34%). All patients received a daily dose of olanzapine of 5 mg or less as first-line treatment (N=35) or second- or later-line treatment (N=50). Nausea NRS decreased from 6.1±2.2 to 1.8±2.0 (differences: -4.3, 95% CI -3.7 to -4.9, p<0.001). The proportion of patients who did not experience vomiting episodes in the last 24 h increased from 40-89%. Mean decrease in nausea NRS by patient-perceived treatment benefit were as follows: -0.8 for "none" (n=4, 5%); -2.8 for "slight" (n=17, 20%); -3.3 for "moderate" (n=14, 16%); -4.7 for "lots" (n=25, 29%); and -6.1 for "complete" (n=25, 29%; p-for-trend<0.001). The most prevalent AE was somnolence (n=15, 18%).ConclusionShort-term and relatively low-dose olanzapine treatment was effective for multifactorial N/V. Confirmatory studies with longer observation periods are needed to clarify the duration of the effect and adverse events.© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.

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