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

Yanai, Tomoko; Iwasa, Satoru; Hashimoto, H.; 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

doi:10.1007/s10147-017-1200-4

Cited by 60 publications

(55 citation statements)

References 18 publications

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“…[ 13 ] Another research, a double-blind randomized phase II study of olanzapine 10 mg versus 5 mg for emesis induced by highly emetogenic chemotherapy (HEC) completed. [ 18 ] They conducted the study to base on olanzapine in combination with standard antiemetic treatment (aprepitant, palonosetron, and dexamethasone). Therefore, we explore the efficacy and safety of the dose of 5 mg olanzapine with palonosetron and dexamethasone for the prevention of HEC in lung cancer patients.…”

Section: Introductionmentioning

confidence: 99%

Olanzapine with ondansetron and dexamethasone for the prevention of cisplatin-based chemotherapy-induced nausea and vomiting in lung cancer

2018

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Olanzapine is an atypical antipsychotic that has shown efficacy for the treatment of nausea, anxiety, and insomnia. This study was conducted to evaluate the efficacy of olanzapine (5 mg) combined with 5-HT3 receptor antagonists and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in lung patients receiving cisplatin-based (25 mg/m2 d1-3) highly emetogenic chemotherapy (HEC).Olanzapine (5 mg) was administered a day prior to cisplatin administration and continued on days 1 to 5. We evaluated complete response (CR) rate and rates of no nausea and no vomiting in 3 periods. In addition, Self-Rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), and The Functional Living Index-Emesis (FLIE) questionnaire were also assessed.A total of 40 lung cancer patients were included. CR for acute, delayed, and over all phases were 82.5%, 75.0%, and 70.0%, respectively. The rate of no nausea in the acute phase was 70.0% and 62.5% in delayed phase. The rate of no vomiting in the acute phase was 85.0%, and 77.5% in delayed phase. The rate of no nausea and no vomiting in the overall phase were 57.5% and 75.0%, respectively. The median SAS and SDS score were 37.9 and 41.6 in pre-chemotherapy, respectively. Up to day 6 after chemotherapy treatment, the median SAS and SDS score were 36.9 and 42.0, respectively. The median FLIE score was 111.7. The main side effects were grade 1 somnolence (35.0%) and mild constipation (52.5%).Around 5 mg olanzapine may be used as a potential, safe, and cost-beneficial alternative to prevent nausea and vomiting for HEC, particular for multiday chemotherapy regimen.

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Section: Introductionmentioning

confidence: 99%

Olanzapine with ondansetron and dexamethasone for the prevention of cisplatin-based chemotherapy-induced nausea and vomiting in lung cancer

2018

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“…Two different olanzapine dosages were used in this review, and subgroup analysis shows that both doses (10 mg and 5 mg olanzapine) provided comparably significant improvement in acute and delayed CINV. The phase 2 trial by Yanai et al 14 found that 5 mg of olanzapine had a higher complete control in delayed CINV compared with 10 mg (83.1% vs 77.6%). Because olanzapine may lead to central nervous system depression, especially in elderly and debilitated patients,33 5 mg per day of olanzapine should be more suitable for cancer patients.…”

Section: Discussionmentioning

confidence: 99%

“…The National Comprehensive Cancer Network (NCCN) guidelines for antiemesis (version 1.2019) also recommend olanzapine combined with a 5-HT3 RA plus dexamethasone after NK-1 RA for high and moderate emetogenic chemotherapy; however, 5 mg per day was considered only when 10 mg per day caused serious sedation. RCTs12 13 demonstrated 5 mg oral olanzapine per day to be effective, and a randomised phase 2 dose-finding study14 even revealed that 5 mg had a higher complete control in delayed CINV compared with 10 mg (83.1% vs 77.6%). Meta-analysis15 also found that both 5 mg and 10 mg olanzapine exhibited similar efficacy.…”

Section: Introductionmentioning

confidence: 99%

Olanzapine combined with 5-hydroxytryptamine type 3 receptor antagonist (5-HT3 RA) plus dexamethasone for prevention and treatment of chemotherapy-induced nausea and vomiting in high and moderate emetogenic chemotherapy: a systematic review and meta-analysis of randomised controlled trials

et al. 2020

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We performed a pooled analysis to evaluate the efficacy and adverse events (AEs) of olanzapine combined with dexamethasone plus 5-hydroxytryptamine type 3 receptor antagonist (5-HT3 RA) compared with 5-HT3 RA plus dexamethasone for the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV) in high and moderate emetogenic chemotherapy based on randomised controlled trials (RCTs). PubMed, EMBASE, Web of Science, the Cochrane Library, China Biomedical Literature database (CBM), WanFang Database, China National Knowledge Infrastructure (CNKI), and Chinese Science and Technology Periodical Database (VIP) (from their inception to April 2019) were searched to capture relevant articles. Relative risk with 95% confidence intervals for CINV and AEs were all extracted or calculated. Eleven studies with 1107 cancer patients were involved in this review. The pooled RR of delayed CINV (RR 0.50, 95% CI 0.38 to 0.66; p<0.01) were significantly decreased in the olanzapine group. The occurrence of insomnia was also statistically decreased, as was the rate of acute CINV (RR 0.60, 95% CI 0.48 to 0.75; p<0.01). However, only the percentages of CINV III and CINV IV were significantly decreased in the acute and delayed phases. Subgroup analysis demonstrated that the efficacy was not statistically significantly different between 5 mg and 10 mg olanzapine. Olanzapine significantly decreased the occurrence of CINV III and IV and insomnia in high and moderately emetogenic chemotherapy. Compared with 10 mg per day, 5 mg oral olanzapine may be more appropriate for patients with cancer.

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“…В 2017 г. Янай Т. (Yanai T.) и соавторы опубликовали результаты рандомизированного двойного слепого исследования II фазы, посвященного сравнению эффективности дозы оланзапина 5 и 10 мг в сочетании со стандартной терапией апрепитантом, палоносетроном и дексаметазоном [24]. Оланзапин назначался в 1-4-й дни курса, остальные препараты -в стандартных терапевтических дозах.…”

Section: рекомендованные режимы применения оланзапинаunclassified

Olanzapine for the Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting

et al. 2018

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Chemotherapy-induced nausea and vomiting (CINV) has tremendous negative impact on daily life of cancer patients and their quality of life. In this article we analyzed current clinical guidelines in preventive measures and treatment of CINV as well as efficacy of recommended standard regimens for CINV prevention in patients receiving high emetogenic chemotherapy (HEC). We summarized existing data about olanzapine – affordable antipsychotic agent with potent antiemetogenic activity which is quite useful for CINV prophylaxis in patients receiving HEC. We highlighted possible future directions for research of olanzapine in oncology and reasons that preclude integration of this drug in routine clinical practice in Russia.

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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

Abstract: UMIN000014214.

Cited by 60 publications

References 18 publications

Olanzapine with ondansetron and dexamethasone for the prevention of cisplatin-based chemotherapy-induced nausea and vomiting in lung cancer

Olanzapine with ondansetron and dexamethasone for the prevention of cisplatin-based chemotherapy-induced nausea and vomiting in lung cancer

Olanzapine combined with 5-hydroxytryptamine type 3 receptor antagonist (5-HT3 RA) plus dexamethasone for prevention and treatment of chemotherapy-induced nausea and vomiting in high and moderate emetogenic chemotherapy: a systematic review and meta-analysis of randomised controlled trials

Olanzapine for the Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting

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