Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting

• Published in: Journal of experimental & clinical cancer research 2009-09, Vol.28 (1), p.131-131, Article 131
• Main Authors: Tan, Lijun, Liu, Jiangtao, Liu, Xiuli, Chen, Jie, Yan, Zhijun, Yang, Huifen, Zhang, Daxin
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antiemetics - therapeutic use; Antineoplastic Agents - adverse effects; Benzodiazepines - therapeutic use; Bridged Bicyclo Compounds, Heterocyclic - therapeutic use; Cancer; Cancer therapies; Chemotherapy; Dexamethasone - therapeutic use; Disease prevention; Drug dosages; Drug therapy; Female; Humans; Male; Middle Aged; Nausea; Nausea - etiology; Nausea - prevention & control; Neoplasms - drug therapy; Oxazines - therapeutic use; Psychotropic drugs; Quality of Life; Serotonin 5-HT3 Receptor Antagonists; Studies; Vomiting; Vomiting - etiology; Vomiting - prevention & control
• ISSN: 1756-9966; 0392-9078; 1756-9966
• DOI: 10.1186/1756-9966-28-131

This study was designed to mainly evaluate the activity and safety of olanzapine compared with 5-hydroxytryptamine 3(5-HT3) receptor antagonists for prevention of chemotherapy-induced nausea and vomiting(CINV) in patients receiving highly or moderately emetogenic chemotherapy (HEC or MEC). The second goal was to evaluate the impact of olanzapine on quality of life (QoL) of cancer patients during the period of chemotherapy. 229 patients receiving highly or moderately emetogenic chemotherapy were randomly assigned to the test group [olanzapine(O) 10 mg p.o. plus azasetron (A) 10 mg i.v. and dexamethasone (D) 10 mg i.v. on day 1; O 10 mg once a day on days 2-5] or the control group (A 10 mg i.v. and D 10 mg i.v. on day 1; D 10 mg i.v. once a day on days 2-5). All the patients filled the observation table of CINV once a day on days 1-5, patients were instructed to fill the EORTC QLQ-C30 QoL observation table on day 0 and day 6. The primary endpoint was the complete response (CR) (without nausea and vomiting, no rescue therapy) for the acute period (24 h postchemotherapy), delayed period (days 2-5 postchemotherapy), the whole period (days 1-5 postchemotherapy). The second endpoint was QoL during chemotherapy administration, drug safety and toxicity. 229 patients were evaluable for efficacy. Compared with control group, complete response for acute nausea and vomiting in test group had no difference (p > 0.05), complete response for delayed nausea and vomiting in patients with highly emetogenic chemotherapy respectively improved 39.21% (69.64% versus 30.43%, p < 0.05), 22.05% (78.57% versus 56.52%, p < 0.05), complete response for delayed nausea and vomiting in patients with moderately emetogenic chemotherapy respectively improved 25.01% (83.07% versus 58.06%, p < 0.05), 13.43% (89.23% versus 75.80%, p < 0.05), complete response for the whole period of nausea and vomiting in patients with highly emetogenic chemotherapy respectively improved 41.38% (69.64% versus 28.26%, p < 0.05), 22.05% (78.57% versus 56.52%, p < 0.05), complete response for the whole period of nausea and vomiting in patients with moderately emetogenic chemotherapy respectively improved 26.62% (83.07% versus 56.45%, p < 0.05), 13.43% (89.23% versus 75.80%, p < 0.05). 214 of 299 patients were evaluable for QoL. Comparing test group with control group in QoL evolution, significant differences were seen in global health status, emotional functioning, social functioning, fatigue, nausea and vomiting