Efficacy Of Olanzapine Research Articles

The effect of differences in trial design on estimates of efficacy of olanzapine in randomized studies

BackgroundDifferences in trial design may affect estimates of efficacy of psychotropic drugs. The purpose of this meta-analysis is to evaluate whether the use of Olanzapine (OLZ) as either investigational or control drug affects the observed efficacy of OLZ. MethodsWe performed a search for Randomized-Controlled Trials (RCTs) in which the efficacy of OLZ is assessed in patients with schizophrenia or schizoaffective disorder. We assessed overall efficacy of OLZ and performed subgroup analyses of studies with OLZ as intervention or comparator. Mixed-effect meta-regression analyses were performed. ResultsOf the 25 RCTs included, OLZ was considered as investigational drug or active control in 13 and 12 studies, respectively. The reduction of PANSS score was greater in trials in which OLZ was used as investigational drug. Multivariate meta-regression models showed that a higher PANSS score at baseline and trial duration were the main predictors of greater PANSS score reduction. ConclusionsTrials with OLZ used as investigational drug differ from those of trials with OLZ as comparator for baseline PANSS scores and study duration; these differences may produce differences in estimates of efficacy. As a consequence, the severity of illness at enrollment and trial duration should be carefully considered to ensure the reliability of indirect comparisons among antipsychotics.

Brief psychotic disorder treatment with Olanzapine in a patient with Phelan-McDermid syndrome

IntroductionThe patient is a 50-year-old female, with multiple admissions in the PICU. At her first admission, at the age of 30 she presented the following main symptoms :mutism, negativism, crying and loss of bladder and bowel control. After collecting her complete family history, it was determined that her mother and one of her brothers were diagnosed with mild intellectual disability. Concerning her childhood history, she presented with late milestones as an infant and toddler and difficulties throughout primary education. Little information concerning her adult life was given, since the patient remained mute during the entirety of her first hospitalization.ObjectivesDetermination of the efficacy of olanzapine in a patient with Phelan-McDermit syndrome with mild intellectual disability and psychotic symptoms such as auditory hallucinations, delusional ideas and disrupted behavior.MethodsPANSS Test, intellectual capacity test, genetic testing.ResultsPANSS Scale Score at the 1st day of admission:100PANSS Scale Score at the last day: 79Intellectual capacity test: mild intellectual disabilityGenetic testing results: Phelan-McDermit syndromeConclusionsAfter 20 days, symptoms showed mild recession in responce to 20mg of olanzapine. In a period of 12 months, the patient showed no signs of relapse and she was not readmitted in the PICU.Disclosure of InterestNone Declared

Association study between D2 receptor A-241G, rs1799978 genetic variation and olanzapine efficacy in Iraqi schizophrenic patients

Association study between D2 receptor A-241G, rs1799978 genetic variation and olanzapine efficacy in Iraqi schizophrenic patients

OLANZAPINE FOR NAUSEA AND VOMITING IN VARIOUS ETIOLOGIES : A REVIEW

Nausea is an unpleasant response followed by the risk of vomiting that results rapid forced ejection of gastric substance from the stomach upwards and out of the mouth. The Gastrointestinal tract, vestibular system, and thalamus are the sites that cause this event. Serotonin type 3 (5-HT3), Mu, neurokinin-1 (NK-1), kappa opioids, dopamine type 2 (D2) are CTZ receptors that cause emesis. 5-HT3 antagonists, antihistamines, and phenothiazines are common antiemetic agents. Olanzapine is an atypical antipsychotic second-generation medication with antiemetic properties. This article review used a classical method to identify studies related to the mechanism and efficacy of olanzapine as an antiemetic. The journal article related to olanzapine in nausea and vomiting that published on 2002 until 2022 for critical appraisal. The purpose of this literature review is to provide a review of antiemetics, especially olanzapine as a therapy option, as well as to evaluate the mechanism and efficacy of olanzapine. The activity of olanzapine with several receptors associated with nausea and vomiting suggests that it may have antiemetic activity. Olanzapine inhibits the 5-HT2C receptor, which is located near small intestine enterochromaffin cells and is required for the emetic response. In CINV therapy, research suggests combining olanzapine 10 mg with a 5-HT3 antagonist, NK-1 antagonist, dexamethasone. There is a lack of data in literature on the use of olanzapine in hyperemesis gravidarum. From the review we concluded that olanzapine can be considered for use as a therapy for the treatment of nausea and vomiting.

32P Efficacy of olanzapine in the prophylaxis of delayed chemotherapy-induced nausea and vomiting in breast cancer patients receiving dose-dense AC with a steroid-sparing regimen: A single-center pilot study

32P Efficacy of olanzapine in the prophylaxis of delayed chemotherapy-induced nausea and vomiting in breast cancer patients receiving dose-dense AC with a steroid-sparing regimen: A single-center pilot study

Effect of combined use of Buyang Huanwu decoction and olanzapine on clinical symptoms, neurological function, and degree of dementia in patients with vascular dementia after cerebral ischemic stroke

Purpose: To determine the efficacy and safety of Buyang Huanwu Decoction (BHD) + olanzapine in the treatment of vascular dementia (VD) after cerebral ischemic stroke (CIS).Methods: Ninety patients with VD after CIS were assigned to 2 groups: a conventional group treated with olanzapine, and a combination group given olanzapine + BHD. Traditional Chinese medicine (TCM) symptom score was evaluated in each group. Neurological function, degree of dementia, and activities of daily living (ADL) were evaluated using National Institute of Health Stroke Scale (NIHSS), Clinical Dementia Rating (CDR) scale, and ADL scale, respectively. Levels of inflammatory factors, oxidative stress, and neurotrophic factors in peripheral blood were also determined. Middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), and vertebral artery (VA) blood flow velocity (BFV) were assessed. Therapeutic effects and adverse reactions (ARs) were recorded as well.Results: The TCM symptom, NHSS, and CDR scores were decreased in the combination group, while ADL scores were increased (p < 0.05). Levels of hs-CRP, IL-6, and malondialdehyde (MDA) also decreased, while IL-10, GPx, SOD, NT3, MCA, ACA, PVA, and VA BFV, and BDNF levels increased (p < 0.05). Clinical effectiveness (CE) levels in the conventional and combination groups were 73.3 and 93.3 %, while the incidence of ARs were 11.11 and 6.7 %, respectively (p < 0.05).Conclusion: Olanzapine + BHD mitigates clinical symptoms, enhances neurological function, decreases the degree of dementia, and increases ADL in patients with vascular dementia after CIS. Moreover, it improves cerebral blood flow, and it is safe to use. An increase in sample size will be needed to compare the long-term efficacy of olanzapine alone, and that of its combination with BHD in the treatment of VD after CIS.

Olanzapine for Non-Chemotherapy Related Nausea and Emesis in Patients with a Palliative Care Consult.

Current palliative care guidelines lack a specific treatment algorithm for nausea and emesis. Olanzapine is an atypical antipsychotic with antiemetic activity that's recommended in the guidelines for the treatment of chemotherapy induced nausea and vomiting, but outside of oncologic indications there is a lack of research. To describe the safety and efficacy of olanzapine for nausea and emesis in the palliative care domain, excluding patients actively undergoing chemotherapy or radiation. This retrospective chart review encompassed hospitalized adult patients from six hospitals across a large health system admitted from August 2020 through August 2021, with a palliative care consult, and being treated with olanzapine for nausea or emesis. Data was collected on antiemetic therapy affordability, the ability for patients to tolerate medications by mouth, and safety outcomes such as QTc prolongation and increased liver function tests. A total of 78 patients were included in the study. Olanzapine decreased the number of doses required of antiemetic medications, the median doses of antiemetic medications pre-olanzapine was 1.6 (IQR 0.8-2.8) and post-olanzapine was 0.6 (IQR 0-2.4) (P=0.0006). After olanzapine was initiated, appetite was improved (P < 0.001), cost of antiemetic therapy was reduced by 65 cents per day (P=0.059) and olanzapine was prescribed at discharge in 69% of patients. QTc prolongation was observed in 19% of patients, and increased ALT and AST were observed in 4.3% and 0%, respectively. This retrospective review demonstrated benefit to utilizing olanzapine for nausea and emesis in palliative care patients and should be considered to aid in symptom management.

Efficacy and Safety of Olanzapine for the Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Chemotherapy-induced nausea and vomiting (CINV) remain the most distressing event in patients receiving highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC). This meta-analysis was conducted to evaluate the efficacy and safety of olanzapine containing regimen in preventing CINV in children on HEC and MEC. We searched PubMed, Embase, and Cochrane central register of controlled trials electronic databases to identify randomized clinical trials that compared 2 groups who either got olanzapine (olanzapine group) or placebo/no olanzapine (control group) for the prevention of CINV in children. The primary outcome was to determine the efficacy of olanzapine (complete response). The secondary outcomes were nausea control, the need for rescue medications, and adverse events of olanzapine. Three randomized clinical trials (n=394 patients) were included in this meta-analysis (olanzapine group, n=194, and placebo/control group, n=200). The pooled analysis of this meta-analysis found that olanzapine had a higher complete response in all phases of emesis in the HEC group and only in the acute phase in HEC/MEC groups compared with the control group. Olanzapine had higher nausea control in all phases of HEC but no nausea control in HEC/MEC. Olanzapine also reduced the need for rescue medications. A significant number of patients in the olanzapine group experienced somnolence (grades 1 and 2), but none of the participants discontinued the study due to side effects. In conclusion, this meta-analysis showed that olanzapine significantly prevented CINV in HEC. There was also a lesser need for rescue medications in the olanzapine group. Somnolence was higher in the olanzapine group, but it was clinically insignificant.

EE23 Economic Impact of Discontinuation and Relapse Rates Among Patients with Schizophrenia Newly Initiated on Lybalvi Versus Olanzapine during First Year Use

Schizophrenia is associated with substantial economic burden on the US health care system. Olanzapine (OLZ), a 2nd generation antipsychotic (AP) treatment has been an effective treatment for patients with schizophrenia has been associated with weight gain and cardiometabolic sequelae. During 2021, the US Food and Drug Administration approved a combination of OLZ and samidorphan (OLZ/SAM [LYBALVI®]) for the treatment of adults diagnosed with schizophrenia or bipolar I disorder. OLZ/SAM has demonstrated clinical efficacy of olanzapine but with less weight gain. The rates of discontinuations to AP are very high in patients with schizophrenia, leading to relapse rates. It is important to understand the potential economic impacts of relapse rates in schizophrenia patients initiated on OLZ/SAM versus OLZ to inform health care decision makers.

Efficacy of Olanzapine in Addition to Standard Triplet Antiemetic Therapy for Cisplatin-Based Chemotherapy

It is unknown whether olanzapine combined with triplet antemetic therapy is effective for all patients undergoing highly emetogenic chemotherapy. A secondary analysis of randomized clinical trials using olanzapine may provide insight into the effectiveness of olanzapine for chemotherapy-induced nausea and vomiting (CINV), including cisplatin. To examine the add-on effect of olanzapine according to risk factors for CINV. This preplanned secondary analysis evaluated results of the J-FORCE trial, a large double-blind, placebo-controlled phase 3 randomized clinical trial conducted in Japan from February 9, 2017, to July 18, 2018. Participants were enrolled from 26 participating hospitals across Japan and included patients aged 20 to 75 years who had a malignant tumor and were cisplatin-naive. The efficacy analysis population of the J-FORCE trial was analyzed according to allocation adjustment factors (sex [male or female], age [≥55 years or <55 years], and cisplatin dose [≥70 mg/m2 or <70 mg/m2]) and patient-related risk factors (history of motion sickness, drinking habit [defined as alcoholic drinks consumption in excess of occasional drinking], and history of morning sickness during pregnancy). Statistical analysis was performed from February 18 to April 18, 2020. Patients were randomized 1:1 to receive 5 mg of olanzapine or placebo combined with standard triplet antiemetic therapy. The primary end point was complete response (CR, defined as no vomiting and no use of rescue medication) in the delayed phase (24-120 hours after cisplatin-based chemotherapy administration). Secondary end points were CR, complete control, and total control in the acute, delayed, and overall phases for 6 CINV risk factors as well as time to treatment failure. The CR point estimates and 95% CIs of the differences between groups were calculated, and a Mantel-Haenszel test was performed. Of the 705 patients (mean [SD] age, 63.0 [9.2] years; 471 males [66.8%]) included in the efficacy analysis population; 581 patients (82.4%) were 55 years or older, and 526 (74.6%) were treated with a cisplatin dose of 70 mg/m2 or more. Risk difference (RD) for a CR in the delayed phase was significantly greater in the olanzapine group than the placebo group in males (RD, 12.6% [95% CI, 5.0%-20.1%]; P = .001); in females (RD, 14.5% [95% CI, 2.2%-26.3%]; P = .02); in those 55 years or older (RD, 11.1% [95% CI, 3.9%-18.2%]; P = .003) or younger than 55 years (RD, 23.6% [95% CI, 7.3%-38.3%]; P = .005); for a cisplatin dose of 70 mg/m2 or more (RD, 13.5% [95% CI, 5.9%-21.0%]; P < .001); for those without a history of motion sickness (RD, 13.9% [95% CI, 6.9%-20.6%]; P < .001); for those with a drinking habit (RD, 14.9% [95% CI, 6.1%-23.4%]; P = .001) or without a drinking habit (RD, 12.0% [95% CI, 2.5%-21.3%]; P = .01); and for those with a history of morning sickness during pregnancy (RD, 27.2% [9.7%-42.6%]; P = .002). In other subgroups, a delayed CR was higher in the olanzapine group than the placebo group, although not significantly higher. Results of this study suggest a benefit of using 5 mg of olanzapine plus triplet antiemetic therapy to counter CINV regardless of the presence or absence of risk factors. University Hospital Medical Information Network Clinical Trials Registry Identifier: UMIN000024676.

Multicentre, randomised, double-blind, placebo-controlled phase II study of prophylactic olanzapine for patients with metastatic breast cancer receiving T-DXd treatment: protocol for the ERICA study (WJOG14320B)

IntroductionThe antibody-drug conjugate trastuzumab deruxtecan (T-DXd) has led to a change in the clinical management of breast cancer. Nausea and vomiting are the most common adverse events of T-DXd, which...

A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of olanzapine plus triple antiemetic regimen for the prevention of multiday highly emetogenic chemotherapy-induced nausea and vomiting (OFFER study).

Evidence supports prophylactic use of olanzapine for the treatment of chemotherapy-induced nausea and vomiting (CINV). However, most studies to date have focused on patients with single-day highly emetogenic chemotherapy (HEC). Currently, administration of antiemetic therapies for nausea and vomiting induced by multiday chemotherapy regimens remains a challenge. In this study, we evaluated the efficacy of olanzapine combined with triple antiemetic therapy for the prevention of CINV in patients receiving multiday chemotherapy. We performed a randomized, double-blind, placebo-controlled phase 3 trial in 22 hospitals. Eligible patients were between 18 and 75 years old, were diagnosed with malignant solid tumors, and they had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. All the study participants were scheduled to be treated with chemotherapy regimens containing 3-day cisplatin (3-day total dose ≥75mg/m2). Randomization was computer generated and stratified by gender and chemotherapy treatment history. Allocation was done via an interactive web response system. Enrolled patients were randomly assigned 1:1 to receive either 5mg olanzapine or placebo orally before bedtime for 5 days combined with intravenous fosaprepitant (150mg) 1h before the administration of cisplatin on day 1, ondansetron hydrochloride intravenously, and dexamethasone orally 30min before cisplatin from days 1 to 3. Dexamethasone was also administered at the same time on days 4 and 5. The primary endpoint was the proportion of subjects with complete response (no vomiting and no rescue therapy) within the overall phase (days 1-8) after starting chemotherapy. Baseline plasma concentrations of P-substance and 5-HT were measured for exploratory analysis. This study was registered at ClinicalTrials.gov, number NCT04536558. Between December 2020 and September 2021, 349 patients with malignant solid tumors were enrolled in the study, with 175 participants randomly assigned to receive olanzapine and 174 participants assigned to receive placebo. The proportion of patients who achieved a complete response in the overall phase was significantly higher in the olanzapine group than in the placebo group (69% vs. 58%, P=0.031). A complete response benefit was observed in the olanzapine group versus the placebo group in almost all the subgroups. Four factors were considered significantly associated with complete response in multivariable analysis: treatment group, gender, baseline plasma concentration of 5-HT, and prior radiotherapy. All the reported adverse events associated with olanzapine administration were grades 1 and2. Olanzapine (5mg) combined with fosaprepitant, ondansetron, and dexamethasone was better than triple antiemetic therapy alone for patients receiving multiday chemotherapy regimens. Based on these results, the four-drug combination should be recommended as the best antiemetic regimen given to patients receiving multiday cisplatin-based chemotherapy and baseline plasma concentration of 5-HT may be used to identify individuals who are prone to CINV. However, all these findings need to be further validated in future studies. Jiangsu Hansoh Pharmaceutical Group Co., Ltd. provided research grant and study drugs for this investigator-initiated study.

Efficacy of Olanzapine in Anxiety Dimension of Schizophrenia: A Systematic Review of Randomized Controlled Trials.

Anxiety symptoms and anxiety disorders are frequent in patients with schizophrenia and are associated with greater severity of both positive and negative symptoms, cognitive impairment, poorer functioning and quality of life. Accumulating evidence suggests that atypical antipsychotics may have a role in treating comorbid anxiety symptoms. A systematic review was conducted following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) and Cochrane guidelines, selecting randomized control trials (RCTs) that evaluated efficacy of olanzapine on anxiety symptoms in patients diagnosed with schizophrenia and included anxiety evaluation scales. We searched PubMed and Web of Science databases for articles in English language available until September 2021. We selected 7 studies (3 with primary data analysis, 4 with secondary data analysis) regarding the use of olanzapine in patients with schizophrenia. In fours studies olanzapine was superior to haloperidol in improving anxiety symptoms. Four studies compared olanzapine versus risperidone: in two of them risperidone was superior to olanzapine, although one study was limited by a relatively small sample size. In the other two there were no significant differences between olanzapine and risperidone-treated patients. One study found that olanzapine and clozapine were comparable in terms of efficacy. Although olanzapine was superior to haloperidol in treating anxiety, this symptom was a secondary outcome measure in most of the considered studies. Future RCTs comparing different antipsychotics and larger sample sizes may allow to develop more solid treatment strategies.

275MO Phase III double blind placebo-controlled study of olanzapine for chemotherapy related anorexia in patients with advanced gastric, hepatopancreaticobiliary and lung cancer

Anorexia occurs in 30-80% of patients with advanced malignancies which worsens with chemotherapy. This may worsen weight loss with resultant increase in toxicity and poor oncological outcomes. There is no current standard therapy for anorexia. This trial was designed to assess the efficacy of olanzapine as an orexigenic agent in patients receiving cytotoxic chemotherapy.

Efficacy of Olanzapine for Symptom Relief in Cancer Patients

Olanzapine is an atypical antipsychotic and is widely used for prophylaxis of chemotherapy-induced nausea and vomiting in cancer patients. Previous studies have suggested its potential efficacy for the relief of various symptoms in cancer patients, especially gastrointestinal and psychiatric symptoms. We retrospectively reviewed the prescription of olanzapine to cancer patients at our hospital. Between 2008 and 2020, olanzapine was prescribed to 41 patients for relief of symptoms associated with cancer other than prophylaxis of chemotherapy-induced nausea and vomiting. Of those patients, symptom relief was seen in 53.7%. Notably, olanzapine was effective in 13 of 14 patients with chemotherapy-induced nausea and vomiting refractory to guideline-recommended prophylaxis. Of 16 patients in whom this symptom was not relieved by olanzapine, 13 (81.3%) continued taking olanzapine even after it was judged ineffective. No treatment-related adverse events were seen in this study. Our observation implies good efficacy of olanzapine for refractory chemotherapy-induced nausea and vomiting and a tendency to continue olanzapine even in those for whom it was ineffective.

Homocysteine Levels and Clinical Outcomes in Schizophrenia—A Pilot Randomized Controlled Trial

Objectives: To find out the relation between homocysteine levels in peripheral blood and the effectiveness as well as the safety of haloperidol and olanzapine in schizophrenia treatment. Materials and Methods: A prospective randomized parallel-group open-label interventional clinical trial was conducted on 40 mild to moderate schizophrenia patients. To compare the efficacy of olanzapine and haloperidol Brief Psychiatric Rating Scale (BPRS) score was used. Homocysteine levels of peripheral blood and Abnormal Involuntary Movement Scale scores were evaluated. Results: BPRS score improved in both groups on day 14 and day 28. But significantly more with olanzapine ( P value =.001). The olanzapine group showed a higher reduction (13.91±0.47 to 9.74±0.5) in homocysteine levels than the haloperidol group. Also, the BPRS scores negatively correlated ( r = –0.66) to homocysteine levels. Conclusion: Therefore, our study shows that peripheral blood homocysteine levels can be used to predict and assess the treatment outcome in schizophrenia patients. Biomarker driven approach in schizophrenia will allow the patients to be treated promptly with the right drug. In this light, personalized treatment holds great potential in the future.

Meta-Analysis of the Efficacy and Safety of Olanzapine versus Clozapine when Treating Senile Dementia.

Objective To systematically assess the safety and efficacy of olanzapine versus clozapine when treating senile dementia and to provide evidence-based medicine basis for its promotion and use. Methods PubMed, Embase, ScienceDirect, Cochrane Library, China Knowledge Network Database (CNKI), China VIP Database, Wanfang Database, and China Biomedical Literature Database (CBM) online database were searched for randomized controlled trials (RCT) of olanzapine and clozapine when treating senile dementia. The retrieval time limit is from the establishment of the database to the present. The data were extracted independently by two researchers, and the bias risk of each contained literature was analyzed in accordance with the standard of Cochrane Handbook 5.3. RevMan 5.4 statistical software was used to analyze the collected data by meta-analysis. Results Finally, 6 randomized controlled trial articles were included, with a total of 490 samples. Meta-analysis of clinical efficacy showed that the clinical efficacy was similar and there was no significant difference (P > 0.05). Two articles used Alzheimer's disease pathological behavior rating scale (BEHAVE-AD) to compare the pathological behavior of different stages after treatment. Statistical analysis showed that there was no significant difference between the total score of BEHAVE-AD and the scores of each factor in each week after treatment. The non-treatment adverse reaction scale (TESS) of the study group and the control group was analyzed by meta-analysis. The TESS score of the study group after treatment was significantly lower than that of the control group. The BPRS scores of different stages after treatment were analyzed by meta-analysis, and there was no significant difference in the total score and factor scores of BPRS in each week after treatment. Two clinical trials reported the incidence of neurological symptoms after treatment. Olanzapine and clozapine treatment can effectively reduce the risk of aging. There was no significant difference in the incidence of neurological symptoms in patients with dementia (P > 0.05). According to the analysis of meat products, the incidence of adverse reactions in the study group was significantly lower than that in the control group (P < 0.05). Conclusion Olanzapine and clozapine have similar efficacy when treating mental and behavioral disorders in patients with senile dementia, in which olanzapine is more effective in improving the symptoms of patients with Alzheimer's disease (AD), with less adverse reactions and high safety, which is worth popularizing in clinical practice. However, more studies and follow-up with higher methodological quality and longer intervention time are needed to further verify.

Efficacy of Olanzapine 5 mg versus 10 mg for the Prophylaxis of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving High Emetic Risk Chemotherapy without Neurokinin-1 Receptor Antagonist.

Objective: To compare the efficacy and safety of two different dosage levels of olanzapine for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving high emetic risk chemotherapy. Methods:This study was a randomized, double-blind, controlled trial designed to show non-inferiority in the efficacy of olanzapine 5 mg compared to 10 mg in patients treated with high dose cisplatin or doxorubicin/cyclophosphamide. Non-inferiority was defined as a lower margin of the 95% confidence interval (95% CI) that not lower than the margin set at -25%. Result:A total of 140 patients were randomized to 5 mg group (n=70) or 10 mg group (n=70) of olanzapine. The complete response (CR) rate in the overall phase of olanzapine 5 and 10 mg was 58.6% v 62.9% (95%CI: -20.4, 11.8). The CR rate comparison between olanzapine 5 and 10 mg was 81.4% v 74.3% (95%CI: -6-6, 20.8) and 66.7% v 76.1% (95%CI: -23.5, 6.3) for the acute and delayed phase, respectively. No nausea rates in acute, delayed and overall phase were 70.0% v 68.6% (95%CI: -13.8, 16.6), 45.7% v 48.6% (95%CI: -19.4, 13.6) and 43.5% v 47.9% (95%CI: -19.2, 13.6). The rate of adverse events (AE) including somnolence were not different between the 5 and 10 mg groups. Conclusion:The two dosage levels of olanzapine were not different in terms of the efficacy and AE in the prophylaxis of CINV.

Efficacy of olanzapine, netupitant, and palonosetron in controlling nausea and vomiting associated with highly emetogenic chemotherapy in patients with breast cancer (OLNEPA).

12104 Background: Chemotherapy induced nausea and vomiting (CINV) is a highly prevalent adverse event1,2 that can result in decreased quality of life, dose reduction and interruptions of treatment.3 Four drug protocol including Olanzapine, 5-hydroxytryptamine type 3 receptor (5HT3) antagonist, a neurokinin 1 receptor (NK1) antagonist and dexamethasone is the current standard of care for highly emetogenic chemotherapy (HEC) 2,4-6. Corticosteroids are associated with side effects like insomnia and weight gain. To our knowledge, total Dexamethasone omission has not been addressed previously. Methods: This is a prospective single arm phase II study designed to evaluate the efficacy of Olanzapine, Netupitant and Palonosetron in controlling nausea and vomiting induced by highly emetogenic chemotherapy. Eligible patients were women with histologic confirmed breast cancer, planned to start treatment with Doxorubicin and Cyclophosphamide. Exclusion criteria included use of opioids or antipsychotic medications, medical condition that could potentially cause vomiting or inability to take oral medications. Patients were assigned to take Olanzapine 5mg QD, days 1 – 5, Netupitant 300mg and Palonosetron 0.5mg on day one. No corticosteroid use was allowed. The null hypothesis considered that the scheme containing Olanzapine, Netupitant and Palonosetron could not effectively control nausea. Based on a previous phase III study with Olanzapine (Navari et al.), we set the control of nausea at 20% and the expected control rate at 40% for the present study. To reach 5% (two-sided) significance and 80% statistical power, we calculated that a minimum sample size of 50 patients was required, assuming a 5% dropout rate. We used the one-sample T-test of proportion to analyze the data, based on intent-to-treat (ITT) The primary endpoint was complete control of nausea in the first 5 days after chemotherapy administration. Secondary endpoints were complete emesis control (no emesis, no use of rescue medication) and complete control (no emesis, no rescue and no nausea) Results: Fifty patients were enrolled from January 2020 to December 2021. The median age was 47.6 years-old (range: 29 – 78 years) and 48 patients (96%) received chemotherapy with curative intent. For the primary endpoint, complete nausea control rate was 46% (IC 32 – 59%) and p &lt; 0.0001. The emesis control rate was 68% (IC 55 – 80%) and overall control rate was 46% (IC 32 – 59%). One patient dropped out for dizziness and drowsiness following administration of Olanzapine. Conclusions: Omitting Dexamethasone for highly emetogenic chemotherapy is feasible and showed similar control of nausea and vomiting compared to standard four-drug protocol. This could be a potential prophylactic regimen of choice for patients who have a contraindication for Dexamethasone use. Clinical trial information: NCT04669132.

Olanzapine versus fosaprepitant for prevention of chemotherapy induced nausea and vomiting in patients receiving carboplatin (AUC ≥ 4) containing chemotherapy regimen: A phase 3 randomized, double-blind, placebo-controlled trial.

TPS12149 Background: Chemotherapy-induced nausea and vomiting (CINV) is a common adverse effect affecting quality of life of patients of cancer undergoing chemotherapy. Carboplatin alone or in combination with various other chemotherapy drugs is one of the most commonly used drug in solid malignancies. It is categorised as a highly emetogenic drug in doses above AUC≥4 and multiple past studies revealed high CINV incidence. Current international antiemetic guidelines suggest NK1 receptor antagonist based triplet drugs as an effective regimen of CINV control in these patients. However, the nausea control rates are largely inadequate. Olanzapine, an atypical antipsychotic drug, is another drug that has shown significant activity in CINV control and is an integral part of current chemotherapy induced emesis and nausea prevention. However, robust comparative studies of olanzapine based triplets with NK1 based combination have been lacking. Hence we planned this study to compare efficacy of olanzapine containing triplet with NK1 receptor antagonist (fosaprepitant) based triplet drug combination in a phase 3 randomised study. Methods: This study is an investigator initiated phase 3 prospective randomised double blind placebo controlled trial comparing efficacy of olanzapine, 5HT3 receptor antagonist(ondansetron) and dexamethasone (experimental arm) against fosaprepitant, 5HT3 receptor antagonist(ondansetron) and dexamethasone (standard arm) for prevention of CINV among chemo-naïve patients (aged ≥18 years) receiving carboplatin (AUC ≥4) based chemotherapy regimen. Primary objective is to compare the number of patients with no nausea during overall periods (0-120 hours post-chemotherapy). Secondary objectives are to compare complete response (no emetic episodes and no use of rescue medication) in the acute(0-24 hr), delayed(25-120 hr),overall periods(0-120 hr) and to assess the frequency of rescue medication use. The other secondary objective includes assessment of adverse events in both the arms. Statistical Design: Planned accrual is total 214 patients including 10% drop out rate. It is a superiority design with an absolute improvement of 20% in the proportion of patients with no nausea from a baseline prevalence of 40% in the standard arm and two sided alpha of 5% as well as power of 80%. Conduct to date :Study activation : March 2021. Enrolment : 138 subjects. Clinical trial information: CTRI/2021/03/032165.