Olanzapine for the prevention and treatment of cancer-related nausea and vomiting in adults.
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SUBMITTER: Sutherland A
PROVIDER: S-EPMC6513437 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundWe examined the efficacy of olanzapine for the prevention of nausea and vomiting in patients receiving highly emetogenic chemotherapy.MethodsIn a randomized, double-blind, phase 3 trial, we compared olanzapine with placebo, in combination with dexamethasone, aprepitant or fosaprepitant, and a 5-hydroxytryptamine type 3-receptor antagonist, in patients with no previous chemotherapy who were receiving cisplatin (≥70 mg per square meter of body-surface area) or cyclophosphamide-doxorubicin. The doses of the three concomitant drugs administered before and after chemotherapy were similar in the two groups. The two groups received either 10 mg of olanzapine orally or matching placebo daily on days 1 through 4. Nausea prevention was the primary end point; a complete response (no emesis and no use of rescue medication) was a secondary end point.ResultsIn the analysis, we included 380 patients who could be evaluated (192 assigned to olanzapine, and 188 to placebo). The proportion of patients with no chemotherapy-induced nausea was significantly greater with olanzapine than with placebo in the first 24 hours after chemotherapy (74% vs. 45%, P=0.002), the period from 25 to 120 hours after chemotherapy (42% vs. 25%, P=0.002), and the overall 120-hour period (37% vs. 22%, P=0.002). The complete-response rate was also significantly increased with olanzapine during the three periods: 86% versus 65% (P<0.001), 67% versus 52% (P=0.007), and 64% versus 41% (P<0.001), respectively. Although there were no grade 5 toxic effects, some patients receiving olanzapine had increased sedation (severe in 5%) on day 2.ConclusionsOlanzapine, as compared with placebo, significantly improved nausea prevention, as well as the complete-response rate, among previously untreated patients who were receiving highly emetogenic chemotherapy. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT02116530.).
| S-EPMC5344450 | biostudies-literature
Project description:ImportanceNausea and vomiting, unrelated to chemotherapy, can be substantial symptoms in patients with advanced cancer.ObjectiveTo evaluate the utility of olanzapine for treating chronic nausea/vomiting, unrelated to chemotherapy, in patients with advanced cancer.Design, setting, and participantsThis study is a double-line, placebo-controlled, randomized clinical trial conducted from July 2017 through April 2019, with analysis conducted in 2019. Eligible participants were outpatients with advanced cancer who had persistent nausea/vomiting without having had chemotherapy or radiotherapy in the prior 14 days. Chronic nausea was present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).InterventionsPatients received olanzapine (5 mg) or a placebo, orally, daily for 7 days.Main outcomes and measuresPatient-reported outcomes were used for study end points. Data were collected at baseline and daily for 7 more days. The primary study end point (the change in nausea numeric rating scores from baseline to the last treatment day) and the study hypothesis were both identified prior to data collection.ResultsA total of 30 patients (15 per arm) were enrolled; these included 16 women and 14 men who had a mean (range) age of 63 (39-79) years. Baseline median nausea scores, in all patients, were 9 out of 10 (range, 8-10). After 1 day and 1 week, the median nausea scores in the placebo arm were 9 out of 10 (range, 8-10) on both days, compared with the olanzapine arm scores of 2 out of 10 (range, 2-3) after day 1 and 1 out of 10 (range, 0-3) after 1 week. After 1 week of treatment, the reduction in nausea scores in the olanzapine arm was 8 points (95% CI, 7-8) higher than that of the placebo arm. The primary 2-sided end point P value was <.001. Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being. One patient, on the placebo, stopped treatment early owing to lack of perceived benefit. No patients receiving olanzapine reported excess sedation or any other adverse event.Conclusions and relevanceOlanzapine, at 5 mg/d, appeared to be effective in controlling nausea and emesis and in improving other symptoms and quality-of-life parameters in the study population.Trial registrationClinicalTrials.gov Identifier: NCT03137121.
| S-EPMC7206532 | biostudies-literature
Project description:BackgroundChemotherapy induced nausea and vomiting (CINV) remains the most distressing event in patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).ObjectiveTherefore, this meta-analysis was conducted to evaluate the efficacy of olanzapine containing regimen in preventing acute, delayed and overall phases of CINV.MethodsPubMed, EBSCO, and Cochrane central register of controlled trials electronic databases were searched to identify RCTs that compared the effects of olanzapine with non-olanzapine regimen in preventing CINV. Randomized clinical trials (RCTs) that compared olanzapine containing regimen with non-olanzapine regimen were included. The primary outcomes were the percentage of patients achieving no vomiting or no nausea in acute, delayed and overall phases.Results13 RCTs that enrolled 1686 participants were included in this meta-analysis. 852 patients were assigned to olanzapine and 834 patients were assigned to non-olanzapine regimen (other standard antiemetic regimen). The percentages of no emesis achieved were 87.5%, 76.2%, 73.6% in olanzapine versus 76.7%, 61.8%, and 56.4% in non-olanzapine regimen in acute, delayed and overall phases, respectively. The percentages of no nausea were 82%, 64.3%, 61.6% in olanzapine group versus 71.3%, 41.8%, and 40.6% in non-olanzapine group in acute, delayed and overall phases, respectively. In general, olanzapine containing regimen achieved statistical superiority to non-olanzapine regimen in no vomiting endpoint in acute phase (OR 2.16; 95%CI 1.60 to 2.91, p<0.00001; I-square=5%; p=0.40), delayed phase (OR 2.28; 95%CI 1.1.46 to 3.54, p=0.0003; I-square=65%; p=0.001) and overall phase (OR 2.48; 95%CI 1.59 to 3.86, p<0.0001; I-square=69%; p< 0.0001).ConclusionThe current meta-analysis showed that olanzapine was statistically and clinically superior to non-olanzapine regimen in preventing CINV in most domains of the parameters.
| S-EPMC5386623 | biostudies-literature
Project description:ObjectivesChemotherapy-induced nausea and vomiting (CINV) are distressing symptoms. This randomized study evaluated the antiemetic efficacies of standard antiemetic regimen with/without olanzapine.Patients and methodsEligible patients were chemotherapy-naive Chinese breast cancer patients who were planned for (neo)adjuvant doxorubicin/cyclophosphamide. Antiemetic regimen for all studied population included aprepitant, ondansetron and dexamethasone; patients were randomized to Olanzapine (with olanzapine) or Standard arms (without olanzapine). Patients filled in self-reported diaries and completed visual analogue scales for nausea, as well as Functional Living Index-Emesis questionnaires. Blood profiles including fasting glucose and lipids were monitored.Results120 patients were randomized. In Cycle 1 doxorubicin/cyclophosphamide, the Olanzapine arm had significantly higher rates of "Complete Response" than the Standard arm: 65.0% vs 38.3% in the overall period (p = 0.0035), 70.0% vs 51.7% in the acute period (p = 0.0397) and 92.9% vs 74.2% in the delayed period (p = 0.0254). Olanzapine arm also had significantly higher rates of "No significant nausea" and "No nausea" during all 3 time-frames and better QOL. Similar findings were also revealed throughout multiple cycles. Pre-study abnormalities in glucose and lipids occurred in 39.7% and 34.2% of the studied population respectively; there were no differences in these parameters between the two arms at end-of-study assessment.ConclusionThe addition of olanzapine to standard aprepitant-based antiemetic regimen provides clinically meaningful improvement in controlling CINV. This was associated with a positive impact on QOL and tolerable toxicity profiles among Chinese breast cancer patients receiving doxorubicin/cyclophosphamide chemotherapy. Further studies on metabolic profiles of breast cancer patients are warranted.
| S-EPMC7375549 | biostudies-literature
Project description:ContextPostoperative nausea and vomiting (PONV) is common after ambulatory surgery performed under general anesthesia. Anecdotal evidence suggests that caffeine may be useful in preventing PONV.AimsThe aim of the study was to determine efficacy of intravenous (IV) caffeine given prior to surgery is effective prophylaxis against PONV.Settings and designWe conducted a prospective, randomized, double-blind, placebo-controlled study.Subject and methodsPatients at moderate or high risk of PONV were randomized to receive IV caffeine (500 mg) or saline placebo during general anesthesia; all patients received dexamethasone and dolasetron.Statistical analysisStatistical comparisons were tested using bivariable linear and logistic regression for each outcome and then adjusted for high/low risk.ResultsNausea in the postanesthesia care unit (PACU) was more common in the caffeine (16 of 62 patients) than the placebo group (seven of 69; P = 0.02). There were no significant differences in the use of rescue antiemetics in the PACU, in the incidence of nausea or vomiting over 24 h postoperatively, nor in other outcomes (headache, fatigue, or overall satisfaction) either in the PACU or at 24 h; time-to-discharge was similar for both groups.ConclusionCaffeine was not effective in the prevention of PONV or headache, and did not improve time-to-discharge or patient satisfaction.
| S-EPMC3819849 | biostudies-literature
Project description:ObjectivesTo examine the frequency and types of preventive and self-management behaviors reported by participants, as well as report acceptability and usability data for the electronic Symptom Self-Management Training-Chemotherapy-Induced Nausea and Vomiting (CINV) serious game.Sample & setting80 adults who were aged 60 years or older and newly diagnosed with cancer were recruited from a community cancer center.Methods & variablesParticipants were randomized to an intervention or control group. A symptom management checklist was used to record preventive and self-management behaviors used after each chemotherapy treatment at home. Acceptability and usability were assessed using a brief survey.ResultsThe intervention group reported using more preventive behaviors, and the control group reported using more self-management behaviors. Antiemetics were the most common strategy used, followed by dietary strategies. Participants rated all aspects of the serious game highly for usability and acceptability.Implications for nursingOncology providers can help older adults plan for self-managing treatment-related side effects at home. Recording self-management behaviors may reinforce the importance of active prevention and management of CINV.
| S-EPMC7574328 | biostudies-literature
Project description: Not available
| S-EPMC6494172 | biostudies-literature
Project description:Postoperative nausea and vomiting (PONV) and postdischarge nausea and vomiting (PDNV) remain common and distressing complications following surgery. The routine use of opioid analgesics for perioperative pain management is a major contributing factor to both PONV and PDNV after surgery. PONV and PDNV can delay discharge from the hospital or surgicenter, delay the return to normal activities of daily living after discharge home, and increase medical costs. The high incidence of PONV and PDNV has persisted despite the introduction of many new antiemetic drugs (and more aggressive use of antiemetic prophylaxis) over the last two decades as a result of growth in minimally invasive ambulatory surgery and the increased emphasis on earlier mobilization and discharge after both minor and major surgical procedures (e.g. enhanced recovery protocols). Pharmacologic management of PONV should be tailored to the patient's risk level using the validated PONV and PDNV risk-scoring systems to encourage cost-effective practices and minimize the potential for adverse side effects due to drug interactions in the perioperative period. A combination of prophylactic antiemetic drugs with different mechanisms of action should be administered to patients with moderate to high risk of developing PONV. In addition to utilizing prophylactic antiemetic drugs, the management of perioperative pain using opioid-sparing multimodal analgesic techniques is critically important for achieving an enhanced recovery after surgery. In conclusion, the utilization of strategies to reduce the baseline risk of PONV (e.g. adequate hydration and the use of nonpharmacologic antiemetic and opioid-sparing analgesic techniques) and implementing multimodal antiemetic and analgesic regimens will reduce the likelihood of patients developing PONV and PDNV after surgery.
| S-EPMC7429924 | biostudies-literature
Project description:PurposePrescribing guideline-recommended anti-emetics is an effective strategy to prevent CINV. However, the rate of guideline-concordant care is not well-understood. The purpose of this study was to describe the proportion of pediatric, adolescent, and young adult patients receiving HEC or MEC who received guideline-concordant antiemetic prophylaxis for acute CINV and to identify potential predictors of guideline-concordant antiemetic prophylaxis.MethodsUsing electronic health record data from 2016 through 2018, a retrospective single-institution cohort study was conducted to investigate how often patients less than 26 years of age receiving moderately or highly emetogenic chemotherapy receive guideline-concordant prophylaxis for acute CINV. Guideline-concordant care was defined according to guidelines from the Pediatric Oncology Group of Ontario for patients < 18 years and the American Society of Clinical Oncology for those ≥ 18 years. Independent variables included: sex, age, insurance status, race, ethnicity, cancer type, chemotherapy regimen, clinical setting, chemotherapy emetogenicity, and patient location. Predictors of receiving guideline-concordant care were determined using multiple logistic regression.ResultsOf 180 eligible patients, 65 (36.1%) received guideline-concordant care. In multivariable analysis, being treated in adult oncology setting (aOR 14.3, CI95 5.3-38.6), with a cisplatin-based regimen (aOR 3.5, CI951.4-9.0), solid tumor diagnosis (aOR 2.2, CI95 1.0-4.8), and commercial insurance (aOR 2.4, CI95 1.1-5.2) were associated with significantly higher likelihood of receiving guideline-concordant care.ConclusionsMulti-level factors were associated with receiving guideline concordant care for prevention of CINV in children, adolescents, and young adults receiving emetogenic chemotherapy. These findings can inform current efforts to optimize implementation strategies for supportive care guidelines.
| S-EPMC7375924 | biostudies-literature
Project description:A variety of triple antiemetic regimens are being used to prevent cisplatin-based chemotherapy induced delayed emesis and nausea in cancer patients. We performed a network meta-analysis to compare the efficacies of the different regimens. Electronic searches of the PubMed, Cochrane Library and MEDLINE databases were performed to identify randomized controlled trials, and data were analyzed using JAGS, Stata 14.0 and R project. The primary outcome was a complete response (CR). The secondary outcomes were no vomiting (NV) and no nausea (NN). Among the 398 studies identified, 10 were eligible and included, providing data on nine regimens. In the CR analysis, the absolute rank of netupitant + palonosetron + dexamethasone (NEPA) was 0.8579. In the NV and NN analyses, NEPA's absolute ranks were 0.8631 and 0.7902, respectively. The compliance of patients treated with rolapitant + granisetron + dexamethasone (RGD) was the best due to a low incidence of adverse events, and good compliance was also observed with NEPA. It was difficult to achieve good compliance with aprepitant + granisetron + dexamethasone (AGD). Overall, NEPA was the best regimen, and aprepitant + ondansetron + dexamethasone (AOD) is also worthy of recommendation because of its low cost and good effect. For patients with severe constipation, hiccups, asthenia and/or delayed nausea, RGD is worthy of consideration.
| S-EPMC5029710 | biostudies-literature