Emetogenic Chemotherapy Research Articles

Chemotherapy Induced Nausea and Vomiting in Children: A Literature Review and Recommendation for Antiemetic Prophylaxis in Resource Limited Countries

Chemotherapy induced nausea and vomiting (CINV) are the most common side effects that impacts quality of life in children receiving cancer treatment. Inadequately controlled CINV impairs functional activity increases the healthcare utilization and compromises treatment adherence. The availability of new antiemetic agents results in substantially improvement of emetic control; however, in real-world practice, many developing countries have limited access to newly-developed antiemetic agents. This is a major obstacle in achieving adequate CINV control. Recent studies have recommended the “triple therapy” regimen (a 5-HT3 antagonist, dexamethasone, and a neurokinin-1 antagonist), as the backbone for antiemetic prophylaxis. Olanzapine, an atypical antipsychotic drug that improves CINV control in adult cancer patients. Together with ‘triple therapy” olanzapine is now recommended as the first line CINV prophylaxis in adults receiving highly emetogenic chemotherapy. Herein, we reviewed the recent published guidelines for the prevention and treatment of CINV in children. Furthermore, due to limited drug accessibility to neurokinin-1 antagonists, we proposed an institutional CINV guideline to replace the neurokinin-1 antagonist with olanzapine, which might be more reasonable in terms of economic constraints in resource limited countries.

A phase 3 safety study of fosnetupitant as an antiemetic in patients receiving anthracycline and cyclophosphamide: CONSOLE-BC.

BACKGROUNDFosnetupitant (FosNTP), an intravenous neurokinin 1 receptor antagonist, demonstrated a favorable safety profile with a potentially low risk of injection site reactions (ISRs) and promising antiemetic efficacy in patients receiving cisplatin‐based highly emetogenic chemotherapy in a previous phase 2 study. We conducted a randomized, double‐blind safety study to evaluate the safety profile of FosNTP, including ISRs, in patients receiving doxorubicin‐cyclophosphamide or epirubicin‐cyclophosphamide (AC/EC) chemotherapy.METHODSPatients scheduled to receive AC/EC were randomized 1:1 to receive 235 mg of FosNTP or 150 mg of fosaprepitant (FosAPR), both in combination with 0.75 mg of intravenous palonosetron and 9.9 mg of dexamethasone on day 1. The stratification factors were age category (<55 vs ≥55 years) and study site. The primary end point was the incidence of treatment‐related adverse events (TRAEs) with FosNTP.RESULTSOverall, 102 patients were randomized to FosNTP (n = 52) or FosAPR (n = 50), and all were treated with the study drug and evaluated for safety. The primary end point, the incidence of TRAEs, was similar with FosNTP (21.2%; 95% confidence interval [CI], 11.1%‐34.7%) and FosAPR (22.0%; 95% CI, 11.5%‐36.0%), with any‐cause ISRs observed in 5.8% and 26.0% of patients, respectively, and treatment‐related ISRs observed in 0% and 10.0%, respectively. The overall (0‐120 hour) complete response (defined as no emetic event and no rescue medication) rate, standardized by age category in the full analysis set, was 45.9% (23 of 51 patients) with FosNTP and 51.3% (25 of 49 patients) with FosAPR.CONCLUSIONSFosNTP demonstrated a favorable safety profile with a very low risk of ISRs in the AC/EC setting.

FLOT (a chemotherapy regimen for gastric/esophagogastric junction cancer): to be treated as a highly emetogenic regimen or a moderately emetogenic one? Comparison of the emetogenic potential of FLOT versus FOLFOX and TAC regimens.

The current study aimed at investigating the efficacy of aprepitant-containing triple antiemetic regimen in FLOT (fluorouracil + leucovorin + oxaliplatin + docetaxel) recipients as well as the emetogenic potential of FLOT regimen, through comparison of nausea and vomiting rates in a moderately emetogenic chemotherapy, FLOT, and a highly emetogenic chemotherapy recipients. Patients planned to receive one of FLOT, FOLFOX (fluorouracil + leucovorin + oxaliplatin/moderate-emetic risk), or TAC (docetaxel + doxorubicin + cyclophosphamide/high-emetic risk) regimens were recruited. All patients were treated with the same triple antiemetic regimen containing aprepitant. A total of 165 chemotherapy-naïve patients (52 FLOT recipients) were eligible to enter the study. At the end of day 5, "complete response" (primary efficacy endpoint) was achieved by 84.6%, 63.5%, and 61.5% of the FLOT-receiving patients in acute, delayed, and overall phases, respectively. A significant difference was seen among the odds of FLOT recipients and FOLFOX recipients concerning "complete response" achievement in delayed (p = 0.014) and overall (p = 0.017) phases, "no emesis" in delayed (p = 0.018) and overall (p = 0.010) phases, and also "complete protection" in acute (p = 0.023), delayed (p = 0.009), and overall (p = 0.006) phases; however, the difference between the odds of FLOT recipients and TAC recipients, in relation to achieving these endpoints, was insignificant. FLOT group showed significantly faster time-to-antiemetic regimen failure and time-to-first emetic episode in comparison with the FOLFOX group, which was insignificant in comparison with the TAC group. According to the findings, FLOT has to be considered as a high-emetic-risk regimen; provided that, as recommended by the antiemetic guidelines towards better management of delayed nausea and vomiting induced by highly emetogenic regimens, executing clinical trials concerning the efficacy of continuing dexamethasone on days 2-4 in aprepitant-containing triple antiemetic regimen schedule is required.

Fatores de risco relacionados a náuseas e vômitos induzidos por quimioterapia aguda e tardia em pediatria: análise multivariada

OBJECTIVES: This study aimed to characterize the clinical profile and the factors that predispose chemotherapy-induced nausea and vomiting (CINV) in the acute and delayed phases. METHODS: A retrospective cohort study was conducted in a Brazilian hospital with pediatric patients under 18 years old receiving moderately or highly emetogenic chemotherapy. Thus, a descriptive analysis was performed to characterize this population, followed by univariate and multivariate analysis to evaluate the risk factors for CINV. In both phases, considering significant the variables with p-values <0.05. RESULTS: The median age was 6 and 71% of the patients included used highly emetogenic protocols. Furthermore, 41% and 76% did not have vomit in the acute and delayed phase, respectively. Through logistic regression, it is noted that patients with bone tumors and sarcomas have higher CINV in the acute phase (OR 10.0, 95%IC 1.1-88.9, p=0.039), while patients who do not have complete control in the acute phase are more likely to have CINV in the delayed phase (OR 11.8, 95%IC 1.1-130.5, p=0.044). CONCLUSION: These results suggest that bone tumors and sarcomas are associated with an increase in CINV in the acute phase. In addition, control in the acute phase is associated with a complete response in the delayed phase.

POSA159 Cost-Effectiveness of Netupitant/Palonosetron in the Treatment of Chemotherapy-Induced Nausea and Vomiting in the UK

Chemotherapy-induced nausea and vomiting (CINV) is among the most common side-effects reported by cancer patients undergoing chemotherapy. This analysis aimed to evaluate the cost-effectiveness of fixed-combination netupitant/palonosetron (NEPA) compared with other commonly used antiemetic treatments for the prevention of CINV in patients undergoing highly emetogenic chemotherapy (HEC) in the UK.

Comparison of Efficacy and Safety between Standard Triple Antiemetic Therapy and Additional Olanzapine Therapy for Chemotherapy-induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: A Meta-analysis of Randomized Controlled Trials

Comparison of Efficacy and Safety between Standard Triple Antiemetic Therapy and Additional Olanzapine Therapy for Chemotherapy-induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: A Meta-analysis of Randomized Controlled Trials

Stability indicating Rp-UPLC method development and validation for the simultaneous estimation of fosnetupitant and palonosetron in bulk and injection dosage form

A stability indicating UPLC method has been developed and validated for the simultaneous determination of fosnetupitant and palonosetron in bulk and in injection dosage form. This combination is used for the prevention of acute and delayed nausea and vomiting associated with initial and repeated courses of highly emetogenic chemotherapy for cancer. The chromatographic analysis was performed on an HSS, RP C18 column (2.1 x 100 mm, 1.8 µm) with an isocratic mobile phase composed of 0.25 M potassium dihydrogen orthophosphate buffer (pH 6.5), pH adjusted with dilute sodium hydroxide:acetonitrile (55:45 v/v), at a flow rate of 0.5 mL/min, and the eluents were monitored at an isosbestic point of 286 nm. The developed method was validated according to the ICH guidelines pertaining to specificity, precision, accuracy, linearity and robustness, and the stability indicating nature of the method was established by forced degradation studies. The retention times of fosnetupitant and palonosetron were observed at 1.390 and 2.404 min, respectively. The developed method proved to be accurate and precise. Linearity was established between 4.70 and 14.10 µg/mL for fosnetupitant and between 0.05 and 0.15 µg/mL for palonosetron. The LOD and LOQ were 0.115 and 0.385 µg/mL, respectively, for fosnetupitant, and 0.005 and 0.016 µg/mL, respectively, for palonosetron. Therefore, the proposed UPLC method was reliable, reproducible, precise and sensitive for the quantification of fosnetupitant and palonosetron.

Addition of metoclopramide to triple antiemetic therapy towards prevention of anthracycline-based chemotherapy-induced nausea and vomiting in breast cancer patients

Objective: The aim of this study was to evaluate if addition of metoclopramide to the triplet antiemetic therapy is superior to the triplet antiemetic therapy for prevention of delayed chemotherapy-induced nausea and vomiting. Materials and Methods: A randomized single-blind trial was performed on 200 chemotherapy-naïve breast cancer patients who have to receive anthracycline-based highly emetogenic chemotherapy (HEC). The patients were randomized to study arm (n = 100) and control arm (n = 100). Triplet antiemetic therapy (fosaprepitant on day 1, 5-HT3 antagonist on day 1, and dexamethasone for days 1–4) was used in both the arms and metoclopramide (day 1–5) was added to the study arm. Response to antiemetic prophylaxis was assessed in terms of “complete response (CR),” “only nausea,” and “both nausea and vomiting.” CR is defined as no nausea, no vomiting, and no rescue medication during the overall phase (days 1–5). Nausea/vomiting was detected by using the Visual Analog Scale and its impact on quality of life was determined by using the Functional Living Index Emesis (FLIE) score. Results: The demographical and clinical features were similar in both the groups. Majority of patients in both the arms presented with Eastern Cooperative Oncology Group PS 0, Stage III, and positive hormone receptor status. CR was observed more in the study arm than that of the control arm (51% vs. 37%; P = 0.046). The mean total FLIE score was 29.23 in the study arm and 31.16 in the control arm (P = 0.036). Conclusion: This study resulted in a significant CR and clinically relevant improvement in FLIE score for addition of metoclopramide to triple antiemetic prophylaxis. Therefore, a quadruple antiemetic combination including metoclopramide might be an antiemetic prophylaxis option for breast cancer patients receiving anthracycline-based HEC for better compliance to treatment.

Effect of Transcranial Direct Current Brain Stimulation of the Motor Cortex on Chemotherapy-Induced Nausea and Vomiting in Female Patients with Breast Cancer.

Chemotherapy-induced nausea and vomiting (CINV) is an adverse outcome associated with chemotherapy and is sometimes difficult to manage. This study aimed to examine the impact of a single session of transcranial direct current brain stimulation (tDCS; 2 mA) over the motor cortex for 20 minutes before chemotherapy in patients receiving a highly emetogenic chemotherapy. Prospective randomized double-blind sham-controlled study. Academic medical center. Sixty patients with breast cancer who were scheduled for chemotherapy treatment were selected and allocated randomly into two equal groups: a stimulation group and a sham group. tDCS was implemented over the primary motor area (M1) (2 mA) for 20 minutes. Patients' nausea was measured by a cumulative index of nausea, a visual analog scale for nausea (VAS-N), episodes of vomiting, and the Edmonton Symptoms Assessment Scale (ESAS) to assess symptoms like pain, malaise, and sense of well-being. Evaluation was done before stimulation and every 24 hours for 72 hours after the end of infusion of chemotherapy. The tDCS group showed a reduction in the cumulative index of nausea (P < 0.001, F = 50), the VAS-N (P < 0.001, F = 52), the ESAS malaise score (P < 0.001, F = 37.6), and the sense of well-being score (P < 0.001, F = 25) vs the sham group. Six patients (20%) in the tDCS group required rescue antiemtic therapy vs 14 patients (46.7%) in the sham group (P < 0.028). A single session of M1 tDCS is suggested as an effective adjuvant therapy to control CINV in female patients suffering from breast cancer and receiving highly emetogenic chemotherapy. Corroboratory studies are needed.

A Smartphone-Based Decision Support Tool for Predicting Patients at Risk of Chemotherapy-Induced Nausea and Vomiting: Retrospective Study on App Development Using Decision Tree Induction.

BackgroundChemotherapy-induced nausea and vomiting (CINV) are the two most frightful and unpleasant side effects of chemotherapy. CINV is accountable for poor treatment outcomes, treatment failure, or even death. It can affect patients' overall quality of life, leading to many social, economic, and clinical consequences.ObjectiveThis study compared the performances of different data mining models for predicting the risk of CINV among the patients and developed a smartphone app for clinical decision support to recommend the risk of CINV at the point of care.MethodsData were collected by retrospective record review from the electronic medical records used at the University of Missouri Ellis Fischel Cancer Center. Patients who received chemotherapy and standard antiemetics at the oncology outpatient service from June 1, 2010, to July 31, 2012, were included in the study. There were six independent data sets of patients based on emetogenicity (low, moderate, and high) and two phases of CINV (acute and delayed). A total of 14 risk factors of CINV were chosen for data mining. For our study, we used five popular data mining algorithms: (1) naive Bayes algorithm, (2) logistic regression classifier, (3) neural network, (4) support vector machine (using sequential minimal optimization), and (5) decision tree. Performance measures, such as accuracy, sensitivity, and specificity with 10-fold cross-validation, were used for model comparisons. A smartphone app called CINV Risk Prediction Application was developed using the ResearchKit in iOS utilizing the decision tree algorithm, which conforms to the criteria of explainable, usable, and actionable artificial intelligence. The app was created using both the bulk questionnaire approach and the adaptive approach.ResultsThe decision tree performed well in both phases of high emetogenic chemotherapies, with a significant margin compared to the other algorithms. The accuracy measure for the six patient groups ranged from 79.3% to 94.8%. The app was developed using the results from the decision tree because of its consistent performance and simple, explainable nature. The bulk questionnaire approach asks 14 questions in the smartphone app, while the adaptive approach can determine questions based on the previous questions' answers. The adaptive approach saves time and can be beneficial when used at the point of care.ConclusionsThis study solved a real clinical problem, and the solution can be used for personalized and precise evidence-based CINV management, leading to a better life quality for patients and reduced health care costs.

Real-world multicenter study of the safety and efficacy of netupitant plus palonosetron fixed-dose combination to prevent chemotherapy-induced nausea and vomiting among Malaysian patients receiving moderately or highly emetogenic chemotherapy.

A large proportion of cancer patients are at high risk for chemotherapy-induced nausea and vomiting (CINV), but the choice of anti-emetics for CINV in Malaysia is limited. This was a real-world study of a fixed-dose combination of netupitant and palonosetron (NEPA) to inhibit CINV in adult patients receiving moderately (MEC) or highly emetogenic chemotherapy (HEC) for solid/hematological malignancies at eight Malaysian centers. Each HEC/MEC cycle received one dose of NEPA + dexamethasone for CINV prevention. Complete response (no emesis, no rescue medication) (CR), no more than mild nausea (severity score≤2.5), and complete control (CR) (no more than mild nausea) during the acute (0-24h), delayed (25-120h), and overall (0-120h) phases post-chemotherapy were measured. Treatment-related adverse events (AEs) were recorded. During March 2016-April 2018 (NMRR-17-3286-38282), NEPA + dexamethasone was administered to 54 patients (77.8% solid, 22.2% hematological malignancies). Note that 59.3% received HEC, while 40.7% received MEC regimen. During the overall phase of the first cycle, the majority had CR (77.8%), no more than mild nausea (74.1%), and complete control (61.1%). Seventeen patients received two consecutive cycles at any point of chemotherapy cycles. During the overall phases across two consecutive cycles, all patients achieved CR, and the majority reported no more than mild nausea and complete control. No grades 3-4 AEs were reported. NEPA had sustained efficacy and tolerability at first administration and across two cycles of MEC/HEC for CINV prevention.

Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis.

Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis.

Background sensitivity to chemotherapy-induced nausea and vomiting and response to antiemetics in paediatric patients: a genetic association study.

Chemotherapy-induced nausea and vomiting (CINV) remains a common adverse effect for children with cancer. In children, chemotherapy emetogenicity and patient factors such as susceptibility to motion sickness and age group determine a patient's risk of CINV. Besides known risk factors, genetic factors may play a role in interindividual variation in the occurrence of CINV. We investigated the influence of candidate gene polymorphisms on the efficacy of antiemetics and on the background sensitivity to CINV in children. This prospective study included 100 children with cancer (median age 6.4 years, range 0.8-17.9) who received moderately to highly emetogenic chemotherapy. Participants registered nausea and vomiting episodes in a mobile app. Genotypes were determined by whole-genome sequencing (n = 79) or Sanger sequencing (n = 21) for 71 genetic polymorphisms involved in motion sickness and antiemetic pathways. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated to estimate associations between acute CINV and genotypes adjusting for susceptibility to motion sickness and age group. Rs3782025 in the 5-hydroxytryptamine type 3 (5-HT3) receptor gene (HTR3B) [minor allele frequency (MAF): 0.48] affected response to 5-HT3 receptor antagonists; acute CINV occurred in 76% of patients with GA/AA genotypes and in 41% of patients with GG genotype (OR 5.59; 95% CI 1.74-17.9, dominant genetic model). Rs2975226 in the dopamine transporter gene (SLC6A3) (MAF: 0.54) was associated with acute CINV (OR 5.79; 95% CI 1.09-30.67, recessive genetic model). Polymorphisms in HTR3B and SLC6A3 may contribute to the variability in response to antiemetic prophylaxis for CINV in children.

Cost-effectiveness analysis of antiemetics therapy in breast cancer patients with moderate emetogenic chemotherapy in Prof. Dr. Margono Soekarjo Hospital, Indonesia

Chemotherapy-induced nausea and vomiting (CINV) significantly reduce the life quality of cancer patients. A 5-HT3 receptor antagonist, corticosteroid, and H2-blocker have been used to control moderate nausea and vomit in cancer patients. The exploration of the cost-effectiveness of several antiemetic combinations in breast cancer patients in Prof. Dr. Margono Soekardjo Hospital, Purwokerto, Indonesia was the aim of this research. Seventy-four Breast cancer patients who have prescribed moderate-emetogenic chemotherapy during the year 2017-1019 were included in this research. There were fifteen patients treated with the combination of ondansetron and dexamethasone (OD). Fourteen patients were treated with the combination of ondansetron and ranitidine (OR). Thirty-five patients were treated using ondansetron, dexamethasone, and ranitidine (ODR) combination. The effectiveness was represented by the absence of acute nausea and vomiting after receiving chemotherapy. The ODR combinations showed the highest effectivity on diminishing nausea and vomiting among breast cancer patients (0.400), followed by the OD combination (0.267) and the OR combination (0.214). However, the ODR combination generates the highest cost (4.6 million rupiahs) compared to other antiemetics combinations. Compared to the combination of ondansetron and dexamethasone, the combination of ODR provides higher ICER (ICER of 13 Million Rupiahs per case prevented) than the combination of OR (ICER of 8.5 million Rupiahs per case prevented). In conclusion, the combination of ondansetron, dexamethasone, and ranitidine generates the highest cost. It also provides the highest effectiveness in preventing nausea and vomiting.

1672P Single-dose NEPA versus 3-day aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with risk factors receiving moderately emetogenic chemotherapy (MEC)

In this first head-to-head neurokinin (NK) 1 receptor antagonist (RA) comparative study in patients receiving anthracycline cyclophosphamide (AC) and non-AC MEC, a single dose of NEPA (fixed combination NK1RA, netupitant, and 5-HT3RA, palonosetron) was non-inferior to a 3-day aprepitant (APR) regimen in preventing CINV. The overall (0-120 h) complete response (CR; no emesis, no rescue) rates were 65% NEPA vs 54% APR. While chemotherapy emetogenicity may be the primary consideration when choosing antiemetics, it is established that patient factors also play a role in determining emetic risk.

LBA63 Placebo-controlled, double-blinded phase Ⅲ study comparing dexamethasone on day 1 with dexamethasone on days 1 to 4, with combined neurokinin-1 receptor antagonist, palonosetron, and olanzapine in patients receiving cisplatin-containing highly emetogenic chemotherapy: SPARED trial

Olanzapine (OLZ) 5 mg combined with dexamethasone (DEX), neurokinin-1 receptor antagonist (NK1-RA), and palonosetron (PALO) has been established as the standard for patients (pts) receiving cisplatin (CDDP)-containing highly emetogenic chemotherapy (HEC). This study aimed to clarify the non-inferiority of DEX sparing when combined with NK1-RA, PALO, and OLZ in CDDP-containing HEC.

Prevalence of Breakthrough Chemotherapy-Induced Nausea Vomiting in Patients on Highly Emetogenic Chemotherapy

Introduction: Chemotherapy-induced nausea and vomiting (CINV) is a distressing side-effect of cancer chemotherapy which may lead to noncompliance with treatment or delay in treatment. Breakthrough nausea and vomiting is the current unmet need in the management in of CINV. Objectives: The present study was planned to determine the prevalence of breakthrough CINV in patients on highly emetogenic chemotherapy (HEC) and to evaluate the need for rescue medications in them. Materials and Methods: The present observational study was conducted on chemotherapy-naive patients, who were scheduled to receive HEC. The patients who received at least 2 cycles of HEC over a 1-year study period enrolled as a study sample. All patients were subjected to a questionnaire which consists of the demographic details, details of disease and prescribed chemotherapy, and probable risk factors for CINV. The severity of nausea vomiting was calculated using the Multinational Association of Supportive Care in Cancer antiemetic tool. The incidence of breakthrough nausea vomiting was assessed and accordingly the rescue medication was used. Results: A total of 100 patients received at least 2 cycles of HEC which consisted of breast carcinomas (n = 74), ovarian carcinoma (n = 13), lung carcinoma (n = 2), periampullary carcinoma (n = 3), sarcoma (n = 4), lymphoma (n = 3), and seminoma (n = 1). Anthracycline-cyclophosphamide combination for breast cancer was the most prescribed chemotherapy regimen. Forty-six patients developed breakthrough nausea/vomiting. Domperidone followed by olanzapine was the preferred rescue medications used. History of CINV in previous cycle and young age (&lt;50 years) were the risk factors associated with breakthrough nausea vomiting in our study. Conclusion: Breakthrough nausea vomiting is a major challenge in patients receiving HEC regimen.

LBA64 Olanzapine, an alternative to dexamethasone for preventing nausea and vomiting induced by cisplatin-based doublet highly emetogenic chemotherapy: A non-inferiority, prospective, multi-centered, randomized, controlled, phase III clinical trial

LBA64 Olanzapine, an alternative to dexamethasone for preventing nausea and vomiting induced by cisplatin-based doublet highly emetogenic chemotherapy: A non-inferiority, prospective, multi-centered, randomized, controlled, phase III clinical trial

English

BACKGROUND Chemotherapy-induced nausea and vomiting (CINV) is a frequent and feared adverse effect of cancer chemotherapy. International guidelines recommend combinations of 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists, dexamethasone, and/or neurokinin-1 (NK1) receptor antagonists for the control of CINV in patients receiving highly emetogenic chemotherapy (HEC) as a part of their treatment. Even though, nausea in delayed period is less controlled and poses a major concern for these patients. METHODS This open label, prospective study was conducted in a rural medical college in Etawah District in Uttar Pradesh, India from November 2017 to November 2018 over a period of 1 year to observe the efficacy of low dose (5 mg OD) olanzapine in combination with standard anti-emetic regimen for the prevention of CINV. Olanzapine is a food and drug administration (FDA) approved antipsychotic drug that has anti-emetic activity and has shown to improve CINV. Low dose olanzapine along with a standard combination of ondansetron, dexamethasone and aprepitant was given to patients receiving highly emetogenic chemotherapy (Cisplatin &gt;70 mg/m2 or doxorubicin-cyclophosphamide combination). CINV was assessed using common toxicity criteria of adverse events (CTCAE) version 5.0. RESULTS Complete response to nausea was observed in 90.90 %, 60.60 % and 54.54 % in acute, delayed and overall period respectively. Complete response to vomiting was observed in 96.96 %, 69.69 % and 66.66 % in acute, delayed and overall period respectively. Complete response to Grade-2 (or above) nausea was observed in 96.96 %, 93.93 % and 90.90 % in acute, delayed and overall period, respectively. Daytime Grade -3 somnolence which was seen in 2/33 patients (6.06 %) was attributable to olanzapine. Patients receiving olanzapine were more likely to have complete response of nausea and emesis in the early, late, and overall assessment periods especially of higher grade (G2 and G3). CONCLUSIONS The authors concluded that low dose olanzapine 5 mg OD combined with an NK1- receptor antagonist, a 5-HT3–receptor antagonist, and dexamethasone is safe and efficacious in the prevention of CINV in patients receiving HEC. KEYWORDS Olanzapine, Low Dose, CINV, HEC

Antiemetic Regimen with Olanzapine in Pediatric Patients Receiving Highly Emetogenic Chemotherapy

Antiemetic Regimen with Olanzapine in Pediatric Patients Receiving Highly Emetogenic Chemotherapy