Emetogenic Chemotherapy Research Articles

A prospective randomized controlled clinical trial investigating the efficacy of low-dose olanzapine in preventing nausea and vomiting associated with oxaliplatin-based and irinotecan-based chemotherapy

ObjectiveThe aim of this study is to assess the clinical efficacy of a 5 mg dosage of olanzapine in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) among female patients diagnosed with gastrointestinal tract tumors.MethodsPatients undergoing the oxaliplatin/irinotecan chemotherapy regimen were enrolled in this prospective controlled study. The olanzapine group received a 5 mg dosage of olanzapine along with palonosetron and dexamethasone, while the control group received a standard two-combination regimen consisting of dexamethasone and palonosetron. The primary endpoints included the total protection (TP) rates for the entire age group and the subgroup aged 60 years and above. Secondary endpoints encompassed the total protection rates during the acute and delayed phases within the two age brackets, as well as the total control (TC) rates and complete remission (CR) rates across all three phases (total, acute, and delayed). Additionally, the study involved the assessment of quality of life and the collection of adverse events associated with the interventions.Results1) Regarding the primary endpoint, the total phase TP rates within both the entire age group and the age group exceeding 60 years demonstrated superiority in the olanzapine group when compared to the control group (66.7% vs 37.25%, P = 0.003; 68.8% vs 44.4%, P = 0.044). 2) In terms of secondary endpoints, the olanzapine group exhibited superior acute phase TP rates in both age brackets when compared to the control group (P < 0.05). The olanzapine group also demonstrated higher delayed-phase TP rates, TC rates across all three phases, and CR rates within the two age brackets, although the differences were not statistically significant (P > 0.05). Furthermore, the quality of life in the olanzapine group surpassed that of the control group for both age brackets (P < 0.05), characterized by enhanced appetite and a higher incidence of drowsiness in the patients treated with olanzapine when compared to those in the control group (P < 0.05).ConclusionOlanzapine can enhance CINV induced by MEC regimen in female patients across all age groups, including the elderly, and therefore improve the quality of life for these patients.Clinical Trial Registration:https://www.chictr.org.cn/index.html, identifier: ChiCTR20000368269, 25/08/2020.

Outcome of antiemetic prophylaxis among pediatric cancer patients receiving moderate to highly emetogenic chemotherapy at pediatric hemato-oncology ward of Tikur Anbessa specialized hospital: A prospective observational study.

Chemotherapy-induced nausea and vomiting (CINV) is a major issue for chemotherapy pediatric patients, especially in developing countries due to limited access to essential antiemetics. This study aimed to assess antiemetic prophylaxis outcomes in pediatric cancer patients at Tikur Anbessa Specialized Hospital in Addis Ababa, Ethiopia. A longitudinal prospective observational study design was conducted among 201 pediatric cancer patients followed up to 120 h post-chemotherapy. The majority of patients (75.1%) received combination prophylactic antiemetics in the acute phase. Complete response (CR) was the highest in the acute phase (71.1%). Emesis episodes occurred most frequently on the first day of treatment (28.4%) and gradually decreased over time. History of motion sickness, platinum-based chemotherapy, and prior chemotherapy-induced vomiting (CIV) were associated with emesis during the acute phase whereas multiple-day chemotherapy, prior CIV, receipt of antiemetics, and a history of motion sickness in the delayed phase. However, the odds of CIV were reduced with steroid presence in the chemotherapy regimen. A considerable number of participants could not achieve a CR. It is important for clinicians to be cognizant of risk factors that influence the outcome of antiemetic prophylaxis to achieve better control of CINV among pediatric cancer patients.

Fire dragon cupping in prevention and treatment of chemotherapy-induced nausea and vomiting in breast cancer: a randomized controlled trial

To observe the clinical efficacy and safety of fire dragon cupping in prevention and treatment of chemotherapy-induced nausea and vomiting (CINV) in breast cancer. Sixty breast cancer patients receiving medium-high emetogenic chemotherapy regimen were randomly divided into an observation group (30 cases, 3 cases dropped out) and a control group (30 cases, 3 cases dropped out). In both groups, 5 mg tropisetron hydrochloride was given intravenously on the day of chemotherapy and 1st to 3rd days after chemotherapy. In the observation group, fire dragon cupping on the abdomen was applied on 1st, 3rd and 5th days after chemotherapy. The incidence of nausea, vomiting, loss of appetite, abdominal pain, abdominal distension, the severity of nausea, vomiting on 1st to 6th days after chemotherapy, and the duration of nausea, vomiting, loss of appetite were observed in the two groups. The self-rating anxiety scale (SAS) score, general comfort questionnaire scale (GCQ) score before and after treatment and remedy antiemetic medication were observed in the two groups, and the safety was evaluated. On 2nd to 6th days after chemotherapy, the number of patients with nausea, loss of appetite and abdominal distension and nausea scores in the observation group were lower than those in the control group (P<0.05). On 1st to 3rd days after chemotherapy, the number of patients with vomiting and vomiting scores in the observation group were lower than those in the control group (P<0.05). The duration of nausea, vomiting and loss of appetite in the observation group were shorter than those in the control group (P<0.05). In the observation group, there was no significant difference in SAS and GCQ scores before and after treatment (P>0.05). After treatment, the GCQ score in the control group was decreased compared with that before treatment (P<0.05). After treatment, there was no significant difference in SAS and GCQ scores between the two groups (P>0.05). There was no significant difference in the number of patients using remedy medication between the two groups (P>0.05). No adverse reaction occurred during treatment in both groups. Fire dragon cupping can effectively reduce the incidence of nausea, vomiting, loss of appetite and the severity of nausea, vomiting related to chemotherapy in breast cancer, and improve patient comfort, and have good safety.

Olanzapine versus standard antiemetic prophylaxis for the prevention of post-discharge nausea and vomiting after propofol-based general anaesthesia: A randomised controlled trial.

Post-discharge nausea and vomiting (PDNV) is a pertinent problem in patients undergoing ambulatory surgery. The objective of this study was to assess the efficacy of the novel drug olanzapine, which has proved its efficiency in patients undergoing highly emetogenic chemotherapy for PDNV prevention. This randomised controlled trial recruited 106 adult patients (18-65 years) undergoing highly emetogenic daycare surgeries with propofol-based general anaesthesia (GA). Group O received preoperative oral olanzapine 10 mg, and Group C, acting as a control, received 8 mg of intravenous dexamethasone and 4 mg of ondansetron intraoperatively. The primary outcome was nausea (numeric rating scale >3) and/or vomiting 24 h after discharge. Secondary outcomes included nausea and vomiting in the post-anaesthesia care unit (PACU), severe nausea, vomiting and side effects. Normality was assessed using the Shapiro-Wilk test, and the independent samples t-test or the Mann-Whitney U test was used to compare continuous variables. Fisher's exact test was used to assess any non-random associations between the categorical variables. The incidence and severity of postoperative nausea and vomiting were similar in both groups within PACU (four patients experienced nausea and vomiting, three had severe symptoms in Group O, P = 0.057) and in the post-discharge period (three patients in Group O had nausea and vomiting compared to five patients in Group C, of which four were severe, P = 0.484). The side effects (sedation, dizziness, and light-headedness) were comparable between the two groups. A single preoperative oral olanzapine can be an effective alternative to standard antiemetic prophylaxis involving dexamethasone and ondansetron for preventing PDNV in highly emetogenic daycare surgeries with propofol-based GA.

Abstract RF01-08: A randomized, open-label phase III trial Evaluating Low-Dose Vs standard-dose Olanzapine with triple Antiemetic therapy for Prevention of highly emetogenic chemotherapy- induced Nausea and vomiting in solid tumors (OLAnzaPiNE)

Abstract Background Chemotherapy induced nausea and vomiting (CINV) is a major adverse event for cancer patients. Olanzapine (OLZ) in standard 10 mg dose along with triple antiemetics (TAE), has shown effectiveness in treating CINV with highly emetogenic chemotherapy (HEC), however, significant day time somnolence (DTS) precludes its widespread use. Steroids related side effects are another major concern. Hence, a lower dose of OLZ, with single dose (SD) steroid use is worth exploring in a randomized fashion. Methods Solid tumors planned for anthracycline-cyclophosphamide &amp; high-dose cisplatin chemotherapy was randomized (1:1) to receive either 10mg OLZ (standard arm) or 2.5mg (experimental arm) till day 4 with TAE regimen [5-hydroxytryptamine type 3 (5-HT3) receptor antagonists, dexamethasone (SD, without delayed doses), and neurokinin-1 (NK1) receptor antagonists] in both arms. Primary objective was to evaluate Complete control rate (CCR) defined as proportion of subjects with no emetic episodes (EE), no use of rescue medications (RM), no or mild nausea assessed in overall phase (OP) =0-120 hours(h) in both groups. Secondary objectives were to compare two groups for the CCR in acute(AP) and delayed phase(DP);Complete response rate (CRR)=no EE and no use of RM in AP(0- 24h), DP(25-120h) and OP; Total control rate(TCR)= no EE, no use of RM, and no nausea) in AP, DP, OP; Time to treatment failure(TTF), defined as mean duration from chemotherapy initiation to first episode of nausea, EE, use of RM; Incidence of significant daytime somnolence(DTS).Tertiary objectives were effect on appetite loss. Subjects maintained a daily record of nausea, EE, RM use with the severity graded on a four-category scale. Statistical analysis CCR, CRR, TCR are given in counts and proportions. Occurrence of nausea, EE, DTS and their grades were compared using Chi-square test. Results A total of 275 subjects were enrolled, among them 267 were analyzable, inclusive of 132 subjects in 2.5mg and135 in 10mg arms with well-balanced baseline characteristics (Table 1) Proportion of patients with CCR in OP (Primary end point) in 2.5mg vs. 10mg arms were, 44.7 % vs. 43.7 % (P = 0.87) respectively. CCR in 2.5mg vs. 10mg arms in AP, DP were 50% vs. 48.9%(p=0.856) and 50.8% vs. 58.5% (P=0.203) respectively. CRR in 2.5mg vs. 10mg in AP, DP and OP were 56.1% vs. 57 % (P=0.872), 55.3% vs. 63% (P = 0.203), and 50.8 % vs. 51.1% (P=0.954), respectively. TCR in2.5mg vs. 10mg in AP, DP, and OP were25% vs. 23 % (P=0.697), 20.5% vs. 22% (P = 0.725), and 13.6 % vs. 15.6% (P=0.657), respectively. Subjects receiving 2.5 mg as compared with those receiving 10 mg, had statistically significant decreased DTS on overall grades 65.2%vs 89.6% vs. (p &amp;lt; 0.001); severe grade DTS was more on day1 i.e., 4.5%vs. 40% (p &amp;lt; 0.001) and although successively reduced from day 2-5 in both the arms, however, 2.5 mg fared better on all the days (table 1). No statistically significant effect of reduced appetite noted in 2.5mg vs. 10mg i.e., 17.4% vs. 24.4 %(p=0.208) Conclusion Low dose olanzapine (2.5mg) is non inferior to 10mg olanzapine in controlling CINV without requirement of delayed steroids, and is superior with respect to DTS (all days, all grades, severe grades) in subjects receiving HEC. This merits wide recognition as a new steroid sparing antiemetic regimen of choice with HEC. Demographic data, Clinical characteristics and Outcomes Citation Format: Jyoti Bajpai, Venkatesh Kapu, Sushmita Rath, Sravan Kumar, Anbarasan Sekar, Srikanth Anne, Akash Pawar, Sujay Srinivas, Prabhat Bhargava, Seema Gulia, Rajiv Sarin, Rajendra Badwe, Sudeep Gupta. A randomized, open-label phase III trial Evaluating Low-Dose Vs standard-dose Olanzapine with triple Antiemetic therapy for Prevention of highly emetogenic chemotherapy- induced Nausea and vomiting in solid tumors (OLAnzaPiNE) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr RF01-08.

Evaluation of Antiemetic Consistency in Chemotherapy-Induced Nausea and Vomiting Among NHL Patients in Sana'a, Yemen.

Chemotherapy-induced nausea and vomiting (CINV) is a prevalent and distressing adverse effect that can negatively affect a patient's quality of life and treatment adherence. This study aimed to evaluate the consistency of antiemetic use with standard guidelines and to examine the factors influencing it. This cross-sectional study was conducted at the National Oncology Center (NOC) of Al-Jomhouri Teaching Hospital, Sana'a, Yemen, from November 2022 to September 2023. Demographic data, chemotherapy and antiemetic regimens, dosages, and patient-related risk factors were collected via direct interviews, medical records, and treatment charts. This study evaluated the consistency of antiemetic practices among non-Hodgkin's Lymphoma (NHL) patients using the National Comprehensive Cancer Network (NCCN) guidelines. The chi-squared test and regression were used to determine the factors associated with guideline consistency. A total of 251 patients with NHL were recruited for the study; 57.4% were male and 60.6% were aged between 18-49. Most of the patients received moderately emetogenic chemotherapy (81.3%). The overall consistency with the NCCN guidelines was only 23.9%, with antiemetic drug selection and dosage reported inconsistently in 62.9% and 16.7% of patients, respectively. Furthermore, 62.5% of the patients received an under-prescribed antiemetic prophylactic regimen. Treatment duration, number of chemotherapy cycles, emetogenic risk potential, and overall patient risk, as well as age, sex, and marital status, were significantly associated with guideline inconsistency (p < 0.05). This study revealed a notable gap in the consistency of antiemetic prescriptions among patients with NHL. Inappropriate drug selection, dosing, and under-prescription are common problems. Patient regimen risk factors significantly influenced the consistency of the National Comprehensive Cancer Network guidelines. Personalized approaches are essential to enhance adherence to guidelines and improve antiemetic strategies.

Efficacy and Safety of Ginger on Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Chemotherapy-induced nausea and vomiting (CINV) is a prevalent and distressing side effect. Historically, ginger has been explored as a potential remedy for various ailments, including its potential efficacy against CINV. The aim of this study was to determine whether taking ginger supplements can relieve CINV. A comprehensive search was conducted across PubMed, EMBASE, Cochrane Library, and the Wanfang database. Randomized controlled trials meeting our inclusion criteria were analyzed. The primary outcomes were the incidence and severity of CINV. The protocol was registered on PROSPERO, and the number is CRD4202232104. Of the 35 randomized controlled trials analyzed, 22 trials employed ginger capsules as the primary intervention, whereas 13 studies evaluated the prophylactic effects of ginger-partitioned moxibustion. The outcomes indicated that combining ginger capsules with standard antiemetic agents can significantly reduce the incidence of grade 3 acute nausea (Risk Ratio [RR], 0.19; P < .001) and the incidence of high-grade overall vomiting (RR, 0.47; P = .01). Moreover, ginger-partitioned moxibustion can significantly alleviate the incidence of both mild (RR, 0.56; P = .001) and severe (RR, 0.39; P < .00001) vomiting. Only 2.8% of patients experienced dizziness after ginger-partitioned moxibustion. Our findings indicate that ginger capsules, when used alongside antiemetic drugs, enhance the management of severe CINV, particularly in highly emetogenic chemotherapy regimens. Based on our findings, we recommend initiating ginger supplements before chemotherapy, in conjunction with standard antiemetics, to reduce the severity of CINV. The promising results warrant more rigorous clinical trials to firmly establish the role of ginger in CINV management.

Generic Netupitant Plus Palonosetron and Dexamethasone for Prophylaxis of Chemotherapy-Induced Nausea and Vomiting (CINV) in Cancer Patients Receiving Highly or Moderately Emetogenic Chemotherapy: A Retrospective Study

Chemotherapy-induced nausea and vomiting (CINV) is a challenging adverse effect that is associated with deteriorating quality of life. Inhibiting neurokinin 1 and 5-hydroxytryptamine type 3 receptors involved in the major emesis pathways has significantly prevented CINV and is recommended as standard treatment in international antiemetic guidelines. This retrospective study was conducted to explore the efficacy of formulated netupitant (NE; 300 mg) and palonosetron (PA; 0.50mg) tablets with dexamethasone in patients receiving high and moderate emetogenic chemotherapy. A single dose of NE, PA, and dexamethasone was given 1 hour prior to the chemotherapy for 4 days. The key end-points were to assess complete response (CR), complete protection (CP), and complete control (CC) with no emesis, no nausea, and no use of rescue medication during acute (0–24 hours) and delayed phase (24–120 hours) of CINV. This study conducted on 212 patients showed overall rates of CR, CP, and CC as 97.5, 91.1, and 92.19%, respectively, in the acute phase and 95.09, 88.06, and 87.74% in a delayed phase. These patients underwent 1,387 cycles of chemotherapy involving both high emetogenic chemotherapy and moderate emetogenic chemotherapy regimens. A decrease in the rate of CR, CP, and CC from 93.47, 76.20, and 73.90% (acute phase) to 86.95, 69.67, and 67.37% (delayed phase) with highly emetogenic chemotherapy was observed, while the combination treatment achieved 100 CR, CP, and CC in both the acute and delayed phase with the moderately emetogenic chemotherapy regimen. Our study demonstrated the promising efficacy of the triple treatment with formulated NE and PA tablets in combination with dexamethasone in preventing and managing CINV in real-world settings.

Comparing the Efficacy of Palonosetron versus Ondansetron in the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients; A Randomized Controlled Trial

Objectives: To compare the efficacy of Palonosetron and Ondansetron as premedication in the prevention of early and delayed chemotherapy-induced nausea and vomiting (CINV) in pediatric patients with cancer receiving moderately or highly emetogenic chemotherapy. Methodology: This randomized controlled trial study was conducted at the Oncology Department of Children’s Hospital, PIMS Islamabad, on patients aged 6 months to 12 years undergoing chemotherapy. Patients were divided in 2 groups by stratified random sampling and random allocation. Patients in Group 1 received a single intravenous dose of 20 microgram/kg Palonosetron and dexamethasone before chemotherapy, while Group 2 received intravenous Ondansetron 8 hourly along with dexamethasone. Nausea and vomiting severity were assessed from 0–120-hour interval using the CTCAE V 5.0 grading system. Data analysis was performed using SPSS version 23, employing chi-square and Fisher exact tests to compare outcomes between the two groups. Result: 218 pediatric oncology patients were included who received moderate or high intensity chemotherapy with the mean age of 5.25 ± 2.96 years. The majority of the participants were male (58.7%). The most common diagnosis was Wilms tumor (37.6%), followed by acute lymphoblastic leukemia (21.1%) and Ewing sarcoma (9.6%). Complete response to antiemetics was significantly more in Group 1 as compared to group 2, on day 1 and 2 with p value of 0.004 and 0.001 respectively. Grade of vomiting was significantly less on day in Group 1 study participants. Conclusion: Pediatric oncology patient receiving moderately or highly emetogenic chemotherapy showed effective response to palonosetron as compared to ondansetron in prevention and control of early and delayed chemotherapy induced nausea and vomiting.

Risk Factors Associated with Chemotherapy-Induced Nausea and Vomiting Among Women with Breast Cancer Receiving Highly Emetogenic Chemotherapy: Individual Patient-Based Analysis of Three Prospective Antiemetic Trials.

Although risk factors related to chemotherapy-induced nausea and vomiting (CINV) have been identified in previous studies, only a few studies have evaluated the risk factors associated with contemporary antiemetic prophylaxis, including olanzapine/aprepitant- or NEPA-containing regimens. This study aimed to identify the risk factors associated with CINV development in Chinese breast cancer patients receiving doxorubicin and cyclophosphamide chemotherapy. Data from 304 patients enrolled in 3 previously reported prospective antiemetic studies were included. Multivariate logistic regression models were used to predict risk factors associated with CINV occurrence. Additionally, the likelihood of treatment failure in relation to the number of risk factors in individual patients was evaluated. Multivariate analysis of the entire study group revealed that obesity status (defined as body mass index/= 25.0 kg/m2) and the use of olanzapine/aprepitant- or NEPA-containing anti-emetic regimens were associated with a high likelihood, while a history of motion sickness was associated with a lower likelihood, complete response (CR), and "no nausea" in the overall phase. A history of vomiting during pregnancy was also associated with a lower likelihood of an overall CR. Patients with an increasing number of risk factors had a higher likelihood of treatment failure and shorter time to first vomiting. Those who did not achieve CR and "no nausea" in the first cycle were less likely to achieve these parameters in the subsequent cycle of chemotherapy. The present study confirmed previously reported risk factors for CINV in Chinese breast cancer patients receiving doxorubicin and cyclophosphamide. Further optimization of CINV control is required for patients with identifiable risk factors; olanzapine/aprepitant- or NEPA- containing prophylaxis are the preferred contemporary anti-emetics regimens for Chinese breast cancer patients undergoing doxorubicin and cyclophosphamide chemotherapy.

Abstract 3560: Quantified kinematics and wearable sensors to predict serious adverse events in patients undergoing cancer therapy trials

Abstract Background: Serious adverse events (SAEs) are a critical determinant of drug toxicity in clinical trials. However the drivers of toxicity may be related to patient factors as much or more than drug related factors. Prior studies have shown that time in non-sedentary activity predicted toxicity in cancer patients receiving highly emetogenic chemotherapy. SAEs are a critical determinant of drug toxicity in clinical trials. However, predicting SAEs using conventional PS scales measurements, such as ECOG is challenging because measurements can vary among observers. Prior studies have used activity trackers to measure physical activity and showed that time spent in non-sedentary activity predicted toxicity in cancer patients receiving highly emetogenic chemotherapy. Here, we sought to extend these findings to early phase clinical trial participants by examining data collected in two single-arm, observational, prospective studies at USC Keck and MD Anderson centers. We explored the use of out-of-clinic wearable sensors as an objective metric of frailty so as to identify patients at risk for therapy complications. Methods: Adult patients diagnosed with cancer and enrolled in early stage clinical trials across USC Keck and MD Anderson centers were included in parallel single-arm, observational, prospective studies. Patients used a consumer grade wearable activity tracker (Fitbit) and the study examined associations between the number of severe adverse events to activity levels measured by metabolic equivalents (METs) and get-up-go times across the first 30 days. Trends were assessed using t-tests. Results: 36 eligible patients were included in METs activity analysis. There was a total of 16 recorded incidences of SAEs within the first 30 study days, with 10 patients experiencing at least one SAE. The median non-sedentary time for patients with no SAEs was 27.5 hours above 1.5 METs per week, compared to 21.5 hours for those with at least one SAE occurrence (p-value=0.0146, r2=0.1629). The median get-up-go times for those without SAEs was 10.0 seconds (n=26) and with SAEs was 9.8 seconds (n=10), (p-value=0.828, r2=0.0014). Conclusions: Non-sedentary time, as an objective measure of activity, can be used to identify those patients who are at greatest risk for SAEs in clinical trials. Widely available and inexpensive consumer grade sensors can be used as a stratification tool. Findings should be confirmed in larger patient cohorts across a wider variety of trial settings. Figure 1: Weekly non-sedentary hours vs. presence of SAE in first 30 days of trial enrollment Citation Format: Eli Tran, Luciano Nocera, Anand Kolatkar, Anthony El-Khoueiry, Jacob Thomas, Peter Kuhn, Andrew Zeng, Megumi Kai, Meghan Karuturi, Jorge Nieva. Quantified kinematics and wearable sensors to predict serious adverse events in patients undergoing cancer therapy trials [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3560.

An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo® in the Management of Chemotherapy-Induced Nausea and Vomiting in India.

Background Chemotherapy-induced nausea and vomiting is a common and unpleasant treatment-related side effect reported by cancer patients receiving chemotherapy. Akynzeo® or NEPA (NEtupitant + PAlonosetron) is the first fixed combination of netupitant and palonosetron that targets both critical pathways involved in emesis while providing a convenient, single oral dose therapy. The current study aimed to assess the effectiveness and safety of NEPA in a real-world setting in India. Methodology This was an open-label, multicenter, prospective, single-arm study conducted at six different locations across India. The study included patients of either gender, aged ≥18 years, naive to chemotherapy, scheduled to receive highly or moderately emetogenic chemotherapy (HEC/MEC), and scheduled to receive oral NEPA, as determined by the investigator. Results A total of 360 people were screened and enrolled in the study. HEC was prescribed to 289 (81.64%) patients, while MEC was prescribed to 65 (18.36%) patients. Complete response was achieved in 94.92% of patients during the acute phase, 95.20% during the delayed phase, and 93.22% during the overall phase. During the overall phase, 92.73% and 95.38% of patients on the HEC and MEC regimens, respectively, achieved complete response. Adverse events were reported in 3.88% of patients. Conclusions Oral NEPA was found to be effective in the Indian real-world setting, eliciting a >90% complete response with HEC and MEC regimens across the acute, delayed, and overall phases.

Retrospective analysis of real-world prescribing data for managing cisplatin-based chemotherapy-induced nausea and vomiting in China.

The current utilization of neurokinin-1 receptor antagonists (NK1RAs) and the impact of updated guidelines on prescription patterns of antiemetic drugs among Chinese patients receiving highly emetogenic chemotherapy (HEC) remain undetermined. This study aims to analyze the present situation of Chinese cancer patients using antiemetic drugs and assess the appropriateness of antiemetic regimens. Prescription data were collected between January 2015 and December 2020 from cancer patients receiving cisplatin-based chemotherapy at 76 hospitals in six major cities in China. Trends in the use of antiemetic drugs, prescribing patterns and adherence to antiemetic guidelines were assessed. Among the 108,611 patients included in this study, 6 classes and 17 antiemetic drugs were identified as monotherapy or combination therapy in 93,872 patients (86.4%), whereas 14,739 patients (13.6%) were administered no antiemetic treatment. 5-hydroxytryptamine 3 receptor antagonists (5-HT3RAs) and glucocorticoids were the two most frequently used classes of antiemetics, followed by metoclopramide. NK1RAs were underused across the six cities, only 9332 (8.6%) and 1655 (1.5%) cisplatin-based treatments were prescribed aprepitant and fosaprepitant, respectively. Prescriptions of olanzapine and lorazepam were very low throughout the study period. In prescribing patterns of antiemetic drugs, dual combination regimens were the most common (40.0%), followed by triple combination therapy and monotherapy (25.8% and 15.1%, respectively). Overall, the adherence to antiemetic guidelines for patients undergoing cisplatin-based regimens was only 8.1% due to inadequate prescription of antiemetic drugs. Finally, our study also revealed that 5-HT3RAs and glucocorticoids were overprescribed in 8.8% and 1.6% of patients, respectively. The current study reveals suboptimal utilization of recommended antiemetic drugs for managing cisplatin-based HEC-induced nausea and vomiting in China. Improving the management of CINV is crucial, and these findings provide valuable insights into optimizing antiemetic drug practices.

Palonosetron in pediatric patients: A single-center, retrospective evaluation of policy and clinical practice guideline discordance.

Clinical practice guidelines (CPGs) recommending palonosetron for the prevention and management of chemotherapy-induced nausea and vomiting (CINV) were adapted for use at our institution. Palonosetron was restricted for use in patients experiencing breakthrough CINV and receiving highly emetogenic chemotherapy (HEC) or undergoing stem cell transplant conditioning and in patients with refractory CINV receiving HEC. Given the significant cost of palonosetron, we aimed to determine the proportion of chemotherapy blocks where palonosetron use was discordant with the institutional policy or source CPG. A retrospective review of the health records of patients who received palonosetron between 1 July 2019 and 30 June 2020 was undertaken. Details of palonosetron use, antiemetic regimen and the date and time of each vomit during the acute and delayed phases were collected for each chemotherapy block where palonosetron was given. Discordance with the institutional policy and the source CPG was determined by assessing the indication for palonosetron and the dose. In the subset of chemotherapy blocks where information regarding vomiting episodes was available, the extent of acute phase chemotherapy-induced vomiting (CIV) control was reported. Four hundred thirty-eight chemotherapy blocks, representing 122 patients (mean age 9 years), receiving 595 palonosetron doses were included. Palonosetron use was discordant with institutional policy during most (72%; 314/438) of the chemotherapy blocks analyzed. However, palonosetron use was concordant with the source CPG during most chemotherapy blocks (74%; 326/438). Complete CIV control during the acute phase was observed in 66% (195/295) of chemotherapy blocks where palonosetron was given, irrespective of concomitant antiemetics administered. The majority of palonosetron use at our institution was discordant with institutional policy, but concordant with the source CPG. Our institutional policy has since been updated to be more aligned with the source CPG.

Adherence to antiemetic guidelines in solid cancer patients receiving highly emetogenic chemotherapy in Korea.

Highly emetogenic chemotherapy (HEC) is known to induce nausea and vomiting (CINV) in approximately 90% of cancer patients undergoing this regimen unless proper prophylactic antiemetics are administered. This study aimed to analyze the use of a three-drug prophylactic antiemetic regimen during the first cycle of chemotherapy and assess the compliance rate with the National Comprehensive Cancer Network (NCCN) guidelines. This retrospective study utilized data from the National Inpatient Sample database from 2016 to 2020 provided by the Health Insurance Review and Assessment Service. The claims data encompassed 10 to 13% of inpatients admitted at least once each year. Patients with solid cancers treated with two HEC regimens, namely anthracycline + cyclophosphamide (AC) and cisplatin-based regimens, were selected as the study population. We evaluated the use of a three-drug prophylactic antiemetic regimen, including a neurokinin-1 receptor antagonist, a 5-hydroxytryptamine-3 receptor antagonist, and dexamethasone and compliance with the NCCN guidelines. Multiple logistic regression was conducted to estimate the influence of variables on guideline adherence. A total of 3119 patients were included in the analysis. The overall compliance rate with the NCCN guidelines for prophylactic antiemetics was 74.3%, with higher rates observed in the AC group (87.9%) and lower rates in the cisplatin group (60.4%). The AC group had a 6.37 times higher likelihood of receiving guideline-adherent antiemetics than the cisplatin group. Further analysis revealed that, compared to 2016, the probability of complying with the guidelines in 2019 and 2020 was 0.72 times and 0.76 times lower, respectively. This study showed that a considerable proportion of HEC-treated patients received guideline-adherent antiemetic therapies. However, given the variations in adherence rates between different chemotherapy regimens (AC vs. cisplatin), efforts to improve adherence and optimize antiemetic treatment remain essential for providing the best possible care for patients experiencing CINV.

Trial Sequential Analysis and Meta-Analysis of Olanzapine in Pediatric Patients for Chemotherapy-Induced Nausea and Vomiting (CINV).

Background and Objective: Olanzapine (OLZ) containing regimens are approved in adults for chemotherapy-induced nausea and vomiting (CINV) receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC), and the same has not been approved in the pediatric population. In order to generate data regarding the efficacy and safety of OLZ as an adjunct to the standard of care (SoC) for CINV in pediatric patients receiving HEC/MEC, the review authors performed this systematic review and meta-analysis. Methods: A systematic literature search was performed through the databases Cochrane Library, Pub Med, and clinicaltrials.gov, from inception to September 2023, using keywords: "chemotherapy" and "olanzapine," "nausea" and "vomiting." Randomized clinical trials published in English that analyzed the efficacy and safety of olanzapine as an adjunct to SoC were included. The essential outcomes included in this study were the proportion of patients with no emesis in the acute and delayed phase, patients with no nausea in the acute and delayed phase, the proportion of patients requiring rescue medication, and the proportion of patients with reduced CNS arousal. Results: In the OLZ group, a greater number of patients had no emesis both in the acute and delayed phase (RR = 1.22; 95% CI = 1.09-1.37; P = .0004); and (RR = 1.23; 95% CI = 0.92-1.63; P = .16) respectively. Similarly, a higher number of patients showed no nausea both in the acute and delayed phase (RR = 1.08; 95% CI = 0.78-1.48; P = .66) and (RR = 1.12; 95% CI = 0.79-1.61; P = .52) respectively. The use of rescue medication was significantly less in the OLZ group (RR = 0.62; 95% CI = 0.42-0.91; P = .01). More patients experienced reduced CNS arousal in the OLZ group (RR = 2.97; 95% CI = 2.02-4.38; P < .0001). Conclusions: Olanzapine as an adjunct to the SoC may be effective in acute emesis, which may also reduce the use of rescue medication. Reduced CNS alertness was the significant adverse effect observed. For other endpoints, more studies are required to substantiate its role in CINV.

Pediatric oncology provider perspectives and patient/family perceptions of chemotherapy-induced nausea and vomiting management: Experiences at an academic medical center.

Chemotherapy-induced nausea and vomiting (CINV) is common in children undergoing cancer treatment, and significantly impacts quality of life. Clinical practice guidelines (CPGs) have been developed to guide CINV management, though many patients do not receive guideline-concordant care. Few studies have examined provider perspectives on CINV management or preferred improvement approaches, or pediatric patient perception of CINV control. A cross-sectional study of pediatric oncology providers was conducted at a large freestanding children's hospital. Providers completed an anonymous online survey about CINV control in patients admitted for scheduled chemotherapy, and their knowledge and utilization of CINV CPGs. A survey of English and Spanish-speaking pediatric oncology patients admitted for scheduled chemotherapy was conducted to assess CINV management, with key demographics used to understand association with perceptions and adherence to antiemetic guidelines. For providers, 75% of respondents felt CINV management could be moderately or extremely improved, significantly more so by chemotherapy prescribers and pediatric medical residents than nurses. Over half of respondents did not have awareness of CINV CPGs, particularly pediatric medical residents. For patients, nausea was reported to be extremely well controlled in 44% of cases, and vomiting extremely well controlled in 50% of cases. There were no significant differences in patient-reported CINV across demographics, when considering emetogenicity of chemotherapy received, or concordance to guidelines. Implementing education in this area may help to improve provider comfort, and ultimately, the patient experience. Future studies will expand upon this novel patient perception, and develop and evaluate CINV management interventions.

Safety and tolerability of intravenous aprepitant and fosaprepitant in children with cancer: A retrospective, single-center review.

NK-1 receptor antagonists (NK1-RA) are key agents for chemotherapy-induced nausea and vomiting (CINV) prevention in patients receiving highly emetogenic chemotherapy. Current pediatric practice guidelines recommend the use of intravenous fosaprepitant or oral aprepitant. However, there are reports of hypersensitivity reactions with fosaprepitant due to polysorbate 80. Intravenous aprepitant does not contain polysorbate 80, but its use in pediatric patients has not been described. In this retrospective, single-center study, 106 pediatric patients received either fosaprepitant or intravenous aprepitant as part of their antiemetic regimen. Intravenous aprepitant was well tolerated and did not lead to any instances of hypersensitivity reactions requiring discontinuation.

Low-dose versus standard-dose olanzapine with triple antiemetic therapy for prevention of highly emetogenic chemotherapy-induced nausea and vomiting in patients with solid tumours: a single-centre, open-label, non-inferiority, randomised, controlled, phase 3 trial

Olanzapine is an effective antiemetic agent but it results in substantial daytime somnolence when administered at the standard dose. Our aim was to compare the efficacy of low-dose versus standard-dose olanzapine after highly emetogenic chemotherapy in patients with solid tumours. This was a single-centre, open-label, non-inferiority, randomised, controlled, phase 3 trial done in a tertiary care referral centre in India (Tata Memorial Centre, Homi Bhabha National Institute, Mumbai). Patients aged 13-75 years with an Eastern Cooperative Oncology Group performance status of 0-2, who were receiving doxorubicin-cyclophosphamide or high-dose cisplatin for a solid tumour were eligible. Patients were randomly assigned (1:1), with block randomisation (block sizes of 2 or 4) and stratified by sex, age (≥55 or <55 years), and chemotherapy regimen, to receive low-dose (2·5 mg) oral olanzapine or standard-dose (10·0 mg) oral olanzapine daily for 4 days, in combination with a triple antiemetic regimen. Study staff were masked to treatment allocation but patients were aware of their group assignment. The primary endpoint was complete control, defined as no emetic episodes, no rescue medications, and no or mild nausea in the overall phase (0-120 hours), assessed in the modified intention-to-treat (mITT) population (ie, all eligible patients who received protocol-specified treatment, excluding those who had eligibility violations and who withdrew consent after randomisation). Daytime somnolence was the safety endpoint of interest. Non-inferiority was shown if the upper limit of the one-sided 95% CI for the difference in the complete control proportions between the treatment groups excluded the non-inferiority margin of 10%. This study is registered with the Clinical Trial Registry India, CTRI/2021/01/030233, is closed to accrual, and this is the final data analysis. Between Feb 9, 2021, and May 30, 2023, 356 patients were pre-screened for eligibility, of whom 275 patients were enrolled and randomly assigned (134 to the 2·5 mg olanzapine group and 141 to the 10·0 mg olanzapine group). 267 patients (132 in the 2·5 mg group and 135 in the 10·0 mg group) were included in the mITT population, of whom 252 (94%) were female, 15 (6%) were male, and 242 (91%) had breast cancer. 59 (45%) of 132 patients in the 2·5 mg olanzapine group had complete control in the overall phase versus 59 (44%) of 135 in the 10·0 mg olanzapine group (difference -1·0% [one-sided 95% CI -100·0 to 9·0]; p=0·87). In the overall phase, there were significantly fewer patients in the 2·5 mg olanzapine group than in the 10·0 mg olanzapine group with daytime somnolence of any grade (86 [65%] of 132 vs 121 [90%] of 135; p<0·0001) and of severe grade on day 1 (six]5%] vs 54 [40%]; p<0·0001). Our findings suggest that olanzapine 2·5 mg is non-inferior to 10·0 mg in antiemetic efficacy and results in reduced occurrence of daytime somnolence among patients receiving highly emetic chemotherapy and should be considered as a new standard of care. Progressive Ladies Welfare Association.

Prevalence of anticipatory nausea and vomiting in breast cancer patients undergoing highly emetogenic chemotherapy.

Anticipatory nausea and vomiting are unpleasant symptoms observed before undergoing chemotherapy sessions. Less is known about the occurrence of symptoms since the advent of the new neurokinin-1 antagonist. This prospective cohort study was performed at a single Brazilian Institution. This study included breast cancer patients who received doxorubicin and cyclophosphamide chemotherapy and an appropriate antiemetic regimen (dexamethasone 10 mg, palonosetron 0.56 mg, and netupitant 300 mg in the D1 followed by dexamethasone 10 mg 12/12 h in D2 and D4). Patients used a diary to record nausea, vomiting, and use of rescue medication in the first two cycles of treatment. The prevalence of anticipatory nausea and vomiting was assessed before chemotherapy on day 1 of C2. From August 4, 2020, to August 12, 2021, 60 patients were screened, and 52 patients were enrolled. The mean age was 50.8 (28-69) years, most had stage III (53.8%), and most received chemotherapy with curative intent (94%). During the first cycle, the frequency of overall nausea and vomiting was 67.31%, and that of severe nausea and vomiting (defined as grade>4 on a 10-point visual scale or use of rescue medication) was 55.77%. Ten patients had anticipatory nausea and vomiting (19.23%). The occurrence of nausea and vomiting during C1 was the only statistically significant predictor of anticipatory nausea and vomiting (OR=16, 95%CI 2.4-670.9, p=0.0003). The prevalence of anticipatory nausea is still high in the era of neurokinin-1 antagonists, and failure of antiemetic control in C1 remains the main risk factor. All efforts should be made to control chemotherapy-induced nausea or nausea and vomiting on C1 to avoid anticipatory nausea.