Acute Chemotherapy-induced Nausea And Vomiting Research Articles

Palonosetron for prevention of delayed chemotherapy-induced nausea and vomiting in pediatric patients: a meta-analysis.

Chemotherapy-induced nausea and vomiting (CINV) are common adverse events in patients undergoing emetogenic chemotherapy. Palonosetron, a second-generation 5-hydroxytryptamine-3 receptor antagonist (5-HT3 RA), has demonstrated non-inferiority to first-generation 5-HT3 RAs for CINV in pediatric patients. Although palonosetron has a long half-life and prolonged antiemetic action, its efficacy against delayed CINV in pediatric patients is not well understood. Therefore, this meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the efficacy of palonosetron for delayed CINV in pediatric patients. A literature search of MEDLINE/PubMed, Embase, Cochrane Library, and Web of Science databases was performed. A meta-analysis was performed using forest plots, and risk ratios (RRs) and 95% confidence intervals (CIs) were calculated. A funnel plot was constructed to explore publication bias. The literature search retrieved 842 records, of which 23 full-text articles were assessed, including six RCTs. Meta-analysis of four RCTs that reported on the complete response (CR: defined as no emesis and no rescue medication) rate for delayed CINV revealed that palonosetron was statistically superior to first-generation 5-HT3 RAs (RR =1.21 [95% CI 1.09-1.35]; p < 0.01). Although the number of studies included was small, no publication bias was observed in the funnel plots. In addition, the CR rate for overall and acute CINV was also significantly higher for palonosetron (RR = 1.25 [95% CI 1.01-1.54]; p = 0.04 and RR = 1.06 [95% CI 1.01-1.12]; p = 0.03, respectively). Palonosetron is effective in the prophylaxis of delayed CINV in pediatric patients.

Chemotherapy induced nausea and vomiting may cause anxiety and depression in the family caregivers of patients with cancer.

To investigate the impact of chemotherapy induced nausea and vomiting (CINV) on the anxiety and depression of the primary family caregivers of patients with cancer. This study screened family caregivers of patients with cancer undergoing highly emetogenic chemotherapy (HEC) containing a 3-day cisplatin regime. Caregivers who did not experience anxiety or depression at baseline screening were enrolled in this study. Based on the patients' CINV status during chemotherapy, their family caregivers were divided into two groups: patients who experienced CINV (CINV group) and patients who did not experience CINV (No-CINV group). All enrolled family caregivers completed the Hospital Anxiety and Depression Scale (HADS) questionnaire on the fourth and 8 days of chemotherapy. A total of 256 family caregivers were screened for this study, of which 195 caregivers without anxiety or depression at baseline were included. A total of 150 (76.9%) patients undergoing chemotherapy experienced acute CINV; 63 (42%) of their family caregivers experienced anxiety, and 65 (43.3%) developed depression. This was significantly higher than the experiences of the No-CINV group (2.2%, P < 0.001; 0%, P < 0.001, respectively). Among the patients undergoing chemotherapy, 86 (44.1%) experienced delayed CINV. The incidence of anxiety and depression in the family caregivers of patients with delayed CINV were 27.9 and 36%, respectively, both of which were significantly higher than that in the family caregivers of the No-CINV group (0.9%, P < 0.001; and 0.9%, P < 0.001, respectively). Acute and delayed CINV occurring in patients during chemotherapy may induce anxiety and depression in their family caregivers.

Effect of a Standardized Ginger Root Powder Regimen on Chemotherapy-Induced Nausea and Vomiting: A Multicenter, Double-Blind, Placebo-Controlled Randomized Trial

BackgroundThere is substantial interest in the role of ginger as an adjuvant therapy for chemotherapy-induced nausea and vomiting (CINV). However, available evidence lacks robust methodology. ObjectiveTo assess the effect of adjuvant ginger compared with placebo on chemotherapy-induced nausea-related quality of life (QoL) and CINV-related outcomes. DesignA parallel, double-blind, placebo-controlled randomized trial with 1:1 allocation was conducted. Participants/settingOne hundred three chemotherapy-naïve adults scheduled to receive moderately to highly emetogenic chemotherapy at two hospitals in Australia were enrolled and analyzed. InterventionFour standardized ginger capsules (totaling 84 mg/day active gingerols/shogaols), or placebo, were administered commencing the day of chemotherapy and continuing for 5 days for chemotherapy cycles 1 through 3. Main outcome measuresThe primary outcome was chemotherapy-induced nausea-related QoL. Secondary outcomes were vomiting- and CINV-related QoL; anticipatory, acute, and delayed nausea and vomiting; fatigue; nutritional status; depression and anxiety; health-related QoL; and adverse events. Statistical analyses performedIntention-to-treat analysis was performed. Mixed analysis of variance with repeated measures determined differences between groups. The null hypothesis was no difference between groups. After applying a Bonferroni multiple testing correction, evidence against the null hypothesis was considered at P= 0.003. ResultsOne hundred three participants (ginger: n = 52; placebo: n = 51) were enrolled and analyzed. There was clinically relevant evidence against the null hypothesis, favoring ginger, in change scores for nausea-related QoL (F[df] = 9.34[1,101]; P = 0.003; partial η2 = 0.09), overall CINV-related QoL (F[df] = 12.26[1,101]; P < 0.001; partial η2 = 0.11), delayed nausea severity (F[df] = 9.46[1,101]; P = 0.003; partial η2 = 0.09), and fatigue (F[df] = 10.11[1,101]; P = 0.002; partial η2 = 0.09). There was a clinically meaningful lower incidence of delayed nausea and vomiting in the ginger group at Cycle 2 (53% vs 75%; P = 0.020 and 4% vs 27%; P = 0.001, respectively) and Cycle 3 (49% vs 79%; P = 0.002 and 2% vs 23%; P = 0.001, respectively). There was a clinically meaningful lower incidence of malnutrition in the ginger group at Cycle 3 (18% vs. 41%; P = 0.032) and in change scores for Patient-Generated Subjective Global Assessment (F[df)] = 4.32[1,100]; P = 0.040; partial η2 = 0.04). Change scores between groups favored ginger for vomiting-related QoL and number of vomiting episodes; however, findings were not clinically meaningful. There was no effect of ginger on anticipatory or acute CINV, health-related QoL, anxiety, or depression. No serious adverse events were reported. ConclusionsGinger supplementation was a safe adjuvant to antiemetic medications for CINV that enhanced QoL during chemotherapy treatment. Future trials are needed to examine dose-dependent responses to verify optimal dosing regimens.

Addressing adherence to guidelines on prevention of acute chemotherapy-induced nausea and vomiting in pediatric patients.

Chemotherapy-induced nausea and vomiting (CINV) is a distressing adverse effect in children receiving cancer treatment. There are evidence-based pediatric clinical practice guidelines (CPG) on chemotherapy emetogenicity and acute CINV prevention, but adherence to these guidelines is low. A quality improvement-based study was conducted at McMaster Children's Hospital. The SMART aim was to increase adherence to guidelines on prevention of acute CINV in hospitalized patients receiving high (HEC) and moderately emetogenic chemotherapy (MEC) from baseline 25% to more than 70% by June 2021. Barriers were identified by process mapping, and a series of interventions were implemented. Guideline adherence was assessed in 270 inpatient chemotherapy administrations (HEC, MEC). Data were collected on 131 charts pre interventions and 139 charts post interventions. Interventions included education, addition of guideline-recommended anti-emetics to the inpatient formulary, and implementation of a standardized CPG tool. Initial rates of total CINV guideline adherence were 25%, which improved to 72% post intervention (p<.001). In subgroup analysis, guideline adherence in the MEC group improved from 13% to 34% (p=.015), and in the HEC group from 32% to 93% (p<.001). The most common reason for nonadherence in the HEC group was failure to use aprepitant as anti-emetic, and in MEC was option for ondansetron monotherapy prophylaxis. Using quality improvement methodology, barriers to guideline adherence were identified and interventions implemented. Guideline adherence for prevention of CINV improved, particularly in the HEC group but less for the MEC group. Future steps will include sustainability of interventions and addressing adherence in the MEC group.

Efficacy and Safety of Ginger on the Side Effects of Chemotherapy in Breast Cancer Patients: Systematic Review and Meta-Analysis.

Cancer is one of the leading causes of death in the world, with breast cancer being the most prevalent cancer. Chemotherapy-induced nausea and vomiting (CINV) is one of the most serious side effects of chemotherapy. Because the current CINV treatment option has several flaws, alternative treatment options are required. Ginger has traditionally been used to treat nausea and vomiting, and it also has anticancer properties in breast cancer cells. Based on these findings, researchers investigated whether using ginger to treat CINV in breast cancer patients is both effective and safe. We searched PubMed, Embase, Cochrane Library, CNKI, and Wanfang from inception to June 2022. Outcomes included Rhodes Index Scores of Nausea, Vomiting, and Retching, severity and frequency of CINV. Five RCTs were included. We pooled all included data and performed subgroup analysis by types of CINV. Overall, authors found that ginger was associated with a reduction in CINV. Subgroup and sensitivity analysis revealed that managing severity of acute CINV in breast cancer patients with ginger was efficient. In terms of managing delayed CINV in breast cancer patients, ginger was also statistically significant. The authors concluded that ginger may be helpful in lowering both acute and delayed CINV in breast cancer patients. Since there were no serious side effects, ginger is thought to be safe.

Interventions for the prevention of acute phase chemotherapy-induced nausea and vomiting in adult and pediatric patients: a systematic review and meta-analysis.

To identify effective and safe interventions to prevent acute phase chemotherapy-induced nausea and vomiting (CINV) in adult and pediatric patients. We conducted a systematic review of randomized trials evaluating interventions to prevent acute CINV. Outcomes assessed were complete chemotherapy-induced vomiting (CIV) control, complete chemotherapy-induced nausea (CIN) control, complete CINV control, and discontinuation of antiemetics due to adverse effects. The search identified 65,172 citations; 744 were evaluated at full-text, and 295 (25 pediatric) met eligibility criteria. In patients receiving highly emetogenic chemotherapy (HEC), complete CIV (risk ratio (RR) 1.23, 95% confidence interval (CI) 1.05-1.44) and CIN (RR 1.34, 95% CI 1.10-1.62) control improved when olanzapine was added. The addition of a neurokinin-1 receptor antagonist (NK1RA) to a corticosteroid plus a serotonin-3 receptor antagonist (5HT3RA) also improved complete CIV (RR 1.11, 95% CI 1.08-1.14) and CIN (RR 1.05, 95% CI 1.01-1.08) control. Compared to granisetron/ondansetron, palonosetron provided improved complete CIV control when the 5HT3RA was given alone or when combined with dexamethasone. In patients receiving moderately emetogenic chemotherapy (MEC), dexamethasone plus a 5HT3RA improved complete CIV control compared to a 5HT3RA alone (RR 1.29, 95% CI 1.21-1.39). Only a single meta-analysis evaluating the safety outcome was possible. For patients receiving HEC, various antiemetic regimens improved CIV and CIN control. For patients receiving MEC, administration of a 5HT3RA plus dexamethasone improved CIV control. Analysis of antiemetic safety was constrained by lack of data.

The effect of using an interactive mobile application for the management of chemotherapy-induced nausea and vomiting in children: Randomized controlled study.

This study was conducted to develop an interactive mobile application called 5inD, and investigate the effect of 5inD on the management of chemotherapy-induced nausea and vomiting (CINV) in pediatric oncology patients. The prospective, parallel-group and randomized controlled study was conducted in a university hospital between October 2019 and January 2021 with 57 children aged 8-18 years who were treated with chemotherapy and their mothers. In this study, a mobile application called "5inD" was developed, which includes five distraction methods to reduce CINV. Data were collected about CINV through the Adapted Rhodes Index for Nausea & Vomiting child version (ARINVc), and parent version (ARINVp). CINV of the children was evaluated for seven days starting from the first day of chemotherapy. In the study, Child ARINVc and Parent ARINVp mean scores of the intervention groups were lower than the control group during the seven days (p<0.05). There was a statistically significant difference between the group's Adapted Rhodes Index of Nausea and Vomiting for Pediatrics by Child (ARINVc) and by Parent (ARINVp) mean scores in terms of the group, time, and group*time interaction. While a statistically significant difference was found between the intervention group's and control group's mean scores in terms of the group, time, and group*time for the acute CINV (p<0.05), there was no statistically significant difference for delayed CINV between groups scores in terms of the time, and group*time interaction (p>0.05). This study supports the findings that the interactive mobile application was found effective in reducing CINV in children. Additionally, it can be said 5inD is more effective for the management of acute CINV than delayed CINV.

Evaluating Aprepitant single-dose plus granisetron and dexamethasone in children receiving highly emetogenic chemotherapy for the prevention of chemotherapy-induced nausea and vomiting: A triple-blinded randomized clinical trial

IntroductionThis study was performed to evaluate the degree of 3-day chemotherapy-induced nausea and vomiting (CINV) in children with cancer who received highly emetogenic chemotherapy (HEC) to ascertain the efficacy of aprepitant single-dose on dayL 1 plus granisetron and dexamethasone (DEX). MethodsThis clinical trial study was conducted on 120 patients in the age range of 5 to 18 years old who received chemotherapy. Patients were divided into two groups; Group A received aprepitant at 125 mg/kg on day 1 orally, followed by 80 mg/kg daily on days 2 and 3 and Group B received a single dose of aprepitant 125 mg/kg on day 1 orally and placebo on days 2 and 3. All groups received granisetron 3 mg/m2 on day 1 and DEX on days 1 to 3. The primary and secondary endpoints were to evaluate the proportion of patients with acute, delayed and overall CINV within each group. ResultsThere were no significant differences between the two groups for vomiting, nausea or the use of rescue therapy. The number of patients without vomiting on day 1 was similar in both groups (96.5% vs. 98.3%, respectively; p = 0.848). ConclusionAccording to the results of this study, a single dose of aprepitant 125 mg/kg was as effective as administering three doses of aprepitant on 3 days. Therefore, the use of a single dose of aprepitant in combination with other standard treatment regimens to prevent CINV in children who received HEC was safe and efficacious and can be beneficial.

Effects of auricular acupressure on chemotherapy-induced nausea and vomiting in breast cancer patients: a preliminary randomized controlled trial

BackgroundAuricular acupressure (AA) has been viewed as a promising approach to managing chemotherapy-induced nausea and vomiting (CINV) but relevant research evidence has been inconclusive. This study aimed to examine the effects of AA on CINV in breast cancer (BC) patients undergoing chemotherapy.MethodsA preliminary randomized controlled trial was conducted in 114 BC patients. Participants were randomly allocated to a true AA group (n = 38), a sham AA group (n = 38), and a standard care group (n = 38). All the participants were provided with standard antiemetic treatment and care, while the true AA group and the sham AA group received an additional 5-day true AA and a 5-day sham AA, respectively. Acute and delayed CINV were assessed by using the MASCC Antiemesis Tool (MAT), anticipatory nausea and vomiting were measured by the Index of Nausea, Vomiting, and Retching (INVR), and patients’ quality of life (QoL) was evaluated by the Functional Assessment of Cancer Therapy-Breast (FACT-B).ResultsBoth the true and sham AA groups reported improved CINV outcomes than the standard care group, with the true AA demonstrating larger effects than the sham comparison. The true and sham AA groups had higher complete response (CR) rates of CINV when compared with the standard care group, with the difference in the CR of acute CINV achieving statistical significance (p = 0.03). Both the true and sham AA groups demonstrated lower incidence and severity of acute CINV compared with the standard care group with the among-group difference reaching statistical significance for the occurrence (p = 0.04) and severity (p = 0.001) of acute nausea. No significant differences in anticipatory CINV and QoL were found among the groups.ConclusionThe use of AA plus standard antiemetic treatment and care was superior to the use of standard antiemetic treatment and care alone in managing CINV among BC patients receiving chemotherapy. The antiemetic effects of AA were identified to be more profound in improving acute CINV, particularly acute nausea. The antiemetic effects of AA were deemed to be a mixture of specific treatment effects and placebo effects, and the placebo effects were very large and even reached clinical significance.Trial registrationClinicalTrials.gov; NCT02403037; Registered March 31, 2015.

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.

The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial.

BackgroundCancer is a chronic disease with an incidence of 24.5 million and 9.6 million deaths worldwide in 2017. Lung and colorectal cancer are the most common cancers for both sexes and, according to national and international recommendations, platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting (CINV) may persist. Moreover, cancer patients are increasingly interested in alternative and complementary medicines and have expressed the desire that nonpharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology significantly decreases the severity of CINV in patients with breast cancer.ObjectiveThe primary aim of this study was to assess the benefits of foot reflexology as a complement therapy to conventional treatments regarding the severity of acute CINV in patients with digestive or lung cancer. The secondary objectives assessed were the frequency and severity of delayed CINV, quality of life, anxiety, and self-esteem.MethodsThis study was conducted between April 2018 and April 2020 in the Hospices Civils de Lyon, France. This was an open-label randomized controlled trial. Participants were randomized into two groups: the intervention group (ie, conventional care with foot reflexology; n=40) and the control group (ie, conventional care without foot reflexology; n=40). Foot reflexology sessions (30 minutes each) were performed on outpatients or inpatients. Eligible participants were patients with lung or digestive cancer with an indication for platinum-based chemotherapy.ResultsThe severity of acute nausea and vomiting was assessed with a visual analog scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for the control group (7/34, 21%; P=.001). Across all cycles, the foot reflexology group showed a trend toward less frequent delayed nausea (P=.28), a significantly less frequent consumption of antiemetic drugs (P=.04), and no significant difference for vomiting (P=.99); there was a trend toward a perception of stronger severity for delayed nausea in the control group (P=.39). Regarding quality of life and anxiety, there was no significant difference between the intervention group and the control group (P=.32 and P=.53, respectively).ConclusionsThis study’s results indicate that foot reflexology provides significantly better management of acute nausea severity and decreased consumption of antiemetic drugs in patients with lung or digestive cancer. In order to fulfill patients’ desires to use nonpharmacological treatments and complementary and alternative medicines in hospitals, foot reflexology could be provided as a complementary intervention to conventional antiemetic drugs. Foot reflexology did not result in adverse effects. To assess the benefits of foot reflexology in routine practice, a larger study with several health care centers would be needed with a cluster randomized controlled trial.Trial RegistrationClinicalTrials.gov NCT03508180; https://clinicaltrials.gov/ct2/show/NCT03508180International Registered Report Identifier (IRRID)RR2-10.2196/17232

Improving Guideline-Congruent Care for Chemotherapy-Induced Nausea and Vomiting Prophylaxis in Pediatric Oncology Patients.

Chemotherapy-induced nausea and vomiting (CINV) is a very common side effect of pediatric cancer therapy. High-quality, evidence-based, pediatric-specific guidelines for prophylaxis and treatment of CINV are available. At many centers, guideline-concordant care is uncommon. We formed a multidisciplinary quality improvement team to implement guideline-concordant care for CINV prophylaxis at our center. We present the results following the first year of our interventions. We planned and implemented a multipronged approach in three key phases: (1) developing and publishing an acute CINV prophylaxis pathway, (2) education of providers, and (3) updating the computerized provider order entry system. We used iterative, sequential Plan-Do-Study-Act cycles and behavioral economic strategies to improve adherence to guideline-concordant CINV prophylaxis. We focused on aprepitant usage as a key area for improvement. At the beginning of the study period, < 50% of patients were receiving guideline-concordant CINV prophylaxis and < 15% of eligible patients were receiving aprepitant. After 1 year, more than 60% of patients were receiving guideline-concordant care and 50% of eligible patients were receiving aprepitant. We describe the development and implementation of a standardized pathway for prevention of acute CINV in pediatric oncology patients. With a multidisciplinary, multifaceted approach, we demonstrate significant improvements to guideline-congruent CINV prophylaxis.

Chemotherapy-Induced Nausea and Vomiting in Breast Cancer Patients: A Multicenter Prospective Observational Study

Objective:This study aimed to assess the occurrence of chemotherapy-induced nausea and vomiting (CINV) in acute phase (24 h after chemotherapy) and delayed phase (2–5 days after chemotherapy) after standard antiemetic therapy and to explore the risk factors of CINV in the acute and delayed phases.Methods:This prospective and observational study analyzed the data of 400 breast cancer patients scheduled for chemotherapy in two hospitals. The self-report survey was developed to assess the occurrence of CINV and their associated factors. On day 2 and day 6 of chemotherapy, CINV was evaluated by the Multinational Association of Supportive Care in Cancer Antiemetic Tool (MAT). The incidence of acute and delayed CINV was expressed as frequency and percentage.Results:Among 400 patients, 29.8% and 23.5% experienced acute and delayed CINV, respectively. Logistic regression analysis showed that the risk factors associated with acute CINV included pain/insomnia, history of CINV, and highly emetogenic chemotherapy. The history of motion sickness (MS), history of CINV, number of chemotherapy cycles completed, and the incidence of acute CINV were significant risk factors for delayed CINV (all P < 0.05).Conclusions:The results of this study are helpful for nurses to identify high-risk patients with CINV, formulate effective treatment plans, and reduce the incidence of CINV.

Efficacy of Granisetron in the Prevention of Nausea and Vomiting among Paediatric Oncology Patients Receiving Moderate to Highly Emetogenic Chemotherapy: A Single-Blinded, Non-Inferiority Trial

This single-blinded, non-inferiority trial was conducted over an 8-month period to examine the efficacy of intravenous granisetron at two differing doses in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV)among paediatric patients receiving moderate to highly emetogenic chemotherapy. Seventeen patients (9 males and 8 females) were recruited and randomly assigned to receive alternating granisetron dosages of 0.01 mg/kg and 0.04 mg/kg during each chemotherapy cycle. The severity of CINV during and three days post-completion of chemotherapy, as well as common side effects of granisetron were recorded. A total of 78 cycles of chemotherapy (38 cycles of 0.01 mg/kg and 40 cycles of 0.04 mg/kg) were evaluated. The median age of the study population was 5.2 years (interquartile range 25th, 3.8; 75th, 8.7). Patients’ diagnoses comprised of haematological malignancy, bone tumour and cerebral neoplasm. From this study, we demonstrated that intravenous (IV) granisetron 0.01 mg/kg was non-inferior to 0.04 mg/kg in terms of achieving a complete response for acute CINV. However, a similar observation was not seen in the post-treatment period analysis (delayed CINV). In conclusion, IV granisetron at 0.04 mg/kg/dose provides effective protection and prophylaxis of both acute and delayed CINV. Further study with a larger sample size may be required before a definite conclusion can be made with regards to efficacy of 0.01 mg/kg dose.

Antiemetic Prophylaxis with Granisetron and Fosaprepitant during Moderate and High Emetogenic Chemotherapy in Pediatric Patients

BackgroundPediatric patients that undergo chemotherapy and hematopoietic stem cell transplantation regularly experience chemotherapy-induced nausea and vomiting (CINV), which represents a major impairment of the patients' quality of life. Antiemetic prophylaxis is thus an important factor in cancer therapy management. Risk for CINV is defined by >30-60% in moderate and by >60% in high emetogenic therapy. International guidelines recommend antiemetic prophylaxis with a combination of corticosteroids, 5-HT3R-antagonists (5-hydroxytryptamine-3 receptor) and NK1R-antagonists (neurokinin-1 receptor). Especially the water-soluble NK1R-antagonist fosaprepitant has shown favorable results in adult patients when used in a combination prophylaxis with the 5-HT3R-antagonist granisetron. This is the first comparative analysis to assess the efficacy and safety of a combination of intravenous fosaprepitant, granisetron and dexamethasone versus a standard prophylaxis regimen with granisetron and dexamethasone alone in 86 pediatric patients.ResultsIn this retrospective single-center chart analysis, a total of 86 pediatric patients with a median age of 7 years (2-17 years) were enrolled between 2015 and 2017. The patients received either antiemetic prophylaxis with intravenous infusion (<30 minutes) of granisetron (2x20 µg per kg bodyweight and day (maximum 3 mg), fosaprepitant 3.5 - 4 mg per kg bodyweight (maximum 150 mg) and dexamethasone 0.1 mg per kg bodyweight (maximum 4 mg) (fosaprepitant group; FG; n=45) or granisetron and dexamethasone alone (control group; CG; n=41) for the prevention of CINV in 308 courses of moderate or high emetogenic chemotherapy. Patients experiencing vomiting or receiving antiemetic medication within 48 hours before the start of antiemetic prophylaxis were excluded from this analysis. Antiemetic efficacy of the two prophylaxis regimens was comparatively analyzed with respect to vomiting frequency, percentages of patients experiencing vomiting, and additional therapeutic medication with dimenhydrinate in the acute (<24h) and delayed (24-100h) CINV phases. Safety was assessed comparing drug-related clinical (exanthema, sweating, and gastrointestinal symptoms) and laboratory (relevant changes of liver and kidney parameters, electrolytes) side effects.Both prophylaxis regimens were similarly safe and not significantly different (p>0.05) with respect to clinical or laboratory drug-related adverse events. Discontinuation of the antiemetic medication was not indicated for any of the patients of the CG or FG. Percentages of patients experiencing vomiting was significantly lower in the FG, both in the acute CINV phase (p<0.01) and in the delayed CINV phase (p<0.001) when compared to the CG. Likewise, significantly fewer vomiting events were registered during antiemetic prophylaxis with additional fosaprepitant in the acute (p<0.001) and the delayed CINV phase (p<0.001). This effect was also seen in significantly less administered dimenhydrinate doses (p<0.001) and a significantly lower percentage of patients needing additional medication with dimenhydrinate (p<0.001).ConclusionIn conclusion, additional single-dose fosaprepitant in combination with the standard antiemetic regimen with granisetron and dexamethasone proved to be safe and effective as antiemetic prophylaxis in pediatric patients receiving moderate or high emetogenic therapy. Observed drug-related side effects were similar in both study groups. Efficacy of a triple-prophylaxis with the NK1R-antagonists fosaprepitant in combination with the 5-HT3R-antagonist granisetron and the corticosteroid dexamethasone was significantly superior when compared to a prophylaxis regimen with granisetron plus dexamethasone alone.AcknowledgmentsThis study was supported by the Stefan-Morsch-Stiftung, Birkenfeld, Germany. DisclosuresHandgretinger:Miltenyi Biotec GmbH: Patents & Royalties, Research Funding.

Breast Cancer Patients’ Perceptions of Their Experience With Chemotherapy-Induced Nausea and Vomiting and Its Impact on Quality of Life in Jeddah, Saudi Arabia

BackgroundBreast cancer accounts for 11.6% of all neoplasms worldwide and is the commonest cancer among Saudi females (29.7%). Chemotherapy-induced nausea and vomiting (CINV) is a very common side effect of chemotherapy that has a great impact on the quality of life (QoL) of patients. Literature is still scarce about this effect on the Saudi population. This study aims to explore breast cancer patients’ perception of their experience with CINV and its impact on QoL.MethodsThis is a cross-sectional retrospective study conducted on Saudi adult female breast cancer patients who underwent chemotherapy at King Abdulaziz Medical City, Jeddah, Saudi Arabia. Data collected through patients’ records review, face-to-face and telephone structured interviews using a questionnaire composed of four parts: sociodemographic characteristics, nature of acute CINV (within 24 hours) and delayed CINV (after 24 hours), impact on QoL, and general information on their experience.ResultsOut of a total population of 173, 98 (56.65%) patients participated in the study. The main findings show that 78.6% experienced nausea, whereas 35.7% experienced vomiting. Most participants had a moderate-to-extreme impact on their QoL due to nausea (74.0%) and vomiting (62.9%). Overall, 57.5% rated anti-emetics as excellent for controlling CINV, whereas 22.9% rated them as moderate to good; 83.5% were completely compliant on anti-emetics and 71.1% reported that they received completely comprehensive education about CINV. Religious practices (74.4%), diet (57.7%), and relaxation techniques (44.9%) were found to be the most common non-pharmacological methods used to control CINV. No significant correlation was found between the effect of CINV on QoL and sociodemographic characteristics (p > 0.05).ConclusionsCINV is very common among Saudi adult female breast cancer patients; despite being completely compliant and receiving comprehensive education and effective anti-emetics; CINV still had a high impact on different aspects of QoL. Health care professionals should consider CINV as an issue and should find effective strategies for alleviating patients’ suffering.

Effectiveness of a novel, fixed dose combination of netupitant and palonosetron in prevention of chemotherapy induced nausea and vomiting: A real-life study from India.

BACKGROUNDA new, oral fixed dose combination of highly selective neurokinin-1 receptor antagonist, netupitant with 5HT3 receptor antagonist, netupitant and palonosetron (NEPA) was approved in India for prevention of chemotherapy induced nausea and vomiting (CINV).AIMTo assess effectiveness of NEPA in real-world scenario.METHODSWe retrospectively assessed the medical records and patient dairies of adult patients who received highly emetogenic or moderately emetogenic chemotherapy (HEC/MEC) and treated with NEPA (Netupitant 300 mg + Palanosetron 0.50 mg) for prevention of CINV. Complete response (CR) was defined as no emesis or no requirement of rescue medication in overall phase (0 to 5 d), acute phase (0-24 h) and delayed phase (2 to 5 d).RESULTSIn 403 patients included in the analysis, mean age was 56.24 ± 11.11 years and 55.09% were females. Breast cancer (25.06%) was most common malignancy encountered. HEC and MEC were administered in 54.6% and 45.4% patients respectively. CR in overall phase was 93.79% whereas it was 98.01% in acute CINV and 93.79% in delayed CINV. Overall CR in HEC and MEC groups was 93.63% and 93.98% respectively. CR was more than 90% in different chemotherapy cycles except in group of patients of cycle 4 where CR was 88.88%.CONCLUSIONNEPA is a novel combination that is effective in preventing CINV in up to 93% cases treated with highly emetogenic or moderately emetogenic chemotherapy. This study brings the first real-life evidence of its effectiveness in India population.

Adherence to ASCO for Prophylaxis of Acute Chemotherapy- Induced Nausea and Vomiting in Iran.

Introduction:Chemotherapy-induced nausea and vomiting (CINV) is one of the scariest chemotherapy-induced adverse effects. We evaluated the adherence to the 2017 American Society of Clinical Oncology (ASCO), the latest guideline recommendations, for the management of acute CINV at our institute. Methods:During a 6-months cross-sectional study on outpatient’s cancer patients, we collected data from the prescription documents during temporary hospitalization and compared the results with ASCO guideline recommendations. Results:The most prescribed prophylactic regimens for the management of CINV were combination of aprepitant, granisetron, and dexamethasone and metoclopramide (51.8%). Regarding prescription compatibility in our center with ASCO guideline recommnedations, selection of different regimens for prophylaxis of acute CINV in our institute was compliant in 0 %, 22%, 4%, and 40% of high, moderate, low, and minimal emetogenic potential of chemotherapy regimen groupss, respectively. Conclusion:Although our hospital is a referral and university-affiliated center, adherence to the ASCO guideline recommendations for prophylaxis of CINV was poor.

Music interventions for chemotherapy-induced nausea and vomiting: a systematic review and meta-analysis.

Chemotherapy-induced nausea and vomiting (CINV) is the most common and severe side effects brought by chemotherapeutics. The role of music interventions in relieving CINV is uncertain. The aim of this systematic review was to test the effects of music interventions on three categories of CINV. A systematic search was conducted in Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, EMBASE, China National Knowledge Infrastructure (CNKI), WanFang, and Chinese Biomedical Database (CBM) in order to capture randomized controlled trials (RCTs) investigating the comparative efficacy of music interventions and others. Two investigators screened, sorted, and extracted the data, and appraised the risk of bias. All statistical analyses were performed using RevMan 5.3 software. The literature search yielded 608 studies of which only ten RCTs fulfilled the eligibility criteria with 632 patients retrieved. Although the duration, the frequency of interventions, and the type of selected music varied across studies, commonly used elements included music listening. Results showed that music interventions were associated with reducing the incidence of anticipatory CINV and lowering the severity of delayed vomiting (MD = - 0.65, 95% CI = - 1.08 to - 0.23). However, strongly controversial results existed in terms of reducing the incidence of acute and delayed CINV, the severity of acute CINV, the severity of delayed nausea, and improving patients' quality of life. Music interventions may effectively reduce the incidence of anticipatory CINV and relieve the severity of delayed vomiting in patients with chemotherapy based on limited data. However, the conclusion should be interpreted with caution and further research is required to design with large-scale and rigorous methods.

Pharmacogenetics of antiemetics for chemotherapy-induced nausea and vomiting: A systematic review and meta-analysis.

A substantial proportion of cancer patients experience chemotherapy-induced nausea and vomiting (CINV) despite the use of antiemetic drugs. Prevalent genetic polymorphisms involved in antiemetic drug metabolism, drug transport and receptor pathways likely affect the effectiveness of antiemetics. Knowledge on which polymorphisms to integrate into individualised clinical care is needed. We did a systematic review evaluating the association between polymorphisms and effectiveness of antiemetics in cancer patients receiving moderately to highly emetogenic chemotherapy. Twenty studies n = 2331 evaluated eight polymorphisms in five candidate genes involved in 5-HT3 antagonist pathways. HTR3C C1214G increased the risk of acute chemotherapy-induced vomiting in the dominant model (odds ratio (OR) = 2.67, 95 % confidence interval (CI): 1.08-6.63). ABCB1 C3435T reduced the risk of acute CINV in the recessive model (OR = 0.60, 95 % CI: 0.44-0.81). Future studies should evaluate candidate genes that affect pharmacogenetics of other antiemetics beside 5-HT3 antagonists.