Pooled analysis of combination antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with colorectal cancer treated with oxaliplatin-based chemotherapy of moderate emetic risk

Background Among patients with colorectal cancer (CRC) treated with oxaliplatin (L-OHP)-based chemotherapy, delayed chemotherapy-induced nausea and vomiting (CINV) have not been well controlled. Methods We pooled data from two prospective observational studies in Japan and one phase III clinical trial to assess whether delayed CINV could be controlled with a combination of three antiemetics adding a neurokinin-1 receptor antagonist and identified individual risk factors, using an inverse probability treatment-weighted analysis. Results A total of 661 patients were evaluable in this study (median age: 64 years; 391 male, and 270 female). 3 antiemetics controlled delayed nausea (33.18% vs. 42.25%; p = 0.0510) and vomiting (4.15% vs. 16.08%; p < 0.0001) better than with 2 antiemetics. Female and 2 antiemetics were risk factors for both delayed nausea (female—odds ratio [OR]: 1.918; 95% confidence interval [CI]: 1.292–2.848; p = 0.0012; 2 antiemetics—OR: 1.485; 95% CI: 1.000–2.204; p = 0.0498) and delayed vomiting (female—OR: 2.735; 95% CI: 1.410–5.304; p = 0.0029; 2 antiemetics—OR: 4.551; 95% CI: 2.116–9.785; p = 0.0001). Conclusions Identifying individual risk factors can facilitate personalized treatments for delayed CINV. We recommend a 3-antiemetic combination prophylaxis for CRC patients treated with L-OHP-based chemotherapy, especially for female patients.

Efficacy of Auricular Acupressure in Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting in Patients with Cancer: A Systematic Review and Meta-Analysis

Background. More than 40% of patients with cancer have reported that chemotherapy-induced nausea and vomiting (CINV) remained the most debilitating side effects of treatment even in the era of new antiemetics. Objective. The purpose of this review was to systematically evaluate the clinical effect of auricular acupressure (AA) in prevention and treatment of chemotherapy-induced nausea and vomiting. Methods. The following databases were searched: PubMed, Cochrane Library, EMBASE, the Web of Science, Chinese Biological Medicine (CBM), Chinese National Knowledge Infrastructure (CNKI), Wanfang, and VIP (from database inception to April 2020). Eligible randomized controlled trials of auricular acupressure in treating CINV were collected, including crossover randomized design study. The meta-analysis was carried out by RevMan software (5.3). Results. Totally 19 RCTs with 1449 patients met the inclusion criteria. Compared with control groups, the relief efficiency of overall CINV was enhanced by AA combined with antiemetics (RR = 1.31, CI 1.22 to 1.41, p ≤ 0.001). Although the therapeutic effect on acute nausea and vomiting was not obvious, AA still played an important role in reducing delayed nausea and vomiting (delayed nausea frequency: RR = 0.68, CI −1.01 to −1.35, p ≤ 0.001; delayed vomiting frequency: RR = 0.91, CI −1.22 to −0.61, p ≤ 0.001). The likelihood of adverse reactions related to antiemetics was reduced by AA combined with antiemetics (RR = 0.62, CI 0.53 to 0.74, p ≤ 0.001). Statistically significant association was found between AA and incidence of constipation, diarrhea, and tiredness, while there was no statistically significant association between AA and abdominal distension or headache. Conclusion. Auricular acupressure supplementation benefited delayed chemotherapy-induced nausea and vomiting as well as constipation, diarrhea, and tiredness. AA alone or AA supplementation has little effect on acute nausea and acute vomiting. There is no conclusion on whether AA alone is superior to antiemetics in the management of delayed CINV. Further studies are needed to confirm the efficacy of auricular acupressure alone in delayed CINV and anticipatory CINV. The results of this review provided the basis for further research with more rigorous study designs, adequate sample sizes, and standardized implementation to confirm the efficacy of auricular acupressure.

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.

Chemotherapy-Induced Nausea and Vomiting Breast Cancer Patients from a Chinese Multicenter Prospective Longitudinal Observational Study

Aims: To assess the occurrence of Chemotherapy-induced nausea and vomiting (CINV) after standard antiemetic therapy in the acute (24 h post-chemotherapy) and delayed (2&ndash;5 days post-chemotherapy) phases, as well as to identify risk factors for CINV in the acute and delayed phases. Methods: This prospective longitudinal and observational study analyzed the data of 400 breast cancer patients scheduled for chemotherapy over two cycles in two hospitals. The self-report survey was developed to assess the occurrence of CINV and their associated factors. CINV was evaluated with a Multinational Association of Supportive Care in Cancer Antiemetic Tool (MAT) on days 2 and 6 of chemotherapy. The incidence of acute and delayed CINV were presented by frequency and percentage. Generalized equation estimates (GEE) was used to identify risk factors of acute and delayed CINV. Results: There were 400 evaluable patients with complete Round 1 data, 334 for Round 2 data. Among 400 patients, 29.8% and 23.5% experienced acute and delayed CINV, respectively. Risk factors associated with for acute CINV were pain/insomnia, history of CINV, history of motion sickness (MS), and highly emetogenic chemotherapy regimen, while history of MS, CINV history, number of completed chemotherapy cycle number &lt; 3, and the incidence of acute CINV were risk factors of delayed CINV (all p &lt; 0.05). Conclusions: The findings may help nurses working for Chinese population in identifying patients at risk for CINV and in planning effective program to reduce the occurrence of CINV.

A cross-sectional study on effectiveness of antiemetic regimens for chemotherapy-induced nausea and vomiting: A single-center retrospect study of 1,000 patients.

e24100 Background: Chemotherapy-induced nausea and vomiting (CINV) is a common symptom in patients who undergoing chemotherapy, it is very important to control CINV to maintain dose intensity and patients' quality of life. To analyse the current situation of CINV for the tumor patients who undergoing chemotherapy, we used a cross-sectional survey to assess CINV status in those patients, and whether the drugs used by doctors in each department met the guidelines, and compared the efficacy of different antiemetic regimens on acute and delayed CINV overall post-chemotherapy periods. Methods: 1,000 patients were randomly selected from 5,468 patients with chemotherapy discharged from different departments of Zhejiang cancer hospital in China between April 1 and April 30, 2019, and there were 87 responses totally. Medical records were collected on patient’s department (internal medicine, surgery, radiotherapy, interventional), chemotherapy regimens, anti-vomiting program, etc. Patients' feedbacks were recorded by CTCAE4.03 standard using MASCC antiemetic tool (Mat). Participants reported the frequency, severity, and impact on daily life of CINV from the day of chemotherapy administration up to 5 days thereafter and nausea and vomiting, as well as pharmacologic and chemotherapy used. Results: A total of 66 antineoplastic drugs were investigated, of which 52 were given intravenously and 14 orally.There were 9, 7, 50 drugs with high, moderate and low emetic risk respectively.The most prescribed prophylactic regimens for the management of CINV were aprepitant, 5-HT3R, H1-RA and dexamethasone and metoclopramide. The overall incidence of CINV were 44.34%, 24.57% and 39.66% patients reported nausea or vomiting in the acute and delayed phases. 19.89% patients had both acute and delayed CINV. The consistency rate of antiemetic with guideline was 63.19% in internal medicine department, 61.41% in surgery department and 52.91% in radiotherapy department, which showed a significant gap between the actual use of drugs and the recommended guidelines(P = 0.001). In 875 patients, 518 patients received guideline recommended antiemetic regimen, the CINV rates of complete response (CR), defined as no vomiting with no rescue medication, were 61.58%. While the CR rates in other 357 patients were 47.06%(P < 0.001). Nausea was more frequent across the overall observation period (43.77% VS 18.86%). However, vomiting was more sever and had a greater impact on life than nausea. Conclusions: Overall, adherence to the guideline recommendations in different departments were poor with varying degrees. Future studies should set hard outcomes, such as the absence of any symptoms, as a primary end point. The standardized management of CINV in patients need to be further strengthened and doctors need to use drugs more regularly to reduce the occurrence of CINV in patients.

A cross-sectional study on the effectiveness of antiemetic regimens for chemotherapy-induced nausea and vomiting: A single center retrospect study of 1,000 patients.

e24055 Background: Chemotherapy-induced nausea and vomiting (CINV) is a common symptom in patients who undergoing chemotherapy, it is very important to control CINV to maintain dose intensity and patients' quality of life. To analyse the current situation of CINV for the tumor patients who undergoing chemotherapy, we used a cross-sectional survey to assess CINV status in those patients, and whether the drugs used by doctors in each department met the guidelines, and compared the efficacy of different antiemetic regimens on acute and delayed CINV overall post-chemotherapy periods. Methods: 1,000 patients were randomly selected from 5,468 patients with chemotherapy discharged from different departments of Zhejiang cancer hospital in China between April 1 and April 30, 2019, and there were 87 responses totally. Medical records were collected on patient’s department (internal medicine, surgery, radiotherapy, interventional) , chemotherapy regimens, anti-vomiting program, etc. Patients' feedbacks were recorded by CTCAE4.03 standard using MASCC antiemetic tool (Mat). Participants reported the frequency, severity, and impact on daily life of CINV from the day of chemotherapy administration up to 5 days thereafter and nausea and vomiting, as well as pharmacologic and chemotherapy used. Results: A total of 66 antineoplastic drugs were investigated, of which 52 were given intravenously and 14 orally.There were 9, 7, 50 drugs with high, moderate and low emetic risk respectively.The most prescribed prophylactic regimens for the management of CINV were aprepitant, 5-HT3R, H1-RA and dexamethasone and metoclopramide. The overall incidence of CINV were 44.34%, 24.57% and 39.66% patients reported nausea or vomiting in the acute and delayed phases. 19.89% patients had both acute and delayed CINV. The consistency rate of antiemetic with guideline was 63.19% in internal medicine department, 61.41% in surgery department and 52.91% in radiotherapy department, which showed a significant gap between the actual use of drugs and the recommended guidelines(P = 0.001). In 875 patients, 518 patients received guideline recommended antiemetic regimen, the CINV rates of complete response (CR), defined as no vomiting with no rescue medication, were 61.58%. While the CR rates in other 357 patients were 47.06%(P < 0.001). Nausea was more frequent across the overall observation period(43.77% VS 18.86%). However, vomiting was more sever and had a greater impact on life than nausea. Conclusions: Overall, adherence to the guideline recommendations in different departments were poor with varying degrees. Future studies should set hard outcomes, such as the absence of any symptoms, as a primary end point.The standardized management of CINV in patients needs to be further strengthened and doctors need to use drugs more regularly to reduce the occurrence of CINV in patients.

A cross-sectional study on the guideline adherence to antiemetic regimens for chemotherapy-induced nausea and vomiting: A single center retrospective study of 1000 patients.

Background Chemotherapy-induced nausea and vomiting (CINV) is a common symptom in patients who undergoing chemotherapy, it is very important to control CINV to maintain dose intensity and patients' quality of life. To analyze the current situation of CINV for the tumor patients who undergoing chemotherapy, we used a cross-sectional survey to assess CINV status in those patients, and whether the drugs used by doctors in each department met the guidelines, and compared the incidence of acute and delayed CINV overall post-chemotherapy periods. Methods This was a single-center, cross-sectional retrospective study of patients with chemotherapy discharged from different departments of Zhejiang Cancer Hospital in China. Participants reported the occurrence, severity, and impact on daily life of nausea and vomiting from the day of chemotherapy administration up to 5 days, and physicians collected the clinical data from the medical records. Results Data were collected from 875 responses totally. In this study, the overall incidence rate of CINV was 44.34%, acute CINV was 24.57%, and delayed CINV was 39.66%. 19.89% patients had both acute and delayed CINV. The consistency rates of antiemetic with guideline in different departments showed significant gap between the actual usage of drugs and the recommended guidelines (P=0.001). In 875 patients, 518 patients received guideline recommended antiemetic regimen, the CINV rates of complete control (CC), defined as the absence of any symptoms, were 61.58%. While the CC rates in other 357 patients were 47.06%(P<0.001). Conclusion Overall, clinician adherence to antiemetic guideline recommendations in different departments remained poorly characterized with varying degrees. Future studies should focus on the complete rate as a primary end point rather than complete remission. The standardized management of CINV in patients need to be further strengthened and doctors need to use drugs more regularly to reduce the occurrence of CINV in patients.

NEPA as antiemetic prophylaxis after failure of 5HT3-RA plus dexamethasone in patients receiving carboplatin and gemcitabine chemotherapy: A monocentric real-life experience

Introduction Chemotherapy-induced nausea and vomiting (CINV) may affect adherence to planned chemotherapy treatments and compromise patients’ quality of life during the therapy. NEPA is an oral fixed combination of netupitant, a highly-selective NK1-RA and palonosetron, a 5HT3-RA, approved for the prevention of acute and delayed CINV. The aim of this study was to evaluate the efficacy and safety of NEPA with dexamethasone for CINV prophylaxis in the challenging setting of carboplatin and gemcitabine combination chemotherapy, after failure of prophylaxis with 5HT3 receptor antagonist. Methods Eligible patients were undergoing carboplatin and gemcitabine combination chemotherapy for metastatic non-small cell lung cancer (NSCLC), ovarian cancer or urothelial cancer and experienced nausea and/or vomiting after the first cycle of chemotherapy, despite an antiemetic prophylaxis with a 5HT3-RA and dexamethasone. Primary efficacy endpoint was complete response (CR: no emesis, no rescue medication) obtained with NEPA, during the overall phase (0–120 h), after the start of chemotherapy. Results During the first cycle of chemotherapy, 15 out of 30 (50%) patients did not properly control CINV with a 5HT3-RA plus dexamethasone used as primary antiemetic prophylaxis and then were switched to NEPA from the subsequent cycle. During NEPA administration, 13 out of 15 patients (86.7%) achieved an overall CR (no emesis, no rescue medication). Antiemetic treatment with NEPA was very well tolerated with only two patients (13.3%) that experienced a grade 1 TEAE. Conclusions Our experience showed that NEPA has proven to be very effective and well tolerated in the prophylaxis of CINV induced by carboplatin-based chemotherapy.

A prospective analysis of chemotherapy-induced nausea and vomiting in gastrointestinal cancers: Results from a tertiary cancer center.

12111 Background: Chemotherapy-induced nausea and vomiting (CINV) is a bothersome side-effect associated with cancer chemotherapy which adversely impacts both quality of life and the ability to carry out the activities of daily living. This study was conducted to assess the proportion of patients developing CINV after receiving chemotherapy for gastrointestinal (GI) cancers, in spite of receiving antiemetic prophylaxis as per the standard guidelines. Methods: Consecutive patients with GI malignancy who had not received previous chemotherapy were eligible for enrollment in the study if they were scheduled to receive at least one cycle of chemotherapy. SPSS version 20 was used for all statistical calculations. Results: 701 patients fulfilling the eligibility criteria were included in this study, out of which 55.4% were males, median age was 51 years (range 22-77). Biliary tract cancer (34%) was the most common diagnosis followed by colorectal (30.2%) and gastric cancer (19.6%). As per MASCC guidelines, 22.1% patients received highly emetogenic chemotherapy, 56.0% moderately emetogenic chemotherapy (MEC) while 19.9% received regimen with low emetogenicity. Failure to achieve complete response (CR, absence of acute and delayed CINV) was found in 27.4% patients. On separately analysing MEC group, overall CR was not achieved in 33.8% with failure in acute settings in 17.8% and delayed in 16.0% patients. Only significant factor for not achieving CR was use of oxaliplatin based chemotherapy (p = 0.018 for acute and p = 0.014 for delayed CINV). Conclusions: More than one fourth patients failed to achieve complete response for CINV in gastrointestinal cancers despite using prophylaxis as per standard guidelines. Use of oxaliplatin based therapy is an important factor for MEC causing CINV. There is urgent need to update the guidelines for prophylaxis in this setting. [Table: see text]

Olanzapine for the Prevention and Treatment of Nausea and Vomiting Induced by Chemotherapy for Lung Cancer: protocol for a multicenter, double-blind and randomized controlled trial

BackgroundChemotherapy-induced nausea and vomiting (CINV) is frequently observed after the administration of chemotherapy and significantly influences the quality of life (QoL) of patients. Olanzapine has a high control rate of CINV in patients with cancer when combined with the NK-1 receptor antagonist dexamethasone and 5-hydroxytryptamine (5-HT3) receptor antagonists. The efficacy of a regimen without an NK-1 receptor antagonist remains unknown. Therefore, we designed this randomized trial to provide evidence for the management of CINV.Methods and ananlysisThis is a double-blind, multicenter and randomized controlled trial. Patients with histologically confirmed lung cancer will be assessed by physicians based on the inclusion and exclusion criteria, and 156 participants will be enrolled and randomized to a placebo group or experiment group to receive treatment for CINV. The primary endpoint is the incidence of delayed CINV. The secondary endpoints are complete response (CR) of acute CINV, CR of delayed CINV, effective control rate (ECR) of CINV and QoL. During the six days after administration, these endpoints will be evaluated and recorded by physicians.Ethic and disseminationThis study has received approval from the institutional ethical review board of the Affiliated Hospital of Zunyi Medical University (ref approval No. 58). Written informed consent will be signed by all participants prior to enrolling. Participants will be randomly assigned to the experimental group or comparator group by blocked randomization.Article summaryStrengths and limitationsThis study will provide evidence for physicians to find an affordable and effective treatment regimen for CINV through this study.Because of the variety of pharmaceutical companies, medical care and other factors, problem of cost will be further explored in the following studies.Although the study is designed as a double-blind randomized controlled trial, QoL will be measured by a questionnaire that is filled out by patients themselves. This may influence the conclusions.