Cost-effectiveness analysis of aprepitant in the prevention of chemotherapy-induced nausea and vomiting in Belgium

OBJECTIVES: Chemotherapy-induced nausea and vomiting (CINV) remains a major adverse effect of cancer chemotherapy which may increase morbidity, reduce quality of life and threaten the success of cancer therapy. Aprepitant is effective in preventing CINV, achieving higher complete response (no emesis and no rescue therapy) compared to standard prevention, in patients receiving either highly (HEC) or moderately emetogenic chemotherapy (MEC; absolute reduction = 11 and 13%, respectively). We assessed the cost effectiveness of aprepitant-based vs standard prevention in these indications in Belgium. MATERIALS AND METHODS: A decision analytical model was developed in MS Excel (Fig. 1). To estimate resource use, two approaches were used. The first is based on the preventive regimens applied in randomized controlled trials comparing aprepitant-based CINV prevention (for HEC: aprepitant days 1-3, ondansetron 32 mg i.v. day 1, oral placebo twice daily days 2-4, oral dexamethasone days 1-4; for MEC: aprepitant days 1-3, ondansetron 16 mg p.o. day 1, placebo on days 2-3, oral dexamethasone day 1), vs a standard regimen (for HEC: oral placebo days 1-3, ondansetron 32 mg i.v. day 1 and 16 mg p.o. days 2-4, oral dexamethasone days 1-4; for MEC: oral placebo, ondansetron 16 mg p.o. days 1-3, dexamethasone day 1) The second analysis is based on current real-world resource use in the Belgian setting in the prevention of CINV using a longitudinal Hospital Database. CINV-specific utility values were used to calculate quality-adjusted life years (QALYs). Drug costs were obtained from official reimbursement listings. Treatment costs for CINV were obtained from a German study and adapted to Belgium. RESULTS: The aprepitant-based regimen is associated with 0.003 and 0.014 more QALYs in HEC and MEC, respectively and with per patient savings of 66.84 (trial based) and 74.62 (real-life based) for HEC and 17.95 (trial based) and 21.70 (real-life based) for MEC. Hence, aprepitant is both more effective and less expensive (=dominant). One-way sensitivity analyses were performed on treatment cost of emesis, the clinical benefit of aprepitant and the cost of ondansetron and showed that the results were robust on the first two parameters but sensitive on the decrease in cost of ondansetron for the moderately emetogenic chemotherapy regimens. CONCLUSIONS: In both approaches, the aprepitant-based strategy is more effective and less expensive compared to standard care.     

Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting

Goals of work  Ginger has been used to treat numerous types of nausea and vomiting. Ginger has also been studied for its efficacy for acute chemotherapy-induced nausea and vomiting (CINV). However, its efficacy for delayed CINV in a diverse oncology population is unknown. Materials and methods  We performed a randomized, double-blind, placebo-controlled trial in 162 patients with cancer who were receiving chemotherapy and had experienced CINV during at least one previous round of chemotherapy. All participants were receiving a 5-HT₃ receptor antagonists and/or aprepitant. Participants were randomized to receive either 1.0 g ginger, 2.0 g ginger daily, or matching placebo for 3 days. The primary outcome was change in the prevalence of delayed CINV. Secondary outcomes included acute prevalence of CINV, acute and delayed severity of CINV, and assessment of blinding. Main results  There were no differences between groups in the prevalence of delayed nausea or vomiting, prevalence of acute CINV, or severity of delayed vomiting or acute nausea and vomiting. Participants who took both ginger and aprepitant had more severe acute nausea than participants who took only aprepitant. Participants were able to accurately guess which treatment they had received. Ginger appeared well tolerated, with no difference in all adverse events (AEs) and significantly less fatigue and miscellaneous AEs in the ginger group. Conclusions  Ginger provides no additional benefit for reduction of the prevalence or severity of acute or delayed CINV when given with 5-HT₃ receptor antagonists and/or aprepitant. This trial is registered in ClinicalTrials.gov ID: NCT00065221.     

Rationale for the use of a single fixed intravenous dolasetron dose for the prevention of cisplatin-induced nausea and vomiting

Dolasetron mesilate is a selective 5-HT₃ receptor antagonist that prevents chemotherapy-induced and postoperative nausea and vomiting. For the majority of patients in intravenous dolasetron trials for chemotherapy-induced nausea and vomiting, dosing has been based on body weight (mg/kg). The approved weight-based dose is 1.8 mg/kg based on results of controlled clinical trials. However, trials of dolasetron evaluating oral doses for prevention of chemotherapy-induced emesis, and intravenous doses for prevention and treatment of postoperative emesis have used a fixed milligram dose. To identify an appropriate intravenous fixed milligram dose for the prevention of chemotherapy-induced nausea and vomiting, this analysis was performed to derive efficacy results for fixed milligram doses from pooled results obtained with dosing based on body weight. Intravenous dolasetron doses for 1,598 patients treated on a mg/kg basis (0.3, 0.6, 1.2, 1.8, 2.4, 3.0 and 5.0 mg/kg) in 14 clinical trials were converted to fixed milligram doses based on weight. Fixed-dose groups were established at doses of 50, 75, 100, 125, 150, and 200 mg. Doses less than or equal to the midpoint between two dose groups were included in the lower dose group. Pooled results showed that the 100 mg intravenous dolasetron dose group (who received actual doses of 88–112 mg) produced the highest rate (53%) of complete response (0 emetic episodes and no rescue medication in the 24-h period following initiation of chemotherapy).     

The cost of chemotherapy-induced nausea and vomiting in Italy

Goals of work The aim of this paper is to analyze the costs of chemotherapy-induced nausea and vomiting (CINV) in Italy. Materials and methods In this prospective observational study at seven public oncology centers, incidence and intensity of CINV daily for 8 days after chemotherapy in consecutive patients receiving cisplatin-containing chemotherapy were recorded. All costs related to CINV (direct medical, direct nonmedical, and indirect) were recorded (in 2003 euros). Main results A total of 172 patients were enrolled; cost data were available for 168 patients. Thirty-seven percent of patients experienced acute CINV, and 57% experienced delayed CINV; 39% achieved total control, defined as no nausea, vomiting, or rescue therapy. Mean per-patient costs of acute and delayed CINV were €30.03 from the hospital perspective, €4.9 from the patient perspective, and €26.85 from the National Health Service (NHS) perspective. Costs of CINV were highly variable among oncology centers, largely because of differences in procedures for preventing delayed CINV. These costs were four times higher when antiemetic drugs were prescribed and paid for by the NHS than when antiemetic prophylaxis was provided directly from hospital pharmacies. Moreover, in the delayed phase, the NHS incurred a 94% increase in costs for patients without total control. Overall costs for patients who did not experience total control of CINV were €35.57 higher than for those who did (85% increase). Conclusions Costs of CINV for the Italian NHS could be reduced if hospitals furnished antiemetic prophylaxis directly to patients. Better control of both acute and delayed CINV would improve patient well-being as well as reduce the budgetary impact of CINV in Italy.     

化疗相关性恶心呕吐的评估和管理的循证实践

目的评估目前与化疗相关性恶心、呕吐的评估和管理相关的循证证据,将与化疗相关性恶心、呕吐的评估和管理相关的最佳证据应用到护理实践中,通过质量审查促进临床护理质量的改进。方法 2015年6-7月,在查询澳大利亚乔安娜·布里格斯研究中心(Joanna Briggs Institute,JBI)在线临床治疗及护理证据网络(COnNECT+)数据库中有关化疗相关性恶心、呕吐的最佳证据推荐后,根据证据制订5条审查标准,对我市某三级医院的化疗科病区30名化疗患者进行了证据应用前的基线审查,分析了证据应用存在的障碍、可获得的资源及解决办法,制订了相应的循证实践方案,并将现有的最佳证据整合到护理实践中,于2015年8-9月,对该病区的另30名化疗患者实施干预并执行干预后的第2轮审查,比较两组审查结果。结果在基线审查中,5条审查标准的依从性为0~43%,将最佳证据引入到护理实践后,第2轮审查中,5条审查标准的依从性达到了80%~100%;护士和患者对化疗知识的掌握得到了提升。结论本次最佳证据应用改进了化疗相关性恶心、呕吐的评估和管理的护理实践,提高了护理质量。     

化疗后恶心呕吐防治的研究进展

文章指出了现代医学对恶心呕吐的认识及化疗后恶心呕吐的发生机制,并从药物、葡萄汁、音乐疗法及肌肉放松疗法、芳香疗法、耳穴压豆、针灸、穴位按摩、中药汤剂等方面对国内外化疗后恶心呕吐的研究进展进行综述,以期对临床的防治工作提供实证依据。     

Patient-controlled antiemesis for cancer chemotherapy-induced nausea and vomiting

Nausea and emesis during cancer chemotherapy are very common, but can often be controlled with repetitive boli of antiemetic drugs. However, some patients, especially those with anticipatory symptoms, experience nausea and emesis despite antiemetic prophylaxis. An increased participation of these patients in the prophylaxis and treatment of these highly subjective symptoms may lead to better palliation. A patient controlled infusion pump was assessed in nine patients receiving cisplatin, in whom high-dose metoclopramide (5 mg/kg) had failed (>3 emetic episodes) during previous treatment cycles. Improved palliation was achieved in every case with on-demand boli in combination with a continuous infusion of metoclopramide or droperidol. Eight of the nine patients preferred the patient-controlled system to the conventional fixed-dose bolus regimens. The infusion pump functioned safely and reliably. Antiemetic treatment with the patient-controlled device was superior to previous conventional methods in this group of diffcult-to-treat patients.     

Diphenhydramine for nausea and vomiting related to cancer chemotherapy with cisplatin

High dose metoclopramide and adjuvant drugs, such as corticosteroids, benzodiazepines, and drugs with antidopaminergic, anticholinergic, or antihistaminic effects, are the most widely used antiemetics in cancer patients receiving chemotherapy, particularly cisdichloro-diammine platinum II (cisplatin). The purpose of our prospective randomized study was to investigate the possible antiemetic efficacy of diphenhydramine as an adjuvant antiemetic drug when combined with metoclopramide (MCP). A total of 91 patients were assigned to either group A (N = 44) who received only MCP and group B (N = 47) who received the combination of MCP and diphenhydramine. All patients received cisplatin-based combination chemotherapy for the first time and were evaluated only once in order to exclude the effects of anticipatory nausea and vomiting. There were no statistically significant differences between the two groups except that patients treated with diphenhydramine presented more sedative effects and had more limited activity. Also diphenhydramine did not give absolute protection from the extrapyromidal side effects of MCP. Side effects of diphenhydramine were minimal and well tolerated. We conclude that diphenhydramine is not a useful adjuvant drug in the antiemetic therapy.     

一种化疗所致恶心呕吐的防护尺装置制作与临床应用

目的 探讨一种化疗所致恶心呕吐的防护尺装置的制作与应用效果。方法选择2020年1月-2021年6月在复旦大学附属中山医院肿瘤内科化疗患者150例为研究对象,采用随机数字表将患者随机分为观察组和对照组各75例。对照组和观察组入院时均进行营养评定量表(PG-SGA)评分,两组患者存在营养不良差异无统计学意义（P＞0.05）,针对PG-SGA评分≥4分的患者均给予营养干预。对照组给予我院化疗所致恶心呕吐护理常规,观察组教会患者使用防护尺装置进行CINV评估记录,并选择芳香物质气味卡来缓解恶心呕吐症状。评价两组患者恶心呕吐的发生率,两组方法的操作简单、取用便捷、是否缓解症状、可接受度及便于保存。结果 化疗前观察组的恶心发生率高于对照组,化疗后观察组的恶心、呕吐发生率明显低于对照组,差异存在统计学意义（P＜0.05）;化疗后观察组的呕吐发生率及I级、II级、III级的发生比例明显低于对照组,差异存在统计学意义（P＜0.05）;防护尺装置在操作简单、取用便捷、缓解症状、可接受度及便于保存方面比较差异均有统计学意义（P＜0.05）。结论 一种化疗所致恶心呕吐的防护尺装置结构简单,增加患者使用时的便捷性,帮助患者缓解不适症状,且易于接受和保存。     

渐进式肌肉放松训练对乳腺癌高致吐方案化疗所致恶心呕吐的效果观察

目的 探讨渐进式肌肉放松训练对乳腺癌高致吐方案化疗所致恶心呕吐(CINV)的治疗效果。方法 收集我院2017年1月-2017年6月行表阿霉素联合环磷酰胺(EC)方案化疗的乳腺癌患者68例,按照随机数字表法分为观察组和对照组,每组各34例。对照组给予托烷司琼注射液、地塞米松治疗;观察组在此基础上进行渐进式肌肉放松训练,比较两组对预防CINV的临床疗效。结果 急性期两组恶心、呕吐发生率、恶心缓解率及呕吐频次比较,差异均无统计学意义(P>0.05);延迟期两组恶心发生率比较,差异无统计学意义(P>0.05),观察组呕吐发生率、呕吐频次明显低于对照组,恶心缓解率明显高于对照组,差异有统计学意义(P<0.05)。结论 渐进式肌肉放松训练能显著降低乳腺癌高致吐方案化疗延迟期呕吐发生率、呕吐频次和恶心程度,简便易行,可用于临床防治乳腺癌高致吐方案化疗所致CINV。     

护理干预对控制癌症化疗患者恶心和呕吐的作用

目的探讨护理干预对控制癌症化疗患者恶心、呕吐的作用。方法将2008年6月-2009年1月收治的206例接受化疗癌症患者随机分为干预组（103例）和对照组（103例）,化疗前后均给予患者盐酸格拉司琼止吐。干预组在化疗前、化疗中、化疗后对患者进行护理干预,对照组只进行一般护理。结果干预组患者0级、Ⅰ级、Ⅱ级恶心、呕吐发生率明显低于对照组,两组比较,差异具有统计学意义（P〈0．05）;干预组对护理干预效果满意度明显优于对照组,两组比较,差异具有统计学意义（P〈0．05）。结论护理干预可降低化疗患者恶心、呕吐发生率,确保化疗顺利完成,减轻了患者的痛苦,提高了患者对护理服务的满意度。     

Palonosetron plus 3-day aprepitant and dexamethasone to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy

Background

The combination of a neurokinin-1 receptor antagonist, dexamethasone, and a 5-HT₃ receptor antagonist is currently the standard antiemetic treatment in patients receiving cisplatin-based high emetogenic chemotherapy (HEC). The aim of this study was to evaluate the efficacy of a combination of palonosetron, a unique second-generation 5-HT₃ receptor antagonist, aprepitant, the only approved neurokinin-1 receptor antagonist, and dexamethasone as antiemetic prophylaxis in patients receiving HEC (cisplatin ??50?mg/mq).

Methods

Chemotherapy-na?ve adult patients, receiving cisplatin-based HEC, were treated with palonosetron 0.25?mg/i.v., dexamethasone 20?mg/i.v., and aprepitant 125?mg/p.o., 1-h before chemotherapy. Aprepitant 80?mg/p.o. and dexamethasone 4?mg p.o. were administered on days 2?C3. Primary end point was complete response (CR; no vomiting and no use of rescue medication), during the overall study period (0?C120?h). Secondary end points were complete control (CR and no more than mild nausea), emesis-free rate, and nausea-free rate during the acute (0?C24?h), delayed (24?C120?h), and overall (0-120?h) periods. Safety was also evaluated.

Results

A total of 222 patients were included in the study. Median age was 62?years, 76.6% were male and 23.4% female, and most common tumors were lung (66.7%) and head and neck (15.8%); 70.3% of patients achieved CR during the overall study period. Complete control, emesis-free rate, and nausea-free rate were 70.3%, 92.8%, and 59.9%, respectively, during the overall phase. The most commonly reported side effects were constipation (39% of patients) and headache (5%).

Conclusions

This study shows that palonosetron in combination with aprepitant and dexamethasone is effective to prevent chemotherapy-induced nausea and vomiting in patients treated with cisplatin-based HEC.     

Acupuncture and acupressure for the management of chemotherapy-induced nausea and vomiting

PURPOSE: To review existing research, the National Institutes of Health (NIH) consensus statement, and federal regulations regarding the use of acupuncture and acupressure in the management of chemotherapy-induced nausea and vomiting in order to give nurse practitioners (NPs) the information they need to provide the best care for patients undergoing chemotherapy treatment for cancer. DATA SOURCES: Selected scientific literature and Internet sources. CONCLUSIONS: Research supports the effectiveness of acupuncture and acupressure for the treatment of chemotherapy-induced nausea and vomiting. Used in conjunction with current antiemetic drugs, acupuncture and acupressure have been shown to be safe and effective for relief of the nausea and vomiting resulting from chemotherapy. IMPLICATIONS FOR PRACTICE: Even with the best antiemetic pharmacological agents, 60% of cancer patients continue to experience nausea and vomiting when undergoing chemotherapy treatments. Because the NIH supports the use of acupuncture for nausea and vomiting, the NP is obligated to be knowledgeable about the use of these and other effective complementary treatments in order to provide the best care.     

Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving allogeneic hematopoietic stem cell transplantation

Purpose

The primary aim of this study was to evaluate the efficacy of palonosetron combined with dexamethasone in the prevention of vomiting, and especially nausea, in patients receiving allogeneic stem cell transplantation.

Methods

Palonosetron 0.25 mg was given to 27 patients receiving allogeneic transplantation on the first day of conditioning, and then every other day during the entire conditioning period. Dexamethasone was given daily also during conditioning. Vomiting and nausea were recorded daily according to CTCAE version 4.0 from the start of conditioning to Day 7 after transplantation. In addition, MASCC antiemetic tool (MAT) was also used in parallel to evaluate the intensity of nausea.

Results

The treatment was well tolerated; 25.9 and 40.7 % of the patients had grade 2/3 vomiting and nausea respectively during conditioning. The incidences of grade 2/3 vomiting and nausea were even higher in the first week after transplantation (40.7 and 51.8 %, respectively). The score of MAT correlated well with the grade of CTCAE. However, the difference in the mean intensity of nausea between period of conditioning and the first week after HSCT was significant only by using MAT (0.96?±?1.829 vs. 3.81?±?3.386, p?=?0.001) but not CTCAE (1.26?±?0.903 vs. 1.63?±?0.967, p?=?0.152).

Conclusion

Palonosetron combined with dexamethasone is effective in preventing vomiting during conditioning. However, more effort should be made to alleviate nausea during conditioning and both nausea and vomiting in the first week after transplantation. Furthermore, MAT has a higher discriminant power than CTCAE in assessing the intensity of nausea in patients receiving allogeneic transplantation.     

The impact of chemotherapy-induced nausea and vomiting on health-related quality of life

Goal of work The objectives of this prospective observational study were to estimate the frequency of patients who reported an impact of chemotherapy-induced nausea and vomiting (CINV) on their daily life and to evaluate the determinants of such an impact. Materials and methods Adult cancer patients at seven Italian oncology centers who were receiving cisplatin-containing regimens reported incidence and intensity of CINV for eight consecutive days in a diary and completed a Functional Living Index for Emesis (FLIE) questionnaire. Main results Overall, 34% of patients reported vomiting and 62% reported nausea after chemotherapy. On days 1 to 5 after receiving chemotherapy, 67% of patients who had at least one emetic episode and 77% of those who suffered from at least mild nausea experienced an impact on their daily activities as measured on the FLIE questionnaire. More than 90% of all patients with both acute and delayed nausea or vomiting reported an impact on their daily life. Both acute and delayed vomiting contributed in similar measure to impact daily life; however, the importance of delayed nausea was greater than that of acute nausea. Conclusions Despite antiemetic prophylaxis, CINV is still prevalent and often impacts the daily life of patients in Italy, especially in the delayed phase. The duration more than the severity seems to be responsible for the impact of CINV on the patients’ daily lives.     

化疗病人恶心呕吐的护理

从恶心呕吐的定义、恶心呕吐对机体的影响、引起恶心呕吐的相关因素等方面综述了化疗病人的护理,目的在于提高化疗病人的生活质量。     

化疗病人恶心呕吐的护理

从恶心呕吐的定义、恶心呕吐对机体的影响、引起恶心呕吐的相关因素等方面综述了化疗病人的护理．目的在于提高化疗病人的生活质量。     

肿瘤患者化疗所致恶心呕吐的护理干预

目的探讨护理干预对血液科肿瘤患者化疗所致恶心、呕吐(CINV)的影响。方法将107例接受化疗方案的血液科肿瘤患者随机分为干预组54例与对照组53例,2组均接受常规护理,干预组另加心理干预、行为干预、饮食干预。结果干预组患者的预期性、急性、延迟性CINV的发生率均较对照组明显降低,程度较对照组明显减轻(P<0.05)。结论护理干预在减少血液科肿瘤患者的CINV中起积极作用,通过心理干预、行为干预、饮食干预,可使患者恶心、呕吐的发生率明显降低,程度减轻。     

Aprepitant in antiemetic combinations to prevent chemotherapy-induced nausea and vomiting

Aprepitant is an oral neurokinin-1 receptor antagonist which acts centrally to block chemotherapy-induced emesis. Its main pathway of elimination is by the cytochrome p450 isozyme CYP3A4, which is the basis for drug interactions with dexamethasone and oral contraceptives. Aprepitant is well tolerated, and phase II trials in high-dose cisplatin-induced emesis showed that it is most effective when 125 mg orally is added to a 5-hydroxytryptamine-3 receptor antagonist and dexamethasone for acute emesis and then an 80 mg oral dose continued with dexamethasone on days 2 and 3 to prevent delayed emesis. Two pivotal phase III trials enrolling a total of 1099 patients showed that the complete control of emesis improved by 20% in patients receiving aprepitant as compared with standard therapy, with the most impressive differences being in delayed emesis. Control was maintained over multiple cycles and occurred in both males and females and young and old adults.     

营养状况对肺癌化疗患者所致恶心呕吐的影响

目的 探讨营养状况对以顺铂为基础化疗的肺癌患者所致化疗相关性恶心呕吐（CINV）的影响。方法 选取常州市第一人民医院采用顺铂化疗的肺癌住院患者200例,均选用昂丹司琼作为止吐药物,根据营养评定量表（PG SGA）评分分为营养不良组,无营养不良组,分析两组临床资料、营养相关指标、CINV。对存在营养不良的患者进行营养干预,比较营养干预前后CINV持续时间。结果 纳入的200例患者中PG SGA评分≥4分122例,61%的患者存在营养不良。两组性别、年龄、肿瘤类型、肿瘤分期、化疗方案等临床资料差异均无统计学意义(P＞0.05）。多因素回归分析营养不良是CINV的独立危险因素。对存在营养不良的患者进行营养干预后,恶心呕吐持续时间较前改善（P＜0.01）。结论 营养不良是CINV的独立危险因素,进行营养干预可改善CINV持续时间。