枢复宁防止肿瘤化疗所致呕吐的疗效观察

本文报道用枢复宁防止肿瘤化疗所致呕吐,共计３０例,其中１２例在使用枢复宁前曾用灭吐灵（作为自身对照）。结果发现枢复宁组防止化疗呕吐的完全控制率、有效率均显著高于灭吐灵组（分别是６３．３％１６．７％、９６．７％比５８．３％,Ｐ＜０．００）。且其副作用少而轻微。因此,枢复宁是一种安全而有效的止吐剂。     

枢复宁预防超大剂量单次全身放疗所致的恶心呕吐

１１６例急、慢性白血病患者因行骨髓移植接受单次超大剂量全身放疗，总剂量７００～７７０Ｇｙ，剂量率０．０５Ｇｙ／ｍｉｎ。７０例患者采用枢复宁＋地塞米松预防急性恶心呕吐反应，结果该组患者无恶心率４３％（３０／７０），轻度恶心率为４４％（３１／７０），呕吐完全控制率为６６％（４６／７０），每天１～２次呕吐发生率为１９％（１３／７０），总有效率为８４％（５９／７０）。而以灭吐灵＋地塞米松组无恶心率及轻度恶心率分别为２％（１／４６）和９％（４／４６），呕吐控制及部分控制率分别为２％（１／４６）和１７％（８／４６）。枢复宁抗全身放疗诱发急性恶心呕吐疗效明显优于灭吐灵。     

枢复宁预防由顺铂化疗所致恶心呕吐的疗效观察

随机将４６例接受顺铂化疗的病人分成两组，分别采用枢复宁和灭吐灵预防顺铂引起的恶心呕吐，两组病人一般情况相近，所用化疗方案以顺铂为主，使用顺铂的剂量为３０ｍｇ－５０ｍｇ／次，每日一次，连用３天，枢复宁剂量１６ｍｇ／日，连服３天，灭吐灵剂量４０ｍｇ／天，边疆肌注３天。结果：枢复宁控制恶心的效果明显优于灭吐灵；对急性呕吐、枢复宁组有效率显著高于灭吐灵组；对控制延缓性呕吐的效果，两组无差异。     

枢复宁控制手术后恶心、呕吐的国际会议在伦敦召开

枢复宁(又名Ondenstron及Zofran)是一种5-羟色胺_3(5-HT_3)受体拮抗剂,为新型有效控制恶心和呕吐的药物。大量临床资料表明,在癌瘤患者进行放、化疗过程中使用枢复宁能起到有效止吐作用,尤其与地塞米松合用对顺铂治疗引起严重恶心及呕吐的控制远较灭吐灵等药为佳。近来各国研究证实枢复宁对术后、尤其对麻醉后导致恶心及呕吐症状也起到良好的控制作用。因而1992年2月28日于伦敦召开枢复宁在控制术后恶心及呕吐的国际会议,通称     

单剂枢复宁加地塞米松控制各种化疗方案引起的呕吐

1992年6月至1993年6月,作者对60例接受不同化疗方案的恶性肿瘤患者随机采用单剂枢复宁加地塞米松和灭吐灵加地塞米松两种止吐方法,报告如下:1 资料与方法1.1 分组情况 枢复宁组30例.男24例,女6例.首次化疗26例,中位年龄50岁.化疗方案EP 9例,CAP1例,FAM 6例,CHOP2例,肝动脉灌注8例,CMF1例,BPF例,BMP1例,HDCF/5—FU1例,其中含DDP方案20例(DDP 80mg/m~2,肝动脉灌注DDP80mg/次,下同).灭吐灵组30例,男23     

康泉、灭吐灵、地塞米松在顺铂化疗中的应用

目的：观察康泉、灭吐灵、地塞米松联合应用时18例卵巢癌40人次以顺铂为主的联合化疗所产生的恶心、呕吐作预防性治疗。方法：康泉3mg溶于生理盐水40ml缓慢静注，灭吐灵10mg、地塞米松5mg肌注，半小时后开始化疗、化疗结束后半小时重复使用后两种药，24小时记录恶心呕吐次数及程度。连续7天，结果0度：22人次，Ⅰ度：15人次，止吐有效率92．5％（37／40）。急性呕吐有效率92．5％（37／40），延迟期呕吐有效率95％（38／40）均高于献报导的单独用康泉或灭吐灵止吐有效率，结论：康泉、灭吐灵、地塞米松联合镇吐有效可行，且用量小，副作用小。     

康泉、灭吐灵、地塞米松在顺铂化疗中的应用

目的观察康泉、灭吐灵、地塞本松联合应用时18例卵巢癌40人次以顺铂为主的联合化疗所产生的恶心、呕吐作预防性治疗。方法康泉3mg溶于生理盐水40ml缓慢静注、灭吐灵10mg、地塞米松5mg肌注,半小时后开始化疗,化疗结束后半小时重复使用后两种药。24小时记录恶心、呕吐次数及程度、连续7天。结果O度：22人次,I度：15人次,止吐有效率92．5％（37／40）。急性呕吐有效率92．5％（37／40）,延迟期呕吐有效率95％（38／40）均高于文献报导的单独用康泉或灭吐灵止吐有效率。结论康泉、灭吐灵、地塞米松联合镇吐有效可行,且用量小,副作用少。     

中剂量灭吐灵,地塞米松联用对DDP化疗时的镇吐作用：94例分析

本文介绍中剂量灭吐灵、地塞米松联用时的镇吐疗效。无呕吐率67％,较文献报道的大剂量地塞米松的无呕吐率56％及大剂量灭吐灵的28％要好。治疗组与对照组相比,各反应梯次,均有非常显著差异。对DDP等强致吐药物,灭吐灵联用时,单次剂量以不少于40mg为宜。     

单剂欧必亭加地塞米松预防大剂量顺铂所致的恶心呕吐

目的　研究单剂欧必亭加地塞米松预防大剂量顺铂化疗所致恶心呕吐的疗效。方法　将 93例接受大剂量顺铂化疗的患者随机分为欧必亭组和枢复宁组 ,分别于第 1天用顺铂前 30min静滴地塞米松 1 0mg ,静注欧必亭 5mg或枢复宁 8mg ,观察两组急性和迟发性恶心呕吐的控制率。 结果　欧必亭组预防急性恶心、呕吐的有效率分别为 97.9%和 95 .8% ,CR率均为 91 .6 % ;预防迟发性恶心、呕吐的有效率均在 80 %以上 ,但CR率偏低 ,有超过一半的患者其迟发性恶心未完全控制。与枢复宁组比较 ,除预防急性恶心的CR率欧必亭组优于枢复宁组外 ,其余指标两组均无显著性差异。结论　单剂欧必亭加地塞米松能有效预防大剂量顺铂化疗所致的急性恶心、呕吐 ,但迟发性恶心、呕吐的完全控制率偏低。     

应用枢复宁及胃复安控制化疗所致胃肠道反应的效果观察

目的 恶性肿瘤病人在化疗中导致的恶心呕吐、消化道症状是困扰癌症的一大难题。正确处理化疗所致的胃肠道反应,对改善恶性肿瘤病人的生活质量,推动肿瘤治疗的发展具有积极作用。方法 采用自身对照方法观察55例应用枢复宁及胃复安控制化疗所致胃肠道反应的效果。第1周期胃复安与化疗日期同步应用,第2周期枢复宁只在化疗第一组应用。结果 枢复宁在各组方案及含顺铂方案控制急性呕吐有效率分别为96.4％和82.8％,明显优于胃复安组(X~2=34.55,10.54,P<0.01);对于迟发性呕吐有效率在各组化疗,方案第五组无差异(P>0.05),含顺铂方案第二组枢复宁优于胃复安差异显著(X~2=5.52,5.84,P<0.05),第三组无差异(P>0.05)。结论 枢复宁治疗呕吐的疗效显著优于胃复安的疗效。胃复安组副反应发生率为34.5％高于枢复宁为9.1％。差异非常显著(X~2=10.44,P<0.01)。     

Comparative trial of oral granisetron and intravenous ondansetron in patients receiving chemotherapy for breast cancer. Study Group of Granisetron

This multicentric randomized trial compared two strategies in the prevention of acute and delayed nausea and vomiting induced by moderately emetogenic chemotherapy in patients with breast cancer. The antiemetic efficacy and side effects of oral granisetron, followed by metoclopramide, were compared to those of intravenous (IV) ondansetron followed by oral ondansetron. 198 chemonaive patients with breast cancer, treated with a moderately emetogenic chemotherapy, were randomly assigned to receive either oral granisetron 1 mg twice a day on day 1, followed by metoclopramide, 60 mg on day 2 and 3, or ondansetron, 8 mg IV on day 1, followed by ondansetron 8 mg tablet twice a day on day 2 and 3. Both treatments have shown similar control of acute emesis: complete response was achieved in 71% of granisetron group and 66% of ondansetron, and total response in respectively 49% and 53%. However, granisetron plus metoclopramide showed a trend towards better efficacy than oral ondansetron in the prevention of delayed emesis. Furthermore, during the overall study period (day 1 to 5), the percentage of complete responses in the group receiving oral granisetron followed by oral metoclopramide was significantly higher than in the group receiving ondansetron (53% versus 37%; p = 0.022). In conclusion, oral granisetron has shown similar efficacy as IV ondansetron in the prevention of acute emesis induced by moderately emetogenic chemotherapy. Oral granisetron followed by metoclopramide seems more efficient than IV plus oral ondansetron in the prevention of delayed emesis.     

A randomized double-blind comparison of ondansetron and metoclopramide in the prophylaxis of emesis induced by cyclophosphamide, fluorouracil, and doxorubicin or epirubicin chemotherapy

Seventy-five breast cancer patients scheduled to receive a first course (in a new cycle) of cyclophosphamide, fluorouracil, and doxorubicin (FAC) or epirubicin (FEC) participated in a double-blind crossover study to compare the antiemetic efficacy and safety of ondansetron (GR38032), a 5-hydroxytryptamine3 (5-HT3) receptor antagonist, and metoclopramide. Ondansetron was given as an 8 mg loading dose (4 mg intravenously [IV] plus 4 mg orally) before chemotherapy followed by 8 mg every 8 hours orally for 3 to 5 days. Metoclopramide was given as an 80 mg loading dose (60 mg IV plus 20 mg orally) before chemotherapy followed by 20 mg every 8 hours orally for 3 to 5 days. A "period" interaction in the analysis of emetic response in the first 24 hours necessitated a parallel group analysis of first treatments only, 68 patients being assessable for this parameter. In the first 24 hours, complete or major control (zero to two emetic episodes) of emesis was achieved in 30 of 35 (86%) patients receiving ondansetron and in 14 of 33 (42%) patients receiving metoclopramide (P less than .001). Ondansetron was also more effective in reducing acute nausea. On days 2 to 3, the complete or major responses were significantly better with ondansetron (81% v 65%; P = .033), but there was no statistical difference in the control of nausea. There was a significant patient preference for ondansetron (63% v 26%; P = .001). Extrapyramidal reactions were observed in two metoclopramide treatments; both treatments were otherwise well tolerated. These results are consistent with serotonin (5-HT), being a significant neurotransmitter of cyclophosphamide/doxorubicin- or epirubicin/fluorouracil-induced emesis.     

A randomized open-label parallel-group study comparing ondansetron with ondansetron plus dexamethasone in patients with metastatic breast cancer receiving high-dose epirubicin. A Hellenic Cooperative Oncology Group study

AIMS AND BACKGROUND: The purpose of this multicenter randomized, open-label, parallel-group study was to assess whether the addition of low-dose dexamethasone to ondansetron results in improved control of chemotherapy-induced emesis in patients undergoing first-line chemotherapy with high-dose epirubicin. METHODS & STUDY DESIGN: Patients were randomized to receive either 24 mg of ondansetron or 24 mg of ondansetron plus 8 mg of dexamethasone administered as an intravenous infusion 30 minutes prior to administration of chemotherapy. Both groups of patients received 8 mg of ondansetron given orally from day 2 to 5 two times daily. Fifty-three patients received ondansetron and 50 received ondansetron plus dexamethasone. The patients recorded nausea and the number of vomits and retches daily on diary cards. RESULTS: Significantly more patients in the ondansetron plus dexamethasone group experienced neither vomiting nor retching during the first day of the first course of chemotherapy compared to those receiving ondansetron alone (79.6% vs 53.8%, P = 0.0062). Furthermore, there was a trend in favor of ondansetron plus dexamethasone in the control of nausea. There was no statistically significant difference between ondansetron plus dexamethasone versus ondansetron alone in protecting patients from emesis between days 2 and 5 of the first course of chemotherapy (66.7% vs 62.7%, P = 0.68). This was probably due to the small sample size. Ondansetron was well tolerated, with 15 patients (15%) reporting adverse events such as headache or constipation. CONCLUSIONS: It appears that ondansetron given intravenously in combination with dexamethasone is more effective than ondansetron alone in the control of acute emesis in patients undergoing their first course of chemotherapy with high-dose epirubicin. No difference between the regimens was found with regard to nausea and delayed emesis control.     

High efficacy of a single oral dose of ondansetron 8 mg versus a metoclopramide regimen in the prevention of acute emesis induced by fluorouracil, doxorubicin and cyclophosphamide (FAC) chemotherapy for breast cancer

The aim of our single-center, prospective, randomized, open study was to evaluate the antiemetic efficacy and tolerability of a regimen based on a single oral dose of ondansetron 8 mg in comparison with a metoclopramide-based regimen, for prevention of acute FAC (fluorouracil, doxorubicin and cyclophosphamide) chemotherapy-induced emesis. A total of 149 chemotherapy-naive, female outpatients, under 50 years of age and with no history of alcohol consumption, scheduled to receive their first cycle of FAC chemotherapy, were included. The patients received either oral ondansetron (8 mg) or metoclopramide (1.5 mg/kg, i.v.), both combined with dexamethasone (16 mg, i.v.) and alprazolam (0.5 mg t.i.d. orally). No antiemetic prophylaxis was given for delayed emesis. Complete control of acute vomiting was obtained in 69/74 (93%) of patients receiving ondansetron, and in 49/75 (65%) of those receiving metoclopramide (p=0.00003). Complete control of acute nausea was obtained in 58% of patients receiving ondansetron and in 36% of those receiving metoclopramide (p=0.007). Complete prevention of delayed vomiting/nausea was achieved in 73%/20% and 60%/16% of patients, respectively. Sedation was more frequent in the metoclopramide arm (p=0.04). As far as we know this is the first study that supports the efficacy of a regimen based on a single oral dose of ondansetron 8 mg in the prevention of acute FAC chemotherapy-induced emesis. The ondansetron regimen was highly effective in female patients and was superior to the metoclopramide based regimen.     

Aprepitant versus metoclopramide,both combined with dexamethasone,for the prevention of cisplatin-induced delayed emesis: a randomized,double-blind study

BackgroundA combination of aprepitant, a 5-HT3 receptor antagonist (r.a.), and dexamethasone is recommended for the prophylaxis of cisplatin-induced nausea and vomiting in the acute phase, and aprepitant + dexamethasone (A + D) in the delayed phase. The aim of this study was to verify if A + D is superior to metoclopramide plus dexamethasone (M + D) in preventing delayed emesis in cancer patients receiving the same prophylaxis for acute emesis.Patients and methodsA randomized double-blind study comparing A + D versus M + D was completed in previously untreated cancer patients. Before chemotherapy, all patients were treated with intravenous palonosetron 0.25 mg and dexamethasone 12 mg, and oral aprepitant 125 mg. On day 2–4, patients randomly received oral dexamethasone 8 mg plus aprepitant 80 mg once daily (days 2–3) or metoclopramide 20 mg four times daily plus dexamethasone 8 mg bid. Primary endpoint was rate of complete response (no vomiting, no rescue treatment) in day 2–5 after chemotherapy.ResultsDue to difficulty in the accrual of patients, 303 of the 480 planned patients were enrolled, 284 were fully evaluable, 147 receiving A + D, 137 M + D. Day 1 results were similar in both arms. On day 2–5, complete response rate was not significantly different (80.3% with A + D versus 82.5% with M + D, P < 0.38, respectively), and all secondary endpoints were also similar (complete protection, total control, no vomiting, no nausea, and score of Functional Living Index-Emesis; P < 0.24). Adverse events incidence was not significantly different between the two treatments.ConclusionsIn cancer patients submitted to cisplatin-based chemotherapy, receiving the same antiemetic prophylaxis for acute emesis, A + D is not superior to M + D in preventing delayed emesis, and both treatments present similar toxicity.ClinicalTrials.gov numberNCT00869310.     

Ondansetron plus dexamethasone is superior to ondansetron alone in the prevention of emesis in chemotherapy-naive and previously treated patients

BACKGROUND: This prospective, randomized, double-blind study assessed whetherthe addition of dexamethasone to ondansetron leads to improvedcontrol of chemotherapy - induced emesis, both in patients undergoingtheir first course of highly emetogenic chemotherapy and inchemotherapypretreated patients refractory to standard anti-emetics. PATIENTS AND METHODS: Patients were randomized to receive either 20 mg dexamethasoneas an intravenous infusion or placebo plus ondansetron 8 mg15 minutes prior to and 4 and 8 hours after the administrationof chemotherapy. According to the randomisation code patientsreceived from day 2 to day 5 either ondansetron 8 mg p.o. +placebo p.o., three times daily, or ondansetron 8 mg p.o. +dexamethasone 4 mg p.o., three times daily. Patients undergoingmultiple-day treatment received intravenous study treatmenton the days of chemotherapy and thereafter oral treatment asoutlined above. RESULTS: A total of 215 patients were entered into the study. Of these,207 were evaluable (111 previously-untreated and 96 previously-treatedpatients). In the chemotherapynaive patients the combinationof ondansetron plus dexamethasone was significantly superiorto ondansetron plus placebo in protecting the patients completelyfrom emesis (retching and vomiting) (81% versus 64%, p –0.04). The mean number of vomiting episodes was significantlylower in the ondansetron-plus-dexamethasone-treated patientsthan in those receiving ondansetron plus placebo (0.8 versus2.1, p – 0.03). In this group of patients there was significantlysuperior protection from emesis on the second day (pvalue –0.04), and a trend towards a better protection on the thirdand fourth days. On each day the active combination offeredbetter protection from nausea with an approximately 20% differencein favor of ondansetron plus dexamethasone. In the group ofestablished vomiters the combination of ondansetron plus dexamethansonewas superior to ondansetron plus placebo in protecting the patientsfrom acute emesis, with 70% versus 48% of the patients beingcompletely protected (p = 0.03). The mean number of vomitingepisodes was significantly lower in the ondansetron-plusdexamethasone-treated-patientsthan in those receiving ondansetron plus placebo (0.9 versus2.1, p = 0.02). In the ondansetron-plus-dexamethasone arm 55%of the patients had complete protection from nausea, retchingand vomiting compared to 35% in the ondansetron-plus-placebo-treatedgroup (p = 0.05). Overall 22% of the patients (20% in the ondansetronplus-placeboand 25% in the ondansetron-plus-dexamethasone arm) experiencedat least one, usually mild, adverse event. More patients inthe ondansetron-plus-dexamethasone arm complained of epigastricpain or burning (8/101 versus 4/112, p-value = 0.16). The differencein patients reporting constipation (6/101 versus 0/112) washighly significant at a p-value of 0.008. CONCLUSIONS: The combination of dexamethasone plus ondansetron is more effectivein protecting chemotherapynaive patients undergoing their firstcourse of highly emetogenic chemotherapy with cisplatin andchemotherapy-pretreated patients refractory to standard antiemeticsfrom chemotherapy-induced nausea and vomiting compared to ondansetronplus placebo. nausea, vomiting, chemotherapy, ondansetron, dexamethasone, delayed emesis     

Chemotherapy-induced emesis: management of early and delayed emesis in milder emetogenic regimens

 The objective of the present study was to examine the problem of the control of nausea and vomiting induced by non-cisplatin containing cyclophosphamide-based chemotherapy regimens in breast cancer patients. This was randomized, double-blind, parallel-group and placebo-controlled study comparing the efficacy of three antiemetic therapeutic regimens (ondansetron for 3 days, ondasetron plus metoclopramide, and ondansetron given in a single dose) in breast cancer patients receiving cyclophosphamide-based chemotherapy regimens on an outpatient basis. Both the primary and the secondary efficacy were measured. The primary efficacy variable was the number of emetic episodies (considering early and delayed emesis). The secondary efficacy variable measured was the quality of life. Two-by-two tables using the chi-square test and relative-risk concept were elaborated for statistical analysis. There was no difference between high-dose ondansetron and ondansetron plus metoclopramide among patients given CMF (cyclophosphamide, methotrexate, 5-fluorouracil). The single-dose ondansetron regimen showed the worst results. In patients given an FEC regimen (cyclophosphamide, epirubicin, 5-fluorouracil) the antiemetic efficacy was best for the high-dose ondansetron regimen, followed by the ondansetron plus metoclopramide regimen, and was worst for single-dose ondansetron administration. Despite the use of different antiemetic schedules, nausea and emesis are significant problems in patients receiving cyclophosphamide-based chemotherapy. Their adequate control should be the aim of any antiemetic approach. Received: 23 September 1995/Accepted: 25 January 1996     

Ondansetron versus metoclopramide in the prevention of chemotherapy-induced nausea and vomiting - a metaanalysis

Nausea and vomiting remain important clinical problems occuring in 25 to 50% of patients receiving chemotherapy for cancer. Clinical trials comparing a new antiemetic drug, ondansetron, to metoclopramide have suggested improved control of nausea and vomiting but studies disagree on the magnitude of the treatment effect and its statistical significance. We combined evidence from randomized controlled trials in a meta-analysis of the efficacy and safety of ondansetron compared to metoclopramide in the prevention of acute (less-than-or-equal-to 24 hours) nausea and emesis associated with chemotherapy. Literature search identified six randomised controlled trials of ondansetron versus metoclopramide in an adult population. Study outcomes were the observed incidence of emesis (vomiting or retching) and patient-reponed grades of nausea after chemotherapy. For meta-analysis of each outcome we defined therapeutic success as complete protection (ie. zero episodes during 24 hours following chemotherapy). The relative odds of success (ondansetron/metoclopramide) was calculated for each trial and all trials combined. Results were expressed as a relative risk (RR) for zero emesis or nausea at 24 hours. The six trials reported on 705 patients (median age range 53-59 years; 57% female). Relative odds for complete control of emesis was greater than one in all trials but was nonsignificant (p>0.05) in two trials, including the largest trial. When trials were combined, summary odds ratios for control of emesis and nausea were greater than one (p<0.05). RR of zero emesis with ondansetron was 1.72 (95% CI 1.45 to 1.97) and was similar for nausea (RR= 1.78, 95% CI 1.39 to 2.13). In trials using high-dose cisplatin chemotherapy, higher rates of extrapyramidal affects and diarrhea were associated with metoclopramide (p<0.05) while headache was frequently associated with ondansetron (p<0.05). Combined clinical trial evidence supports the conclusion. that, relative to metoclopramide, ondansetron places patients at a much lower risk of nausea and emesis following chemotherapy with moderately or highly emetogenic regimens.     

Ondansetron compared with metoclopramide in the control of emesis and quality of life during repeated chemotherapy for breast cancer.

This was a multicentre, randomised, double-blind, parallel-group study which included female breast cancer patients, receiving their first of 6 scheduled courses of chemotherapy (cyclophosphamide greater than or equal to 500 mg/m2). Patients received an intravenous dose of 16 mg dexamethasone with either 8 mg ondansetron or 60 mg metoclopramide before chemotherapy, followed by oral dosing with 8 mg ondansetron or 20 mg metoclopramide 3 times daily for 5 days. A total of 93 patients were treated with ondansetron and 94 patients with metoclopramide. On day 1 of their first course of treatment 91 and 60% of patients in the ondansetron and metoclopramide groups respectively were free of emesis (p less than 0.001). Over the 5-day treatment period, the corresponding figures were 81 and 48% (p less than 0.001). The results for nausea also revealed highly statistically significant treatment differences (p less than 0.001) in favour of ondansetron for both day 1 and day 1-5 analyses of the first treatment course. Over the series of courses, 67% of patients receiving ondansetron completed all 6 courses with a maximum of 2 emetic episodes on their worst day, compared with 28% of patients receiving metoclopramide (p less than 0.001). A similar analysis for nausea revealed that 49% of patients receiving ondansetron completed all 6 courses with 'none' or 'mild' nausea compared with 27% of patients receiving metoclopramide (p less than 0.001). These differences were reflected in quality of life data (Rotterdam Symptom Checklist). After the first course of treatment, a statistically significant improvement (p = 0.002) in the psychological subscale scores was observed after ondansetron compared with metoclopramide. No differences were observed in the physical or functional activity subscales after the first course. However, the quality of life results over the series of courses revealed a more pronounced difference in favour of ondansetron in the psychological subscale scores (p less than 0.001) as well as trends in favour of ondansetron in the physical (p = 0.096) and functional activity (p = 0.056) subscales. Extrapyramidal symptoms were reported in 19% of patients in the metoclopramide group and resulted in 15% of patients withdrawing from their randomised anti-emetic schedule, either during or between treatment courses. Other adverse events were generally minor in nature and did not necessitate withdrawal from treatment. In conclusion, this study shows that ondansetron is significantly superior to metoclopramide (each with a single pre-treatment dose of dexamethasone) in the control of emesis over 6 courses of chemotherapy for breast cancer.(ABSTRACT TRUNCATED AT 400 WORDS)     

Prevention of delayed chemotherapy-induced nausea and vomiting after moderately high to highly emetogenic chemotherapy: comparison of ondansetron, prochlorperazine, and dexamethasone

The purpose of this article is to assess the comparative antiemetic efficacy of prochlorperazine, ondansetron, and dexamethasone in the prevention of delayed chemotherapy-induced nausea and vomiting (CINV) after moderately high to highly emetogenic chemotherapy. Cancer patients (n = 232) receiving moderately high to highly emetogenic chemotherapy were randomized to 1 of 3 treatments: 15 mg prochlorperazine spansules twice daily; 8 mg ondansetron tablets twice daily; or 8 mg dexamethasone tablets twice daily on days 2 through 5. All patients received 24 mg ondansetron and 20 mg dexamethasone orally before chemotherapy. Daily assessment (days 1 through 5) included the number of episodes of retching and vomiting, severity of nausea, restlessness, difficulty concentrating and fatigue, treatment satisfaction, and overall quality of life (measured using a 10-cm VAS). The Functional Living Index-Emesis (FLIE) was completed on day 5. Other side effects attributed to antiemetic therapy were recorded daily. For acute CINV, total control, defined as no vomiting, retching, nausea <1 cm on a 10-cm visual analog scale, and no administration of rescue medications, was achieved in 78% in the overall group and was not significantly different in the patients randomized to the 3 treatment arms for delayed CINV. Delayed CINV was reported by 43% to 57% of patients, with the highest incidence reported on day 3. For delayed CINV, patients receiving prochlorperazine reported the lowest average nausea score on days 2 to 5, whereas patients receiving ondansetron reported the highest nausea score (P = 0.05). No statistically significant differences in CINV or side effects of antiemetic therapy were noted between treatment groups on days 2 to 5. For patients similar to those included in this study, there does not appear to be a clinically important difference in efficacy, adverse effects, or treatment satisfaction among dexamethasone, prochlorperazine, and ondansetron in the doses used in these delayed CINV regimens on days 2 to 5 in this study.