A comparison of ondansetron with metoclopramide in the prophylaxis of chemotherapy-induced nausea and vomiting: A randomized,double-blind study

The efficacy of ondansetron was compared with metoclopramide in the prophylaxis of nausea and vomiting induced by cyclophosphamide ≥ 500 mg/m² in combination with doxorubicin ≥ 40 mg/m² or epirubicin ≥ 40 mg/m². Complete anti-emetic protection in the 24 h following chemotherapy was achieved in 26 of 40 (65%) patients treated with ondansetron compared with 17 of 42 (41%) patients treated with metoclopramide. Severe nausea was present in 3% of patients in the ondansetron group and 31% in the metoclopramide group. A worst day analysis of control of emesis and nausea on days 2 and 3 following chemotherapy also demonstrated ondansetron to be more effective than metoclopramide. Both treatments were well tolerated. Ondansetron is more effective as an anti-emetic than metoclopramide in this type of cytostatic therapy.     

Efficacy of ondansetron against nausea and vomiting caused by dacarbazine-containing chemotherapy.

BACKGROUND AND METHODS. The antiemetic activity of ondansetron (Zofran, Glaxo Pharmaceuticals, Research Triangle Park, NC) was evaluated in 25 patients with recurrent melanoma who were treated sequentially with dacarbazine (DTIC), vinblastine, and cisplatin. The antiemetic regimen included ondansetron alone in 11 patients; ondansetron plus lorazepam (Ativan, Wyeth-Ayerst, Philadelphia, PA) in 9 patients; and ondansetron plus lorazepam plus metoclopramide (Reglan, A. H. Robins Co., Richmond, VA) in 5 patients. Twenty-one patients had no prior exposure to chemotherapy, whereas 4 patients had previously received the same chemotherapy regimen and had severe vomiting despite administration of standard antiemetics. RESULTS. The antiemetic efficacy of ondansetron was impressive. Administration of a single dose of 10 mg resulted in complete control of nausea and vomiting in 22 patients, and the remaining 3 patients had only mild vomiting. CONCLUSIONS. Ondansetron is highly effective in controlling the nausea and vomiting caused by dacarbazine.     

Phase III double-blind comparison of intravenous ondansetron and metoclopramide as antiemetic therapy for patients receiving multiple-day cisplatin-based chemotherapy.

BACKGROUND. Ondansetron hydrochloride is a selective serotonin subtype 3 (5HT3) receptor antagonist that has been shown to be an effective antiemetic in patients receiving cisplatin chemotherapy. METHODS. This double-blind study compared the safety and efficacy of intravenous ondansetron with metoclopramide in patients receiving a 4- or 5-day regimen of cisplatin (20-40 mg/m2/day) combination chemotherapy. Forty-five patients were enrolled, and efficacy of the drug therapy could be studied for all 45. Patients were randomly assigned (1:1) to receive three daily intravenous doses of either 0.15 mg/kg ondansetron or 1 mg/kg metoclopramide. All patients were monitored daily for the number of emetic episodes (vomiting or retching), severity of nausea, adverse events, and laboratory safety parameters. RESULTS. Seven (30%) patients who received ondansetron had no emetic episodes throughout the entire study period compared with two (9%) who received metoclopramide (P = 0.077). The greatest difference in antiemetic efficacy was seen on day 1, when 18 (78%) patients who received ondansetron had no emetic episodes compared with 3 (14%) patients who received metoclopramide (P < 0.001). Significantly fewer antiemetic treatment failures (more than five emetic episodes or withdrawal from the study) occurred with patients given ondansetron (9%) than with those given metoclopramide (50%) during the entire study period (P = 0.002). The most commonly reported adverse event associated with ondansetron therapy was headache (controlled with acetaminophen), whereas diarrhea and restlessness were the most commonly reported adverse events associated with metoclopramide therapy. Extrapyramidal symptoms were judged to have occurred in 13 patients who received metoclopramide and 1 patient who received ondansetron. However, the patient who received ondansetron subsequently was judged to have had an anxiety attack. In patients with low or normal baseline transaminase values, a greater percentage who received ondansetron had transient increases as great as twice the upper limit of normal in aspartate transaminase (5% versus 0%) and alanine transaminase (17% versus 6%) than those who received metoclopramide. CONCLUSIONS. Ondansetron is superior to metoclopramide as antiemetic therapy for multiple-day cisplatin-based chemotherapy.     

甲状腺癌根治术后恶心呕吐的预防

[目的]研究枢丹和格拉司琼在甲状腺癌根治术患者术后的抗呕吐作用 ,并比较两者对术后恶心呕吐(PONV)的预防效果。[方法]选择甲状腺癌根治术患者90例 ,随机分为枢丹组(4mg,n=30)、格拉司琼组(3mg,n=30)和安慰剂组(生理盐水 ,n=30) ,诱导前静推枢丹或格拉司琼或安慰剂 ,双盲法观察术后24小时恶心、呕吐的发生率。[结果]枢丹组恶心、呕吐的发生率(23 % ,17 %)与格拉司琼组(20 % ,13 %)无显著性差异(P>0 05) ,用药组恶心、呕吐的发生率明显低于安慰剂组(67 % ,57 %;P<0 01)。[结论]枢丹和格拉司琼均能有效地预防甲状腺癌根治术后的恶心、呕吐 ,两者对PONV的预防效果无明显差别。     

甲氧氯普胺联合氟哌啶醇改善癌性恶心呕吐及乏力的临床研究

背景与目的：癌性恶心呕吐及乏力可使晚期癌症患者机体功能严重受损并出现多种并发症，严重影响患者生活质量，甚至导致其死亡。该研究旨在探讨甲氧氯普胺联合氟哌啶醇对晚期癌症患者癌性恶心呕吐及乏力的影响。方法：选取晚期肿瘤伴恶心呕吐患者536例，随机分为甲氧氯普胺组（n=135）、氟哌啶醇组（n=132）、甲氟联合组（n=136）和昂丹司琼组（对照组，n=133）。采用WHO抗癌药不良反应恶心及呕吐分级标准、恶心、呕吐及干呕指数评价量表（Index of Nausea，Vomiting，and Retching，INVR）、药物不良反应及多维疲乏症状量表-简表（Multidimensional Fatigue Symptom Inventory-Short Form，MFSI-SF）分别对患者用药48 h、2和4周时的变化进行跟踪测评。结果：昂丹司琼组48 h后止吐有效率为66.2%，显著优于甲氟联合及两药单用组（P＜0.05）；而甲氟联合组应用第2、4周时止吐有效率分别为86.8%和94.9%，显著优于对照组和单药组（P ＜0.05），且INVR评分显著低于对照组和单药组（P＜0.05）。甲氟联合组不良反应与两药单用相近，但显著低于对照组（P＜0.05）。甲氟联合组应用2和4周时MFSI-SF评分均显著低于对照组和单用组（P＜0.05）。结论：甲氧氯普胺联合氟哌啶醇对晚期癌性恶心呕吐具有明显的改善效果，并在一定程度上有改善癌性乏力的作用，值得临床推广。     

Oral ondansetron in the prophylaxis of nausea and vomiting induced by cyclophosphamide, methotrexate and 5-fluorouracil (CMF) in women with breast cancer. Results of a prospective, randomized, double-blind, placebo-controlled study

BACKGROUND:: The combination of cyclophosphamide, methotrexate and 5-fluorouracil(CMF) is a widely used chemotherapy regimen in breast cancerpatients. However, the control of nausea and vomiting inducedby oral CMF is a rarely examined problem. Therefore we felta randomized, placebo controlled study justified in order toimprove currently available antiemetic therapy. SUBJECTS AND METHODS:: In a randomised double-blind trial ondansetron given orally,8 mg three times a day for 15 days, was compared with placeboin 82 breast cancer patients receiving chemotherapy with CMF(cyclophosphamide 100 mg/m² orally days 1–14, methotrexate40 mg/m² i.v. days 1 and 8 and 5-fluorourcil 600 mg/m² i.v.days 1 and 8). The patients recorded nausea and the number ofvomits and retches daily on diary cards. Forty-two patientsreceived ondansetron and 40 received placebo. RESULTS:: Significantly more patients who received ondansetron experiencedneither vomiting nor retching (emesis) compared to those receivingplacebo over a 15 day treatment period (60% vs. 35%, p = 0.027).The difference, with 95% confidence limits, was estimated as25 (4.45%). Furthermore, there was a trend in favour of ondansetronin the control of nausea. Ondansetron was well tolerated, with25 patients (59%) reporting at least 1 adverse event comparedto 18 patients (45%) receiving placebo (p = 0.191). CONCLUSION:: The results indicate that ondansetron given orally for 15 daysis safe and effective in the control of emesis induced by CMF.It is however too early to recommend ondansetron as standardantiemetic therapy for oral CMF, as the treatment of nauseaand vomiting in this setting has not been studied thoroughlyenough. prospective, randomized, double-blind trial, ondansetron and placebo, oral CMF-regimen, breast cancer     

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.     

Ondansetron — a new safe and effective antiemetic in patients receiving high-dose melphalan

Summary A total of 33 patients with myeloma receiving treatment with high-dose melphalan (140–200 mg/m² i.v.) were given the 5HT₃ antagonist Ondansetron (Glaxo) as an antiemetic. In 42% of patients, emetic episodes were either abolished (15%) or reduced to two or less (27%). Efficacy was not related to scheduling (two regimens) or total dose. No sedative or other significant side effects were seen. Ondansetron is a highly effective non-sedative antiemetic that justifies further assessment in combination with other antiemetics in patients receiving cytotoxic drugs associated with the production of severe nausea and vomiting.     

枢复宁防止由非顺铂化疗所致呕吐的疗效观察

本文报道用枢复宁十地塞米松与灭吐灵十地塞米松随机对照,控制非顺铂化疗诱发的呕吐。58例病人经随机分组后,28例用枢复宁加地塞米松,30例按本院常用剂量灭吐灵加地塞米松治疗。枢复宁十地塞米松对急性恶心和呕吐的完全控制率均显著高于灭吐灵十地塞米松(分别为87％比72％,P<0.05,94％比67％,P<0.001)。对延缓性呕吐的完全控制。枢复宁十地塞米松也高于灭吐灵十地塞米松,分别为85％—94％比58％—82％(P<0.05)。枢复宁十地塞米松副作用轻,主要有头痛(13％)和便秘(9％),不引起锥体外系反应。因此,枢复宁十地塞米松是一个较为有效的联合止吐方案。     

国产恩丹西酮预防化疗引起恶心呕吐80例临床观察

采用随机对照法观察了恩丹西酮对８０例顺铂及非顺铂类化疗药的止吐作用，化疗第１周期用恩丹西酮或胃复安，第２周期交换。结果显示，恩丹西酮对控制急性呕吐的有效率为９１．３％，而胃复安仅为５８．８％（Ｐ〈０．０１），其对非顺铂类的止吐作用，前２天优于顺铂（Ｐ〈０．０５），它对迟发性呕吐的疗效也优于胃复安，本研究认为，恩丹西酮控制顺铂及非顺铂类化疗引起的恶心呕吐均有良好的疗效，副作用少。     

The Effect of Ondansetron on Radiation-Induced Emesis and Diarrhoea

Fractionated radiotherapy of malignancies in the abdomen induces nausea and vomiting in approximately 50% of the patients. During abdominal irradiation the damaged gastrointestinal mucosa releases 5-HT with ensuing activation of 5-HT₃ receptors which may explain the nausea and vomiting. Ondansetron is a new 5-HT₃-antagonist with antiemetic properties. In this consecutive study, 33 patients receiving fractionated upper abdominal irradiation (100 cm², 1, 8-4 Gy daily dose for a mean of 13 days) were treated with ondansetron (8 mg t.d.s. p.o.). Emesis was completely controlled in 26/33 (79%) patients throughout their radiation course, which embraced 628 (94%) treatment days. Ondansetron was well tolerated. Eleven patients developed mild constipation. No patients experienced diarrhoea (a common distressing side-effect of abdominal irradiation). It is suggested that ondansetron can be of value in preventing emesis in patients receiving fractionated radiotherapy. The possible beneficial effect in preventing diarrhoea must be further evaluated.     

A single-blind comparison of intravenous ondansetron, a selective serotonin antagonist, with intravenous metoclopramide in the prevention of nausea and vomiting associated with high-dose cisplatin chemotherapy

Ondansetron (GR 38032F), a selective antagonist of serotonin subtype 3 receptors, is effective in the prevention of emesis associated with cisplatin as well as other chemotherapeutic agents. In this randomized, single-blind, multicenter, parallel group study, we compared the efficacy and safety of intravenous (IV) ondansetron with IV metoclopramide in the prevention of nausea and vomiting associated with high-dose (greater than or equal to 100 mg/m2) cisplatin chemotherapy. Three hundred seven patients receiving their first dose of cisplatin, either alone or in combination with other antineoplastic agents, were randomized to receive ondansetron 0.15 mg/kg IV every 4 hours for three doses or metoclopramide 2 mg/kg IV every 2 hours for three doses, then every 3 hours for three additional doses. The study prohibited the concurrent administration of other antiemetics or dexamethasone. Patients receiving ondansetron had a higher rate of complete protection from emesis (40% v 30%, P = .07), a higher complete plus major response rate (65% v 51%, P = .016), a lower rate of failure (21% v 36%, P = .007), and a lower median number of emetic episodes (one v two, P = .005) than did those receiving metoclopramide. The median time to the first emetic episode was longer on ondansetron (20.5 v 4.3 hours, P less than .001). Adverse events occurred in 48% of patients receiving ondansetron and 69% of those receiving metoclopramide (P less than .001). Akathisia and acute dystonic reactions occurred only on metoclopramide; headache (controlled with acetaminophen) was significantly more frequent with ondansetron. Ondansetron is more effective, produces fewer adverse events, and is easier to administer than metoclopramide for the prevention of emesis associated with high-dose cisplatin chemotherapy.     

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.     

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 versus granisetron, both combined with dexamethasone, in the prevention of cisplatin-induced emesis: Italian Group for Antiemetic Research

Background: Differences in pharmacodynamic and pharma-cokineticcharacteristics among serotonin-receptor antagonists have beenreported in preclinical studies. This prompted us to carry outa study to determine whether such differences are importantin terms of clinical efficacy or tolerability Patients and methods: 973 consecutive cancer patients scheduledto receive cisplatin for the first time (at doses > 50 mg²),entered a double-blind multicenter randomized study comparingintravenous ondansetron 8 mg versus granisetron 3 mg. Dexamethasone20 mg was added to both serotonin antagonists. On days 2 to4 after chemotherapy all patients received oral metoclopramideplus intramuscular dexamethasone as antiemetic prophylaxis fordelayed emesis. Nausea and vomiting were assessed daily untilday 6 after chemotherapy Results: We evaluated 966 patients (483 receiving ondansetronand 483 granisetron). Complete protection from acute vomiting/nauseawas obtained in 79.3%/72.0% of patients receiving ondansetronand in 79.9%/71.8% of those receiving granisetron. Completeprotection from delayed vomiting\nausea was obtained in 69.7%/52.9%and 70.0%/ 49.6% of patients receiving the ondansetron or granisetronregimens, respectively. Adverse effects were mild and not significantlydifferent between the two antiemetic regimens Conclusions: Ondansetron 8 mg and granisetron 3 mg, both combinedwith dexamethasone, showed similar efficacy and tolerabilityin the prevention of cisplatin-induced emesis. The choice betweenthe two regimens can be dictated by their respective purchaseprices antiemetics, cisplatin, dexamethasone, granisetron, ondansetron     

Antiemetic efficacy of high-dose dexamethasone: randomized,double-blind,crossover study with high-dose metoclopramide in patients receiving cancer chemotherapy

A double-blind, randomized, crossover study was conducted to compare the efficacy and safety of high-dose dexamethasone and high-dose metoclopramide in the treatment of chemotherapy-induced nausea and vomiting. All entered patients had no prior chemotherapy and all received inpatient emetogenic chemotherapy mainly without cisplatin. Of the 40 evaluable patients, 23 (58%) had no vomiting with dexamethasone compared with only 11 (28%) receiving metoclopramide (P < 0.025). Dexamethasone was found to have less adverse effect than metoclopramide on patient's appetite and activity (P < 0.025 and P < 0.01, respectively). Twenty-one patients (53%) developed mild to severe somnolence with metoclopramide compared to only seven (18%) who experienced this adverse effect with dexamethasone (P < 0.01). Six patients (15%) developed extrapyramidal manifestations with metoclopramide, but none with dexamethanesone. Furthermore, during dexamethasone therapy, patients developed less diaphoresis, insomnia, headache and dizziness. Upon questioning patients about their preference to future use of the antiemetic drug therapy, 28 patients (70%) preferred dexamethasone, two (5%) preferred metoclopramide and 10 (25%) found no difference. We conclude that high-dose dexamethasone has a greater antiemetic activity and is more safe than high-dose metoclopramide in patients receiving emetogenic chemotherapy mainly without cisplatin.     

Nausea and vomiting after ENT surgeries: A comparison between ondansetron, metoclopramide and small dose of propofol

Aims

To evaluate the antiemetic efficacy of ondansetron, metoclopramide or small dose of propofol following ear, nose and throat (ENT) surgery.

Materials and methods

A prospective randomized study involving 60 patients, both children and adults undergoing elective ENT surgery under standard general anesthesia. At the completion of surgery the patients received either 0.1 mg/kg of ondansetron or 0.2 mg/kg of metoclopramide or 0.5 mg/kg of propofol intravenously. The patients were observed for 24 hrs after operation for any occurrence of nausea and vomiting.

Results

The incidence of postoperative nausea and vomiting (PONV) during first 24 hrs was recorded in 20%, 70%, 50% of patients who had received ondansetron, metoclopr-amide or propofol respectively (p < 0.05). Fewer patients given ondansetron needed rescue antiemetic. The incidence of PONV was higher following middle year surgery.

Conclusion

It was concluded that ondansetron was most effective in preventing occurrence of PONV while metoclopramide was least effective. Propofol was effective only in 50% of patients, thus not recommended for routine use.     

A phase II study of ondansetron as antiemetic prophylaxis in patients receiving carboplatin for advanced ovarian cancer. The North Thames Ovary Group.

Thirty four patients who were receiving carboplatin 400 mg/m2 for advanced epithelial ovarian cancer were treated with ondansetron antiemetic prophylaxis. Ondansetron was given as 4 mg oral +4 mg iv 30 minutes prior to carboplatin followed by 8 mg oral tds for 5 days. Of the evaluable patients complete or major control of emesis on day one was achieved in 94% of previously untreated patients and 81% of patients refractory to conventional antiemetic therapy. For the 5 day period as a whole 88% of untreated patients and 69% of those with refractory emesis reported complete or major control of nausea and vomiting. Fifteen patients noted no side effects with mild headache (30%) and constipation (21%) the most frequent problems in the remainder. Ondansetron is effective antiemetic prophylaxis for carboplatin chemotherapy and should allow the majority of these patients to be managed on an out-patient basis.     

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 Chlorpromazine for Preventing Emesis in Bone Marrow Transplant Recipients: a Double-Blind Randomized Study

Summary

Ondansetron, a selective 5-HT, antagonist, is known to be effective for preventing emesis induced by cisplatin and other antineoplastic agents. We undertook a randomized double-blind study in a series of bone marrow transplantation (BMT) recipients to assess the antiemetic efficacy and the safety of ondansetron in comparison with chlorpromazine, which was being used at our institution, as the standard antiemetic agent for the conditioning regimen. Forty patients submitted to BMT (21 autologous, 19 allogeneic) were included in the study. Patients were randomly assigned to receive ondansetron (as a loading dose of 8 mg iv one hour before the beginning of the conditioning regimen followed by a continuous infusion of 1 mg per hour for the whole treatment period) or chlorpromazine 60 mg/m²/day given by continuous infusion for the same period (maximum 8 days). Twenty patients were assigned to ondansetron, while 20 were assigned to chlorpromazine. The response rate in terms of antiemetic efficacy and in nausea control was similar between the two treatment groups. On the contrary the two groups differed significantly in regard to side-effects: patients receiving ondansetron experienced significantly less sedation (p = 0.002), the absence of extrapyramidal reactions (p < 0.001) and no need for dose reduction (p < 0.001) as compared with patients treated with chlorpromazine.