Efficacy and safety of granisetron in the prevention of chemotherapy-induced emesis in paediatric patients

In an open ascending-dose study, granisetron, a specific 5-HT₃ receptor antagonist, was administered to 24 paediatric patients (17 male, 7 female, mean age 6.2, range 3–15 years) who were receiving moderately or highly emetogenic chemotherapy for malignant disease. Single doses of 10, 20 and 40 μg/kg were administered by intravenous infusion 1 h before chemotherapy. Each dose level was studied in a group of 8 patients. With the 40 μg/kg dose, 5 of 8 patients experienced no nausea or vomiting in the 24 h after granisetron treatment. With 20 μg/kg, a similar response was seen, but with 10 μg/kg only 2 of 8 patients experienced complete antiemetic protection despite additional prophylactic chlorpromazine in this group. Granisetron was very well tolerated, and there were no clinically important changes in pulse rate, blood pressure or Holter electrocardiogram. It is concluded that granisetron was very well tolerated by paediatric patients. In addition, there was clear evidence of a major antiemetic effect for at least 24 h after a single intravenous dose of 20 or 40 μg/kg.     

Granisetron: is there a dose–response effect on nausea and vomiting?

PURPOSE: Nausea and vomiting are two of the most debilitating side effects of cytotoxic chemotherapy. Prevention of nausea and vomiting is, thus, very important to ensure that cancer patients continue to receive optimal cytotoxic therapy while seeking to maintain their quality of life. Significant advances in antiemetic therapy have been achieved since the introduction of the 5-HT(3) receptor antagonists, and these agents are currently regarded as first-line antiemetic agents. The aim of this article is to examine the hypothesis that there is a dose-response effect of granisetron for preventing chemotherapy-induced nausea and vomiting in cancer patients. METHODS: A literature review of relevant publications was undertaken to provide a comprehensive review of issues related to the control of chemotherapy-induced emesis with escalating doses of granisetron. RESULTS: There is evidence to suggest that there is a significant trend towards an improved efficacy of granisetron-in both the control of emesis and secondary end-points such as nausea and anorexia-with increasing doses, up to 40 micro g/kg, in adults. At this dose, the likelihood of treatment success may be enhanced for most patients regardless of their individual emetogenic risk. Additionally, incremental doses of granisetron (up to 9 mg) have been shown to be effective and well tolerated in patients with refractory emesis. CONCLUSIONS: Those patients experiencing inadequate control of nausea and vomiting following granisetron may also benefit from retreatment with supplementary doses of granisetron, and over subsequent chemotherapy cycles, these patients should receive granisetron 40 micro g/kg to ensure emesis protection.     

Comparison of antiemetic efficacy of granisetron and ondansetron in Oriental patients: a randomized crossover study.

A double-blind randomized crossover trial was performed to compare the antiemetic efficacy of two 5-HT3 receptor antagonists, granisetron and ondansetron, in Chinese patients receiving adjuvant chemotherapy (cyclophosphamide, methotrexate and 5-fluorouracil) for breast cancer. Twenty patients were randomized to receive chemotherapy with either granisetron on day 1 and ondansetron on day 8 of the first cycle followed by the reverse order in the second cycle, or vice versa. The number of vomiting episodes and the severity of nausea in the first 24 h (acute vomiting/nausea) and the following 7 days (delayed vomiting/nausea) were studied. Acute vomiting was completely prevented in 29 (72.5%) cycles with granisetron and 27 (67.5%) cycles with ondansetron, and treatment failure (>5 vomiting episodes) occurred in two (5%) cycles with each agent (P = NS). Acute nausea was completely controlled in 15 (37.5%) cycles with granisetron and 14 (35%) cycles with ondansetron, whereas severe acute nausea occurred in four (10%) cycles with each agent (P = NS). However, complete response for delayed vomiting was observed in only 21 (52.5%) cycles with granisetron and 22 (55%) cycles with ondansetron (P = NS), and delayed nausea was completely controlled in only 11 (27.5%) and ten (25%) cycles respectively (P = NS). In conclusion, both granisetron and ondansetron are effective in controlling acute nausea and vomiting in Chinese patients, with equivalent antiemetic efficacy. Control of delayed nausea and vomiting is less satisfactory.     

A controlled,dose-comparison study of granisetron for nausea and vomiting induced by cancer chemotherapy in children

Background We investigated the efficacy and safety of granisetron in 40 pediatric oncology patients who received identical chemotherapy regimens for three courses. Methods During the first course, the emetogenicity of each chemotherapy regimen was evaluated without granisetron. Next patients received one of two doses of intravenous granisetron, i.e. 20 or 40 mcg/kg during the second and third course of chemotherapy in a cross-over fashion. Results Out of the 40 patients, two children had no emetic episode during the 24 hour period following commencement of the first course of chemotherapy. Whereas, 23 patients receiving 20 μ/kg granisetron, and 22 patients receiving 40 μ/kg, obtained complete response (no emetic episode during the 24 hour period following commencement of chemotherapy) in the second or third course. When patients received 20 or 40 μ/kg of granisetron, all measured efficacy parameters were superior in comparison to the period when they were receiving no granisetron. There was no significant difference in the antiemetic effect between the two doses of granisetron. However, a dose-related improvement in efficacy was observed with granisetron in a certain subset of patients; that is, 4 of the 10 patients receiving 20 μ/kg, who had responded poorly with respect to nausea and vomiting, showed a complete or major response when the dose was increased to 40 μ/kg. One child developed somnolence. No other adverse events were observed. Conclusion Granisetron is an effective and safe antiemetic for children receiving intensive chemotherapy regimens containing cisplatin, cyclophosphamide or methotrexate. When comparing the two doses of 20 and 40 μ/kg, 40 μ/kg appeared more effective; although the difference was not statistically significant.     

Oral granisetron solution as prophylaxis for chemotherapy-induced emesis in children: double-blind study of 2 doses

This multicentric double-blind, dose-ranging study was to compare efficacy and safety of two oral doses of granisetron solution in the prevention of chemotherapy-induced emesis in children with malignant diseases : 294 children, aged 1 to 16, treated with a moderately or highly emetogenic chemotherapy were randomly assigned to receive oral granisetron either 20 microg/kg (n = 143) or 40 microg/kg (n = 151) before and 6 to 12 hours after the start of chemotherapy. Fifty-one percent of patients treated with 20 microg/kg bd of oral granisetron solution achieved a complete response (no vomiting, no worse than mild nausea, no rescue therapy and no withdrawal during the specified period) and 59% achieved a major response (no more than one episode of vomiting, no worse than mild nausea, no rescue therapy and no withdrawal during the specified period). There was no difference between the two oral doses of granisetron. Treatment was rated as good or very good by investigators in 70% of cases. In conclusion, oral granisetron suspension either at 20 microg/kg bd or at 40 microg/kg bd showed good efficacy and safety in the prevention of chemotherapy-induced emesis in children with malignant diseases. Oral granisetron solution can be used as prophylaxis of emesis in children receiving moderately or highly emetogenic chemotherapy.     

奥氮平联合格拉司琼控制乳腺癌化疗所致恶心呕吐的疗效观察

目的观察并比较奥氮平联合格拉司琼与单用格拉司琼控制乳腺癌化疗所致恶心呕吐的疗效。方法 120例乳腺癌患者被随机分为研究组（60例）及对照组（60例）,研究组和对照组均在化疗前30 min静脉滴注格拉司琼3 mg,研究组自化疗第1天早晨开始口服奥氮平10 mg,连用3天,第1个周期化疗结束后评价止吐效果。结果研究组的急性恶心呕吐的发生率（33.3%）和迟发性恶心呕吐的发生率（18.3%）均明显低于对照组（53.3%和40%）,差异有统计学意义（P〈0.05）。结论与单用格拉司琼相比,奥氮平联合格拉司琼对于控制乳腺癌化疗所致急性恶心呕吐和延迟性恶心呕吐的效果更好。     

Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population

The objective of this study was to compare the efficacy and tolerability of palonosetron and granisetron in a Chinese population receiving highly emetogenic cisplatin-based chemotherapy or moderately emetogenic chemotherapy. Patients were stratified by chemotherapy with cisplatin (yes/no) and then randomly assigned to receive either palonosetron (0.25 mg i.v.) in the first cycle followed by granisetron (3 mg i.v.) in the second cycle or vice versa. The primary efficacy endpoint was the proportion of patients with complete response 0–24 h post-chemotherapy administration. The proportions of patients with complete response 24–120 and 0–120 h following chemotherapy were also compared. Of the 144 patients randomized, 36 (25%) received 60–80 mg/m² cisplatin; 66 of 72 patients in the palonosetron to granisetron group and 56 of 72 patients in the granisetron to palonosetron group completed treatment with both antiemetics. The efficacy and safety analyses included 128 palonosetron treatments and 138 granisetron treatments. Palonosetron consistently produced numerically higher complete response rates than granisetron in the acute phase (0–24 h, 71.09 vs. 65.22%), the delayed phase (24–120 h, 60.16 vs. 55.80%), and overall (0–120 h, 53.13 vs. 50.00%) though the differences were not significant. Both palonosetron and granisetron were well tolerated. Palonosetron was well tolerated and effective in preventing acute and delayed chemotherapy-induced nausea and vomiting in a Chinese population. When used as monotherapy, 0.25-mg palonosetron was not inferior to 3-mg granisetron for preventing vomiting following highly or moderately emetogenic chemotherapy.     

Effects of granisetron in children undergoing high-dose chemotherapy: a multi-institutional, cross-over study

The efficacy of granisetron hydrochloride 20 microg/kg and 40 microg/kg were compared using a cross-over method to determine the optimal dose in children with solid tumors receiving high-dose chemotherapy. Granisetron controlled the onset of vomiting in 17 of 23 patients (73.9%) who were given 40 microg/kg of granisetron, while 8 of 21 patients (38.1%) were free of vomiting in the 20 microg/kg group. The average frequency of vomiting was 7.22 times in the 20 microg/kg dose versus 4.44 times in the 40 microg/kg dose. No safety problems were associated with either dose. The 40 microg/kg dose of granisetron appears to be more optimal.     

The incidence of anticipatory nausea and vomiting after repeat cycle chemotherapy: the effect of granisetron.

Anticipatory nausea and vomiting (ANV) after repeated cycles of cytotoxic chemotherapy is thought to be a conditioned response to a conditioning stimulus. Good control of acute and delayed emesis may result in a lower incidence of ANV. We have analysed data from 574 chemotherapy patients who received granisetron as their antiemetic treatment during repeat cycle chemotherapy. Per treatment cycle, less than 10% of patients displayed symptoms of anticipatory nausea and 2% or less had symptoms of anticipatory vomiting. It is concluded that the use of granisetron as an antiemetic during the acute phase of chemotherapy may result in a lower incidence of ANV in patients undergoing repeat cycle chemotherapy.     

An open study to assess the safety,tolerance and pharmacokinetics of an intravenous infusion of granisetron given at 3 mg over 30 s in patients receiving chemotherapy for malignant disease

Granisetron is a highly potent and selective 5-hydroxytryptamine₃ (5-HT₃) receptor antagonist indicated for the prevention of cytotoxic-induced nausea and vomiting. Clinical trials have demonstrated granisetron to be effective and well tolerated at a standard dose of 40 g/kg or 3 mg given i.v. as a 5-min infusion. In this study, the efficacy and safety of granisetron given as a 30-s infusion was assessed. A total of 21 patients, scheduled to undergo chemotherapy, received a single 3-mg i.v. dose of granisetron over 30 s, completed at 1 h before chemotherapy administration. Patients were allowed two further i.v. doses of granisetron at 3 mg within the 24-h assessment period. Changes from baseline values in vital signs were analysed prior to granisetron administration and at 30 s as well as 1, 10, 15, 30 and 60 min after granisetron administration. Holter ECG recordings were taken for 6 h prior to and 1 h after administration. No significant change was found in vital signs at 30 s or 1 min after granisetron infusion. There was a small but statistically significant fall in diastolic blood pressure as compared with baseline and a non-significant trend in favour of a reduction in heart rate at 10 and 15 min. No ECG abnormality was recorded post-infusion that had not been present pre-infusion. None of these changes was considered to be clinically relevant. The treatment was well tolerated. The most frequenctly reported adverse events were constipation (n=6) and headache (n=5). Maximal plasma levels of granisetron were within the range of 44.57–410 ng/ml except in one patient. The median values recorded for peak concentration (C_max) and area under the curve (AUC) were 195 ng/ml and 71.2 ng h ml^–1, respectively. In conclusion, granisetron at 3 mg was shown to be safe and well tolerated when given as a 30-s i.v. infusion to patients receiving chemotherapy for malignant disease.     

Phase I/II trial of granisetron: a novel 5-hydroxytryptamine antagonist for the prevention of chemotherapy-induced nausea and vomiting

A new class of antiemetic agents, the 5-hydroxytryptamine (5-HT3) antagonists, have been shown to possess potent antiemetic properties in the ferret model. We conducted a phase I/II trial of the 5-HT3 antagonist BRL43694 (granisetron) in 24 chemotherapy-na?ve patients who were receiving any combination of doxorubicin and/or cisplatin. The first 12 patients received 40 micrograms/kg and the second 12 received 80 micrograms/kg of granisetron intravenously before beginning chemotherapy. Nausea was assessed by a patient-completed visual analogue scale and episodes of retching recorded by the patient and an independent observer. Fifty-two percent of the 22 evaluable patients had no retching or vomiting and 32% had no nausea during the first 24 hours after chemotherapy. Pharmacokinetic measurements were performed. The disposition of granisetron was best described using a two-compartment model. The area under the plasma concentration curve (AUC) was 277 +/- 226 ng.h/mL and 359 +/- 282 ng.h/mL at 40 and 80 micrograms/kg, respectively. The total body clearance was 0.319 +/- 0.315 L/kg/hr and 0.483 +/- 0.504 L/kg/hr at the 40 and 80 micrograms/kg doses. Wide interpatient variation in model independent parameters was observed. There was no suggestion of dose-dependent efficacy at the two dose levels studied. We conclude that granisetron shows promise as a well-tolerated and effective antiemetic. Randomized trials comparing this drug with standard regimens are currently underway.     

The cardiovascular safety of high-dose intravenous granisetron in cancer patients receiving highly emetogenic chemotherapy

Objectives To assess the cardiovascular safety, tolerability and efficacy of high doses of granisetron for the treatment of nausea and vomiting in patients undergoing highly emetogenic chemotherapy.Methods Patients with histologically confirmed malignant disease were given an intravenous infusion of granisetron, 160 g/kg, over 30 min, starting 15 min after highly emetogenic chemotherapy. Patients underwent cardiac monitoring for 24 h following the granisetron infusion. Pulse, blood pressure and electrocardiogram (lead II and ambulatory) measurements were taken, and routine clinical chemistry and haematology tests performed. Blood samples for pharmacokinetic analysis were taken before the granisetron infusion, and at intervals afterwards. Adverse events were self-assessed using a symptom checklist. Self-assessment categorical rating scales were used to evaluate patient nausea, vomiting and retching.Results Ten patients (eight females and two males; average age 41.5 years) completed the trial and were included in the safety and efficacy assessments. No clinically relevant changes in electrocardiogram, pulse rate, blood pressure or laboratory parameters were observed. Furthermore, in the 7 days following dosing there were no serious adverse events leading to withdrawal from the trial. A complete response (no vomiting, retching or, at most, mild nausea) was experienced by five patients. Six patients had no, or mild, nausea and an additional two patients vomited on a maximum of two occasions. Additional antiemetic rescue medication was given to three patients during the 24-h trial period. Despite considerable interpatient variability, C_max and AUC parameters were proportionally greater than values reported for lower doses of granisetron.Conclusions Granisetron administered at four times the upper recommended dose demonstrated good efficacy and tolerability with no clinically important cardiac effects.     

Efficacy of combination with granisetron and methylprednisolone for nausea, vomiting and appetite loss in remission induction chemotherapy of acute myeloid leukemia--a randomized comparative trial between granisetron alone and granisetron plus methylprednisolone]

The prevention of nausea, vomiting and appetite loss induced by remission induction chemotherapy for acute myeloid leukemia was compared by randomization between granisetron alone and combination with granisetron plus methylprednisolone. Granisetron was administered at 40 micrograms/kg during chemotherapy, and methylprednisolone was administered concomitantly at 125 mg/body for 3 days or more in the combination group. The single and combination groups comprised 14 and 13 patients, respectively, and there was no significant difference between the background of both groups. To evaluate the effect they were scored according to 4 grades, and evaluated every 24 hours from the start of chemotherapy to 5 days after its completion. The complete inhibition rate of vomiting was as high as 71.4% and 92.3% in the single and combination groups, respectively, showing no significant difference. The grade of vomiting was mild in both groups. Nausea was noted in 71.4% and 46.2%, respectively, and the inhibitory effect tended to be higher in the combination group. Appetite loss developed in 92.9% and 41.7%, respectively, and the prevention effect was clearly higher in the combination group. The prevention effects on nausea 7, 8 and 10 days after the start of chemotherapy, on appetite loss 2-10 days after it, and 2-5 days after its completion, were higher in the combination group. Granisetron revealed an excellent inhibitory effect on vomiting induced by remission induction chemotherapy for acute myeloid leukemia, but combination with granisetron and methylprednisolone was considered useful for nausea in the latter half of the treatment period and for appetite loss during the whole period.     

Single 8 mg Dose of Oral Ondansetron Failed to Prevent FAC Chemotherapy-Induced Acute Nausea and Vomiting

Abstract

The aim of this open, nonrandomized, monocentric study was to evaluate the efficacy of a single daily dose of 8 mg oral ondansetron in the prophylaxis of acute nausea and vomiting in chemotherapy-naive breast cancer patients receiving their first cycle of chemotherapy with 5-fluorouracil, doxorubicin and cyclophosphamide (FAC). Forty-five female patients were recruited, median age 42 years. The number of emetic episodes and the grade of nausea were recorded. 51 % of patients achieved complete, and 9% major control of acute emesis. 33% of patients experienced no acute nausea, and in 18% nausea was mild. Complete protection from nausea and vomiting (complete prophylaxis) was obtained in 12/45 (27%) of patients. Treatment success (no vomiting with no more than mild nausea) was achieved in 18/45 (40%) of patients. We conclude that the efficacy of a single dose of 8 mg oral ondansetron in controlling acute nausea and vomiting induced by FAC chemotherapy is not high enough to justify its use as a sole antiemetic agent in outpatients.     

盐酸帕洛诺司琼预防含顺铂化疗所致恶心、呕吐的临床观察

目的通过与格拉司琼比较,观察和评价帕洛诺司琼预防含高度催吐危险化疗药物顺铂所致恶心、呕吐的疗效和安全性。方法采用随机、交叉、自身对照法,将84例含顺铂化疗方案治疗的恶性肿瘤患者分成两组：A组第1周期用帕洛诺司琼及地塞米松;B组第1周期用格拉司琼及地塞米松;第2周期A、B组交叉使用。止吐方案：帕洛诺司琼0．25mg,静脉推注d1,d3;格拉司琼3mg,静脉滴注dl-3;地塞米松10nag,静脉推注d1—3。观察化疗后7天内恶心、呕吐的情况以及与止吐药相关不良反应。结果帕洛诺司琼与格拉司琼对化疗后急性呕吐完全控制率分别为77．4％和71．4％,总有效率分别为90．5％和86．9％,差异均无统计学意义（均P〉0．05）;帕洛诺司琼与格拉司琼对化疗后延迟性呕吐完全控制率分别为66．7％和47．6％,总有效率82．1％和59．5％,差异均具有统计学意义（均P〈0．05）;与止吐药相关不良反应主要为便秘和头痛,两药发生率分别为22．6％和25．0％,差异无统计学意义（P〉0．05）。结论帕洛诺司琼对预防含顺铂化疗所致的急性呕吐的疗效与格拉司琼相当,但对预防延迟性呕吐的疗效优于格拉司琼,且不良反应发生率低、程度较轻、安全性好。     

Dose finding study of granisetron in patients receiving high-dose cisplatin chemotherapy. The Granisetron Study Group.

The efficacy and safety of three different doses of granisetron (2 micrograms kg-1, group A; 10 micrograms kg-1, group B; 40 micrograms kg-1, group C) were compared in a randomised, double-blind study of 157 patients due to receive high-dose cisplatin therapy (mean dose > 97 mg m-2). In each group, up to two 3 mg rescue doses of granisetron were allowed if more than mild nausea or vomiting occurred. In group A 30.8%, in group B 61.5% and in group C 67.9% of patients were complete responders (i.e. no vomiting or nothing worse than mild nausea) during the first 24 h. These differences are significant between groups A and B, and A and C. There were no statistically significant differences in any efficacy variable between the 10 micrograms kg-1 and 40 micrograms kg-1 groups, although in each case the trend favoured the higher dose. Additional rescue doses resulted in resolved or improved symptoms in 95.3% for the first rescue dose and 93.3% for the second. Over the 7 days of the study, 82.7%, 82.7% and 86.8% of patients in groups A, B and C respectively were treated with granisetron alone. Headache was the most common side-effect, reported by 9.6% of patients; the majority of headaches were mild. There was no difference between the treatment groups regarding the adverse event rate. We concluded that prophylactic doses of 10 or 40 micrograms kg-1 lead to a safe and satisfactory degree of control of nausea and vomiting induced by high-dose cisplatin.     

Antiemetic effects of granisetron and dexamethasone combination therapy during cisplatin-containing chemotherapy for head and neck cancer: dexamethasone dosage verification trial

Background

Chemotherapy-induced nausea and vomiting (CINV) remains a significant problem for patients and is associated with a substantial deterioration in quality of life; appropriate use of antiemetic drugs is crucial in maintaining the quality of life in patients undergoing chemotherapy.

Methods

This randomized, crossover trial evaluated the antiemetic efficacy and safety of 8 mg per day (low-dose) and 16 mg per day (standard-dose) dexamethasone, in combination with the 5-HT₃ receptor antagonist granisetron, in 36 patients receiving cisplatin (CDDP)-containing chemotherapy for head and neck cancer. Following chemotherapy, the antinausea/vomiting inhibition rate for each dexamethasone dose was measured.

Results

During the 24-h period following administration of chemotherapy (acute phase), the antinausea/vomiting inhibition rates (no nausea and no episodes of vomiting) for 8 mg and 16 mg dexamethasone were comparably high (58.3% and 63.8%, respectively; P = 0.8092). Similar results were seen on days 2–5 following chemotherapy. Efficacy during the acute phase, based on the number of instances of vomiting and degree of nausea, was also comparably high for the two dexamethasone doses (overall efficacy rates were 94.4% and 88.8%, respectively, for 8 mg and 16 mg dexamethasone; P = 0.7637). Both doses maintained an 80% or higher response rate until day 3, and neither dose produced severe side effects.

Conclusion

The results suggest that granisetron and dexamethasone combination therapy is useful in controlling acute and delayed nausea and vomiting induced by CDDP-containing chemotherapy for head and neck cancer. Furthermore, 8 mg and 16 mg dexamethasone have equivalent antiemetic efficacy.     

Comparison of Granisetron,Ondansetron and Tropisetron for Control of Vomiting and Nausea Induced by Cisplatin

Abstract

Severe nausea and vomiting are common and one of the most feared side effects of cisplatin-based chemotherapy. A total of 106 patients were randomized to receive a single dose of 8 mg ondansetron or 3 mg granisetron or 5 mg tropisetron intravenously as prevention of cisplatin-induced acute nausea and vomiting. Antiemetic therapy was done within 30 minutes before initiating chemotherapy. A questionnaire evaluating nausea, vomiting and retches was administered to patients and the responses were categorized as complete, partial or failure. The response determination was repeated in the first 24 hours, and within 24-72 hours following cisplatin administration.

The complete response rates for ondansetron, granisetron and tropisetron in the first 24 hours were 51.4%, 65.7% and 61.1% respectively. All three agents were highly effective against cisplatin-induced acute and late vomiting and the results were statistically significant. This study demonstrated no significant difference in effectiveness of these three antiemetics. 5-HT3 (5-hydrox-ytryptamine 3) receptor antagonists have similar efficacy in the prevention of nausea and vomiting due to cisplatin. Thus, we recommend that drug choice be based on cost-benefit and patient tolerance.     

A comparative study of administration methods of granisetron injection used to treat nausea/vomiting induced by cancer chemotherapy without cisplatin in tumors of hematopoietic organs

Purpose: The antiemetic effect of granisetron injection at a dose of 40 μg/kg used in the treatment of nausea/vomiting induced by multidrug combined cancer chemotherapy excluding cisplatin in patients with tumors of hematopoietic organs was evaluated by comparing a 30-min infusion and a slow intravenous injection given over 30 s. Methods: A two-group random-allocation comparative study was performed with the cooperation of multiple institutions using a central registration system. Results: In the treatment of acute clinical symptoms, appetite was described as “similar to that during good health” by 61.1% of patients (55/93) in the instillation group and by 47.3% (44/93) in the slow injection group, a significant advantage in the infusion group. However, no significant differences in the number of episodes of vomiting, the severity of nausea or clinical efficacy were found. In the final clinical evaluation and assessment of usefulness based on the subjective judgement of physicians throughout the entire therapeutic period, no differences were discernible. No side effects were reported for either method and there was no indication of a sex difference concerning efficacy. However, the efficacy in patients with an anemic tendency was slightly inferior. Conclusions: The maintenance of appetite during the administration of anticancer drugs is very important to maintain patients' daily activities and quality of life. The present results support the usefulness of infusion of granisetron as an administration method during chemotherapy for malignant hemopathy. Received: 27 April 1998 / Accepted: 18 September 1998     

Comparison of granisetron, ondansetron and tropisetron for control of vomiting and nausea induced by cisplatin

Severe nausea and vomiting are common and one of the most feared side effects of cisplatin-based chemotherapy. A total of 106 patients were randomized to receive a single dose of 8 mg ondansetron or 3 mg granisetron or 5 mg tropisetron intravenously as prevention of cisplatin-induced acute nausea and vomiting. Antiemetic therapy was done within 30 minutes before initiating chemotherapy. A questionnaire evaluating nausea, vomiting and retches was administered to patients and the responses were categorized as complete, partial or failure. The response determination was repeated in the first 24 hours, and within 24-72 hours following cisplatin administration. The complete response rates for ondansetron, granisetron and tropisetron in the first 24 hours were 51.4%, 65.7% and 61.1% respectively. All three agents were highly effective against cisplatin-induced acute and late vomiting and the results were statistically significant. This study demonstrated no significant difference in effectiveness of these three antiemetics. 5-HT3 (5-hydroxytryptamine 3) receptor antagonists have similar efficacy in the prevention of nausea and vomiting due to cisplatin. Thus, we recommend that drug choice be based on cost-benefit and patient tolerance.