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PubMed2002

Emesis: antiemetic effect of cyclophosphamide at central receptors of multitransmitter system in the cat.

The antiemetic and emetic actions of the anticancer drug cyclophosphamide injected intracerebroventricularly (i.c.v.) and intravenously (i.v.) through chronically implanted cannulae were investigated in unanaesthetized cats. Cyclophosphamide in single doses was injected into the cerebral ventricles and intravenously for 5 consecutive days. The antiemetic effect was regularly obtained, whereas the emetic effect was unpredictable and of low incidence. The antiemetic effect of i.c.v. and i.v. cyclophosphamide was assessed, when the neurotoxic (mydriasis, restlessness, emesis, ataxia, muscular weakness) signs subsided, against i.c.v. noradrenaline- and clonidine-induced emesis. Noradrenaline-induced emesis was dose-dependently and dose-independently inhibited with i.c.v. and i.v. cyclophosphamide. On the other hand, i.c.v. cyclophosphamide inhibited the clonidine-induced emesis in dose-independent manner, while i.v. injection of the anticancer drug had no significant effect on the emesis. The inhibition of emesis was consistently obtained and no significant differences in the antiemetic potency were found between 1 and 5 consecutive days of treatment with cyclophosphamide. However, the inhibition of noradrenaline-induced emesis was dose-dependent only after first administration of i.c.v. cyclophosphamide. It is assumed that noradrenaline acts at alpha-adrenoceptors within the area postrema and clonidine at alpha-adrenoceptors within and outside the area postrema as well as at muscarinic cholinoceptors, 5-hydroxytryptamine, dopamine and histamine H1 and H2 receptors, outside the area postrema, of multitransmitter system subserving the central regulation of emesis. It is suggested, therefore, that the antiemetic effect of cyclophosphamide at the receptors of the multitransmitter central emetic system is non-specific. In general, the antiemetic effect, even non-specific, of an anticancer drug could have practical implication. Namely, when a combination of two or more anticancer drugs are used for chemotherapy, the emesis could not occur if one of them could antagonize the emesis induced by other anticancer drug/s. Finally, cyclophosphamide injected i.c.v., but not i.v., evoked shortlasting emesis in about 20% of cats. Since the emesis was unpredictable and of low incidence it was not possible to study the mechanism/s and site/s of action of the anticancer drug.

Animals↗
PubMed2001

Impact of an antiemetic protocol on postoperative nausea and vomiting in children.

The objective of the study was to demonstrate a decreased incidence of postoperative nausea and vomiting (PONV) in children through the use of an antiemetic protocol. PONV was recorded in children (1.5-15 years) after inpatient surgery under general anaesthesia in a prospective, interview based survey. Group 1 consisted of children having surgery 1 month before the introduction of a formalized antiemetic protocol and group 2, 2 months after its introduction. Data were collected over a 1-month period in each group. Outcome measures of nausea, emesis, antiemetic requirement and patient satisfaction were monitored for the first 24-h postoperative period. There were 272 children enrolled: 138 in group 1 and 134 in group 2. There was a difference between the two groups for gender (P=0.03), type of surgery (P=0.017), perioperative opioid (P=0.003) and perioperative antiemetic use (P=0.024). However, multivariate analysis did not demonstrate an impact on outcome from these factors. The incidence of postoperative nausea (PON) and postoperative vomiting (POV) following the introduction of the protocol was 36% and 34%, respectively. Moderate to severe nausea was decreased after introduction of the protocol (18% versus 9%, P=0.028) but moderate to severe vomiting failed to reach significance (19% versus 11%, P=0.078). The proportion of children who had repeated nausea decreased after the introduction of the protocol (17% versus 8%, P=0.02) but repeated episodes of vomiting remained unchanged (19% versus 14%). This was attributed to a significant increase in antiemetic prescribing by protocol in group 2 (10% versus 59%, P < 0.001). Patient satisfaction was high in both groups (85% versus 90%). The introduction of a postoperative antiemetic protocol improved prescribing frequency. This resulted in a decreased incidence of moderate to severe PON and a reduction in the number of patients with repeated nausea.

Adolescent↗
PubMed2000

Patient statement of satisfaction with antiemetic treatment is related to quality of life.

The aim of our study was to explore the possible relationship between patient satisfaction with antiemetic treatment and quality of life (QoL). The study sample consisted of 136 chemotherapy-naive patients with breast cancer, with Karnofsky index 90% to 100%, scheduled to receive their first cycle of, mainly adjuvant, 5-fluorouracil/doxorubicin/cyclophosphamide chemotherapy. Two antiemetic regimens were used for the prevention of acute emesis. No antiemetic prophylaxis was given for delayed emesis. QoL was assessed using the Rotterdam Symptom Checklist (RSCL). The RSCL was completed before chemotherapy (day 1) and on day 5. Statement of satisfaction was given on day 5. The change in RSCL scores between day 5 and day 1 was calculated and compared in three subgroups of patients: those very satisfied (n = 55), satisfied (n = 65), and unsatisfied with antiemetic treatment (n = 16). Patient statement of satisfaction was related to psychological distress (p = 0.002), physical symptom distress (p = 0.002), and activity level (p = 0.002). It was also related to the control of nausea (p < 0.01) and vomiting (p < 0.0001). We suggest that patient statement of satisfaction with antiemetic treatment could be an outcome measure for response assessment in antiemetic trials.

Adult↗
PubMed1998

A comparison of the efficacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetics for elective outpatient surgical procedures. S3A-409 and S3A-410 Study Groups.

UNLABELLED: Two identical, randomized, double-blind, placebo-controlled studies enrolled 2061 adult surgical outpatients at high risk of postoperative nausea and vomiting (PONV) to compare i.v. ondansetron 4 mg with droperidol 0.625 mg and droperidol 1.25 mg for the prevention of PONV. The antiemetic drugs or placebo were administered i.v. 20 min before the induction of anesthesia with a barbiturate compound, followed by maintenance with N2O/isoflurane/enflurane. Nausea, emetic episodes, adverse events, and patient satisfaction were analyzed for the 0 to 2 h and 0 to 24 h postoperative periods. In the 0 to 2 h postoperative period, there was a complete response (no emesis or rescue antiemetic) in 46% of subjects given placebo (P < 0.05 versus antiemetic groups), in 62% given ondansetron, in 63% given droperidol 0.625 mg, and in 69% given droperidol 1.25 mg (P < 0.05 versus ondansetron). In the 0 to 24-h postoperative period, there were no significant differences in complete response between the ondansetron and droperidol 0.625 or 1.25 mg groups; all groups remained superior to placebo. The proportion of patients without nausea during the 0 to 24 h postoperative period was greater in the antiemetic groups compared with the placebo group; however, droperidol 1.25 mg was more effective than ondansetron 4 mg or droperidol 0.625 mg (43% vs 29% or 29%, respectively). Headache incidence was higher in the ondansetron group compared with either droperidol group. Patient satisfaction scores did not differ significantly among antiemetic treatment groups, although all were superior to placebo. In conclusion, all antiemetic treatment regimens were superior to placebo for the prevention of PONV in the immediate postoperative period; however, droperidol 1.25 mg was more efficacious than ondansetron during the early recovery period (0-2 h). There were no significant differences between ondansetron and either droperidol dose for emesis prevention during the 0 to 24 h postoperative period. IMPLICATIONS: More than 2000 patients at high risk of postoperative nausea and vomiting were given either placebo, ondansetron 4 mg, or droperidol 0.625 mg or 1.25 mg i.v. before the administration of general anesthesia. After surgery, the incidence of nausea, vomiting, medication side effects, and patient satisfaction were evaluated for 24 h. Droperidol 0.625 or 1.25 mg i.v. compared favorably with ondansetron 4 mg i.v. for the prevention of postoperative nausea and vomiting after ambulatory surgery.

Adolescent↗
PubMed1998

Use of granisetron in patients refractory to previous treatment with antiemetics.

A multicenter, open-label, compassionate-use trial studied the antiemetic efficacy and tolerability of granisetron in patients who had failed other antiemetic therapies in previous cycles of cytostatic chemotherapy. The antiemetics that had been used previously included metoclopramide, dexamethasone and ondansetron. A total of 517 patients, 456 of whom had failed other antiemetics, were treated in up to 15 successive cycles of chemotherapy. The numbers of patients treated in the first six of these cycles were large enough to allow the drawing of meaningful conclusions from the results. During that period, a complete response was achieved in 53-60% of patients. In addition, antiemetic efficacy was sustained throughout these six repeated treatment cycles. Granisetron was less effective against high-dose cisplatin chemotherapy than against other cytostatic regimens. The treatment was well tolerated--the main adverse events reported were headache and constipation; no serious adverse events were considered to be attributable to the drug. It is concluded that granisetron treatment was effective and well tolerated in patients who had previously failed other antiemetic therapies, including treatment with 5-hydroxytryptamine3 antagonists.

Adolescent↗
PubMed1998

Single-dose oral granisetron has equivalent antiemetic efficacy to intravenous ondansetron for highly emetogenic cisplatin-based chemotherapy.

PURPOSE: To compare the antiemetic efficacy of a single dose of an oral antiemetic (granisetron 2 mg) with a single dose of an intravenous (i.v.) antiemetic (ondansetron 32 mg) given before cisplatin-based chemotherapy. PATIENTS AND METHODS: This was a multicenter, randomized, double-blind, parallel-group study. Patients (N = 1,054) scheduled to receive cisplatin (> or = 60 mg/m2)-based chemotherapy were randomized to receive either 2 mg of oral granisetron tablets 1 hour before chemotherapy (n = 534) or i.v. ondansetron (32 mg) 30 minutes before chemotherapy (n = 520). The primary efficacy end point was total control (no emesis, no nausea, and no use of antiemetic rescue medication) over the initial 24 hours after the start of chemotherapy. Dexamethasone or methylprednisolone were permitted, but not required, as concomitant prophylactic antiemetics. RESULTS: Total control was equivalent 24 hours after cisplatin chemotherapy for single-dose oral granisetron (54.7%) and i.v. ondansetron (58.3%) (95% confidence interval [CI], -9.6 to 2.4). Similar proportions of patients remained nausea-free in the granisetron group (55.4%) and the ondansetron group (59%) (95% CI, -9.6 to 2.4). The rate of complete control of emesis was 61.2% in the granisetron group and 67.1% in the ondansetron group (95% CI, -11.7 to -0.1). Both treatment regimens were well tolerated, with similar patterns of adverse reactions, generally of a mild degree. The most common side effects included constipation (14%), headache (15%), and diarrhea (10%). CONCLUSION: Oral granisetron, administered as a single 2-mg dose, provided equivalent total antiemetic control when compared with i.v. ondansetron (32 mg) in patients who received highly emetogenic, cisplatin-based chemotherapy.

Administration, Oral↗
PubMed2005

Optimal timing of acustimulation for antiemetic prophylaxis as an adjunct to ondansetron in patients undergoing plastic surgery.

We designed this study to evaluate the antiemetic efficacy of transcutaneous electrical acupoint stimulation in combination with ondansetron when applied before, after, or both before and after plastic surgery. A randomized, double-blind, sham-controlled study design was used to compare three prophylactic acustimulation treatment schedules: preoperative--an active device was applied for 30 min before and a sham device for 72 h after surgery; postoperative--a sham device was applied for 30 min before and an active device for 72 h after surgery; and perioperative--an active device was applied for 30 min before and 72 h after surgery (n = 35 per group). All patients received a standardized general anesthetic, and ondansetron 4 mg IV was administered at the end of surgery. The incidence of vomiting/retching and the need for rescue antiemetics were determined at specific time intervals for up to 72 h after surgery. Nausea scores were recorded with an 11-point verbal rating scale. Other outcome variables assessed included discharge times (for outpatients), resumption of normal activities of daily living, complete antiemetic response rate, and patient satisfaction with antiemetic therapy and quality of recovery. Perioperative use of the ReliefBand significantly increased complete responses (68%) compared with use of the device before surgery only (43%). Median postoperative nausea scores were significantly reduced in the peri- and postoperative (versus preoperative) treatment groups. Finally, patient satisfaction with the quality of recovery (83 +/- 16 and 85 +/- 13 vs 72 +/- 18) and antiemetic management (96 +/- 9 and 94 +/- 10 vs 86 +/- 13) on an arbitrary scale from 0 = worst to 100 = best was significantly higher in the groups receiving peri- or postoperative (versus preoperative) acustimulation therapy. For patients discharged on the day of surgery, the time to home readiness was significantly reduced (114 +/- 41 min versus 164 +/- 50 min; P < 0.05) when acustimulation was administered perioperatively (versus preoperatively). In conclusion, acustimulation with the ReliefBand was most effective in reducing postoperative nausea and vomiting and improving patients' satisfaction with their antiemetic therapy when it was administered after surgery.

Activities of Daily Living↗
PubMed2006

The use of oral granisetron versus intravenous ondansetron for antiemetic prophylaxis in patients undergoing laparoscopic surgery: the effect on emetic symptoms and quality of recovery.

Based on comparative studies in patients receiving emetogenic chemotherapy, it has been suggested that granisetron would be more effective than ondansetron for the prevention of postdischarge nausea and vomiting (PDNV). However, there have been no direct comparisons of these two popular 5-HT3 antagonists with respect to PDNV and quality of recovery. We designed this randomized, double-blind study to compare the antiemetic efficacy of oral granisetron (1 mg) to a standard IV dose of ondansetron (4 mg) when administered for antiemetic prophylaxis as part of a multimodal regimen in a laparoscopic surgical population. A total of 220 patients undergoing laparoscopic surgery with a standardized general anesthetic technique were enrolled in this prospective study at two major medical centers. Patients were randomly assigned to one of two prophylactic treatment groups: the control (ondansetron) group received an oral placebo 1 h before surgery and ondansetron, 4 mg IV, at the end of the surgery, and the granisetron group received granisetron, 1 mg per os, 1 h before surgery, and normal saline, 2 mL IV, at the end of the surgery. The early recovery profiles, requirement for rescue antiemetics, incidence of PDNV, and the side effects were recorded over the 48 h study period. In addition, nausea scores were assessed using an 11-point verbal rating scale at specific intervals in the postoperative period. The quality of recovery and patient satisfaction scores were recorded at 48 h after surgery. The demographic characteristics were similar in the two prophylaxis treatment groups, as well as the recovery times to patient orientation, oral intake, and hospital discharge. The incidences of PDNV, requirements for rescue antiemetics, and quality of recovery did not differ between the two study groups. The antiemetic drug acquisition costs to achieve comparable patient satisfaction with ondansetron and granisetron were US 25.65 dollars and 47.05 dollars, respectively. Therefore, ondansetron (4 mg IV) was more cost-effective than granisetron (1 mg per os) for routine antiemetic prophylaxis as part of a multimodal regimen in patients undergoing either outpatient or inpatient laparoscopic surgery.

Administration, Oral↗
PubMed2000

Computerized system for outcomes-based antiemetic therapy in children.

OBJECTIVE: To introduce a computerized data collection system used for an outcomes-based approach to antiemetic therapy in children, and to present data collected with this system in support of a new antiemetic dosing regimen. METHODS: A validated nausea/vomiting survey was used to collect data on nausea severity (NSEV), vomiting severity (VSEV), daily activity interference (DAI), and the number of vomiting episodes. NSEV, VSEV, and DAI were rated as 0 = none to 3 = severe. All children and/or their parents were surveyed following the completion of each highly emetogenic chemotherapy regimen. This survey was computerized and transferred to a handheld data entry unit. Time and motion studies were performed to compare the time required to collect nausea/vomiting data and transfer the data to a computerized database with the hand-held system versus traditional paper (manual) surveys. The hand-held technology was used to collect survey data for children receiving a new antiemetic regimen (daily ondansetron and dexamethasone [OD]), which was then compared with data obtained with a previously employed regimen (thrice-daily ondansetron and daily methylprednisolone [OM]). Statistical analysis and a cost-effectiveness analysis (CEA) were performed to compare the two antiemetic regimens. RESULTS: The mean time required for total data entry with the manual system was 5.2 minutes per survey versus 2.4 minutes with the hand-held technology (p = 0.0026). A total of 376 nausea/vomiting surveys in 78 children receiving the OM antiemetic regimen were compared with 153 surveys in 38 children treated with the OD regimen. The mean survey scores were as follows: NSEV (1.2 vs. 0.8), VSEV (1.0 vs. 0.7), DAI (1.0 vs. 0.7), and number of vomiting episodes (4.3 vs. 2.1) for OM and OD, respectively; all were significantly lower with the OD regimen (p < 0.05). The percentage of patients with complete control of nausea and vomiting (19.2% vs. 39.2%) and good control (55.6% vs. 65.4%) were significantly greater with the OD regimen (p < 0.05). The CEA revealed that the OD resulted in a reduction of approximately $31 per patient for good protection and a $258 reduction for complete protection from nausea and vomiting. CONCLUSIONS: A computerized outcomes-based system aided by handheld technology allowed for more prompt and efficient collection of nausea/vomiting data. The OD antiemetic regimen was shown to be a more cost-effective alternative for children receiving severely emetogenic chemotherapy.

Antiemetics↗
PubMed2004

Same old story? Do we need to modify our supportive care treatment of elderly cancer patients? Focus on antiemetics.

The incidence of cancer is highest among individuals > or =65 years of age. Physiological changes associated with aging, such as cognitive decline, renal and hepatic dysfunction, can often complicate treatment options, and the elderly represent a particular challenge to the oncologist because of the high incidence of comorbidity and polypharmacy. Effective supportive care is of particular importance in elderly cancer patients as they may recover less satisfactorily if adverse events are poorly controlled. Nevertheless, evidence suggests that supportive care agents, for example, antiemetics, are underutilised in this patient population. Chemotherapy and radiotherapy regimens are frequently associated with nausea and vomiting--symptoms that can have deleterious effects on vulnerable patients if not adequately managed. The serotonin 5-HT3-receptor antagonists represent a class of antiemetics that are currently regarded as the gold standard treatment for chemotherapy- and radiotherapy-induced nausea and vomiting. They are recommended as first-line treatment for patients at moderate-to-high risk of emesis. However, antiemetic guidelines do not differentiate between these agents and, more importantly, do not contain specific recommendations for the elderly. Pharmacological differences exist between the commonly available 5-HT3-receptor antagonists (dolasetron, granisetron, ondansetron, tropisetron and palonosetron), namely receptor sensitivity, duration of action, metabolism and tolerability profile. Of particular concern with prescriptions to elderly cancer patients is the convenience of once-daily administration, the low potential for drug-drug interactions and cardiovascular adverse effect profile. Moreover, the addition of the newly approved neurokinin NK1-receptor antagonist aprepitant to the choice of antiemetic regimen may complicate therapy and exacerbate the drug-drug interaction risk in elderly patients. Therefore, the use of antiemetics that are well tolerated and with the lowest risk of drug-drug interactions is imperative in this patient population and will enable even those patients with several comorbidities and a high level of polypharmacy to receive effective antiemetic therapy.

Aged↗
PubMed2001

Ondansetron: a review of its use as an antiemetic in children.

UNLABELLED: Ondansetron, a selective serotonin (5-hydroxytryptamine; 5-HT) 5-HT3 receptor antagonist, is an antiemetic agent available for use in adults and children. In children receiving ondansetron (multiple 5 mg/m2 or 0.15 mg/kg intravenous and/or oral doses) in addition to chemotherapy in 2 large (n > 100) non-comparative analyses, < or =2 emetic episodes were observed in 33 and 40% of cisplatin recipients, 48 and 68% of ifosfamide recipients, and 70 and 72% of patients receiving other chemotherapeutic regimens. In comparative trials, ondansetron was significantly more effective at reducing nausea and vomiting than metoclopramide or chlorpromazine (both combined with dexamethasone), although the incidence of delayed symptoms were similar between children receiving ondansetron and metoclopramide. In addition, dexamethasone significantly improved the antiemetic efficacy of ondansetron in 1 randomised trial. When used in children undergoing conditioning therapy (including total body irradiation) prior to bone marrow transplantation, ondansetron was significantly better at controlling nausea and vomiting than combined perphenazine and diphenhydramine therapy. In dose-ranging and large placebo-controlled trials, intravenous (0.075 to 0.15 mg/kg) or oral (0.1 mg/kg) ondansetron was significantly more effective than placebo in preventing emesis in children undergoing surgery associated with a high risk of postoperative nausea and vomiting (PONV) including tonsillectomy or strabismus repair. In comparative studies, intravenous administration of ondansetron 0.1 to 0.15 mg/kg was significantly superior to droperidol 0.02 to 0.075 mg/kg or metoclopramide 0.2 to 0.25 mg/kg in preventing emesis in children undergoing various surgical procedures. In comparison with other antiemetics, including prochlorperazine and dimenhydrinate, ondansetron generally showed greater prophylactic antiemetic efficacy. Ondansetron combined with dexamethasone was significantly more effective than ondansetron or dexamethasone alone, as was the combination of ondansetron with a propofol-based anaesthetic compared with either agent alone. Ondansetron is generally well tolerated in children, rarely necessitating treatment withdrawal. The most frequently reported adverse events were mild to moderate headache, constipation and diarrhoea in patients receiving chemotherapy. Wound problems, anxiety, headache, drowsiness and pyrexia were reported most frequently in patients postsurgery. CONCLUSIONS: Ondansetron has shown good efficacy in the prevention of acute nausea and vomiting in children receiving moderately or highly emetogenic chemotherapy and/or irradiation, particularly when combined with dexamethasone. In the chemotherapy setting, ondansetron is significantly better than metoclopramide and chlorpromazine and has a more favourable tolerability profile. In children undergoing surgery, ondansetron demonstrated superior prophylactic antiemetic efficacy compared with placebo, droperidol and metoclopramide, and was relatively free of adverse events. Ondansetron is thus an effective first-line antiemetic in children undergoing chemotherapy, radiotherapy and surgery.

Adolescent↗
PubMed1999

The efficacy and cost effectiveness of new antiemetic guidelines.

PURPOSE/OBJECTIVES: To develop antiemetic guidelines to improve efficacy, optimize nursing and pharmacy time, increase compliance, and enhance cost savings. DESIGN: Prospective, descriptive survey. SETTING: Outpatient oncology clinic in a large metropolitan city in the mid-Atlantic United States. SAMPLE: 90 patients were evaluated for the study; 52 patients met the eligibility criteria. METHODS: A standard antiemetic form was developed containing the emetogenic classification of the chemotherapeutic drugs and the recommended antiemetic regimen. A patient diary and visual analog scale measured patient satisfaction with the regimen-measured outcomes. MAIN RESEARCH VARIABLES: Episodes of nausea and vomiting, classification of chemotherapeutic drugs, and patient satisfaction. FINDINGS: Seventy-nine percent of patients receiving highly emetogenic chemotherapy demonstrated complete protection from nausea and vomiting during the first 24 hours post-therapy. All the patients receiving moderately and mildly emetogenic regimens achieved complete protection. Patients who received cisplatin-containing regimens and were on the delayed regimen of antiemetics demonstrated complete protection on days two through seven. The mean overall score for patient satisfaction with the regimen was 89 mm on a 100 mm visual analog scale. CONCLUSIONS: The new oral antiemetic regimen compared favorably with published data, was well-tolerated, and resulted in lower pharmacy and nursing costs, with a cost saving potential of $20,000 per year. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses must be able to implement state-of-the-art knowledge of chemotherapy, antiemetics, and nonpharmacologic interventions to effectively manage the care of patients receiving chemotherapy. This must be performed to achieve cost effectiveness as well as useful clinical outcomes.

Adult↗
PubMed2003

[Evaluation of QOL with orally disintegrating antiemetic tablets in outpatient chemotherapy].

An investigation into the effect of orally disintegrating antiemetic tablets (ramosetron OD 0.1 mg) on 16 outpatients undergoing chemotherapy for recurrent gynecologic malignancies was carried out using a questionnaire to evaluate their quality of life (QOL). The patients were divided into 2 groups: a control group in which the patients received only an intravenous drip infusion of 0.3 mg of ramosetron on the day of their chemotherapy and a double antiemetic therapy group in which the patients were treated with orally disintegrating antiemetic tablets for 4 days in addition to the intravenous drip. When outpatient chemotherapy (paclitaxel 80 mg/m2/1 h div + CBDCA AUC 2/1 h div) was performed, a comparison was made between the 2 groups, based on the results of a QOL questionnaire for antiemetic therapy during cancer chemotherapy (Ishihara's QOL survey method). This study found a greater improvement in QOL in the double antiemetic therapy group on days 2 to 4, a period when deterioration in QOL is usually observed. These findings suggest that orally disintegrating antiemetic tablets as a measure to reduce delayed nausea and vomiting are useful for improving QOL.

Administration, Oral↗
PubMed1994

[The clinical development of an antiemetic in oncology. A meta-analysis].

BACKGROUND: To perform meta-analysis (MT) on antiemetic efficacy of LAS 30451 (Pancopride) in high and moderately emetogenic chemotherapy (CT). METHODS: The results of 13 phase II and III clinical trials comparing the efficacy of different doses of the drug under study with or without corticoids, or versus standard treatment (methochlopramide and/or corticosteroids and diphenhydramine) were included. The principal variable was complete protection in the acute phase (0 vomiting following 24 h post treatment). RESULTS: The design was open in 3, simple blind in 4 and double blind in 6, with 11 being parallel and 2 crossed. The trials were carried out in 39 centers of 5 countries with 999 patients who received 1,292 cycles of antiemetic treatment. On comparison of lower or equal doses at 0.2 mg/kg of pancopride vs higher doses global OR was 0.94 (p = 0.72) with a global percentage difference (GPD) of -4.69% (p = 0.23) and GPD equal to -6.90. On treatment without cysplatin global OFR was equal to 1.10 (p = 0.69) with GPD of -8.99% favoring dosage lower than or equal to 0.2 mg/kg. The dexamethasone increased antiemetic efficacy of pancopride in both treatments with cysplatin (50% vs 76%, p = 0.08) and without cysplatin (50% to 89%, p = 0.02). When pancopride was compared with that of standard antiemetic treatment (methochlopramide and/or corticosteroids) global OR was equal to 0.69 (p = 0.07) with GPD of -6.84% favoring the control treatment. In CT containing cysplatin, global OR was equal to 0.73 (p = 0.38) with GPD of -3.28% and with CT without cysplatin the global OR was 0.66. (p = 0.12) with a GPD of -4.92% in both cases favoring the control treatment. CONCLUSIONS: No statistically significant differences were observed with regard to the antiemetic efficacy of pancopride on comparison of different doses of the drug. The antiemetic efficacy of pancopride increases when given together with dexamethasone. The efficacy of pancopride is lower to that of methochlopramide in combination with corticosteroids and/or diphenhydramine although the differences are not statistically significant.

Antiemetics↗
PubMed1997

[Antiemetic efficacy of granisetron in repeated CAF chemotherapy after breast cancer operation].

The antiemetic efficacy of granisetron in repeated CAF chemotherapy after breast cancer operation was investigated. Twenty-three patients who were treated with repeated CAF chemotherapy after breast cancer operation received drip-infused granisetron (3 mg/body) to prevent nausea and vomiting. Antiemetic efficacy was evaluated by means of the severity of nausea and the frequency of vomiting. The antiemetic efficacy rate of the drug was 74.4%. However, the average rate of antiemetic efficacy was 86.9% on the first through the sixth administration of the chemotherapy (first period). 75.9% on the seventh through the twelfth (second period), 48.4% on the thirteenth through the eighteenth (third period), and 31.8% on the nineteenth through the twenty-fourth (fourth period). There were significant differences in the antiemetic efficacy rate among the first, second and third periods. The antiemetic efficacy of granisetron decreased significantly by repeated CAF chemotherapy.

Adult↗
PubMed1997

[Multi-drug antiemetic treatment and effect of treatment duration of concurrent steroids--for complete control of chemotherapy-induced nausea/vomiting in gynecological cancer].

Antiemetic effect and safety of concurrent administration of ondansetron and other antiemetics (dexamethasone, domperidone and ethyl loflazepate), given for complete suppression of nausea/vomiting, were examined in 46 patients (109 courses) with gynecological cancer receiving single high-dose of cisplatin or carboplatin. As for the delayed emesis, antiemetic effect depending on the steroid treatment duration, given concurrently to ondansetron, was compared. The results were as follows; 1. In 78 courses, anticancer drugs were given concurrently to cisplatin or carboplatin only on Day 1. In the remaining 31 courses, those drugs were concurrently administered up to Day 6 at the longest. 2. Complete suppression (i.e., no onsets) rate of acute emesis was 64.2% (70/109 courses) for nausea, and 84.4% (92/109 courses) for vomiting. 3. When the complete suppression depending on duration of concomitant steroid was examined mainly in patients receiving CAP (cyclophosphamide, adriamycin and cisplatin), higher antiemetic effect, especially in nausea, was observed in those on concomitant steroids for 3 days compared to that for 1 day. 4. The food intake rate improved along with nausea symptoms. 5. No adverse event or laboratory abnormality due to the multi-antiemetic treatment was observed. Based on the above, the efficacy of the antiemetic treatment in this study was confirmed. In delayed emesis, concurrent steroids given for 3 days after chemotherapy were considered effective and were also regarded to improve food intake.

Administration, Oral↗
PubMed2002

Treatment of nausea and emesis during cancer chemotherapy. Discrepancies between antiemetic effect and well-being.

The purpose of this study was to describe the relationship between antiemetic effect and well-being in patients receiving four different antiemetic treatment strategies, representing developments in the field during the past 15 years. A total of 162 women with ovarian cancer receiving cisplatin-based chemotherapy and participating in two comparative antiemetic trials were enrolled and studied for up to four cycles. In study I, a combined antiemetic strategy including a nursing intervention program (increased access to support and increased information) and antiemetics based on high-dose metoclopramide and dexamethasone was compared with the standard antiemetic treatment during the 1980s. In study II, ondansetron plus dexamethasone/placebo was evaluated. The assessment methods used were similar for all patients. Questionnaires were used to assess frequency, intensity, and duration of nausea, emesis, anxiety, pain, and well-being at baseline, and for acute (24 hours after chemotherapy) and delayed (up to 2 weeks after chemotherapy) symptoms. The mean intensity of acute nausea during the first cycle was higher in the groups in study I, as compared to the groups in study II. The group receiving a nursing intervention reported better well-being than the other groups. Duration of nausea was an important predictor of well-being, even when nausea intensity was controlled. Apart from nausea intensity, nausea duration and nursing interventions may be important determinants for well-being during chemotherapy.

Drug-Related Side Effects and Adverse Reactions↗
PubMed1991

Antiemetic efficacy of cimetidine randomized, double-blind, crossover study with dexamethasone in cancer patients receiving emetogenic chemotherapy.

In a randomized, double-blind, crossover study the antiemetic effect of cimetidine was compared with that of dexamethasone in cancer patients receiving emetogenic chemotherapy. Thirty-two patients were evaluable and all were chemotherapy-naive. Eight patients (25%) received high doses of cisplatin, 17 (53%) had cyclophosphamide in combination treatment, 2 (6%) received adriamycin, and 1 another chemotherapy of less emetogenic potential. Complete protection (CR) rates of 59.4% and 62.5% were achieved with cimetidine and dexamethasone, respectively. In addition, three (9.4%) and 1 (3%) patients attained partial protection with cimetidine and dexamethasone, respectively. No significant difference was noted between the two antiemetic therapies (p = 0.07). Although CR has not been achieved in any of those patients who received cisplatin, a comparable antiemetic effect was attained. Both antiemetic regimens were well tolerated with minimal side effects. We conclude that the antiemetic potential of cimetidine and its safety deserve further investigation in a larger study, perhaps in combination with other antiemetic agents.

Antineoplastic Combined Chemotherapy Protocols↗