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PubMed2007

Clinical and mechanistic aspects of glucocorticoid-induced chemotherapy resistance in the majority of solid tumors.

BACKGROUND: Glucocorticoids have been used widely in conjunction with cancer therapy due to their ability to induce apoptosis in hematological cells and to prevent nausea and emesis. However, recent data including ours, suggest induction of therapy-resistance by glucocorticoids in solid tumors, although it is unclear whether this happens only in few carcinomas or is a more common cell type specific phenomenon. MATERIAL AND METHODS: We performed an overall statistical analysis of our new and recent data with 157 tumor probes evaluated in vitro, ex vivo and in vivo. The effect of glucocorticoids on apoptosis, viability and cell cycle progression under diverse clinically important questions was examined. RESULTS: New in vivo results demonstrate glucocorticoid-induced chemotherapy resistance in xenografted prostate cancer. In an overall statistical analysis we found glucocorticoid-induced resistance in 89% of 157 analysed tumor samples. Resistance is common for several cytotoxic treatments and for several glucocorticoid-derivatives and due to an inhibition of apoptosis, promotion of viability and cell cycle progression. Resistance occurred at clinically achievable peak plasma levels of patients under anti-emetic glucocorticoid therapy and below, lasted for a long time, after one single dose, but was reversible upon removal of glucocorticoids. Two nonsteroidal alternative anti-emetic agents did not counteract anticancer treatment and may be sufficient to replace glucocorticoids in cotreatment of carcinoma patients. CONCLUSION: These data demonstrate the need for prospective clinical studies as well as for detailed mechanistic studies of GC-induced cell-type specific pro- and anti-apoptotic signalling.

Animals↗
PubMed2005

Establishment of a novel multiplex PCR assay and detection of toxigenic strains of the species in the Bacillus cereus group.

Five different enterotoxins and one emetic toxin of Bacillus cereus have been characterized. To amplify all of the enterotoxin and emetic-specific sequences of the species in the B. cereus group, a multiplex PCR with 12 primer pairs was established. In developing the assay method, a common terminal sequence at the 3' ends of all primers was chosen and a hot start Taq polymerase was used to overcome primer dimer formation. The assay was successfully applied to analyze the toxigenic potential of 162 food-poisoning and food-related strains. Results showed that there were 10 toxigenic patterns for all the test strains. All of the B. cereus strains carried at least one toxin gene. More than 70% of Bacillus mycoides strains carried no known toxin genes. The toxin profiles and toxin genes of B. mycoides strains were significantly different from B. cereus strains (P < 0.05), although the two species were closely related. The results suggest that many B. mycoides strains might be less prone to cause food poisoning. They also indicate the importance of detecting the toxin genes together with the detection of the species in the B. cereus group.

Bacillus cereus↗
PubMed2005

Bacillus cereus food poisoning and its toxins.

The genus Bacillus includes members that demonstrate a wide range of diversity from physiology and ecological niche to DNA sequence and gene regulation. The species of most interest tend to be known for their pathogenicity and are closely linked genetically. Bacillus anthracis causes anthrax, and Bacillus thuringiensis is widely used for its insecticidal properties but has also been associated with foodborne disease. Bacillus cereus causes two types of food poisoning, the emetic and diarrheal syndromes, and a variety of local and systemic infections. Although in this review we provide information on the genus and a variety of species, the primary focus is on the B. cereus strains and toxins that are involved in foodborne illness. B. cereus produces a large number of potential virulence factors, but for the majority of these factors their roles in specific infections have not been established. To date, only cereulide and the tripartite hemolysin BL have been identified specifically as emetic and diarrheal toxins, respectively. Nonhemolytic enterotoxin, a homolog of hemolysin BL, also has been associated with the diarrheal syndrome. Recent findings regarding these and other putative enterotoxins are discussed.

Bacillus cereus↗
PubMed1993

Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy. The Ondansetron Study Group.

OBJECTIVE: To evaluate the efficacy and safety of oral ondansetron (Zofran) as an antiemetic in patients receiving cyclophosphamide-based chemotherapy. DESIGN: A multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted between March 1989 and January 1990. SETTING: Twenty-seven oncology centers including university hospitals, community cancer centers, and private medical oncology practices. PATIENTS: A total of 349 chemotherapy-naive patients having their first cycle of cyclophosphamide (> or = 450 mg/m2)-based chemotherapy. Patients also received methotrexate (> or = 30 mg/m2) or doxorubicin (> or = 35 mg/m2). All patients were evaluated for safety and 318 (91%) were evaluated for efficacy. INTERVENTIONS: Patients were randomly assigned to one of four treatment groups: placebo, 1 mg, 4 mg, or 8 mg of ondansetron. Assigned study medication was taken three times per day for 3 consecutive days. MEASUREMENTS: Time and number of emetic episodes as well as degree of nausea were recorded by patients for each of the 3 study days. RESULTS: Compared with placebo, all three doses of ondansetron were superior (P < 0.001) in preventing vomiting and controlling nausea. A complete response (no emetic episodes) was observed in 19%, 57%, 65%, and 66% of patients in the placebo, 1-mg, 4-mg, and 8-mg ondansetron groups, respectively. For patients who received higher-dose cyclophosphamide and doxorubicin, a dose-related trend in antiemetic efficacy of ondansetron was observed. Mild headache and constipation were the most frequently reported adverse events. No extrapyramidal reactions were observed. CONCLUSION: Oral ondansetron is a safe and effective antiemetic that is more efficacious than placebo for patients receiving cyclophosphamide-based chemotherapy.

Administration, Oral↗
PubMedDate not supplied

[Effect of unithiol on cystamine toxicity in dogs].

In experiments with dogs it was shown that administration of unithiol before administration of cystamine decreases toxic effect of the last: period of excitation induced by cystamine is shortened, the time of emetic reaction decreases and expression of the emetic reaction to this preparation is diminished, the recorded EKG changes of conditions of heart decrease.

Animals↗
PubMed1998

A Comparison of Oral Ondansetron and Intravenous Granisetron for the Prevention of Nausea and Emesis Associated with Cisplatin-Based Chemotherapy.

PURPOSE: To compare the efficacy and safety of oral ondansetron with i.v. granisetron each given as a single dose prior to administration of highly emetogenic cisplatin chemotherapy. PATIENTS AND METHODS: Chemotherapy-naive patients with histologically confirmed malignancies were randomized to receive a single 24 mg ondansetron hydrochloride tablet plus a 50 ml i.v. infusion of normal saline, or a single 10 µg/kg (50 ml) i.v. infusion of granisetron plus a placebo tablet in this multicenter, double-blind, parallel-group trial. Study drug was administered 30 min prior to a single i.v. infusion of cisplatin (50-75 mg/m&sup2;), given over a period of </= 3 h. Concurrent administration of corticosteroids was not allowed. Efficacy measurements included the number of emetic episodes, need for rescue medication, and patient assessments of nausea and appetite. Complete response (CR) was defined as no emetic episodes, rescue, or withdrawal; major response was defined as one or two episodes. Safety was evaluated by monitoring adverse events and changes in laboratory parameters. RESULTS: A total of 371 patients entered the study and received study drug, of whom 184 received ondansetron and 187 received granisetron. For all parameters tested, a single 24 mg oral ondansetron tablet was at least as effective as i.v. granisetron. CR was achieved in 58% of ondansetron-treated patients and 51% of granisetron-treated patients (95% confidence interval on the difference: -4% to 17%). Subjective assessments revealed no difference with regard to complete control of nausea, appetite, or satisfaction with antiemetic therapy. Both drugs were well tolerated; the most common adverse event was headache. CONCLUSION: A single 24 mg oral dose of ondansetron is at least as safe and effective as a single i.v. infusion of 10 µg/kg of granisetron in preventing nausea and vomiting induced by highly emetogenic cisplatin chemotherapy.

Journal Article↗
PubMedDate not supplied

Antiemetic efficacy of single-dose oral granisetron (1 mg vs 2 mg) with moderately emetogenic chemotherapy.

PURPOSE: To compare the efficacy of oral granisetron, 1 mg and 2 mg, administered as one dose in patients who receive moderately emetogenic chemotherapy. PATIENTS AND METHODS: Chemotherapy-naïve patients, scheduled to receive intravenous cyclophosphamide (500 to 1200 mg/m2) or carboplatin (> or = 300 mg/m2), were stratified by dexamethasone/methylprednisolone use (+ DEX, n = 92) or nonuse (- DEX, n = 5). Patients were randomized to one dose of either 1 mg (n = 48) or 2 mg (n = 49) of granisetron administered 60 minutes before chemotherapy. Known important prognostic variables (gender, age, alcohol) were well balanced between groups. RESULTS: Using the most rigorous criterion of total control (no emetic episodes, no nausea, no rescue therapy during the first 24 hours), response rates were 54.2% (26/48) and 57.1% (28/49) in patients receiving 1 mg and 2 mg of granisetron, respectively (95% confidence interval, -0.17, 0.23). Total control rates in patients who received 1 mg and 2 mg of granisetron + DEX were also comparable: 57.8% (26/45) and 55.3% (26/47), respectively. Response rates were similar for the parameters of nausea, emesis, and complete response (no emetic episodes, no more than mild nausea, no antiemetic rescue). Among all patients, one (2.1%) who received 1 mg of granisetron and three (6.1%) who received 2 mg experienced severe nausea. The proportions of 1- and 2-mg-treated patients who received rescue therapy within the first 24 hours were 31.3% (15/48) and 34.7% (17/49), respectively. Reported adverse experiences were generally mild in severity. DISCUSSION: The results of this trial demonstrate good control of emesis with a single 1-mg dose of oral granisetron, with efficacy that compares favorably with that of a 2-mg dose.

Administration, Oral↗
PubMed2000

Prevention of acute and delayed cisplatin-induced nausea and vomiting with intravenous ondansetron plus intravenous dexamethasone.

BACKGROUND: We conducted a prospective study to evaluate the anti-emetic effect of cisplatin-induced nausea and vomiting with intravenous (i.v.) ondansetron plus i.v. dexamethasone. METHODS: One hundred forty-six chemotherapy (CT)-naive patients were enrolled in the study. They were scheduled to receive cisplatin 50 to 100 mg/m2 (mean, 53 mg/m2) on day 1 followed immediately by continuous infusion of 5-fluorouracil with or without other CT agents on the subsequent days. Three 8 mg doses of ondansetron i.v. were given at 4-hour intervals plus 20 mg dexamethasone i.v. infusions from the start of CT, followed by 5 mg dexamethasone i.v. every 12 hours, and the administration of dexamethasone was discontinued after the completion of CT. RESULTS: The rates of complete protection from acute and delayed vomiting/nausea obtained in these patients were 97.3%/93.2% and 71.2%/60.3%, respectively. The rates of complete protection from both acute and delayed nausea were 70.5% and 58.9%, respectively. By comparison, the total control rate of vomiting was less in female patients than in male patients (p = 0.017), and the total control rate of nausea was lower in the age group less than 50 years (p = 0.045). The time from the start of CT to the onset of nausea appeared to be earlier than that for vomiting (log-rank test, p = 0.045). Adverse events tended to be minor, with constipation and hiccups as the most common. CONCLUSION: These results indicate that i.v. ondansetron plus i.v. dexamethasone is a feasible anti-emetic therapy in an inpatient setting. I.v. ondansetron plus i.v. dexamethasone is highly effective in preventing acute cisplatin-induced nausea and vomiting.

Acute Disease↗
PubMed2000

Effect of a novel anti-inflammatory compound, YM976, on antigen-induced eosinophil infiltration into the lungs in rats, mice, and ferrets.

We evaluated the effects of YM976, a selective inhibitor of phosphodiesterase type 4, on antigen-induced eosinophil infiltration into the lungs in rats, mice, and ferrets. In rats, YM976 inhibited the accumulation of eosinophils at an oral ED(50) value of 1.7 mg/kg, and in C57Black/6 mice, exhibited a dose-dependent inhibition at an ED(50) value of 5.8 mg/kg. In the same dose range in the same mouse model, YM976 suppressed interleukin-5 production. We then compared the inhibitory effect of chronic administration with that of single administration in another rat model of eosinophilia induced by repeated antigen exposure. YM976 administered chronically offered more potent inhibition (ED(50) = 0.32 mg/kg p.o.) than a single dose (1.4 mg/kg p.o.). These results indicated that chronic administration is more effective in antigen-induced eosinophilia than a single administration. Emetogenicity is known to be a major adverse effect of phosphodiesterase type 4 inhibitors. We compared the anti-inflammatory activity of YM976 with its emetic activity in ferrets, in which it dose dependently suppressed eosinophil infiltration at an ED(50) value of 1.2 mg/kg, but induced no emesis at 10 mg/kg. This suggested that the compound exhibits a considerable dissociation between its anti-inflammatory and emetic effects. In summary, YM976 inhibited eosinophil infiltration in a dose-dependent manner in rats, mice, and ferrets. In ferrets, it suppressed antigen-induced eosinophil infiltration without emesis. Additionally, we demonstrated that the inhibitory effect on eosinophil infiltration was increased by chronic administration. In conclusion, YM976 is a promising drug for the treatment of diseases involving eosinophil activity, such as asthma.

Animals↗
PubMed2001

[Examination on efficacy and safety of concurrent use of ondansetron hydrochloride and steroid in lung cancer patients on cisplatin].

The anti-emetic effect and safety in patients receiving ondansetron hydrochloride (OND group) and concurrent use of ondansetron and dexamethasone (DEX group) in cases of acute and delayed onset emesis induced by a single high dose of cisplatin, given as a chemotherapy to lung cancer patients, were comparatively studied. The study subjects were 78 lung cancer patients. The OND group received 4 mg of ondansetron via slow intravenous injection on Day 1, 30 minutes prior to cisplatin, and for Days 2 to 5, the subjects orally received 4 mg ondansetron tablet each day. The DEX group received the same dose regimen of ondansetron as the OND group for Days 1-5, but in addition the subjects received dexamethasone injection in doses of 8 mg twice daily on Day 1 and 4 mg (1 mg QID) daily for Days 2-5. An anti-emetic effect against acute nausea and vomiting was achieved in 83.8% of the OND group and in a higher rate of 94.6% of the DEX group. Significantly better efficacy was seen in the DEX group as to the complete suppression rate of nausea and vomiting and the improvement of food intake. The group also achieved better efficacy in delayed onset of emesis. Two cases of adverse reactions (hiccups and elevation of ALT and BUN) were observed in the DEX group; however, since the symptoms were all mild, we did not consider there was any problem in safety. We conclude from the above findings that concurrent administration of ondansetron hydrochloride and dexamethasone is a clinically useful treatment for acute and delayed onset emesis induced by a single high dose of cisplatin given to lung cancer patients.

Aged↗
PubMed2001

[Examination on efficacy and safety of concurrent use of ondansetron hydrochloride and steroid in gynecological cancer patients on cisplatin].

The anti-emetic effect and safety in patients receiving ondansetron hydrochloride (OND group) and ondansetron and dexamethasone (DEX group) concurrently in cases of acute and delayed onset emesis induced by a single high dose of cisplatin, given as a chemotherapy to gynecological cancer patients, were comparatively studied. The study subjects were 139 gynecological cancer patients. The OND group received 4 mg of ondansetron via slow intravenous injection on Day 1, 30 minutes prior to cisplatin, and for Days 2 to 5, the subjects orally received 4 mg ondansetron tablet each day. The DEX group received the same dose regimen of ondansetron as the OND group for Days 1-5, but in addition the subjects received dexamethasone injection in doses of 8 mg twice daily on Day 1 and 4 mg (1 mg QID) daily for Days 2-5. An anti-emetic effect against acute nausea and vomiting was achieved in 47.9% of the OND group and in a higher rate of 84.2% of the DEX group. Significantly better efficacy was seen in the DEX group also in the complete suppression rate of nausea and vomiting and the improvement of food intake. The group also achieved better efficacy in delayed onset of emesis. Adverse reactions were observed in 2 cases (2 reports of headache) in the OND group and 5 cases (2 reports of hiccups, 2 headache, 2 diarrhea, one constipation, one hot facial flushes and one elevation of gamma-GTP) in the DEX group; however, since the symptoms were all mild, we did not consider there was any problem in safety. We conclude from the above findings that concurrent administration of ondansetron hydrochloride and dexamethasone is a clinically useful treatment for acute and delayed onset emesis induced by a single high dose of cisplatin given to gynecological cancer patients.

Antiemetics↗
PubMed2001

Use of reversal agents in day care procedures (with special reference to postoperative nausea and vomiting).

There is some confusion about the contribution of reversal of residual paralysis to the occurrence of postoperative nausea and vomiting. The aim of this review is to discuss whether antagonism of residual paralysis is a cause of postoperative nausea and vomiting, and to assess the risk of residual paralysis if the reversal is omitted. Data from a meta-analysis published before 1998 were considered, along with trials published after that date to assess the influence of reversal of residual paralysis on postoperative nausea and vomiting, and the likelihood of harm when antagonism was omitted. Moreover, an overview of pathophysiological consequences, incidence and clinical consequences of residual paralysis is given and the actual criteria of the adequacy of neuromuscular recovery presented. When emetic outcomes are combined across all trials and all different neostigmine doses, there is no beneficial effect from omitting neostigmine on postoperative nausea and vomiting, but there is some evidence of a dose-responsiveness with neostigmine; higher doses may have emetic properties. However, omitting reversal introduces a non-negligent risk of residual paralysis. An improved understanding of the pathological consequences of residual paralysis (i.e. impaired laryngeal and pharyngeal muscle function, alterations in hypoxic ventilatory control, reduced margin of safety) led to establishment of more rigorous criteria for defining adequacy of neuromuscular recovery. A train-of-four ratio of > or = 0.9 is now accepted as the index of adequate recovery of neuromuscular function. Applying this new definition, residual paralysis becomes a frequent adverse side-effect. Neuromuscular recovery should therefore be routinely monitored in ambulatory patients and residual paralysis prevented by reversing neuromuscular block.

Ambulatory Surgical Procedures↗
PubMedDate not supplied

[Comparative experimental study of antiemetic action of latranum in radiation-induced vomiting and vomiting caused by apomorphine].

The experiments on dogs showed that Latranum, a selective blocker of serotonin 5-HT3-receptors, has a moderate capacity to modify emetic reaction caused by dophamin-stimulating action of Apomorphinum. These results, taking in account of our preliminary experimental data obtained by a model of early radiation-induced emetic reactions, show that the high antiemetic effect of Latranum may affect another mechanisms of the initiation of early radiation-inducing vomiting which do not connect immediately with the chemoreceptor trigger zone.

Administration, Oral↗
PubMed2003

[Nausea and vomiting].

Nausea and vomiting are the most distressing side effects reported by patients undergoing CDDP-based cancer chemotherapy. Dopamine receptor antagonists and corticosteroids are used as anti-emetics for chemotherapy induced nausea and vomiting. Recently, a highly selective 5-HT3 receptor antagonist are proved to demonstrate antiemetic activity. 5-HT3 receptor antagonists are developed such as Granisetron, Ondansetron, Ramosetron, Azasetron. For acute emesis, complete control of vomiting was achieved in 80% of patients receiving 5-HT3 receptor antagonists. Though, it is reported to be only 20% effective for the complete control of delayed emesis. Psychiatric medications sometimes play a prominent role in the control of persisting emesis, particularly anticipatory or conditioned nausea. Nausea and vomiting are well controlled using various anti-emetics considering patient's condition and chemotherapy schedule.

Antineoplastic Agents↗
PubMed1992

Phase I and other dose-ranging studies of ondansetron.

Phase I studies of intravenous (IV) ondansetron in cancer patients receiving emetogenic chemotherapy were designed to assess the degree of antiemetic protection and pattern of adverse events produced by ondansetron at various doses. In a study of 44 patients receiving various forms of chemotherapy (including cisplatin), ondansetron was administered in three IV doses 2 hours apart beginning 30 minutes prior to chemotherapy. Antiemetic efficacy was seen at all dose levels (0.04 mg/kg to 0.35 mg/kg), with 54% of patients experiencing no vomiting and 76% experiencing two or fewer vomiting episodes within the first 24 hours. Overall, ondansetron was well tolerated, and no dose-limiting toxicity was observed. The most common adverse events were mild sedation, mild headache, and transient elevations of transaminases. In a second phase I study, 45 patients receiving cisplatin (median dose 100 mg/m2) were given ondansetron in three IV doses (range, 0.01 mg/kg to 0.48 mg/kg) 4 hours apart. There was no statistically significant difference in antiemetic efficacy among dose levels from 0.06 mg/kg to 0.48 mg/kg; however, there was a trend toward a decrease in the number of patients with failure of antiemetic protection at the higher exposures. Overall, 44% of patients had no emetic episodes, and 81% of patients had two or fewer emetic episodes within the first 24 hours. The number and intensity of adverse events, of which headache was the most common, appeared to increase at the 0.48 mg/kg dose level. A randomized double-blind study that compared three dose levels of ondansetron indicated that three doses of 0.15 mg/kg was superior in efficacy to three doses of 0.015 mg/kg, and not significantly different from three doses of 0.30 mg/kg. Dystonic reactions or akathisia were not noted in any study.

Antiemetics↗
PubMed1992

[Evaluation of SN-307 (ondansetron), given intravenously for the treatment of nausea and vomiting caused by anticancer drugs including cisplatin-open study].

The anti-emetic effect, safety and clinical usefulness of ondansetron for the treatment of nausea and vomiting caused by anticancer drugs including cisplatin, was evaluated by a multi-institutional study in patients with various malignancies. In this study, ondansetron was given intravenously with mainly a single dose of 4 mg to intervene nausea and vomiting. 1. Efficacy ratio of overall effects on nausea and emesis observed for 24 hours after treatment was 69.8%. 2. No side effect was observed. Laboratory tests showed temporary elevation of serum uric acid level in 1 patient in the group given 4 mg. 3. From these results, it seems that ondansetron, given intravenously after initial vomiting, was highly safe and clinically useful anti-emetic for the treatment of nausea and vomiting associated with anti-cancer drugs.

Adult↗
PubMed1992

Pharmacology of ondansetron.

Ondansetron is a highly potent and selective antagonist at 5-HT3 receptors. Its anti-emetic actions were first revealed by its ability to antagonize retching and vomiting induced by chemotherapy and radiotherapy in animals and man. Subsequently, the availability of labelled 5-HT3 receptor ligands allowed identification of 5-HT3 receptors, located at highest densities in the area postrema, nucleus tractus solitarius (NTS), in other areas of the brain, and on afferent terminals of the vagus nerve. Postoperative nausea and vomiting may be caused by various factors: the anaesthetic, associated drugs, the surgical procedure, movement of the patient, sex, weight and pain. These factors mediate their effects via the higher brain circuits, the vestibular nuclei, the chemoreceptor trigger zone in the area postrema, or the upper gastrointestinal tract via the vagus nerve, influencing motor and visceral emetic outputs in the hind-brain. It is hypothesized that ondansetron blocks nausea and vomiting by 5-HT3 receptor antagonism at two specific sites: (i) centrally, in the area postrema/NTS; and (ii) peripherally on vagus nerve terminals. The absence of other pharmacological effects of ondansetron ensures an absence of side-effects.

Animals↗
PubMed1992

The clinical development of ondansetron for use in the prevention and treatment of postoperative nausea and vomiting.

An international clinical trial programme has been established to assess the efficacy and safety of ondansetron in the prevention and treatment of postoperative nausea and vomiting. The programme included nine pilot studies and six key placebo-controlled studies. These studies have evaluated both oral and intravenous formulations of ondansetron in the prevention of postoperative nausea and vomiting, and intravenously administered ondansetron in the treatment of established symptoms. Most patients included in the trials were adult women, less than 50 years of age, receiving anaesthesia for gynaecological surgery. The primary efficacy analysis for emesis was based on the assessment of complete response (i.e. absence of emetic episodes or nausea in the first 24 h postoperatively). These trials clearly demonstrated the anti-emetic efficacy of ondansetron in the prevention and treatment of postoperative nausea and vomiting.

Clinical Trials as Topic↗