High-dose intravenous metoclopramide versus combination high-dose metoclopramide and intravenous dexamethasone in preventing cisplatin-induced nausea and emesis: a single-blind crossover comparison of antiemetic efficacy.

1985 ◽  
Vol 3 (2) ◽  
pp. 245-251 ◽  
Author(s):  
S B Strum ◽  
J E McDermed ◽  
D F Liponi
Keyword(s):  
Patient Preference ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Chemotherapy Response ◽  
Antiemetic Efficacy ◽  
Study Results ◽  
Nausea And Emesis ◽  
To Receive ◽  
Single Blind ◽  
Crossover Comparison

We tested the safety and antiemetic effectiveness of intravenous (IV) dexamethasone (DXM) as an adjunct to high-dose IV metoclopramide (MCP) to prevent nausea and vomiting induced by high-dose cisplatin chemotherapy. Response was determined by using objective and subjective criteria. Thirty patients were randomly assigned to receive MCP alone at a dose of 2 mg/kg IV for three doses or the same dose of MCP plus 20 mg of DXM IV for three doses. Twenty evaluable patients received a second course of cisplatin and were crossed over to the opposite arm. Study results did not show a statistically significant advantage of combination MCP plus DXM over MCP alone using strict objective criteria for antiemetic response. However, patients subjectively preferred MCP plus DXM over MCP alone by nearly a 6:1 ratio, regardless of the randomization sequence. Although the addition of DXM does not appear to objectively improve emetic protection with high-dose MCP, we recommend MCP plus DXM to prevent nausea and vomiting induced by high-dose cisplatin chemotherapy when the use of steroids is not contraindicated, in view of patient preference for the combination.

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

1991 ◽  
Vol 9 (5) ◽  
pp. 721-728 ◽  
Author(s):  
J Hainsworth ◽  
W Harvey ◽  
K Pendergrass ◽  
B Kasimis ◽  
D Oblon ◽  
...  
Keyword(s):  
Adverse Events ◽  
Median Number ◽  
Chemotherapeutic Agents ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Concurrent Administration ◽  
Major Response ◽  
Parallel Group ◽  
Blind Comparison ◽  
Single Blind

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

Gemcitabine, Dexamethasone and Cisplatin (GDP regimen) As First Salvage Treatment of Patients with Refractory or Relapsed Diffuse large B Cell Non Hodgkin Lymphoma (DLBCL)

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2696-2696
Author(s):  
Thoraya Mohamed Abdel Hamid ◽  
Mona fawzy Ramadan ◽  
Abeer Bahnassy ◽  
Fouad Abu- Taleb ◽  
Magdy Saber
Keyword(s):  
Conflicts Of Interest ◽  
High Dose ◽  
Chemotherapy Response ◽  
Non Hodgkin Lymphoma ◽  
Study Results ◽  
Significant Difference ◽  
Duration Of Response ◽  
Relapsed Disease ◽  
Time To Relapse

Abstract Abstract 2696 Background: Many chemotherapy regimens have been used for patients with refractory or relapsed DLBCL. No regimen has demonstrated superiority to another in this setting. Specific markers could predict the response to certain agents. Aim: to evaluate the response of GDP regimen in relapsed and refractory DLBCL patients and to assess ribonucleotide reductase subunit M1 (RRM1) as a possible predictor marker to Gemcitabine response. Patients and method: Patients with Relapsed or refractory DLBCL after one previous anthracycline-containing chemotherapy regimen were treated with the GDP regimen. RRM1 was assessed by immunohistochemistry in 55 cases and its expression was correlated to treatment outcome. Patients who could not proceed to stem cell transplantation (SCT) were followed for chemotherapy response and their results are presented. Results: The study included 70 patients with a median age of 40 years (range 18–73). At start of GDP, 19 patients (27.1%) were refractory and 51 (72.9%) were relapsed. After 4 cycles of treatment, 42 patients achieved CR, with a CR rate of 60% (95% CI: 53–68%). The median DFS was 6 months (95% CI: 5 to7 months), this DFS didn't include patients who underwent auto SCT. After a median follow-up of 20 months (range 6 to 30 months), the median OS of the patients who achieved CR was not reached, while those who didn't achieve CR had a median OS of 27.4 months (p= 0.01). Correlation between response and the pretreatment prognostic factors including IPI score or any of its elements, previous line of chemotherapy, time to relapse and status at time of salvage were studied with only significant difference in response to GDP between patients with refractory and those with relapsed disease (CR= 21.1% versus 60% respectively, p < 0.001). There was significant correlation between RRMI study results and response to GDP, 30/31 cases with low RRM1 expression achieved CR (96.8%), while only 7/24 cases with high expression achieved CR (29.2%), (p=0.001). No significant relation could be found between RRM1 expression and DFS. Conclusion: GDP regimen is active for patients with refractory or relapsed DLBCL however, the duration of response is short and high-dose therapy with SCT support is the reference postremission treatment. RRM1expression can predict response to Gemcitabine-based chemotherapy. Disclosures: No relevant conflicts of interest to declare.

Incidence, course, and severity of delayed nausea and vomiting following the administration of high-dose cisplatin.

1985 ◽  
Vol 3 (10) ◽  
pp. 1379-1384 ◽  
Author(s):  
M G Kris ◽  
R J Gralla ◽  
R A Clark ◽  
L B Tyson ◽  
J P O'Connell ◽  
...  
Keyword(s):  
Analogue Scale ◽  
Specific Treatment ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Common Condition ◽  
Delayed Emesis ◽  
Delayed Nausea ◽  
Nausea And Emesis ◽  
Observer Ratings ◽  
First Time

Although many trials have evaluated the severity and treatment of nausea and vomiting immediately after cisplatin administration, no studies have focused on vomiting occurring more than 24 hours after chemotherapy--delayed emesis. Two consecutive trials were undertaken to evaluate the incidence, course (trial 1), and severity (trial 2) of delayed nausea and emesis and to develop methods to study these conditions. Eighty-six patients receiving cisplatin (120 mg/m2) for the first time were entered. On the day of cisplatin treatment, all received intravenous (IV) metoclopramide (3 mg/kg X 2 doses) plus dexamethasone (20 mg IV X 1 dose) with either diphenhydramine (50 mg IV) or lorazepam (1.0 to 1.5 mg/m2). Sixty-two percent of patients experienced no vomiting during the 24 hours immediately after administration of cisplatin. Overall, 93% of studied patients experienced some degree of delayed nausea or vomiting from 24 to 120 hours after cisplatin. In trial 1, the incidence of delayed vomiting ranged from 21% to 61% and delayed nausea from 24% to 78% in 58 patients. The highest incidence of both delayed nausea and emesis occurred during the period from 48 to 72 hours after administration of cisplatin. Patients who had no emesis during the initial 24 hours after cisplatin were less likely to experience delayed emesis. The severity of delayed nausea and vomiting was evaluated in 28 patients in trial 2. The amount of delayed nausea and vomiting was assessed daily by patients using a visual analogue scale and by an observer rating. The highest nausea and vomiting scores were seen during the period from 48 to 72 hours after administration of cisplatin, with acceptable correlation between patient scores and observer ratings. Although the nausea and vomiting occurring 24 or more hours after cisplatin administration is not as severe as that seen during the initial 24 hours after administration of cisplatin in patients not receiving antiemetics, it is a common condition that merits both further study and specific treatment.

Antiemetic Efficacy of High-Dose Metoclopramide: Randomized Trials with Placebo and Prochlorperazine in Patients with Chemotherapy-Induced Nausea and Vomiting

1981 ◽  
Vol 305 (16) ◽  
pp. 905-909 ◽  
Author(s):  
Richard J. Gralla ◽  
Loretta M. Itri ◽  
Sharon E. Pisko ◽  
Anna E. Squillante ◽  
David P. Kelsen ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Antiemetic Efficacy

Acupuncture in the Management of Postoperative Nausea and Vomiting in Patients Receiving Morphine via a Patient-Controlled Analgesia System

1996 ◽  
Vol 14 (1) ◽  
pp. 2-5 ◽  
Author(s):  
Paul McConaghy ◽  
David Bland ◽  
Hilary Swales
Keyword(s):  
Postoperative Nausea ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Visual Analogue Score ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Patient Controlled Analgesia ◽  
Randomised Controlled ◽  
To Receive ◽  
Single Blind

This single-blind, randomised, controlled trial was undertaken to assess the efficacy of acupuncture (ACP) at the PC.6 (Neiguan) point in the management of established postoperative nausea and vomiting (PONV) in patients receiving parenteral morphine via a Patient-Controlled Analgesia System (PCAS). Eighty patients were recruited on the first postoperative day and 30 were treated with ACP after developing PONV lasting more than 10min. Patients were randomly allocated to receive ACP bilaterally at either PC.6 or at a dummy point near the elbow, with manual stimulation for a total of 4min. Only patients with no knowledge of ACP antiemesis were studied, and each patient was thus unaware of the group to which they were allocated. Patients treated with PC.6 ACP had a greater mean improvement in their visual analogue score for nausea (p<0.05). All patients in the PC.6 group improved their score by 20% or more, while only one third in the control group did so (p<0.001). In the PC.6 group 53% of patients did not require any further antiemetic while receiving PCAS morphine. All patients in the control group required further antiemetic treatment (p<0.001). No adverse effects were recorded.

Difference in persistence of efficacy of two antiemetic regimens on acute emesis during cisplatin chemotherapy. The Italian Group for Antiemetic Research.

1993 ◽  
Vol 11 (12) ◽  
pp. 2396-2404 ◽  
Keyword(s):  
Prognostic Factor ◽  
Adverse Events ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Complete Protection ◽  
Double Blind ◽  
Acute Emesis ◽  
The Third ◽  
First Time ◽  
To Receive

PURPOSE AND METHODS We conducted a prospective, double-blind, multicenter study of 287 cancer patients treated for the first time with high-dose cisplatin chemotherapy who were randomly assigned to receive three consecutive cycles of the same antiemetic treatment consisting of ondansetron plus dexamethasone, or metoclopramide plus dexamethasone and diphenhydramine. RESULTS Patients who received the ondansetron combination achieved significantly greater complete protection from vomiting, but not from nausea, in all three cycles of chemotherapy than did patients treated with metoclopramide (78.7% v 59.6%, P < .002 during the first cycle; 73.4% v 51.0%, P < .002 during the second cycle; 73.7% v 47.5%, P < .001 during the third cycle). The ability of ondansetron treatment to protect patients from vomiting during the first cycle did not change in subsequent cycles, but decreased significantly as far as complete protection from nausea and from both nausea and vomiting are concerned. With the metoclopramide combination, a significantly greater reduction of complete protection from vomiting, nausea, and both nausea and vomiting was detected. Protection obtained in previous cycles of chemotherapy was the most important prognostic factor. Adverse events were significantly less frequent with ondansetron treatment during the three cycles of chemotherapy and no cumulative toxic effects were found with either treatment. CONCLUSION Ondansetron plus dexamethasone was significantly more efficacious and better tolerated than metoclopramide plus dexamethasone and diphenhydramine during three cycles of chemotherapy and, in contrast to the metoclopramide regimen, the efficacy of ondansetron plus dexamethasone, at least for vomiting, is maintained in subsequent cycles.

The effectiveness of behavioral intervention for reduction of nausea and vomiting in children and adolescents receiving chemotherapy.

1984 ◽  
Vol 2 (6) ◽  
pp. 683-690 ◽  
Author(s):  
L Zeltzer ◽  
S LeBaron ◽  
P M Zeltzer
Keyword(s):  
Children And Adolescents ◽  
Behavioral Intervention ◽  
Nausea And Vomiting ◽  
Baseline Measurement ◽  
Symptom Ratings ◽  
Nausea And Emesis ◽  
To Receive ◽  
Supportive Counseling

Fifty-one children 6-17 years of age rated the severity of nausea, vomiting, and the extent to which chemotherapy bothered them during each course of chemotherapy. Sixteen patients had no symptoms and the doses administered to 16 others were not constant so that matched courses could not be assessed. After baseline measurement of two matched courses, the remaining 19 patients were randomized to receive hypnosis or supportive counseling during two more matched courses. An additional course with no intervention was assessed in half of the patients. No significant reduction of symptoms was demonstrated prior to intervention. However, intervention with both hypnosis and supportive counseling was associated with significant reductions in nausea, vomiting, and the extent to which these symptoms bothered patients (all p less than 0.001). Also, after termination of intervention, symptom ratings remained significantly lower than baseline. The data indicate that chemotherapy-related nausea and emesis in children can be reduced with behavioral intervention and that reductions are maintained after intervention has been discontinued.

Ramosetron for the Prevention of Cisplatin-Induced Acute Emesis: A Prospective Randomized Comparison with Granisetron

2002 ◽  
Vol 30 (3) ◽  
pp. 220-229 ◽  
Author(s):  
YK Kang ◽  
YH Park ◽  
BY Ryoo ◽  
YJ Bang ◽  
KS Cho ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Patient Compliance ◽  
Adult Patients ◽  
Nausea And Vomiting ◽  
Blind Study ◽  
Acute Emesis ◽  
Significant Difference ◽  
Equivalent Efficacy ◽  
To Receive ◽  
Single Blind

Control of nausea and vomiting is very important in determining patient compliance with cisplatin chemotherapy. A multicentre, randomized, single-blind study was conducted to compare the tolerability and efficacy of ramosetron with those of granisetron over 24 h following cisplatin administration to cancer patients. In eight study centres, a total of 194 adult patients were randomly assigned to receive either intravenous ramosetron 0.3 mg or intravenous granisetron 3.0 mg. The anti-emetic effect of ramosetron determined from the no-vomiting rate lasted longer, but there was no significant difference in the number of acute vomiting episodes or the severity of nausea between the two groups. In the tolerability evaluation, there were no statistically significant differences between the two groups, except for a higher incidence of dull headache in the granisetron group. Ramosetron and granisetron appear to have equivalent efficacy and tolerability profiles, but the effects of ramosetron on the prevention of acute vomiting in patients undergoing cisplatin chemotherapy were longer lasting.

Efficacy and safety of granisetron, a selective 5-hydroxytryptamine-3 receptor antagonist, in the prevention of nausea and vomiting induced by high-dose cisplatin.

1994 ◽  
Vol 12 (10) ◽  
pp. 2204-2210 ◽  
Author(s):  
R M Navari ◽  
H G Kaplan ◽  
R J Gralla ◽  
S M Grunberg ◽  
R Palmer ◽  
...  
Keyword(s):  
Vital Signs ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
First Episode ◽  
High Dose ◽  
Adverse Experiences ◽  
Major Response ◽  
Chemotherapy Patients ◽  
To Receive ◽  
Antiemetic Medication

PURPOSE To assess the antiemetic effects and safety profile of four different doses of granisetron (Kytril; SmithKline Beecham Pharmaceuticals, Philadelphia, PA) when administered as a single intravenous (IV) dose for prophylaxis of cisplatin-induced nausea and vomiting. PATIENTS AND METHODS One hundred eighty-four chemotherapy-naive patients receiving high-dose cisplatin (81 to 120 mg/m2) were randomized to receive one of four granisetron doses (5, 10, 20, or 40 micrograms/kg) administered before chemotherapy. Patients were observed on an inpatient basis for 18 to 24 hours, and vital signs, nausea, vomiting, retching, and appetite were assessed. Safety analyses included incidence of adverse experiences and laboratory parameter changes. RESULTS After granisetron doses of 5, 10, 20, and 40 micrograms/kg, a major response (< or = two vomiting or retching episodes, and no antiemetic rescue) was recorded in 23%, 57%, 58%, and 60% of patients, respectively, and a complete response (no vomiting or retching, and no antiemetic rescue) in 18%, 41%, 40%, and 47% of patients, respectively. There was a statistically longer time to first episode of nausea (P = .0015) and vomiting (P = .0001), and fewer patients were administered additional antiemetic medication in the 10-micrograms/kg dosing groups than in the 5-micrograms/kg dosing group. As granisetron dose increased, appetite return increased (P = .040). Headache was the most frequently reported adverse event (20%). CONCLUSION A single 10-, 20-, or 40-micrograms/kg dose of granisetron was effective in controlling vomiting in 57% to 60% of patients who received cisplatin at doses greater than 81 mg/m2 and totally prevented vomiting in 40% to 47% of patients. There were no statistically significant differences in efficacy between the 10-micrograms/kg dose and the 20- and 40-micrograms/kg doses. Granisetron was well tolerated at all doses.

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