scholarly journals Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and emesis over multiple cycles of moderately emetogenic chemotherapy

Cancer ◽  
2005 ◽  
Vol 104 (7) ◽  
pp. 1548-1555 ◽  
Author(s):  
Jørn Herrstedt ◽  
Hyman B. Muss ◽  
David G. Warr ◽  
Paul J. Hesketh ◽  
Peter D. Eisenberg ◽  
...  
Keyword(s):  
Emetogenic Chemotherapy ◽  
Moderately Emetogenic Chemotherapy ◽  
Nausea And Emesis ◽  
Multiple Cycles

Effect of schedule and maintenance on the antiemetic efficacy of ondansetron combined with dexamethasone in acute and delayed nausea and emesis in patients receiving moderately emetogenic chemotherapy: a phase III trial by the National Cancer Institute of Canada Clinical Trials Group.

1994 ◽  
Vol 12 (5) ◽  
pp. 1050-1057 ◽  
Author(s):  
L Kaizer ◽  
D Warr ◽  
P Hoskins ◽  
J Latreille ◽  
W Lofters ◽  
...  
Keyword(s):  
Emetogenic Chemotherapy ◽  
Phase Iii ◽  
Double Blind Study ◽  
Moderately Emetogenic Chemotherapy ◽  
Severe Nausea ◽  
Double Blind ◽  
Antiemetic Efficacy ◽  
Delayed Nausea ◽  
Nausea And Emesis ◽  
Oral Ondansetron

PURPOSE This study examines whether the schedule of ondansetron significantly influences its antiemetic efficacy in the first 24 hours after chemotherapy, whether the administration of oral ondansetron after 24 hours is effective in preventing delayed emesis, and whether the efficacy of ondansetron is preserved over multiple courses of moderately emetogenic chemotherapy. PATIENTS AND METHODS A multicenter double-blind study randomized 302 cancer patients to one of three treatment arms. Arm A received dexamethasone 10 mg intravenously (i.v.) plus ondansetron (Zofran; Glaxo Canada Inc, Toronto, Canada) 8 mg i.v. prechemotherapy plus ondansetron 8 mg orally every 12 hours postchemotherapy for nine doses. Arm B received dexamethasone 10 mg i.v. plus ondansetron 16 mg i.v. prechemotherapy plus placebo orally postchemotherapy in the same schedule as arm A. Arm C received dexamethasone 10 mg i.v. plus ondansetron 8 mg prechemotherapy plus ondansetron 8 mg orally postchemotherapy for one dose followed by placebo orally every 12 hours for eight more doses. Response was assessed by the number of reported episodes of vomiting and by severity of nausea measured on a visual analog scale (VAS). RESULTS The two schedules of ondansetron used in the first 24 hours were no different in their antiemetic efficacy, with similar rates for complete responses (76.7% v 72.0%, P = .472), complete plus major responses (90.2% v 82.0%, P = .135), and severity of nausea (P = .348). Oral ondansetron after 24 hours was more effective than placebo in preventing delayed nausea and emesis, with superior rates of complete responses (59.6% v 42.1%, P = .012 by one-sided test), complete plus major responses (80.9% v 66.3%, P = .018 by one-sided test), and less severe nausea (9.2 mm v 18.6 mm on a 100-mm VAS, P = .002). The efficacy of ondansetron was maintained over subsequent courses of chemotherapy. CONCLUSION The schedule of ondansetron in the first 24 hours does not influence its efficacy. The use of oral maintenance ondansetron is effective in preventing delayed maintenance ondansetron is effective in preventing delayed nausea and emesis after moderately emetogenic chemotherapy.

Comparison of single-dose oral granisetron versus intravenous ondansetron in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy: a multicenter, double-blind, randomized parallel study.

1998 ◽  
Vol 16 (2) ◽  
pp. 754-760 ◽  
Author(s):  
E A Perez ◽  
P Hesketh ◽  
J Sandbach ◽  
J Reeves ◽  
S Chawla ◽  
...  
Keyword(s):  
Single Dose ◽  
Emetogenic Chemotherapy ◽  
Moderately Emetogenic Chemotherapy ◽  
Double Blind ◽  
Adverse Experiences ◽  
Parallel Group ◽  
Dose Oral ◽  
Nausea And Emesis ◽  
Chemotherapy Initiation ◽  
To Receive

PURPOSE The antiemetic effectiveness and safety of single-dose oral granisetron were compared with intravenous (I.V.) ondansetron in chemotherapy-naive patients who received moderately emetogenic chemotherapy. PATIENTS AND METHODS In this double-blind, parallel-group study, patients naive to emetogenic chemotherapy (N = 1,085) who were scheduled to receive cyclophosphamide- (500 to 1,200 mg/m2) or carboplatin (> or = 300 mg/m2) based chemotherapy, were randomized to receive either oral granisetron (n = 542) or I.V. ondansetron (n = 543). Efficacy assessments included the proportion of patients in each treatment group with total control over the 24 and 48 hours following chemotherapy initiation, as well as incidence and severity of nausea and emesis and use of antiemetic rescue medication. Prophylactic corticosteroids were allowed. Safety assessment was based on patients' reports of adverse experiences. RESULTS Approximately 80% of patients received prophylactic corticosteroids. Single-dose oral granisetron (2 mg) and I.V. ondansetron (32 mg) resulted in equivalent levels of total emetic control during the first 48 hours after chemotherapy. The proportion of nausea- and emesis-free patients at 24 and 48 hours were also approximately equivalent. The most commonly reported adverse experiences were headache, asthenia, and constipation. More patients who received ondonsetron than granisetron reported dizziness (9.6% v 5.4%, respectively; P = .011) and abnormal vision (4.2% v 0.6%, respectively; P < .001). CONCLUSION A single oral dose of granisetron (2 mg) resulted in equivalent levels of antiemetic protection as I.V. ondansetron (32 mg). Both agents were well tolerated, although more dizziness and abnormal vision were reported with ondansetron. Because the two antiemetic regimens exhibited equivalent efficacies, additional factors such as convenience and cost of therapy should be considered.

scholarly journals Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy

1999 ◽  
Vol 80 (3-4) ◽  
pp. 412-418 ◽  
Author(s):  
T Sigsgaard ◽  
J Herrstedt ◽  
L J Andersen ◽  
H Havsteen ◽  
S W Langer ◽  
...  
Keyword(s):  
Emetogenic Chemotherapy ◽  
Moderately Emetogenic Chemotherapy ◽  
Multiple Cycles

Incidence of chemotherapy-induced nausea and vomiting after highly and moderately emetogenic chemotherapy in the era of NK-1 receptor antagonists. Perception versus reality

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20636-e20636
Author(s):  
M. Majem ◽  
E. Moreno ◽  
J. Perez ◽  
N. Calvo ◽  
A. Feliu ◽  
...  
Keyword(s):  
Incidence Rates ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Moderately Emetogenic Chemotherapy ◽  
Acute Nausea ◽  
Medical Oncologists ◽  
Delayed Nausea ◽  
Nausea And Emesis ◽  
Delayed Cinv ◽  
Antiemetic Medication

e20636 Background: Physicians and nurses had underestimated the incidence of chemotherapy-induced nausea and vomiting (CINV) after both high emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC) (Grumberg, Cancer 2004;100:2261–8; Erazo Valle, Curr Med Res Opin 2006;22:2403–10). We have assessed if physicians and nurses’ perception of CNIV in their own practices after the introduction of Aprepitant was closer to reality. Methods: A prospective, observational unicenter study of adult patients receiving their first chemotherapy cycle was performed. Medical oncologists and oncology nurses also estimated the incidence of acute (Day 1) and delayed (Days 2–5) CINV after first administration of HEC and MEC. Eligible patients completed a 6-day diary including emetic episodes, nausea assessment, and antiemetic medication use. Observed incidence rates of acute and delayed CINV were compared with physician/nurse predictions. Results: Twenty-nine physicians and nurses and 95 patients (86.3% receiving HEC and 13.7%MEC) were recruited. Acute nausea and emesis were observed in 14.3% and 2.4% respectively of HEC patients receiving Aprepitant, and delayed nausea and emesis were observed in 14.3% and 7.1% of these patients, respectively. Physicians and nurses accurately predicted the incidence of acute and delayed CINV after HEC patients receiving Aprepitant. Acute nausea and emesis were observed in 22.2% and 0% respectively of MEC patients and delayed nausea and emesis in 33.3% and 22.2% of MEC patients, respectively. All physicians and nurses underestimated the incidence of acute nausea and delayed nausea and emesis after MEC by 15, 28 and 18 percentage points, respectively. Conclusions: The addition of aprepitant in the prevention of CINV after HEC allows a better control of CINV that is perceived accurately by physicians and nurses. By contrary, physicians and nurses continue markedly underestimating the incidence of CINV after MEC. CINV still remain important targets for improved therapeutic intervention and physicians and nurses must be aware about the real incidence of CNIV. No significant financial relationships to disclose.

Ondansetron Plus Metopimazine Compared With Ondansetron Plus Metopimazine Plus Prednisolone as Antiemetic Prophylaxis in Patients Receiving Multiple Cycles of Moderately Emetogenic Chemotherapy

2001 ◽  
Vol 19 (7) ◽  
pp. 2091-2097 ◽  
Author(s):  
T. Sigsgaard ◽  
J. Herrstedt ◽  
J. Handberg ◽  
M. Kjær ◽  
P. Dombernowsky
Keyword(s):  
Drug Combination ◽  
Oral Treatment ◽  
Emetogenic Chemotherapy ◽  
Moderately Emetogenic Chemotherapy ◽  
Intravenous Cyclophosphamide ◽  
Double Blind ◽  
Antiemetic Prophylaxis ◽  
Protection Rate ◽  
Multiple Cycles ◽  
To Receive

PURPOSE: To compare the antiemetic efficacy and tolerability of ondansetron plus metopimazine with ondansetron plus metopimazine plus prednisolone during nine cycles of moderately emetogenic chemotherapy. PATIENTS AND METHODS: A total of 221 women with stage I or II breast cancer and no prior chemotherapy who were scheduled to receive adjuvant chemotherapy with intravenous cyclophosphamide, fluorouracil and methotrexate or cyclophosphamide, epirubicin, and fluorouracil given every 3 weeks were included in a double-blind parallel trial. Patients were randomized to 3 days of oral treatment with ondansetron plus metopimazine, or ondansetron plus metopimazine plus prednisolone. Ondansetron was administered as 8 mg bid, metopimazine as 30 mg qid, and prednisolone as 50 mg qd. RESULTS: In all, 216 patients (97.7%) were assessable for efficacy during a total of 1,462 cycles. In cycle 1, complete protection from emetic episodes/nausea day 1, days 2 through 5, and days 1 through 5 was achieved in 84.4%/51.4%, 82.6%/41.3%, and 79.8%/34.9% with ondansetron plus metopimazine and in 84.1%/57.0%, 86.8%/53.8%, and 79.4%/43.0% with ondansetron plus metopimazine plus prednisolone, respectively. In cycle 1, the three-drug combination was superior only in the treatment of nausea on days 2 through 5 (P = .0497). The cumulative emetic protection rate after nine cycles was 0.52 with ondansetron plus metopimazine and 0.75 with ondansetron plus metopimazine plus prednisolone. Side effects were generally few and mild with both treatments. Constipation was the only adverse event significantly more frequent with the three-drug combination (P = .029). CONCLUSION: Ondansetron plus metopimazine plus prednisolone is highly effective and superior to ondansetron plus metopimazine during nine cycles of moderately emetogenic chemotherapy.

The impact of postchemotherapy nausea and vomiting on quality of life after moderately emetogenic chemotherapy

1998 ◽  
Vol 6 (4) ◽  
pp. 389-395 ◽  
Author(s):  
J. J. Rusthoven ◽  
David Osoba ◽  
Charles A. Butts ◽  
Louise Yelle ◽  
Helen Findlay ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Moderately Emetogenic Chemotherapy ◽  
The Impact
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