Antiemetic efficacy of combination therapy with granisetron plus prednisolone plus the dopamine D 2 antagonist metopimazine during multiple cycles of moderately emetogenic chemotherapy in patients refractory to previous antiemetic therapy

2000 ◽  
Vol 8 (3) ◽  
pp. 233-237 ◽  
Author(s):  
T. Sigsgaard ◽  
J. Herrstedt ◽  
P. Christensen ◽  
O. Andersen ◽  
P. Dombernowsky
Keyword(s):  
Combination Therapy ◽  
Emetogenic Chemotherapy ◽  
Antiemetic Therapy ◽  
Moderately Emetogenic Chemotherapy ◽  
Antiemetic Efficacy ◽  
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.

Efficacy of triple antiemetic therapy (palonosetron, dexamethasone, aprepitant) for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based, moderately emetogenic chemotherapy.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 226-226
Author(s):  
Toshimichi Miya ◽  
Kunihiko Kobayashi ◽  
Mitsunori Hino ◽  
Masahiro Ando ◽  
Susumu Takeuchi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Acute Phase ◽  
Rescue Medication ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Antiemetic Therapy ◽  
Moderately Emetogenic Chemotherapy ◽  
Antiemetic Treatment ◽  
Severe Adverse Events ◽  
Delayed Phase

226 Background: Chemotherapy-induced nausea and vomiting (CINV) is a major adverse toxicity of cancer chemotherapy. Recommended treatments for prevention of CINV vary among guidelines, and optimal care for CINV caused by moderately emetogenic chemotherapy has not been established. This study assess efficacy and safety of triple antiemetic therapy consist palonosetron, dexamethasone and aprepitant for carboplatin-based chemotherapy. Methods: Chemotherapy-naïve patients with lung cancer scheduled for a first course of a carboplatin-containing regimen formed the study cohort. Patients were pretreated with antiemetic therapy consist palonosetron (0.75 mg, i.v.) and dexamethasone (9.9 mg, i.v.) on day 1, and aprepitant (125 mg, p.o.) on day 1 followed by 80 mg on days 2 and 3. Primary endpoint was the proportion of patients who did not experience vomiting and did not require rescue medication (complete response (CR)) in the acute phase (0-24 h), late phase (24-168 h) and overall. Secondary endpoint was the proportion of patients who experienced no vomiting episodes and no more than mild nausea without the need for rescue medication (complete control (CC)). Results: Prevalence of a CR during the acute phase, delayed phase, and overall was 100%, 91.9% and 91.9%, whereas that of CC was 100%, 84.4% and 84.4%, respectively. Most common adverse events were mild constipation; severe adverse events related to antiemetic treatment were not observed. Prevalence of a CR during the acute phase, delayed phase, and overall was 100%, 91.9% and 91.9%, whereas that of CC was 100%, 84.4% and 84.4%, respectively. Most common adverse events were mild constipation; severe adverse events related to antiemetic treatment were not observed. Conclusions: Triple antiemetic therapy comprising palonosetron, dexamethasone and aprepitant shows excellent effects in preventing CINV in patients receiving a carboplatin-containing regimen. Clinical trial information: UMIN000017877.

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

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

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.

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