Persistence of efficacy of three antiemetic regimens and prognostic factors in patients undergoing moderately emetogenic chemotherapy. Italian Group for Antiemetic Research.

1995 ◽  
Vol 13 (9) ◽  
pp. 2417-2426 ◽  
Keyword(s):  
Prognostic Factors ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Double Blind Study ◽  
Moderately Emetogenic Chemotherapy ◽  
Diary Card ◽  
Complete Protection ◽  
Double Blind ◽  
Chemotherapy Administration ◽  
Previous Cycle

PURPOSE To evaluate antiemetic efficacy and tolerability of granisetron, dexamethasone, and their combination over repeated courses of moderately emetogenic chemotherapy, and the influence of the prognostic factors on occurrence of nausea and vomiting. PATIENTS AND METHODS Four hundred twenty-eight consecutive cancer patients were entered onto a multicenter, randomized, double-blind study to compare granisetron 3 mg intravenously, dexamethasone 8 mg intravenously, and 4 mg orally every 6 hours for four doses, or the combination of dexamethasone plus granisetron at the same doses, administered for three consecutive cycles. Occurrence of nausea, retching, and vomiting was monitored for 24 hours after chemotherapy administration by a diary card. RESULTS Three hundred ninety-eight patients were assessable for clinical efficacy at the first cycle, 354 were assessable at the second cycle, and 322 were assessable at the third cycle of chemotherapy. Dexamethasone plus granisetron induced significantly greater complete protection from vomiting, nausea, and both nausea and vomiting than granisetron alone in all three cycles. With respect to dexamethasone alone, complete protection from vomiting was significantly greater at the first and second cycle, and complete protection from nausea and from both nausea and vomiting only at the first cycle. Complete protection did not differ significantly among the three cycles in patients receiving dexamethasone plus granisetron or dexamethasone alone, whereas it decreased significantly, at least for vomiting, in patients receiving granisetron alone. Protection obtained in the previous cycle of chemotherapy was the most important prognostic factor in the occurrence of nausea and vomiting. CONCLUSION The combination of dexamethasone plus granisetron offers the best antiemetic protection because of its greater efficacy with respect to the other two regimens at first cycle, and because its activity is maintained in the subsequent cycles of chemotherapy.

Phase III double-blind comparison of dolasetron mesylate and ondansetron and an evaluation of the additive role of dexamethasone in the prevention of acute and delayed nausea and vomiting due to moderately emetogenic chemotherapy.

1997 ◽  
Vol 15 (8) ◽  
pp. 2966-2973 ◽  
Author(s):  
W S Lofters ◽  
J L Pater ◽  
B Zee ◽  
E Dempsey ◽  
D Walde ◽  
...  
Keyword(s):  
Randomized Study ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Moderately Emetogenic Chemotherapy ◽  
Complete Protection ◽  
Double Blind ◽  
Once Daily ◽  
Oral Dexamethasone ◽  
Delayed Nausea

PURPOSE To compare the efficacy of dolasetron and ondansetron in controlling nausea and vomiting in the first 24 hours; to evaluate the efficacy when dexamethasone is added to either drug in the first 24 hours; and to extend these comparisons over 7 days in patients receiving moderately emetogenic chemotherapy. PATIENTS AND METHODS This was a multicenter, double-blind, randomized study with six parallel arms that used a 2 x 2 factorial design in chemotherapy-naive patients. In arm 1, dolasetron (2.4 mg/kg) was given intravenously (I.V.) prechemotherapy, followed 24 hours later by oral dolasetron (200 mg once daily) for 6 days. Arms 2 and 3 consisted of dolasetron and dexamethasone 8 mg I.V., followed 24 hours later by oral dexamethasone (8 mg once daily) in one arm, and oral dexamethasone and dolasetron in the other, also for 6 days. In arms 4, 5, and 6, ondansetron (32 mg I.V. or 8 mg orally twice daily) was administered in a similar manner to arms 1, 2, and 3 before and 24 hours after chemotherapy. Mean nausea severity (MNS) was assessed on a visual analog scale (VAS) in a daily diary. RESULTS Of 703 patients enrolled, 696 were eligible. There were 343 dolasetron- and 353 ondansetron-treated patients; 57% of dolasetron-treated patients had complete protection in the first 24 hours versus 67% of patients who received ondansetron (P = .013). MNS was also more pronounced on the dolasetron arm (P = .051). Sixty-seven percent of patients who received added dexamethasone in the first 24 hours had complete protection, compared with 55% without dexamethasone (P < .001). MNS was significantly reduced with the addition of dexamethasone (P < .001). At 7 days, dolasetron and ondansetron had equivalent complete protection rates (36% and 39%, respectively). With the addition of dexamethasone, 48% of patients compared with 28% had complete protection (P < .001). MNS was significantly improved with added dexamethasone (P < .001). CONCLUSION At the doses used, dolasetron was significantly less effective than ondansetron at controlling nausea and vomiting in the first 24 hours in patients receiving moderately emetogenic chemotherapy, but there was no demonstrable difference between both drugs over 7 days. The addition of dexamethasone significantly improved the efficacy of both drugs in the first 24 hours and over 7 days.

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.

Prevention of Highly Emetogenic Chemotherapy-Induced Vomiting: A Double Blind, Randomized Crossover Study to Compare Pancopride (LAS 30451) and Pancopride plus Dexamethasone

1995 ◽  
Vol 81 (6) ◽  
pp. 432-434 ◽  
Author(s):  
Enrique Aranda ◽  
Isidoro C. Barneto ◽  
Ma. Jesus Rubio ◽  
Rosario Gonzalez ◽  
Antonio Garcia ◽  
...  
Keyword(s):  
Side Effects ◽  
Crossover Study ◽  
Receptor Antagonist ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Complete Protection ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Order Of Administration ◽  
Randomized Crossover Study

Aims Pancopride (PNC) is a new 5HT3 receptor antagonist which has demonstrated complete protection from nausea and vomiting in 25-73% of patients treated with highly emetogenic chemotherapy. A double-blind, randomized crossover study was carried out to assess whether the addition of dexamethasone (DXM) to PNC increases the antiemetic efficacy. Methods PNC (0.2 mg/kg. i.v. 30 min before chemotherapy) plus placebo (PLC) was compared with PNC (same dose and schedule) plus DXM (20 mg. i.v. immediately before PNC). In the second cycle, patients received the alternative antiemetic treatment. Eighty patients were included in the study (PNC+DXM=39, PNC+PLC=41), 29 of whom were women and 51 men. Fifty-four percent of the patients in the PNC+DXM group and 59% of those in the PNC+PLC group received chemotherapy containing cisplatin. Seventy-seven patients completed the first cycle and 70 the second. Results Complete protection was obtained in 19/16 patients (50/46%) with PNC+PLC and in 32/22 (82/63%) with PNC+DXM (P<0.001). Latency was significantly longer in the PNC+DXM group. The efficacy of both treatments was unaffected by the order of administration. Side effects were mild in both groups. Conclusions The combination of PNC+DXM is more efficacious than PNC+PLC in protection against highly emetogenic chemotherapy-induced vomiting.

Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: A randomized, double-blind study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9626-9626
Author(s):  
J. A. Boice ◽  
H. Schmoll ◽  
C. Brown ◽  
A. Taylor
Keyword(s):  
Rescue Medication ◽  
Medication Use ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Double Blind Study ◽  
Double Blind ◽  
Therapy Regimen ◽  
Control Regimen

9626 Background: Aprepitant (A) has been shown in a previous trial to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC) in breast cancer patients receiving cyclophosphamide and anthracycline. This study assessed A in patients with a variety of tumors receiving a broad range of MEC regimens. Methods: This Phase III, randomized, gender-stratified, double-blind, trial enrolled female and male patients ≥18 years old with confirmed malignancies naïve to MEC or highly emetogenic chemotherapy and scheduled to receive a single dose of 1 or more MEC agent. Patients received A triple-therapy regimen (A 125 mg, ondansetron [O] 8 mg b.i.d., and dexamethasone [D] 12 mg on Day 1 of chemotherapy, A 80 mg q.d. on Days 2–3) or a control regimen (O 8 mg b.i.d. and D 20 mg on Day 1, and O 8 mg q12h on Days 2–3) all administered orally. Episodes of vomiting, nausea, and rescue medication use were recorded in a patient diary. Tolerability was assessed by physical and lab examinations, and adverse event (AE) reporting. Primary and key secondary efficacy endpoints were proportions of patients with No Vomiting and Complete Response (no vomiting and no rescue medication use), respectively, during the 120 hours postchemotherapy. Results: Among 848 randomized patients, 77% were female while 52, 20, 13, and 5% of patients had breast, colorectal, lung, or ovarian cancer, respectively. Significantly more patients in the A group achieved No Vomiting and Complete Response (a difference of 14.1 &12.4 percentage points vs. control, respectively). The incidences of AEs were generally similar in the aprepitant (61.9%) and control groups (66.5%). Conclusions: The aprepitant regimen provided superior efficacy over the control regimen in the treatment of CINV in a broad range of patients receiving MEC in both No Vomiting and Complete Response endpoints. Aprepitant was generally well tolerated. [Table: see text] [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document