Antiemetic efficacy of intravenous (IV) NEPA in patients with breast cancer (BC) receiving anthracycline/cyclophosphamide (AC) chemotherapy.

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 115-115
Author(s):  
Lee S. Schwartzberg ◽  
Matti S. Aapro
Keyword(s):  
Single Dose ◽  
Complete Response ◽  
Hypersensitivity Reactions ◽  
Infusion Site ◽  
Double Blind ◽  
Multi Agent ◽  
Presentation Methods ◽  
Chemotherapy Patients ◽  
Favorable Safety ◽  
To Receive

115 Background: The complexity of administering multi-agent prophylactic antiemetic combinations required to prevent chemotherapy-induced nausea and vomiting (CINV) may contribute to poor guideline adherence seen in multiple studies. NEPA, a combination antiemetic of an NK1 receptor antagonist (RA) [netupitant (oral)/fosnetupitant (IV)] and 5-HT3RA, palonosetron, offers 5-day CINV prevention with a single dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients, thereby minimizing infusion-related toxicities that have been reported with other NK1RAs. This study previously reported the safety of IV NEPA in BC patients receiving repeat cycles of AC; there were no infusion-site or hypersensitivity reactions related to IV NEPA reported. The efficacy results of this study are the focus of this presentation. Methods: This was a Phase 3b, double-blind safety study in females with BC naïve to highly/moderately emetogenic chemotherapy. Patients were randomized 1:1 to receive a single 30-min infusion of IV NEPA or a single oral NEPA capsule on Day 1 prior to AC. Oral dexamethasone was also given to all patients before AC on Day 1 only. Complete response (CR: no emesis, no rescue) and no significant nausea (NSN: < 25mm on 100mm VAS scale) rates were calculated daily during the 5 days (0-120 h) post-AC in Cycle 1. No formal statistical comparison between groups was planned. Results: 402 total patients were included in the analysis. Most patients were white (93%) with ECOG status of 0 (75%); the mean age was 55 years. Comparable CR and NSN rates were seen for IV and oral NEPA during each of the 5 days post-AC. Conclusions: As a simplified single-dose formulation, IV NEPA showed high response rates in BC patients receiving AC, with favorable safety as no treatment-related infusion-site/hypersensitivity reactions were reported. Clinical trial information: NCT03403712. [Table: see text]

Randomized double-blind evaluation of dronabinol for the prevention of chemotherapy-induced nausea.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9061-9061
Author(s):  
Steven M. Grunberg ◽  
Mark F. Munsell ◽  
Phuong Khanh H. Morrow ◽  
Jeffrey Kent Giguere ◽  
Ulla Jo Ule ◽  
...  
Keyword(s):  
Complete Response ◽  
Double Blind ◽  
Mood Changes ◽  
Significant Difference ◽  
P 16 ◽  
Chemotherapy Patients ◽  
Age Range ◽  
To Receive ◽  
Made In ◽  
Antiemetic Agents

9061 Background: Although great progress has been made in the control of chemotherapy-induced vomiting (CIV), prevention of chemotherapy-induced nausea (CIN) has been less successful. Preliminary data suggests that some families of lesser used antiemetic agents, such as the cannabinoids, may have greater efficacy against nausea than against vomiting. Methods: Adult solid tumor patients (pts) receiving cyclophosphamide ≤ 1500 mg/m2 (C) and/or doxorubicin ≥ 40 mg/m2 (A) were eligible. Pts could have received prior mildly emetogenic chemotherapy (EC). Pts were not eligible who were receiving other moderately or highly EC, were receiving cranial, abdominal or pelvic radiotherapy, had CIV/CIN with previous chemotherapy, had other causes for nausea/vomiting besides chemotherapy, or were scheduled to receive other antiemetics. Pts with habitual cannabinoid use were not eligible. All pts received palonosetron 0.25 mg (PALO) and dexamethasone 10 mg (DXM) IV before chemotherapy. Patients were randomized double-blind to receive dronabinol 5 mg (D) or matching placebo (P) 3 times a day for 5 days. Nausea, vomiting and toxicity data was collected daily for 5 days. Results: 62 pts were entered on study – female/male 61/1, White/Black/Hispanic/Other 45/14/2/1, median age (range) 58 (29-76). No significant difference was noted in CIV-dependent endpoints (including No Vomiting, Complete Response, or Complete Protection) or in rescue medication use. However pts receiving D had a shorter duration of nausea – Mean number of days of nausea (D vs P) 1.86 days vs 3.10 days (p=0.027) – and a trend toward greater frequency of No Nausea (D vs P) 37% vs 17% (p=0.143). Common toxicities included fatigue (D/P 17/11), headache (D/P 16/16), dizziness (D/P 14/7), constipation (D/P 14/11), and diarrhea (D/P 13/6) No pt discontinued therapy due to mood changes. Conclusions: Low-dose D decreased the duration of CIN and increased the frequency of No Nausea in pts receiving C and/or A. Agents to prevent CIV (such as PALO and DXM) and to prevent CIN (such as D) have complementary activity and result in improved overall control when used together.

Safety of intravenous (IV) NEPA and oral NEPA for prevention of CINV in patients (pts) with breast cancer (BC) receiving anthracycline/cyclophosphamide (AC) chemotherapy (CT).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11594-11594
Author(s):  
Lee S. Schwartzberg ◽  
Daniel Voisin ◽  
Giada Rizzi ◽  
Kamal Patel ◽  
Matti S. Aapro
Keyword(s):  
Single Dose ◽  
Safety Evaluation ◽  
Complete Response ◽  
Primary Objective ◽  
Double Blind Study ◽  
Infusion Site ◽  
Double Blind ◽  
Antiemetic Agent ◽  
Pivotal Study ◽  
Safety Population

11594 Background: NEPA, a combination antiemetic agent [NK1 receptor antagonist (RA) netupitant (oral) or fosnetupitant (IV) + 5-HT3RA palonosetron] offers 5-day CINV prevention with a single-dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. In a Phase 3 study in pts receiving cisplatin-based CT, there were no infusion site or anaphylactic reactions related to IV NEPA. In contrast, hypersensitivity reactions and anaphylaxis have been reported with IV aprepitant, fosaprepitant and rolapitant, with the highest rate (35%) for fosaprepitant in the AC setting. This study (NCT03403712) evaluates the safety of IV NEPA in BC pts receiving repeat cycles of AC CT. Methods: This was a Phase 3b, double-blind study in females with BC naïve to highly/moderately emetogenic CT. Pts were randomized 1:1 to receive a single 30-min infusion of IV NEPA or a single oral NEPA capsule on Day 1, prior to AC. Oral dexamethasone was also given to all patients before CT. The primary objective was a safety evaluation of IV NEPA based primarily on treatment-emergent adverse events (TEAEs). No formal between groups statistical comparison was planned. Results: 402 pts were treated with IV NEPA or oral NEPA and included in the safety population. The AE profiles were similar for the two groups; cycle 1 results are reported (Table). Comparable complete response (no emesis, no rescue) rates were seen during the cycle 1 overall phase (0-120h) (73.0% IV NEPA, 77.2% oral NEPA). Conclusions: There were no infusion-site AEs related to IV NEPA and no anaphylaxis reported for either formulation. Consistent with the pivotal study, IV NEPA is safe and effective in pts receiving AC. As a simplified single-dose formulation, IV NEPA may be better tolerated than other NK1 RAs. Clinical trial information: NCT03403712. [Table: see text]

scholarly journals Comparison of Ondansetron with Gabapentin for prevention of intrathecal morphine induced pruritus

2019 ◽  
Vol 2 (3) ◽  
pp. 142-148
Author(s):  
Rohini Sigdel ◽  
Anil Shrestha ◽  
Roshana Amatya
Keyword(s):  
Single Dose ◽  
Intrathecal Morphine ◽  
Double Blind Study ◽  
Physical Status ◽  
Hyperbaric Bupivacaine ◽  
Double Blind ◽  
Subarachnoid Block ◽  
Significant Difference ◽  
Group 2 ◽  
To Receive

Background: Ondansetron has been used successfully for prophylaxis and treatment of intrathecal morphine induced pruritus. Gabapentin has anxiolytic, antiemetic, antipruritic effects and has also been shown to potentiate the analgesic effect of intrathecally or epidurally administered opioids. Materials and method: We compared the effectiveness of oral gabapentin with intravenous ondansetron to prevent incidence of intrathecal morphine induced pruritus. In a prospective, double-blind study, sixty patients aged 18-65 years with ASA physical status I and II undergoing surgery under subarachnoid block were randomized to receive placebo tablets (ondansetron group) or gabapentin 1200 mg (gabapentin group) 2 hours before surgery. Patients receiving placebo tablets received 8 mg of intravenous ondansetron and those receiving gabapentin received 4 ml of intravenous normal saline just prior to subarachnoid block with 3 ml of 0.5% hyperbaric bupivacaine plus 0.2 mg morphine. The incidence, onset, severity, location of pruritus and incidence of side effects were studied for next 24 hours. Results: The overall incidence of pruritus was 48.3%. The incidence, severity, location of pruritus was comparable between the two groups. There was significant difference between the onset of pruritus between groups (p=0.009). The incidence and grade of nausea vomiting, requirement of intraoperative sedation was comparable between groups. The incidence of urinary retention was significantly high in gabapentin group (p=0.020). Respiratory depression was observed in one patient. Conclusion: A single dose of 1200 mg oral gabapentin 2 hours before, is as effective as prophylactic intravenous ondansetron 8 mg for prevention of intrathecal morphine induced pruritus.

Netupitant/palonosetron (NEPA) for prevention of delayed chemotherapy-induced nausea and vomiting (CINV) in multiple cycles of chemotherapy.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 211-211
Author(s):  
Lee Steven Schwartzberg ◽  
Richard J. Gralla ◽  
Kimia Kashef ◽  
Hope Rugo
Keyword(s):  
Oral Dose ◽  
Single Oral Dose ◽  
Complete Response ◽  
Control Group ◽  
Double Blind ◽  
Report Data ◽  
Multiple Cycles ◽  
To Receive ◽  
Delayed Phase ◽  
Significant Nausea

211 Background: Prevention of CINV in the delayed phase (24-120 h post-chemotherapy) and over multiple cycles of chemotherapy remains a challenge. NEPA, a fixed combination of the NK1 receptor antagonist (RA) netupitant (300 mg) and the 5-HT3 RA palonosetron (PALO; 0.5 mg), has demonstrated efficacy in multiple studies, in both acute and delayed phases, during the first cycle of moderately or highly emetogenic chemotherapy (MEC and HEC, respectively) regimens. Two clinical trials evaluated NEPA over multiple cycles of chemotherapy. We report data for the delayed phase for each cycle. Methods: Both studies were Phase 3, double-blind, active-controlled studies. In study 1 (MEC), patients were randomized 1:1 to receive a single oral dose of NEPA (n = 724) or PALO 0.5 mg (n = 725) on Day 1; following cycle 1, patients could participate in a multi-cycle extension phase. In study 2 (MEC or HEC), patients were randomized 3:1 to receive a single oral dose of NEPA on Day 1 (n = 309) or oral aprepitant (APR) 125 mg plus oral PALO 0.5 mg on Day 1, then APR 80 mg/d on days 2 and 3 of each cycle (n = 103). In both studies, all patients also received dexamethasone. Efficacy endpoints included complete response (CR; no emesis, no rescue medication) and no significant nausea. Results: In both studies, CR rates were consistently numerically higher with NEPA (Study 1 range: 77%-89%; Study 2 range: 83%-93%) than with PALO (Study 1; range: 69%-83%) or APR/PALO (Study 2; range: 78%-88%) in each cycle up to cycle 6 (Table). In both studies, rates of no significant nausea in the NEPA group were similar to or higher than in the control group. NEPA was well tolerated in both studies; treatment-related adverse events included constipation and headache. Conclusions: These studies demonstrate sustained efficacy of NEPA (administered as a single dose on Day 1) across multiple cycles of MEC or HEC for prevention of CINV in the delayed phase. Clinical trial information: 2009-016775-30; 2010-023297-39. [Table: see text]

scholarly journals EXTENDED ABSORPTION OF LIOTHYRONINE FROM POLY-ZINC LIOTHYRONINE (PZL) IN HUMANS

2021 ◽  
Author(s):  
Alexandra Dumitrescu ◽  
Erin C Hanlon ◽  
Marilyn Arosema ◽  
Olga Duchon ◽  
Matthew Ettleson ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Volunteers ◽  
Drug Product ◽  
Phase 1 ◽  
Placebo Administration ◽  
Double Blind ◽  
Serum T3 ◽  
To Receive ◽  
Administration Methods ◽  
Hypothyroid Patients

Background: Liothyronine (LT3) has been increasingly used in combination with levothyroxine (LT4) in the treatment of hypothyroidism. A metal coordinated form of LT3, known as poly-zinc-liothyronine (PZL), avoided in rats the typical T3 peak seen after oral administration of LT3. Objectives: To evaluate in healthy volunteers (i) the pharmacokinetics of PZL-derived T3 after a single dose, (ii) the pharmacodynamics of PZL-derived T3, (iii) monitoring for the adverse events; (iv) exploratory analysis of the sleep patterns after LT3, PZL or placebo administration. Methods: 12 healthy volunteers 18 to 50 years of age were recruited for a Phase 1, double-blind, randomized, single-dose placebo-controlled, cross-over study to compare PZL against LT3 or placebo. Subjects were admitted three separate times to receive a randomly assigned capsule containing placebo, 50-mcg LT3, or 50-mcg-PZL, and were observed for 48h. A 2-week wash-out period separated each admission. Results: LT3-derived serum T3 levels exhibited the expected profile, with a Tmax at 2h and return to basal levels by 24-36h. PZL-derived serum T3 levels exhibited a ~30% lower Cmax that was 1 h delayed and extended into a plateau that lasted up to 6h. This was followed by a lower but much longer plateau; by 24 hours serum T3 levels still exceeded 1/2 of Cmax. TSH levels were similarly reduced indistinguishably in both groups. Conclusion: PZL possesses the necessary properties to achieve a much improved T3 pharma-cokinetic. Drug product development of PZL should improve the delivery of T3 even further. PZL is on track to provide hypothyroid patients with stable levels of serum T3.

scholarly journals Novel, Single-Dose Microsphere Formulation of Azithromycin versus 7-Day Levofloxacin Therapy for Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults

2005 ◽  
Vol 49 (10) ◽  
pp. 4035-4041 ◽  
Author(s):  
Joseph D'Ignazio ◽  
Marco A. Camere ◽  
Drew E. Lewis ◽  
Daniel Jorgensen ◽  
Jeanne D. Breen
Keyword(s):  
Single Dose ◽  
Confidence Interval ◽  
Clinical Cure ◽  
Community Acquired Pneumonia ◽  
Double Blind ◽  
Treatment Difference ◽  
Treatment Regimens ◽  
Protocol Population ◽  
Cure Rates ◽  
To Receive

ABSTRACT This randomized, double-blind, noninferiority study was designed to demonstrate that a single 2.0-g oral dose of a novel microsphere formulation of azithromycin was at least as effective as 7 days of levofloxacin, 500 mg/day, in the treatment of adult patients with mild to moderate community-acquired pneumonia (Fine classes I, II, and III). In total, 427 subjects were randomly assigned to receive either a single 2.0-g dose of azithromycin microspheres (n = 213) or a 7-day regimen of levofloxacin (n = 214). At baseline, 219 of 423 (51.8%) treated subjects had at least one pathogen identified by culture, PCR, or serology. The primary end point was the clinical response (cure or failure) in the “clinical per protocol” population at test of cure (days 13 to 24). Clinical cure rates were 89.7% (156 of 174) for azithromycin microspheres and 93.7% (177 of 189) for levofloxacin (treatment difference, −4.0%; 95% confidence interval, −9.7%, 1.7%). Bacteriologic success at test of cure in the “bacteriologic per protocol” population was 90.7% (97 of 107) for azithromycin microspheres and 92.3% (120 of 130) for levofloxacin (treatment difference, −1.7%; 95% confidence interval, −8.8%, 5.5%). Both treatment regimens were well tolerated; the incidence of treatment-related adverse events was 19.9% and 12.3% for azithromycin and levofloxacin, respectively. A single 2.0-g dose of azithromycin microspheres was at least as effective as a 7-day course of levofloxacin in the treatment of mild to moderate community-acquired pneumonia in adult outpatients.

scholarly journals Treatment of Bacterial Vaginosis: A Multicenter, Double-Blind, Double-Dummy, Randomised Phase III Study Comparing Secnidazole and Metronidazole

2010 ◽  
Vol 2010 ◽  
pp. 1-6 ◽  
Author(s):  
Jean-Marc Bohbot ◽  
Eric Vicaut ◽  
Didier Fagnen ◽  
Michel Brauman
Keyword(s):  
Single Dose ◽  
Bacterial Vaginosis ◽  
Multiple Dose ◽  
Phase Iii ◽  
Routine Practice ◽  
Vaginal Fluid ◽  
Double Blind ◽  
Nugent Score ◽  
Phase Iii Study ◽  
To Receive

Objective. Multiple-dose metronidazole oral therapy is currently the reference treatment for bacterial vaginosis (BV). This double-blind, double-dummy, noninferiority study compared the efficacy of secnidazole, another nitroimidazole with pharmacokinetics allowing a single dose regimen, to this standard treatment.Methods. A total of 577 patients were randomized to receive metronidazole (500 mg, b.i.d for seven days) or secnidazole (2 g, once). Therapeutic cure at D28 was defined as the resolution of vaginal discharge, positive KOH whiff test, vaginal pH>4.5and Nugent score>7on Gram-stained vaginal fluid.Results. According to this primary endpoint, the single-dose secnidazole regimen was shown to be at least as effective as the multiple-dose metronidazole regimen (60.1% cured women vs59.5% , 95% confidence interval with a noninferiority margin of 10%:[−0.082;0.0094]). Safety profiles were comparable in both groups.Conclusion. The secnidazole regimen studied represents an effective, convenient therapeutic alternative that clinicians should consider in routine practice.

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.

Optimal combination therapy with tropisetron in 445 patients with incomplete control of chemotherapy-induced nausea and vomiting.

1994 ◽  
Vol 12 (11) ◽  
pp. 2439-2446 ◽  
Author(s):  
F Hulstaert ◽  
S Van Belle ◽  
H Bleiberg ◽  
J L Canon ◽  
M Dewitte ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Response Rate ◽  
Complete Response Rate ◽  
Complete Response ◽  
Moderate Increase ◽  
Open Label ◽  
Double Blind ◽  
Once Daily ◽  
Antiemetic Agent ◽  
To Receive

PURPOSE This study evaluated tropisetron (Navoban; Sandoz Pharma, Basle, Switzerland)-based combination therapy in patients who had incomplete control of chemotherapy-induced nausea or vomiting when using tropisetron as a single antiemetic agent. PATIENTS AND METHODS One thousand seventy-two patients, who were scheduled to receive at least two identical cycles of emetogenic chemotherapy, were treated with 5 mg tropisetron once daily in their first chemotherapy course. A 2 x 2 x 2 factorial design was used to evaluate three additional treatments to the recommended 5 mg once daily (intravenously [i.v.] on day 1; orally on days 2 through 6) tropisetron regimen during course 2 in those patients who had shown incomplete control of nausea and/or vomiting on any day of course 1. Four hundred forty-five patients were centrally randomized to receive, in addition, open-label dexamethasone (day 1, 0.2 mg/kg i.v.; days 2 through 6, 8 mg orally) and/or open-label alizapride (day 1, 100 mg i.v. and 4 x 50 mg orally; days 2 through 6, 4 x 50 mg orally) and/or double-blind tropisetron (ie, doubling the dose to 10 mg once daily) or corresponding placebo. RESULTS Complete response rates (no nausea and no vomiting) were 72% for day 1 and 48% for days 1 through 6 of course 1. During course 2, more complete responders were observed when dexamethasone was added, both for day 1 (76% v 66%, P = .020) and for days 1 through 6 (50% v 34%, P = .0004). A moderate increase in the complete response rate was seen with the addition of conventional-dose alizapride (day 1, 75% v 68%, P = .14; days 1 through 6: 47% v 37%, P = .041). Doubling the dose of tropisetron did not change the complete response rate. CONCLUSION The addition of dexamethasone significantly increases the complete response rate of both acute and delayed emesis in patients who have incomplete disease control with tropisetron alone.

Randomized, Double-Blind, Dose-Finding Study of Dexamethasone in Preventing Acute Emesis Induced by Anthracyclines, Carboplatin, or Cyclophosphamide:

2004 ◽  
Vol 22 (4) ◽  
pp. 725-729 ◽  
Author(s):  
Keyword(s):  
Single Dose ◽  
Dose Finding ◽  
Complete Protection ◽  
Double Blind ◽  
Acute Emesis ◽  
Intention To Treat ◽  
Finding Study ◽  
Dose Finding Study ◽  
To Receive ◽  
Different Doses

Purpose Different doses and schedules of dexamethasone, combined with a 5-HT3 antagonist, are used to prevent acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide. Therefore, we planned a randomized, double-blind, dose finding study aimed to identify the preferred dose and schedule of dexamethasone. Patients and Methods All consecutive chemotherapy-naive patients enrolled onto study were randomly assigned to receive for the prevention of acute emesis, during the first 24 hours, one of the following dexamethasone regimens, in combination with ondansetron 8 mg intravenously (IV): for arm A, 8 mg IV before chemotherapy plus 4 mg orally every 6 hours for four doses, starting at the same time of the chemotherapy; for arm B, 24 mg IV single dose before chemotherapy; and for arm C, 8 mg IV single dose before chemotherapy. All patients received from day 2 to 5 oral dexamethasone 4 mg bid. Results A total of 587 patients were enrolled, and 585 were assessed according to the intention-to-treat principle (195 patients in each arm). The rate of complete protection from acute vomiting and nausea, respectively, was not significantly different among the three groups (arm A, 84.6% and 66.7%; arm B, 83.6% and 56.9%; arm C, 89.2% and 61.0%), nor was the rate of complete protection from delayed vomiting and nausea, respectively (arm A, 81.0% and 46.7%; arm B, 81.3% and 45.1%; arm C, 79.8% and 46.1%). The incidence of delayed vomiting and nausea was strictly dependent on the presence of acute vomiting and nausea. Adverse events were mild and not significantly different among the three groups. Conclusion Dexamethasone 8 mg single dose IV before chemotherapy, in combination with a 5-HT3 antagonist, should be considered the preferred dose to prevent acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide.

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