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Evidence supports olanzapine for prophylaxis of chemotherapy-induced nausea/vomiting (CINV) for highly emetogenic chemotherapy (HEC); however, most studies focus on solid malignancies and single day regimens. A randomized, double-blinded, placebo-controlled trial was conducted to compare addition of olanzapine to triplet therapy (fosaprepitant, ondansetron, dexamethasone; FOND-O) versus triplet therapy alone (FOND) in preventing CINV in hematology patients receiving single and multi-day HEC and hematopoietic cell transplant (HCT) regimens (NCT02635984). Primary objective of this study is to compare complete response (
no emesis and minimal nausea, <25mm on 100mm visual analog scale) during overall assessment period (chemotherapy days plus 5 days after). Secondary objectives of number emesis, number rescue medications, percent achieving minimal nausea, and percent achieving complete protection (
no emesis, rescue antiemetic, or significant nausea), all of which are reported as acute (chemotherapy days), delayed (5 days after chemotherapy), and overall phases. Olanzapine 10 mg or matching placebo were given on each chemotherapy day and three days after. Adults with hematologic malignancy receiving HCT regimens of Melphalan, BEAM, BuCy, BuFlu, BuMel, FluCy, FluCy-TBI, Etoposide-TBI as well as the ICE or 7+3 chemotherapy regimens were included. An estimated 98 patients were required using alpha 0.05 and 80% power. No significant differences existed in baseline characteristics between FOND-O (n=51) and FOND (n=50) arms. Mean duration of olanzapine was 7.7 days (4-11 days). Discontinuation for possible adverse event occurred in 3 placebo and 0 olanzapine patients. CR was significantly higher for FOND-O in overall (55% vs. 26%, p=0.003) and delayed (60.8% vs. 30%, p=0.001) but not acute (p=0.13) phases. Significantly more patients receiving FOND-O achieved no more than minimal nausea in overall (p=0.001) and delayed phase (p=0.0002) as well as fewer overall mean emesis counts (p=0.005). CP rates were not different in any assessment phase (p≥0.05 each). Within the HCT subgroup (n=64), the CR, CP, and no significant nausea rates were significantly better for FONDO-O in overall and delayed phases (all p<0.05). Analysis within the HCT subgroup revealed significant improvement in outcomes in delayed and overall phases with FOND-O in the autologous but not allogeneic cohort. Addition of olanzapine to NK1-based triplet antiemetic regimen significantly improves clinically relevant outcomes in the HCT population.
This article was published in the following journal.
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Crossover double blind, randomized placebo-controlled trial.
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The purpose of this study is to determine the appropriate dosing regimen of fosaprepitant, when administered with ondansetron (with or without dexamethasone), for the prevention of CINV in...
The purpose of this study is to evaluate the efficacy and safety of fosaprepitant (MK-0517) plus ondansetron versus ondansetron alone for the prevention of chemotherapy-induced nausea and ...
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This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemother...
Work consisting of a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL.
Work consisting of a clinical trial that involves at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques after phase II trials. A large enough group of patients is studied and closely monitored by physicians for adverse response to long-term exposure, over a period of about three years in either the United States or a foreign country.
Works about a study where participants are assigned to a treatment, procedure, or intervention by methods that are not random. Non-randomized clinical trials are sometimes referred to as quasi-experimental clinical trials or non-equivalent control group designs.
Work that is the report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques based on a small number of healthy persons and conducted over the period of about a year in either the United States or a foreign country.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...