To evaluate the efficacy and safety of a fosaprepitant, tropisetron, and olanzapine antiemetic regimen, with or without dexamethasone, in patients receiving highly emetogenic chemotherapy with epirubicin and cyclophosphamide.
Patients in this study were randomly assigned in a 1:1 ratio to one of two groups using an interactive response system with permuted blocks of four, stratified by age (\<55 vs. ≥55 years). They received either a three-drug antiemetic regimen with fosaprepitant, tropisetron, and olanzapine (triple group) or a four-drug regimen including fosaprepitant, tropisetron, olanzapine, and dexamethasone (quadruple group). All patients were hospitalized for approximately 120 hours post-chemotherapy, documenting emetic episodes, rescue medication use, and nausea ratings on a Likert scale (0 = no nausea, 1 = mild nausea, 2 = moderate nausea, 3 = severe nausea) in a diary. Rescue therapy was available as needed. Clinical staff monitored adverse events every 24 hours using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Subjects who initiated treatment were followed up for endpoints, including complete response (CR), complete control (CC), total control (TC), quality of life, and safety assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
442
Fosaprepitant 150 mg intravenously on Day 1, tropisetron 5 mg intravenously on Day 1, and olanzapine 5 mg orally on Days 1 to 4.
Fosaprepitant 150 mg intravenously on Day 1, tropisetron 5 mg intravenously on Day 1, and olanzapine 5 mg orally on Days 1 to 4. Dexamethasone 12 mg on Day 1, followed by 8 mg on Days 2 to 4.
Henan cacer hospital
Henan, Henan, China
Henan cancer hospital
Zhengzhou, Henan, China
Complete response rate (CR) during overall (0-120 hours after the initiation of anthracycline/cyclophosphamide administration) phase.
CR was determined by the absence of any retching or vomiting and the absence of any requirement for additional antiemetic treatment.
Time frame: 0-120 hours after the initiation of anthracycline/cyclophosphamide administration
CR during the acute (0-24 hours after the initiation of anthracycline/cyclophosphamide administration) and delayed (24-120 hours after the initiation of anthracycline/cyclophosphamide administration) phase
CR was determined by the absence of any retching or vomiting and the absence of any requirement for additional antiemetic treatment.
Time frame: 0-24 hours and 24-120 hours after the initiation of anthracycline/cyclophosphamide administration
Complete control rate (CC) during the acute, delayed, and overall phase
CC is defined as a condition in which a patient does not report more than mild nausea (0 or 1 on a 4-grade categorical scale) (0 = no nausea, 1 = mild nausea, 2 = moderate nausea, 3 = severe nausea).
Time frame: Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration
Total control rate (TC) during the acute, delayed, and overall phases
TC is defined as a condition in which a patient does not report any nausea (0 on a 4-grade categorical scale) (0 = no nausea, 1 = mild nausea, 2 = moderate nausea, 3 = severe nausea).
Time frame: Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration
Safety outcomes
Adverse event incidence rate
Time frame: Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration
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Quality of life based on Functional Living Index-Emesis (FLIE) assessment
Quality of life based on Functional Living Index-Emesis (FLIE) assessment in the overall phase (0-120 h).
Time frame: 0-120 hours after the initiation of anthracycline/cyclophosphamide administration
Exploratory endpoints-The time to the treatment failure
The time to the treatment failure (time to first emetic episode or time to first use of rescue medication, whichever occurred first).
Time frame: 0-120 hours after the initiation of anthracycline/cyclophosphamide administration