Anti-emetic Prophylaxis Using Fosaprepitant , Tropisetron, and Olanzapine, With or Without Dexamethasone for Anthracycline and Cyclophosphamide Chematherapy: A Multicenter, Randomized, Open-labeled Phase 3 Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 442
- 试验地点
- 2
- 主要终点
- Complete response rate (CR) during overall (0-120 hours after the initiation of anthracycline/cyclophosphamide administration) phase.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients receiving their first anthracycline/cyclophosphamide-based HEC regimen (cyclophosphamide 600 mg/m², epirubicin 90-100 mg/m²); divided doses excluded.
- •No prior chemotherapy.
- •Aged 18-70 years.
- •ECOG performance status 0 or
- •Adequate organ function: (including absolute neutrophil count≥1,500/mm3, WBC count≥3,000/mm3, platelet count≥100,000/mm3, AST< 2.5×the upper limit of normal (ULN), ALT< 2.5×ULN, bilirubin< 1.5×ULN, creatinine< 1.5×ULN).
- •No nausea or vomiting within 24 hours before registration.
- •Negative pregnancy test within 7 days prior (women of childbearing potential).
- •No severe cognitive impairment.
- •No hypersensitivity to fosaprepitant, tropisetron, olanzapine, and dexamethasone.
- •No significant cardiac issues: arrhythmia, recent heart failure, or myocardial infarction within 6 months.
- •No symptomatic brain metastasis or carcinomatous meningitis.
- •No diabetes requiring insulin or oral medication.
- •No use of prohibited medications within 48 hours before registration or during treatment.
- •Informed consent obtained.
排除标准
- •History of allergic reactions to study drugs or their analogues.
- •Nausea and vomiting requiring antiemetic treatment at registration.
- •Pregnant or nursing women, those who may become pregnant, or those not planning to use contraception.
- •Mental illness or psychiatric symptoms interfering with daily activities, making study participation difficult.
- •Diabetes treated with insulin/oral hypoglycemics or HbA1c (NGSP) ≥ 6.5% or HbA1c (JDS) ≥ 6.1% at registration.
- •Recent (within 6 months) unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction, or active gastroduodenal ulcer.
- •Convulsive disorders requiring anticonvulsants, ascites needing therapeutic puncture, or gastrointestinal obstruction.
- •Inability to be hospitalized for up to 120 hours (Day 6) post-AC administration initiation.
- •Any other conditions deemed inappropriate for study participation.
研究组 & 干预措施
Triple group
A three-drug antiemetic regimen with fosaprepitant, tropisetron, and olanzapine (triple group)
干预措施: Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen (Drug)
Quadruple group
A four-drug regimen including fosaprepitant, tropisetron, olanzapine, and dexamethasone (quadruple group)
干预措施: Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimen (Drug)
结局指标
主要结局
Complete response rate (CR) during overall (0-120 hours after the initiation of anthracycline/cyclophosphamide administration) phase.
时间窗: 0-120 hours after the initiation of anthracycline/cyclophosphamide administration
CR was determined by the absence of any retching or vomiting and the absence of any requirement for additional antiemetic treatment.
次要结局
- 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(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(Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration)
- Total control rate (TC) during the acute, delayed, and overall phases(Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration)
- Safety outcomes(Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration)
- Quality of life based on Functional Living Index-Emesis (FLIE) assessment(0-120 hours after the initiation of anthracycline/cyclophosphamide administration)
- Exploratory endpoints-The time to the treatment failure(0-120 hours after the initiation of anthracycline/cyclophosphamide administration)
研究者
Zhenzhen Liu
Director, Head of Breast Oncology
Henan Cancer Hospital