Phase III Trial of Doxorubicin /Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D (AC-D) as Front-line Chemotherapy for Metastatic Breast Cancer: Japan Clinical Oncology Group Trial (JCOG9802)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- time to treatment failure
研究概览
简要总结
To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer
详细描述
power to detect a 50% increase in median TTF at 0.025 one-sided alpha in AC vs. D and AC vs. AC-D.
Results: 441pts (146 in AC, 147 in D, 148 in AC-D) were randomized between 01/99 and 05/03. Major grade 3-4 toxicities were neutropenia (26/45/46% for AC/D/AC-D), febrile neutropenia (3/4/6%), nausea/vomiting (3/3/4%). There was no toxic death. One grade 4 diarrhea in AC-D and 1 secondary leukemia (APL) in D were reported. Response (CR/PR) rates were 30, 41, and 35% for AC, D, and AC-D respectively. Median TTF (AC, D, and AC-D) are 6.4, 6.4, and 6.7 months (p =.255 for AC vs. D, p =.275 for AC vs. AC-D), and median overall survival are 22.4, 25.7, and 25.0 months (p=.092 for AC vs. D, p=.076 for AC vs. AC-D). The same difference was shown by the adjusted Cox model.
Conclusions: No benefit was demonstrated in D and AC-D over AC in TTF, however, D and AC-D tended to be superior to AC in response rate and overall survival. Survival benefit of front-line docetaxel should be re-evaluated by further long follow-up.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hormonal therapy-resistant MBC
- •ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after adjuvant hormonal therapy
- •No anthracyclines for MBC and no prior taxanes
- •At least 6 months from the completion of adjuvant chemotherapy
- •Measurable or evaluable lesions
- •Age: 20 to 75 years
- •WBC >= 4,000 /mm3 or ANC >=1,000 /mm3, Platelet >= 100,000 /mm3, SGOT/SGPT <= 1.5 x ULN, T-Bil <= 1.5 mg/dL, Cr <= 1.5 mg/dL
- •Written informed consent
排除标准
- •malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment
- •Active infection
- •other cancer present within the last 5 years
- •previous stem cell transplantation
- •brain metastasis that requires emergent treatment
- •relapse within 6 months after completion anthracycline or during anthracycline
- •more than 250mg/m2 of anthracyclines
- •hypersensitivity of drug
- •interstitial pneumonitis or pulmonary fibrosis
- •positive HBs
- •antipsychotic medication
- •doctor's judgement
结局指标
主要结局
time to treatment failure
次要结局
- progression-free survival
- overall survival
- response rate
- adverse events