Interest of the Addition of Docetaxel to Standard Treatment in First-line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this retrospective study is to evaluate the efficacy and the safety of trastuzumab + chemotherapies with or without taxanes among HER2-positive advanced gastroesophageal adenocarcinoma patients.
详细描述
Studies have reported a beneficial role of trastuzumab combined to platin-5-FU based chemotherapy in first-line advanced HER2 positive gastroesophageal adenocarcinoma. However, the effect of taxanes combined with platin-5FU + trastuzumab (TPFT) is understudied.
In this context, the aim of this study is to evaluate the efficacy and the safety of trastuzumab + chemotherapies with or without taxanes among HER2-positive advanced gastroesophageal adenocarcinoma patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed non-resectable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-esophageal junction;
- •tumor samples scored as 3+ on immunohistochemistry or FISH (Fluorescence in situ Hybridization) positive (HER2:CEP17 ratio ≥2);
- •measurable disease;
- •treated by trastuzumab, platin (cisplatine or oxaliplatine), fluoropyrimidine (5-FU or capecitabine) +/- taxanes (docetaxel or paclitaxel),
- •as first-line therapy for advanced gastric cancer.
排除标准
- •previous chemotherapy by taxane for metastatic disease,
- •previous anti-HER2 therapy.
研究组 & 干预措施
T group
taxanes + platin-5FU + trastuzumab
干预措施: Taxane (Drug)
结局指标
主要结局
Progression free survival
时间窗: up to 12 years
PFS will be defined as the time interval between the date of randomization and the date of first progression (local, regional, metastatic, second cancer) or death regardless of the cause. Patients alive without progression will be censored at the time of the latest news
次要结局
- Overall survival(up to 12 years)
- secondary resectability of primary tumor or metastases in patients with DCR(up to 12 years)
- Tolerance(up to 12 years)
- disease control rate(up to 12 years)
- Objective Response Rate(up to 12 years)