Efficacy and Prognostic Factors of Trastuzumab Based Therapy in HER2 Positive Advanced Gastric Cancer: a Single Center Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with clinicopathologic factors remain unclear. The object of the study is to determine whether the addition of trastuzumab to first-line chemotherapy improves efficacy compared with chemotherapy alone in HER2 positive AGC.
详细描述
A total of 98 patients with HER2 positive AGC were enrolled in this prospective observational study. All patients were treated with trastuzumab plus chemotherapy as the first line therapy. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •pathology and medical imageology proven advanced gastric adenocarcinoma, inoperable;
- •received trastuzumab plus chemotherapy as the first-line palliative chemotherapy;
- •with measurable lesion with a diameter 20 mm using conventional computed tomography (CT) or magnetic resonance imaging (MRI) scans or 10 mm using spiral CT scans;
- •Eastern Cooperative Oncology Group performance status (ECOG PS ) of 0-2;
- •left ventricular ejection fraction(LVEF) more than 50 percents;
- •sufficient bone marrow, liver and renal function.
排除标准
- •received previous systemic therapy for advanced disease (except adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrollment);
- •trastuzumab based adjuvant/neoadjuvant therapy;
- •treatment with any other anticancer therapy (lapatinib, immunotherapy, etc);
- •patients with heart failure, coronary artery disease or myocardial infarction within the previous 6 months.
- •trastuzumab based first line therapy started beyond 4 weeks from the first diagnoses of AGC.
研究组 & 干预措施
HER2 positive AGC treated with H+CT
HER2 expression was assessed by IHC first. In the cases with IHC 2+, fluorescence in situ hybridization (FISH) was used to detect HER2/neu amplification levels. Only patients with high level of HER2 expression (IHC 3+ or IHC 2+ plus FISH positive) were eligible in this study.
干预措施: H+CT (Drug)
结局指标
主要结局
OS
时间窗: 8 years
OS was defined as time from the beginning of first line therapy to death
PFS
时间窗: 8 years
PFS was measured from the start of first line therapy to the date of progressive disease or death, with censoring of patients who were lost to follow-up.
次要结局
未报告次要终点
研究者
Tianshu Liu
Chief doctor and director of Department of medical oncology
Shanghai Zhongshan Hospital