Non-Small-Cell Lung Cancer Patients Treated With Erlotinib Six Months or Longer: Demographics, Treatment and Outcome Characteristics of Patient Cases in a Community-Based Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- demographics
研究概览
简要总结
With roughly 80% of cancer patients receiving their oncology care in the community setting, the investigators are proposing to sample from a community-based center to evaluate the percentage of epidermal growth factor receptor (EGFR)-wild type patients that gain benefit from erlotinib and assess the clinical characteristics that are associated with erlotinib-responders. Additionally, biopsy specimens from enrolled patient cases that are EGFR-wt will be evaluated via exploratory genetic analysis for correlated markers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have had NSCLC.
- •Patients must have received erlotinib (single-agent) for six months or longer for NSCLC in the second/third line setting or as maintenance therapy.
- •Patients must have tissue available for EGFR-mutation status testing (if not previously performed) or EGFR-mutation status test results available.
- •Patients must have tissue available for exploratory genetic analysis.
- •Patients must have all clinical information, treatment response data and outcomes data available for review.
- •Patients must be deceased.
排除标准
- 未提供
结局指标
主要结局
demographics
时间窗: 24 months
To describe patient demographic characteristics of patients with erlotinib (single-agent) treatment duration of six months or longer, including patients who are EGFR-wt. Demographic characteristics include age, race,ethnicity, date of initial diagnosis, age at initial diagnosis, location of biopsy at diagnosis, extent of disease with description and location of metastatic sites, histology,and smoking history.
outcome characteristics
时间窗: 24 months
To describe patient outcome characteristics of patients with erlotinib (single-agent) treatment duration of six months or longer, including patients who are EGFR-wt including the reason for discontinuing erlotinib treatment, best response to erlotinib treatment and did patient receive any dose modifications while receiving erlotinib treatment.
treatment characteristics
时间窗: 24 months
To describe patient treatment and characteristics of patients with erlotinib (single-agent) treatment duration of six months or longer, including patients who are EGFR-wt. Including number and kind of prior therapies, disease stage at initial diagnosis, sites of metastasis at time of erlotinib treatment, prior surgery, and radiation.
次要结局
- Biomarker characteristics(24 months)
- Exploratory genetic analysis(24 months)