Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This was a retrospective non-interventional study evaluating the medical records of patients with neuroendocrine tumor (NET) re-treated with lutetium-177 DOTATATE at a single United States institution - the Excel Diagnostics & Nuclear Oncology Center in Houston, Texas. Initial treatment was defined as the initial regimen of up to 4 doses of Lutetium-177 DOTATATE received by each patient; re-treatment was defined as any additional dose(s) of lutetium-177 DOTATATE given after the patient progressed following the initial treatment, with a minimum time interval of 6 months between the initial treatment and re-treatment.
The study period was from 01 January 2010 to 30 June 2021. The index date was the date of the first ever treatment with lutetium-177 DOTATATE, and the index re-treatment date was the date of the first re-treatment dose of lutetium-177 DOTATATE received. The index (identification) period was from 01 July 2010 to 31 December 2020 to account for minimum 6-month baseline and follow-up periods. Patients were followed from the index date to the occurrence of one of the following events (whichever came first):
- Date of death - the date at which a patient was reported in the database as having died
- Last month active - the last recorded mention of the patient in the dataset
- End of data window - end of the dataset Patient characteristics were assessed at both the index date and the index re-treatment date. Real-world effectiveness and safety outcomes were also assessed from the index date and from the index re-treatment date.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Initial treatment
Patients who received initial treatment with lutetium-177 DOTATATE
干预措施: Lutetium-177 DOTATATE (Drug)
Re-treatment
Patients who received re-treatment with lutetium-177 DOTATATE
干预措施: Lutetium-177 DOTATATE (Drug)
Additional re-treatment
Patients who received additional re-treatment with lutetium-177 DOTATATE
干预措施: Lutetium-177 DOTATATE (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Up to approximately 11 years
Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of progression or death
Percentage of patients with treatment response
时间窗: Up to approximately 11 years
Best overall response was defined per Response Evaluation Criteria In Solid Tumors (RECIST), 1.1. Overall response: complete response (CR) + partial response (PR); CR; PR; stable disease (SD); and progressive disease (PD)
Overall survival
时间窗: Up to approximately 11 years
Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of death
次要结局
- Mean change from baseline in albumin(Up to approximately 11 years)
- Mean change from baseline in bilirubin(Up to approximately 11 years)
- Mean change from baseline in cromogranin A(Up to approximately 11 years)
- Mean change from baseline in alkaline phosphatase (ALP)(Up to approximately 11 years)
- Mean change from baseline in white blood cell (WBC) count(Up to approximately 11 years)
- Mean change from baseline in absolute neutrophil count (ANC)(Up to approximately 11 years)
- Mean change from baseline in pancreatic polypeptide(Up to approximately 11 years)
- Number of patients with adverse events (AEs)(Up to approximately 11 years)
- Mean change from baseline in lymphocyte count(Up to approximately 11 years)
- Mean change from baseline in platelet count(Up to approximately 11 years)
- Mean change from baseline in aspartate aminotransferase (AST)(Up to approximately 11 years)
- Mean change from baseline in hemoglobin(Up to approximately 11 years)
- Mean change from baseline in pancreastatin(Up to approximately 11 years)
- Number of patients who received other treatments prior to initial treatment with lutetium-177 DOTATATE(Prior to initial treatment with lutetium-177 DOTATATE)
- Mean change from baseline in alanine aminotransferase (ALT)(Up to approximately 11 years)
- Mean change from baseline in creatinine(Up to approximately 11 years)
- Mean change from baseline in estimated glomerular filtration rate (eGFR)(Up to approximately 11 years)
- Quantity of lutetium-177 DOTATATE administered, categorized by treatment stage(Up to approximately 11 years)
- Number of patients who received lutetium-177 DOTATATE, categorized by number of doses(Up to approximately 11 years)
- Number of patients who received lutetium-177 DOTATATE, categorized by treatment stage(Up to approximately 11 years)