Retrospective Multicenter Study of Elderly Patients With Ovarian Cancer Treated With Trabectedin and PLD According to SmPC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Serious and non-serious adverse events
研究概览
简要总结
The median age at which ovarian cancer is diagnosed is 63 years (50-75). This is still a significant adverse factor for survival results. Seventy years can be considered the lower limit for the elderly term, since most of age-related changes occur later. Because of this, this group of patients is often not included in clinical trials and sometimes they do not receive adequate treatment. Little information is available on chemotherapy treatments in elderly patients. Data on the use of first-line chemotherapy in this population have recently been published. Trabectedin in combination with PLD is indicated for platinum-sensitive relapsed ovarian cancer and is an option for those patients in whom platinum is not the best option. There are some studies with trabectedin in combination with PLD in which some patients with this profile have been included, although not exclusively. Therefore, it is of interest to study the safety and efficacy profile of this treatment in elderly patients. With this information we will be able to know its real use in routine clinical practice at the national level in Spain in this population for which not much information is available. Safety and efficacy data (e.g. PFS, ORR, OS) will be collected retrospectively in order to draw conclusions about the combination of trabectedin + PLD, as a treatment option in this patient profile.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients) or absence of consent sheet must be signed by the investigator. Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permissions and applicable law for retrospective studies in Spain.
- •Adult women (≥70 years at the time of treatment initiation with trabectedin and PLD).
- •Histological diagnosis of platinum-sensitive relapsed ovarian cancer (PFI ≥ 6 months).
- •Treatment started with trabectedin and PLD (at least one cycle) as standard of care between January 1st 2015 and December 31st
- •Patients must have received at least one cycle of trabectedin + PLD.
排除标准
- •Patients without medical record available (lost, empty or unretrievable clinical information).
- •Patients who explicitly refuse to participate in the study.
结局指标
主要结局
Serious and non-serious adverse events
时间窗: 8 months
Safety profile
Progression-free survival (PFS)
时间窗: 8 months
Time in months since first trabectedin + PLD dose date until radiological progression (or death due to any cause) according to RECIST 1.1 criteria
Overall response rate (ORR)
时间窗: 8 months
Number of patients having a best overall response (BOR) of complete response (CR) or partial response (PR), divided by the total number of response-evaluable patients (according to RECIST 1.1 criteria)
Disease control rate (DCR)
时间窗: 8 months
Percentage of patients having a complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria
Overall survival (OS)
时间窗: 8 months
Number of months since first trabectedin + PLD dose date until death due to any cause
Trabectedin + PLD treatment information (for both drugs)
时间窗: 8 months
Starting dose, total dose
Previous and subsequent treatments to trabectedin + PLD
时间窗: 8 months
Number of previous/subsequent treatments
Patient characteristics and medical history
时间窗: 8 months
Platinum-free interval (PFI)
次要结局
未报告次要终点