Evaluation of Clinical Outcomes, Tolerability, and Costs of Avelumab as First-Line Maintenance Therapy and Pembrolizumab as Second-Line Therapy in Patients With Advanced Urothelial Cancer Without Disease Progression After First-Line Platinum-Based Chemotherapy: A Multicenter Retro-Prospective Observational Study in Real-World Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
The goal of this observational study is to evaluate the clinical outcomes, side effects, and costs of Avelumab maintenance therapy in first-line and Pembrolizumab in second-line for platinum-fit patients with advanced urothelial cancer who have not shown disease progression after 4-6 cycles of platinum-based first-line chemotherapy.
Researchers will compare the effects of Avelumab (used as maintenance in first-line) and Pembrolizumab (used in second-line) to see if there are differences in clinical outcomes, toxicity profiles, and costs.
Participants will:
Receive Avelumab as maintenance therapy in the first-line or Pembrolizumab in the second-line as per standard clinical practice.
Be monitored for clinical outcomes, side effects, and costs over a period of up to 12 months prospectively and 10 years retrospectively.
详细描述
Retrospective-prospective study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •At least 18 years of age
- •ECOG PS 0-2
- •Diagnosis of pathologically confirmed stage IV urothelial cancer, regardless of PD-L1 status
- •Patients treated with platinum-based chemotherapy (Cisplatin or Carboplatin) in the first-line setting who have not shown disease progression after 4-6 cycles of chemotherapy
- •Patients receiving Avelumab as maintenance therapy in the first-line setting or Pembrolizumab in the second-line setting
- •Availability of hospital and/or outpatient medical records for clinical data collection
- •Ability to understand and willingness to provide informed consent, or deceased patients at the time of enrollment, in compliance with Article 110 of the Privacy Code and the safeguards established by the Data Protection Authority in Provision No. 298 of May 9, 2024.
排除标准
- •History of another malignancy or concurrent malignancy (except for cured non-melanoma skin cancer, low-risk prostate cancer, T1/T2 glottic cancer, stage 0 or I breast cancer, non-invasive bladder cancer, or in situ cervical cancer).
结局指标
主要结局
Progression-free survival
时间窗: 1 year
Radiologic Progression-Free Survival (PFS) Evaluation in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy. These patients are treated with Avelumab in first-line maintenance therapy, or Pembrolizumab in second-line therapy. Radiologic progression is defined as the time from the start of first-line platinum-based chemotherapy to the date of radiologic progression (according to RECIST v1.1) after initiation of Avelumab maintenance therapy in the first-line or Pembrolizumab in the second-line, or death from any cause.
Overall Survival
时间窗: 1 year
Overall Survival (OS) Evaluation in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy. These patients are treated with Avelumab in first-line maintenance therapy, or Pembrolizumab in second-line therapy.
次要结局
- Duration of Subsequent Oncologic Treatments(1 year)
- Adverse Events(1 year)
- Serious Adverse Events(1 year)
- Overall Cost of Oncologic Therapy(1 year)