Evaluation of Clinical Outcomes, Tolerability, and Costs of Avelumab Maintenance and Pembrolizumab Second-Line Therapy in Advanced Urothelial Cancer.

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

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.

Retrospective-prospective study

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).