Urothelial Cancer
Conditions
Brief summary
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.
Detailed description
Retrospective-prospective study
Interventions
None listed
Sponsors
Ospedale Mater Salutis-Legnago(Verona), Italy
Casa di Cura Dott. Pederzoli
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Subsequent Oncologic Treatments | 1 year | Duration of Subsequent Oncologic Treatments in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy treated with Avelumab in first-line maintenance therapy compared to patients treated with Pembrolizumab in second-line therapy. |
| Adverse Events | 1 year | Adverse Events of Any Grade Related to Treatment according to CTCAE 5.0, in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy treated with Avelumab in first-line maintenance therapy, compared to patients treated with Pembrolizumab in second-line therapy. Adverse events will be evaluated based on their severity and relationship to the treatment received. |
| Serious Adverse Events | 1 year | Adverse Events of Grade 3 or Higher Related to Treatment according to CTCAE 5.0, 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, compared to patients treated with Pembrolizumab in second-line therapy. Adverse events of grade 3 or higher will be monitored and assessed for their relationship to the treatment received. |
| Overall Cost of Oncologic Therapy | 1 year | Overall Cost of Oncologic Therapy in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy treated with Avelumab in first-line maintenance therapy, compared to patients treated with Pembrolizumab in second-line therapy. The cost will be evaluated for each treatment approach and compared between the two groups. |
Countries
Italy
Outcome results
None listed