Urothelial Carcinoma
Conditions
Keywords
Urothelial Cancer, Bladder Cancer, HER2 Mutations, HER2 Overexpression, HER2 Amplification, Seattle Genetics
Brief summary
This study is being done to learn about urothelial cancers that make HER2 and how that affects treatment choices for participants with urothelial cancer. During this study, the medical and health records of participants will be reviewed to learn more about their health. Participants will have urothelial cancer that has grown in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
Interventions
None listed
Sponsors
Seagen, a wholly owned subsidiary of Pfizer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial cell carcinoma is the predominant cell type. * Locally advanced unresectable or metastatic stage disease * Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details) available for HER2 testing. * At least 1 prior line of systemic therapy for locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including 1 line of platinum-containing chemotherapy. * Initiation of anticancer therapy for UC after prior progression on platinum-based therapy with or without maintenance avelumab between 01 January 2019 and 12 months before the end of data collection * Radiographically documented and measurable disease progression immediately before index date
Exclusion criteria
* Any concurrent malignant neoplasm requiring systemic therapy during the study window * Enrollment in a therapeutic clinical trial and received non-standard of care treatment during index line of therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) | Up to 5 years | The proportion of participants who have a best overall response (BOR) based on complete response (CR) or partial response (PR). The BOR for each participant is the best response (radiographically documented and measurable disease or physician-assessed response) achieved after the start date of the lines of treatment (LOT) prior to the initiation of any subsequent LOT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of HER2+ (IHC3+, IHC2+/ISH+), HER2-low (IHC1+, IHC2+/ISH-), HER2-expressing (IHC1+, IHC2+, and IHC3+), and HER2-zero (IHC0) participants | Up to 5 years | — |
| Characteristics of LA/mUC participants | Up to 5 years | — |
| Real-world Overall Survival (rwOS) | Up to 5 years | Time from the index date to date of death from any cause. |
| Characteristics of treatment patterns in LA/mUC participants | Up to 5 years | Agent, reason for change of LOT, surgery, radiotherapy, number of LOT, treatments in each LOT, mean number of LOT, median time to discontinuation of each LOT |
| Percentages of IHC0, 1+, 2+, and 3+ participants | Up to 5 years | — |
| Real-world Time on Treatment (rwTOT) | Up to 5 years | Time from the start date of the LOT to the end date of the same LOT for any reason. |
| Real-world Time to Next Treatment (rwTTNT) | Up to 5 years | The time from the start date of each LOT to the initiation of the next LOT for any reason. |
| Real-world Progression Free Survival (rwPFS) | Up to 5 years | Time from the index date to the first recorded disease progression (radiographically documented and measurable disease or physician assessed response) or death from any cause, before the start of next LOT whichever occurs first. |
| Real-world Duration of Response (rwDOR) | Up to 5 years | The duration of time from the first documented CR or PR in the LOT to the first recorded disease progression (radiographically documented and measurable disease or physician-assessed response) or death from any cause before the start of the next LOT, whichever occurs first. |
| rwORR for each subsequent LOT following the index LOT | Up to 5 years | The proportion of participants who had a real-world BOR based on CR or PR. The BOR for each participant is the best response (radiographically documented and measurable disease or physician-assessed response) achieved after the start date of the LOT prior to the initiation of any subsequent LOT. |
Countries
Austria, France, Germany, United States
Outcome results
None listed