Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer
Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer
This study is a multi-center, non-interventional study. Patients' background, treatment
 pattern, treatment outcome, efficacy will be collected from medical records in Stage IV
 urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary
 tumor samples will be collected to assay PD-L1 expression and next generation sequencer (NGS)
 assay for tumor mutation burden (TMB).
This study is a multi-center, non-interventional study. Patients' background, treatment
 pattern, treatment outcome, efficacy will be collected from medical records in Stage IV
 urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary
 tumor samples will be collected from each site and conduct programmed cell death 1 ligand 1
 (PD-L1) assay and next generation sequencer (NGS) assay for tumor mutation burden (TMB).
 Based on these data, prevalence of PD-L1, TMB and overall survival (OS), progression free
 survival (PFS) from start of 1st line treatment in stage IV will be assessed.

 In this study, 150 patients will be enrolled from approximately 30 sites in Japan. The
 patients should have received at least 1 cycle of chemotherapy and never receive immune
 oncology drug as 1st line treatment in stage IV. The patients will be enrolled continuously
 from the 1st patient who is enrolled in this study until target number of patients in each
 site.
Inclusion Criteria:

 -  Age > 20, Japanese men and women.

 -  Patients who have started at least 1 cycle of chemotherapy.

 -  Patients who provided informed consent by appropriate methods. In dead case, optout
 will be applicable.

 -  Patients who are diagnosed as stage IV (T4b, any N or any T, N2-3 or M1) UC between
 January 1st in 2017 and December 31st in 2018.

 -  Patients who have FFPE primary tumor sample collected after January 1st in 2017. The
 sample should be collected before any therapies including 1st line treatment in stage
 IV and therapies in stage III and other stages. It is possible to send sliced undyed
 section of primary tumor including 1 HE-stained section of same sample in case that
 patients cannot send FFPE primary tumor block.

 Exclusion Criteria:

 -Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage
 IV.