The purpose of this clinical trial is to learn about the current treatment patterns, safety, and effects of the study medicine (Avelumab) for the treatment of urothelial carcinoma. This study is seeking Japanese participants who: * have urothelial cancer that has spread * are treated with Avelumab for maintenance We will study the experiences of people receiving avelumab. This helps us learn the current treatment patterns, safety, and effects of avelumab. Participants will take part in this study up to 10 months. During this time, they will have no study visits.
Study Type
OBSERVATIONAL
Enrollment
79
As provided in real world setting
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Asahi General Hospital
Asahi, Chiba, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
St. Marianna University School of Medicine
Kawasaki, Kanagawa, Japan
SHOWA University Fujigaoka Hospital
Yokohama, Kanagawa, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
...and 6 more locations
Age of Participants at Baseline
The age of participants at baseline was reported.
Time frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of Participants With Advanced and Metastatic Urothelial Carcinoma by Sex
Number of Participants With Advanced and Metastatic UC by sex was reported.
Time frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of Participants According to Location of Primary Tumor
The primary tumor site is divided into the following categories: "upper urinary tract" for renal pelvis or ureter "lower urinary tract" for bladder and urethra.
Time frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of Participants With Presence of Urothelial Carcinoma Subtype
The subtype of urothelial carcinoma included micropapillary, microcystic, nested, lymphoepithelioma-like, plasmacytoid, sarcomatoid, giant cell, poorly differentiated, lipid rich, clear cell. number of participants with presence of UC subtype was reported.
Time frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of Participants With Metastatic Sites at Start of First Line Chemotherapy
Number of participants with metastatic sites at start of First Line Chemotherapy was reported.
Time frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of First Line Chemotherapy
ECOG PS measured on-therapy (time between first dose and last dose date) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \[\>\] 50% of waking hours \[hrs\]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
Time frame: At the initiation of first line chemotherapy
Number of Participants Who Received First Line (IL) Chemotherapy Regimens
Chemotherapies were categorized as: 1.Gemcitabine + Cisplatin 2. Gemcitabine + Carboplatin 3. Dose-dense methotrexate, vinblastine, doxorubicin, cisplatin 4. Other.
Time frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of First Line Chemotherapy Cycles
Number of Firstline Chemotherapy Cycles in participants at baseline was reported.
Time frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of Participants With Best Response to First Line Chemotherapy According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
Determination of the best overall response to first-line chemotherapy is categorized as following: "Objective response" when "Complete Response" or "Partial Response." "Non-objective response" when "Stable Disease" of "Progressive Disease"
Time frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of Participants With Presence or Absence of Variant Histology
Number of participants with presence or absence of variant histology was reported.
Time frame: At baseline (at the initiation of avelumab maintenance therapy)
Treatment-Free Interval
Treatment free-interval is defined as the time from the end date of first-line chemotherapy to the start date of avelumab administration. Treatment-free interval divided into the following categories. \<4 weeks/4 to 10 weeks/\>10 weeks.
Time frame: At baseline (at the initiation of avelumab maintenance therapy)
Percentage of Participants With Second-Line Treatment Regimen
Second-Line Therapies were categorized as: 1. Platinum Chemotherapy, 2. Enfortumab Vedotin, Gem, Gemcitabine, 3.immune checkpoint inhibitor.
Time frame: At baseline (at the initiation of avelumab maintenance therapy)
Time to Failure (TTF) of Avelumab
TTF was defined as the time from start of avelumab maintenance therapy to the date of end of treatment due to any cause including death. If there is no record of the end of treatment, it be discontinued on the last visit date during the study period.
Time frame: Time from start of avelumab maintenance therapy to the date of end of treatment due to any cause including death, assessed up to 5.9 months
Real-World Progression-Free Survival (Rw-PFS)
rwPFS is defined as: The time from start of avelumab maintenance therapy to date of first disease progression (as clinically assessed by local investigator based on radiology, laboratory evidence, pathology, or other assessments) or death due to any cause, whichever occurred first. If there were no clinical records of death or disease progression, they will be censored at the date of initiation of the next line of therapy for the participants undertaking 2 or more lines of therapy (subsequent therapy after avelumab maintenance therapy) based on the record, or at their last visit date during the study period for the participants undertaking only 1 line of therapy (only avelumab maintenance therapy) based on the record.
Time frame: From index date up to 30 Jun 2022, where index date was date of first prescription for avelumab between 24 February 2021 and 30 November 2021 (maximum observation period was of 16 months approximately)
Overall Response Rate (ORR)
The Best ORR was defined as the percentage of participants having achieved complete response (CR) or partial response (PR) according to RECIST version 1.1 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.
Time frame: Time from start of avelumab maintenance therapy to the date of end of treatment due to any cause including death, assessed up to 5.9 months
Real-World Progression-Free Survival (Rw-PFS) From Chemotherapy (rwPFS-c）
rwPFS-c is defined as the following: The time from start of first-line Chemotherapy to date of first disease progression (as clinically assessed by local investigator based on radiology, laboratory evidence, pathology, or other assessments) or death due to any cause during avelumab treatment, whichever occurred first. If there were no clinical records of death or disease progression, they will be censored at the date of initiation of the next line of therapy for the participants undertaking 2 or more lines of therapy (subsequent therapy after avelumab maintenance therapy) based on the record, or at their last visit date during the study period for the participants undertaking only 1 line of therapy (only avelumab maintenance therapy) based on the record.
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Time frame: Time from start of avelumab maintenance therapy to the date of end of treatment due to any cause including death, assessed up to 5.9 months