Retrospective, Multicenter, Observational Study to Evaluate Current Treatment Patterns and Outcomes in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With First-line Avelumab Maintenance
Overview
- Phase
- N/A
- Intervention
- Avelumab
- Conditions
- Urothelial Carcinoma
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Enrollment
- 79
- Locations
- 16
- Primary Endpoint
- Age of Participants at Baseline
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with locally advanced or metastatic UC before receiving Avelumab 1L maintenance therapy.
- •Started treatment with avelumab for locally advanced or metastatic UC from 24 Feb 2021 (regulatory approval date) to 30 Nov
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •(1) Written consent is not required for patients who were transferred to a hospital, and registration with verbal consent is acceptable.
- •(2) Opt-out enrollment is allowed for patients who have already died. 4)Deceased patients are also required to meet the inclusion criteria 1)-2).
Exclusion Criteria
- •There are no exclusion criteria for this study.
Arms & Interventions
Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma who were treated with avelumab as first-line maintenance therapy
Intervention: Avelumab
Outcomes
Primary Outcomes
Age of Participants at Baseline
Time Frame: At baseline (at the initiation of avelumab maintenance therapy)
The age of participants at baseline was reported.
Number of Participants With Advanced and Metastatic Urothelial Carcinoma by Sex
Time Frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of Participants With Advanced and Metastatic UC by sex was reported.
Number of Participants According to Location of Primary Tumor
Time Frame: At baseline (at the initiation of avelumab maintenance therapy)
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.
Number of Participants With Presence of Urothelial Carcinoma Subtype
Time Frame: At baseline (at the initiation of avelumab maintenance therapy)
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.
Number of Participants With Metastatic Sites at Start of First Line Chemotherapy
Time Frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of participants with metastatic sites at start of First Line Chemotherapy was reported.
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of First Line Chemotherapy
Time Frame: At the initiation 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.
Number of Participants Who Received First Line (IL) Chemotherapy Regimens
Time Frame: At baseline (at the initiation of avelumab maintenance therapy)
Chemotherapies were categorized as: 1.Gemcitabine + Cisplatin 2. Gemcitabine + Carboplatin 3. Dose-dense methotrexate, vinblastine, doxorubicin, cisplatin 4. Other.
Number of First Line Chemotherapy Cycles
Time Frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of Firstline Chemotherapy Cycles in participants at baseline was reported.
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
Time Frame: At baseline (at the initiation of avelumab maintenance therapy)
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"
Number of Participants With Presence or Absence of Variant Histology
Time Frame: At baseline (at the initiation of avelumab maintenance therapy)
Number of participants with presence or absence of variant histology was reported.
Treatment-Free Interval
Time Frame: At baseline (at the initiation of avelumab maintenance therapy)
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.
Percentage of Participants With Second-Line Treatment Regimen
Time Frame: At baseline (at the initiation of avelumab maintenance therapy)
Second-Line Therapies were categorized as: 1. Platinum Chemotherapy, 2. Enfortumab Vedotin, Gem, Gemcitabine, 3.immune checkpoint inhibitor.
Secondary Outcomes
- Time to Failure (TTF) of Avelumab(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 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)(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）(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)