The purpose of this study is to learn about the safety and effects of the study medicine (called avelumab) for the treatment of advanced bladder cancer. This study is including participants who: * Participated in the Canadian avelumab patient support program * Have been diagnosed with advanced bladder cancer * Have been treated with platinum-based chemotherapy without their disease progressing All participants in this study have previously received avelumab first-line maintenance for the treatment of their advanced bladder cancer. Pfizer will examine the experiences of people receiving the study medicine. This will help determine the efficacy and safety of the study medicine for the treatment of bladder cancer.
Avelumab was approved by Health Canada in December 2020 for the maintenance treatment of patients with locally advanced/metastatic urothelial carcinoma (LA/mUC) whose disease has not progressed following first-line (1L) platinum-based chemotherapy. As the urothelial carcinoma treatment landscape evolves with novel indications for previously existing medicines and novel agents entering the market, additional insights are needed to assist in guiding treatment decision making. No observational studies of treatment patterns and outcomes for patients in Canada treated with avelumab first-line maintenance (1LM) have been conducted. The purpose of the current study is to conduct an analysis of patient and disease characteristics and treatment patterns to further elucidate the clinical effectiveness and impact of avelumab 1LM therapy for patients with LA/mUC in Canada. The primary research objective is to assess effectiveness outcomes in a clinical setting for Canadian patients with LA/mUC treated with avelumab 1LM therapy, specifically overall survival (OS) from the date of avelumab 1LM initiation to the date of death from any cause and progression-free survival (PFS) from the date of avelumab 1LM initiation to the date of progression or death from any cause. Selected secondary objectives include describing treatment patterns, describe AEs explicitly attributed to avelumab among patients with LA/mUC treated with avelumab 1LM and response rates from date of avelumab 1LM initiation, and separately, from the date of chemotherapy initiation, and duration of response (DOR) from date of best overall response in each line of therapy.
Study Type
OBSERVATIONAL
Enrollment
150
Patients with LA/mUC who following 4-6 cycles platinum chemotherapy and have not progressed, received avelumab, recommended dose of 10mg/kg body weight, intravenously administered over 60 minutes every 2 weeks
Bayshore Specialty Rx
Mississauga, Ontario, Canada
Overall survival
OS from the date of avelumab initiation to the date of death from any cause
Time frame: 12 months
Progression-free survival
Progression-free survival from the date of avelumab first-line maintenance initiation to the date of progression or death from any cause
Time frame: 12 months
Adverse events explicitly attributed to avelumab
Description of AEs explicitly attributed to avelumab among patients with LA/mUC treated with AVE 1LM
Time frame: 12 months
Response rate
Response rate from date of AVE 1LM initiation, and separately, from the date of chemotherapy initiation, and DOR from date of best overall response in each line of therapy
Time frame: 12 months
Description of patient characteristics
Time frame: 12 months
Overall survival from the date of chemotherapy initiation to the date of death from any cause
OS from the date of chemotherapy initiation (prior to AVE 1LM) to the date of death from any cause
Time frame: 12 months
Progression-free survival from the date of chemotherapy initiation to the date of progression or death from any cause
PFS from the date of chemotherapy initiation (prior to AVE 1LM) to the date of progression or death from any cause
Time frame: 12 months
First-Line therapy description
First-line therapy type, dose, number of cycles, switching and discontinuations
Time frame: 12 months
Time to post-diagnostic imaging
Time to post-diagnostic imaging
Time frame: 12 months
Time to treatment discontinuation
Time to treatment discontinuation
Time frame: 12 months
Time to initiation of AVE 1LM following last dose of chemotherapy
Time to initiation of AVE 1LM following last dose of chemotherapy
Time frame: 12 months
Treatment duration of AVE 1LM
Treatment duration of AVE 1LM
Time frame: 12 months
Time to next treatment
Time to next treatment
Time frame: 12 months
Reasons for treatment discontinuation
Reasons for treatment discontinuation
Time frame: 12 months
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