Urothelial Carcinoma
Conditions
Keywords
Avelumab, Non-interventional study, Effectiveness, France, Maintenance, Immunotherapy, Bladder cancer
Brief summary
A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients.
Interventions
DRUGAvelumab
As provided in real world practice
Sponsors
Pfizer
Merck KGaA, Darmstadt, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient ≥ 18 years of age 2. Patient with locally advanced or metastatic urothelial carcinoma (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response or complete response) following completion of first-line platinum-based chemotherapy and who has been (retrospective), is (retrospective and prospective), will be (prospective) treated with avelumab. * For a patient alive at the moment of the inclusion in the study : the patient must be informed of the study, he/she must be given an information letter signed by the investigator and must not be opposed to the collection of his/her data * For a patient who died before the inclusion in the study : the patient (during his life time) must not be opposed in writing to the collection of his data. 3. Patient benefiting from a social security scheme according to local regulations
Exclusion criteria
4. For a patient alive at the moment of the inclusion in the study: patient without liberty, under tutelage, or unable to give oral consent. 5. Patient enrolled in a prospective interventional clinical trial assessing an investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS): Overall | From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) | OS was defined as the time from the date of first injection of avelumab to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. Analysis was performed using Kaplan-Meier method. |
| OS: by Histology Group | From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) | OS was defined as the time from the date of first injection of avelumab to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. OS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS From Initiation of First-Line Chemotherapy: Overall | From first injection of first line chemotherapy to the date of death due to any cause or censoring date, whichever occurred first (maximum duration of 95 months) | OS from initiation of first-line chemotherapy was defined as the time from the date of first injection of the chemotherapy used in first line (before avelumab initiation) as reported in medical history to death due to any cause. Participants last known to be alive or lost to follow up were censored at date of last contact. Analysis was performed using Kaplan-Meier method with left truncature and right censoring to consider the participant 'immortality' time before avelumab initiation. |
| OS From Initiation of First-Line Chemotherapy: by Histology Group | From first injection of first line chemotherapy to the date of death due to any cause or censoring date, whichever occurred first (maximum duration of 95 months) | OS from initiation of first-line chemotherapy was defined as the time from the date of first injection of the chemotherapy used in first line (before avelumab initiation) as reported in medical history to death due to any cause. Participants last known to be alive or lost to follow up were censored at date of last contact. OS from initiation of first line chemotherapy according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method with left truncature and right censoring to take into account the participant 'immortality' time before avelumab initiation. |
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Overall | From first injection of avelumab and the date of progression or death from any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) | PFS: time between first injection of avelumab and the date of disease progression (PD) or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (including baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. Analysis was performed using Kaplan-Meier method. |
| PFS 1 According to RECIST 1.1: by Histology Group | From first injection of avelumab and the date of progression or death from any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) | PFS:time between first injection of avelumab and the date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. PFS according to histology group:pure urothelial carcinoma,pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. |
| PFS During the Second Line of Treatment Post-Avelumab (PFS 2) According to RECIST 1.1: Overall | From first injection of avelumab to the date of progression or death from any cause during the second line of treatment post-avelumab or censoring date (for a maximum of 62.3 months follow-up) | PFS2: time between first injection and date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of second line of post-avelumab treatment during the study before any progression or death or who were lost to follow-up or had early study discontinuation without progression, death or 2nd line of post-avelumab treatment discontinuation were censored at last contact date. Analysis was performed using Kaplan-Meier method. |
| PFS 2 According to RECIST 1.1: by Histology Group | From first injection of avelumab to the date of progression or death from any cause during the second line of treatment post-avelumab or censoring date (for a maximum of 62.3 months follow-up) | PFS2: time between first injection and date of PD or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study. In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of pre-existing lesions or appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of 2nd line of post-avelumab treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression, death or 2nd line of post-avelumab treatment discontinuation were censored at last contact date. PFS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. |
| Overall Response Rate (ORR) According to RECIST 1.1: Overall | From the date of first dose of avelumab until documented disease progression, death or start of new anticancer therapy (for a maximum of 62.3 months follow-up) | ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as a best response during the avelumab treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. |
| ORR According to RECIST 1.1: by Histology Group | From the date of first dose of avelumab until documented disease progression, death or start of new anticancer therapy (for a maximum of 62.3 months follow-up) | ORR was defined as the percentage of participants with a CR or PR as a best response during the avelumab treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. ORR according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. |
| Duration of Response (DOR): Overall | From the beginning of the response to progression or death from any cause, whichever occurred first (for a maximum of 62.3 months follow-up) | DOR: time between beginning of response (CR or PR) and PD or death from any cause, whichever occurred first. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. |
| DOR: by Histology Group | From the beginning of the response to progression or death from any cause, whichever occurred first (for a maximum of 62.3 months follow-up) | DOR: time between beginning of response (CR or PR) and PD or death from any cause, whichever occurred first. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. Any pathological lymph nodes (target or non-target) must have reduction in short axis to\<10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study. In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions or appearance of any new unequivocal malignant lesion was also considered PD. DOR according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. |
| Duration of Treatment (DOT): Overall | From the first dose of avelumab to the last dose of avelumab or death or censoring date, whichever occurred earlier (for a maximum of 62.3 months follow-up) | DOT was defined as the time between the first and last dose of avelumab. DOT was evaluated using survival analysis where first dose date was considered as date of first study treatment intake until permanent discontinuation of treatment or death due to any cause. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Analysis was performed using Kaplan-Meier method. |
| DOT: by Histology Group | From the first dose of avelumab to the last dose of avelumab or death or censoring date, whichever occurred earlier (for a maximum of 62.3 months follow-up) | DOT was defined as the time between the first and last dose of avelumab. DOT was evaluated using survival analysis where first dose date was considered as date of first study treatment intake until permanent discontinuation of treatment or death due to any cause. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. DOT according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Number of Participants Classified Per Progression Type: Overall | From first injection of avelumab to the date of progression (for a maximum duration of 62.3 months) | The number of participants classified per progression type (new lesions; pre-existing lesions progression; pre-existing lesions progression and new lesions; undefined) were reported in this outcome measure. |
| Number of Participants Classified Per Progression Type: by Histology Group | From first injection of avelumab to the date of progression (for a maximum duration of 62.3 months) | The number of participants classified per progression type (new lesions; pre-existing lesions progression; pre-existing lesions progression and new lesions; undefined) were reported in this outcome measure. Number of participants classified per progression type according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. |
| Duration of Subsequent Treatment: Overall | From the first dose of subsequent treatment to last dose of subsequent treatment or censoring date (up to approximately 24 months) | Duration of subsequent treatment was defined as the time from the first to last dose of subsequent treatment to avelumab. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Analysis was performed using Kaplan-Meier method. |
| Duration of Subsequent Treatment: by Histology Group | From the first dose of subsequent treatment to last dose of subsequent treatment or censoring date (up to approximately 24 months) | Duration of subsequent treatment was defined as the time from the first to last dose of subsequent treatment to avelumab. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Duration of subsequent treatment according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| PFS of Subsequent Treatment: Overall | From first injection of subsequent treatment to the date of progression or death from any cause or censoring date, whichever occurred first (up to approximately 24 months) | PFS of subsequent treatment was defined as time between first injection of subsequent treatment and the date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. Analysis was performed using Kaplan-Meier method. |
| PFS of Subsequent Treatment: by Histology Group | From first injection of subsequent treatment to the date of progression or death from any cause or censoring date, whichever occurred first (up to approximately 24 months) | PFS: time between first injection and date of PD or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. PFS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. |
| ORR of Subsequent Treatment: Overall | From the date of first dose of subsequent therapy until documented disease progression, death or start of new anticancer therapy (up to approximately 24 months) | ORR of subsequent therapy was defined as the percentage of participants with a CR or PR as a best response during the subsequent treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. |
| ORR of Subsequent Treatment: by Histology Group | From the date of first dose of subsequent therapy until documented disease progression, death or start of new anticancer therapy (up to approximately 24 months) | ORR of subsequent therapy was defined as the percentage of participants with a CR or PR as a best response during the subsequent treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. ORR of subsequent therapy according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. |
| OS of Subsequent Treatment: Overall | From first injection of avelumab subsequent treatment to the date of death due to any cause or censoring date, whichever occurred first (up to approximately 24 months) | OS of subsequent treatment was defined as the time from the date of first injection of subsequent treatment to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. Analysis was performed using Kaplan-Meier method. |
| OS of Subsequent Treatment by Histology Group | From first injection of avelumab subsequent treatment to the date of death due to any cause or censoring date, whichever occurred first (up to approximately 24 months) | OS of subsequent treatment was defined as the time from the date of first injection of subsequent treatment to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. OS of subsequent treatment according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Number of Participants With Adverse Events (AEs): Overall | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs included both serious AEs (SAEs) and all non-SAEs. SAE was defined as any untoward medical occurrence at any dose that met 1 or more of following criteria: resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other important medical events. |
| Number of Participants With AEs: by Histology Group | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs included both SAEs and all non-SAEs. SAE was defined as any untoward medical occurrence at any dose that met 1 or more of following criteria: resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other important medical events. AEs according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. |
| Number of Participants With Grade 3, 4 or 5 AEs: Overall | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Severity of AEs were graded as according to NCI CTCAE v5.0 as: Grade 3= severe AE, Grade 4= life-threatening and Grade 5= death. Number of participants with any Grade 3, 4 or 5 were reported in this outcome measure. |
| Number of Participants With Grade 3, 4 or 5 AEs: by Histology Group | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Severity of AEs were graded as according to NCI CTCAE v5.0 as: Grade 3= severe AE and Grade 4= life-threatening and Grade 5= death. Number of participants with any Grade 3, 4 or 5 AEs according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. |
| Number of Participants With AEs Leading to Temporary/Permanent Discontinuation of Avelumab: Overall | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants With AEs leading to temporary/permanent discontinuation of avelumab were reported in this outcome measure. |
| Number of Participants With AEs Leading to Temporary/Permanent Discontinuation of Avelumab by Histology Group | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants With AEs leading to temporary/permanent discontinuation of avelumab according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. |
| Number of Participants With AEs Leading to Death: Overall | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs leading to death are reported in this outcome measure. |
| Number of Participants With AEs Leading to Death: by Histology Group | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs leading to death according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. |
| Number of Participants Who Received at Least One Premedication With Paracetamol Among All Avelumab Injections: Overall | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) | Number of participants who received at least one premedication with paracetamol among all avelumab injections were reported in this outcome measure. |
| Number of Participants Who Received at Least One Premedication With Paracetamol Among All Avelumab Injections: by Histology Group | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) | Number of participants who received at least one premedication with paracetamol among all avelumab injections according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. |
| Number of Participants Who Received at Least One Premedication With Antihistamines Among All Avelumab Injections: Overall | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) | Number of participants who received at least one premedication with antihistamines among all avelumab injections were reported in this outcome measure. |
| Number of Participants Who Received at Least One Premedication With Antihistamines Among All Avelumab Injections: by Histology Group | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) | Number of participants who received at least one premedication with antihistamines among all avelumab injections according to histology group: pure urothelial carcinoma (UC), pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. |
| Change From Baseline in National Comprehensive Cancer Network (NCCN)/Functional Assessment of Cancer Therapy -Bladder Symptom Index-18 (FACT FBlSI-18) at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall | Baseline; at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24 | The NCCN/FACT FBlSI-18 was a self-administered questionnaire to assess participant's bladder cancer-specific symptoms using a 'core' set of 18 questions. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. The response to each of the 18 questions was evaluated using a 5-point scale ranging from 0='not at all' to 4='very much'. For items negatively framed, scores were reversed for analysis so that higher scores indicated a higher degree of bladder symptoms. Total score ranged from 0 to 72, where higher scores indicated a higher degree of bladder symptoms. This outcome measure was planned to be evaluated only in prospectively included participants. Baseline was defined as the time of avelumab initiation. |
| Change From Baseline in NCCN/FACT FBlSI-18 at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 | NCCN/FACT FBlSI-18: self-administered questionnaire to assess participant's bladder cancer-specific symptoms using a 'core' set of 18 questions. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. Response to each of 18 questions was evaluated using a 5-point scale ranging from 0='not at all' to 4='very much'. For items negatively framed, scores were reversed for analysis so that higher scores indicated a higher degree of bladder symptoms. Total score ranged from 0 to 72, where higher scores indicated a higher degree of bladder symptoms. This outcome measure was planned to be evaluated only in prospectively included participants. Baseline=time of avelumab initiation. Change from Baseline in NCCN/FACT FBlSI-18 according to histology group: pure UC, pure variant and UC variant were reported. |
| Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the visual analogue scale (VAS). The index score measures health across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five severity levels from 1= no problems to 5= extreme problems. These responses form a five-digit health state score ranging from 11111 (no problems) to 55555 (extreme problems), which was then converted into a single utility EQ-5D-5L index score between 0 (death) and 1 (perfect health) using a weighted formula from the EQ-5D official website, where higher EQ-5D-5L scores signified better health. Baseline was defined as the time of avelumab initiation. |
| Change From Baseline in EQ-5D-5L Index Score at Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The index score measures health across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five severity levels from 1= no problems to 5= extreme problems. These responses form a five-digit health state score ranging from 11111 (no problems) to 55555 (extreme problems), which was then converted into a single utility EQ-5D-5L index score between 0 (death) and 1 (perfect health) using a weighted formula from the EQ-5D official website, where higher EQ-5D-5L scores signified better health. Baseline was defined as the time of avelumab initiation. Change from Baseline in EQ-5D-5L Index Score according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. |
| Change From Baseline in EQ-5D-5L-VAS Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The EQ VAS records participants' self-rated health on a vertical scale ranging from 0= worst health you can imagine to 100= best health you can imagine, where higher scores signified better health. Baseline was defined as the time of avelumab initiation. |
| Change From Baseline in EQ-5D-5L- VAS Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The EQ VAS records participants' self-rated health on a vertical scale ranging from 0= worst health you can imagine to 100= best health you can imagine, where higher scores signified better health. Baseline was defined as the time of avelumab initiation. Change from Baseline in EQ-5D-5L- VAS Score according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. |
Countries
France
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Participant flow
Recruitment details
This was a multicenter ambispective (retrospective and prospective) non-interventional study which collected data from participants with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 72.1 Years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 102 Participants |
| Sex: Female, Male Male | 494 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 369 / 596 |
| other Total, other adverse events | 427 / 596 |
| serious Total, serious adverse events | 345 / 596 |
Outcome results
None listed