Carcinoma, Renal Cell
Conditions
Keywords
Real World Chart Review, Retrospective, Germany
Brief summary
The purpose of this study is to learn about the treatments used in for advanced renal cell carcinoma as well as effectiveness of these treatments in the real world. Study participants must be: At least 18 years of age or older. Confirmed renal cell carcinoma Received first line treatment
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants diagnosed with locally advanced or metastatic renal cell carcinoma * Participants with full medical information is available regarding all treatments before, during and after 1st line
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | From treatment initiation date until PD, death or end of follow-up period whichever was earlier (maximum follow-up of 47.1 months) | PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Analysis was performed by Kaplan-Meier method. |
| PFS Rate at Month 6 | 6 months post treatment initiation date (during maximum follow-up of 47.1 months) | PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS. |
| PFS Rate at Month 9 | 9 months post treatment initiation date (during maximum follow-up of 47.1 months) | PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS. |
| PFS Rate at Month 12 | 12 months post treatment initiation date (during maximum follow-up of 47.1 months) | PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS. |
| PFS Rate at Month 18 | 18 months post treatment initiation date (during maximum follow-up of 47.1 months) | PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | From first disease response until tumor progression (maximum follow-up of 47.1 months) | DOR was defined as time from first disease response (CR/PR) to tumor progression among participants with a documented response and also had a documented date of response. CR was defined as complete resolution of all visible disease as per the treating physician's opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. Analysis was performed by Kaplan-Meier method. |
| Time to Progression (TTP) | From treatment initiation until tumor progression or end of follow-up whichever occurred first (maximum follow-up of 47.1 months) | TTP was defined as time from start of treatment of systemic 1 L therapy up to tumor progression without including deaths. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Analysis was performed by Kaplan-Meier method. |
| Time to Next Therapy (TTNT) | From last systemic 1 L therapy to start of new therapy (maximum follow-up of 47.1 months) | TTNT was defined as time from last systemic 1 L therapy administered up to start of next therapy among those participants who completed 1L therapy. Analysis was performed by Kaplan-Meier method. |
| Overall Survival (OS) | From treatment initiation to death due to any cause or last day of contact, whichever occurred first (maximum follow-up of 47.1 months) | OS was defined as time from treatment initiation of systemic 1-L therapy to date of death due to any cause or last day of contact. Analysis was performed by Kaplan-Meier method. |
| Number of Participants Continuing Therapy After Dose Modification | From treatment initiation to end of follow-up (maximum follow-up of 47.1 months) | A dose modification was defined as dose reduction of 1 or all drugs. Number of participants with dose modification of one or two drugs but continuing therapy were reported in this outcome measure. |
| Number of Participants With Discontinuation of One or Two Drugs | From treatment initiation to end of follow-up (maximum follow-up of 47.1 months) | Number of participants with discontinuation of one or two drugs were reported in this outcome measure. |
| Number of Participants Continuing Therapy After Temporary/Permanent Discontinuation of Single Drugs | From treatment initiation to end of follow-up (maximum follow-up of 47.1 months) | Number of participants continuing therapy after temporary/permanent discontinuation of single drugs are reported in this outcome measure. |
| Number of Participants With at Least 1 Dose Modification or Drug Discontinuation | From treatment initiation to end of follow-up (maximum follow-up of 47.1 months) | A dose modification was defined as dose reduction of 1 or all drugs. Number of participants with dose modifications or with an interim/permanent discontinuation of one or all drugs of a therapy were reported in this outcome measure. |
| OS Rate at Months 12 and 18 | 12- and 18-months post treatment initiation date (during maximum follow-up of 47.1 months) | OS was defined as time from treatment initiation of systemic 1-L therapy to date of death due to any cause or last day of contact. OS rate was measured as percentage of participants alive at specified time points. |
| Number of Participants According to Different Treatments Received | From treatment initiation to end of follow-up (maximum follow-up of 47.1 months) | Number of participants were classified according to different drug groups prescribed: Immune checkpoint inhibitors + Tyrosine kinase inhibitor (ICI +TKI), ICI+ICI, TKI alone and ICI alone. |
| Number of Participants With Different Drug Therapies | From treatment initiation to end of follow-up (maximum follow-up of 47.1 months) | Number of participants were classified according to different drug regimen therapies prescribed: pembrolizumab + axitinib, nivolumab + ipilimumab, sunitinib, nivolumab, cabozantinib, tivozanib, pembrolizumab, pazopanib, axitinib and avelumab + axitinib. |
| Best Overall Response | From treatment initiation until first documented PD or death or end of follow-up, whichever occurred first (maximum follow-up of 47.1 months) | Best overall response was documented as the best response documented in the participant record. CR was defined as complete resolution of all visible disease as per the treating physician's opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Stable disease was defined as not qualifying for CR, PR, PD. In this outcome measure percentage of participants with best responses are recorded. |
Countries
United States
Participant flow
Recruitment details
Data of participants with advanced renal cell carcinoma (aRCC) who were greater than or equal to 18 years of age and received first-line (1L) treatment under routine clinical practice in Germany was collected retrospectively from their medical records. Available retrospective data was evaluated/curated per objectives of this study between 15-Oct-2022 to 13-Dec-2023 (approximately 14 months) in the current retrospective observational study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Eligible participants with aRCC who were treated with 1L systemic anticancer treatment in the real world setting under routine clinical practice \[started or completed between 01-Jan-2020 to 31-Dec-2021\] were included. | 104 |
| Total | 104 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Customized 30-39 years | 1 Participants | — |
| Age, Customized 40-49 years | 11 Participants | — |
| Age, Customized 50-59 years | 20 Participants | — |
| Age, Customized 60-69 years | 40 Participants | — |
| Age, Customized 70-79 years | 21 Participants | — |
| Age, Customized 80-89 years | 11 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 76 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 36 / 104 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
PFS Rate at Month 12
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
Time frame: 12 months post treatment initiation date (during maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | PFS Rate at Month 12 | 41.3 Percentage of participants |
Primary
PFS Rate at Month 18
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
Time frame: 18 months post treatment initiation date (during maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | PFS Rate at Month 18 | 29.8 Percentage of participants |
Primary
PFS Rate at Month 6
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
Time frame: 6 months post treatment initiation date (during maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | PFS Rate at Month 6 | 64.4 Percentage of participants |
Primary
PFS Rate at Month 9
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
Time frame: 9 months post treatment initiation date (during maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | PFS Rate at Month 9 | 52.9 Percentage of participants |
Primary
Progression Free Survival (PFS)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Analysis was performed by Kaplan-Meier method.
Time frame: From treatment initiation date until PD, death or end of follow-up period whichever was earlier (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Progression Free Survival (PFS) | 9.4 Months |
Secondary
Best Overall Response
Best overall response was documented as the best response documented in the participant record. CR was defined as complete resolution of all visible disease as per the treating physician's opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Stable disease was defined as not qualifying for CR, PR, PD. In this outcome measure percentage of participants with best responses are recorded.
Time frame: From treatment initiation until first documented PD or death or end of follow-up, whichever occurred first (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Best Overall Response | PR | 35.6 Percentage of participants |
| All Participants | Best Overall Response | SD | 5.8 Percentage of participants |
| All Participants | Best Overall Response | PD | 1.9 Percentage of participants |
| All Participants | Best Overall Response | Not Evaluable | 5.8 Percentage of participants |
| All Participants | Best Overall Response | Not Applicable | 45.2 Percentage of participants |
| All Participants | Best Overall Response | CR | 5.8 Percentage of participants |
Secondary
Duration of Response (DOR)
DOR was defined as time from first disease response (CR/PR) to tumor progression among participants with a documented response and also had a documented date of response. CR was defined as complete resolution of all visible disease as per the treating physician's opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. Analysis was performed by Kaplan-Meier method.
Time frame: From first disease response until tumor progression (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Duration of Response (DOR) | 9.3 Months |
Secondary
Number of Participants According to Different Treatments Received
Number of participants were classified according to different drug groups prescribed: Immune checkpoint inhibitors + Tyrosine kinase inhibitor (ICI +TKI), ICI+ICI, TKI alone and ICI alone.
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants According to Different Treatments Received | ICI + TKI | 48 Participants |
| All Participants | Number of Participants According to Different Treatments Received | ICI + ICI | 21 Participants |
| All Participants | Number of Participants According to Different Treatments Received | TKI alone | 24 Participants |
| All Participants | Number of Participants According to Different Treatments Received | ICI alone | 11 Participants |
Secondary
Number of Participants Continuing Therapy After Dose Modification
A dose modification was defined as dose reduction of 1 or all drugs. Number of participants with dose modification of one or two drugs but continuing therapy were reported in this outcome measure.
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Continuing Therapy After Dose Modification | 23 Participants |
Secondary
Number of Participants Continuing Therapy After Temporary/Permanent Discontinuation of Single Drugs
Number of participants continuing therapy after temporary/permanent discontinuation of single drugs are reported in this outcome measure.
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Continuing Therapy After Temporary/Permanent Discontinuation of Single Drugs | 1 Participants |
Secondary
Number of Participants With at Least 1 Dose Modification or Drug Discontinuation
A dose modification was defined as dose reduction of 1 or all drugs. Number of participants with dose modifications or with an interim/permanent discontinuation of one or all drugs of a therapy were reported in this outcome measure.
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With at Least 1 Dose Modification or Drug Discontinuation | 32 Participants |
Secondary
Number of Participants With Different Drug Therapies
Number of participants were classified according to different drug regimen therapies prescribed: pembrolizumab + axitinib, nivolumab + ipilimumab, sunitinib, nivolumab, cabozantinib, tivozanib, pembrolizumab, pazopanib, axitinib and avelumab + axitinib.
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Different Drug Therapies | Pembrolizumab + Axitinib | 46 Participants |
| All Participants | Number of Participants With Different Drug Therapies | Nivolumab + Ipilimumab | 21 Participants |
| All Participants | Number of Participants With Different Drug Therapies | Sunitinib | 11 Participants |
| All Participants | Number of Participants With Different Drug Therapies | Nivolumab | 8 Participants |
| All Participants | Number of Participants With Different Drug Therapies | Cabozantinib | 6 Participants |
| All Participants | Number of Participants With Different Drug Therapies | Tivozanib | 3 Participants |
| All Participants | Number of Participants With Different Drug Therapies | Pembrolizumab | 3 Participants |
| All Participants | Number of Participants With Different Drug Therapies | Pazopanib | 3 Participants |
| All Participants | Number of Participants With Different Drug Therapies | Axitinib | 1 Participants |
| All Participants | Number of Participants With Different Drug Therapies | Avelumab + Axitinib | 2 Participants |
Secondary
Number of Participants With Discontinuation of One or Two Drugs
Number of participants with discontinuation of one or two drugs were reported in this outcome measure.
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With Discontinuation of One or Two Drugs | 9 Participants |
Secondary
OS Rate at Months 12 and 18
OS was defined as time from treatment initiation of systemic 1-L therapy to date of death due to any cause or last day of contact. OS rate was measured as percentage of participants alive at specified time points.
Time frame: 12- and 18-months post treatment initiation date (during maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | OS Rate at Months 12 and 18 | Month 12 | 65.4 Percentage of participants |
| All Participants | OS Rate at Months 12 and 18 | Month 18 | 49.0 Percentage of participants |
Secondary
Overall Survival (OS)
OS was defined as time from treatment initiation of systemic 1-L therapy to date of death due to any cause or last day of contact. Analysis was performed by Kaplan-Meier method.
Time frame: From treatment initiation to death due to any cause or last day of contact, whichever occurred first (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Overall Survival (OS) | 17.5 Months |
Secondary
Time to Next Therapy (TTNT)
TTNT was defined as time from last systemic 1 L therapy administered up to start of next therapy among those participants who completed 1L therapy. Analysis was performed by Kaplan-Meier method.
Time frame: From last systemic 1 L therapy to start of new therapy (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Time to Next Therapy (TTNT) | 8.3 Months |
Secondary
Time to Progression (TTP)
TTP was defined as time from start of treatment of systemic 1 L therapy up to tumor progression without including deaths. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Analysis was performed by Kaplan-Meier method.
Time frame: From treatment initiation until tumor progression or end of follow-up whichever occurred first (maximum follow-up of 47.1 months)
Population: Analysis population included all eligible participants whose data was retrieved and observed retrospectively in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Time to Progression (TTP) | 9.7 Months |