Trial Outcomes & Findings for Treatment Patterns and Clinical Outcomes Among Patients With Advanced Renal Cell Carcinoma (aRCC) Receiving Systemic First-line (1st Line) Anti-cancer Treatment Under Daily Routine in Germany: Retrospective Medical Chart Review (RENALISTIC Study). (NCT NCT05534789)
NCT ID: NCT05534789
Last Updated: 2025-01-20
Results Overview
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.
TERMINATED
106 participants
From treatment initiation date until PD, death or end of follow-up period whichever was earlier (maximum follow-up of 47.1 months)
2025-01-20
Participant Flow
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.
Participant milestones
| Measure |
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. Data was collected retrospectively for included participants.
|
|---|---|
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Overall Study
STARTED
|
104
|
|
Overall Study
COMPLETED
|
104
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=104 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.
|
|---|---|
|
Age, Customized
30-39 years
|
1 Participants
n=104 Participants
|
|
Age, Customized
40-49 years
|
11 Participants
n=104 Participants
|
|
Age, Customized
50-59 years
|
20 Participants
n=104 Participants
|
|
Age, Customized
60-69 years
|
40 Participants
n=104 Participants
|
|
Age, Customized
70-79 years
|
21 Participants
n=104 Participants
|
|
Age, Customized
80-89 years
|
11 Participants
n=104 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=104 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
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|---|---|
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Progression Free Survival (PFS)
|
9.4 Months
Interval 0.7 to 46.7
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
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|---|---|
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PFS Rate at Month 6
|
64.4 Percentage of participants
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PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
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|---|---|
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PFS Rate at Month 9
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52.9 Percentage of participants
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PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
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|---|---|
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PFS Rate at Month 12
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41.3 Percentage of participants
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PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
|
|---|---|
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PFS Rate at Month 18
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29.8 Percentage of participants
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
|
|---|---|
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Overall Survival (OS)
|
17.5 Months
Interval 0.3 to 47.1
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
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|---|---|
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OS Rate at Months 12 and 18
Month 12
|
65.4 Percentage of participants
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OS Rate at Months 12 and 18
Month 18
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49.0 Percentage of participants
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
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|---|---|
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Number of Participants According to Different Treatments Received
ICI alone
|
11 Participants
|
|
Number of Participants According to Different Treatments Received
ICI + TKI
|
48 Participants
|
|
Number of Participants According to Different Treatments Received
ICI + ICI
|
21 Participants
|
|
Number of Participants According to Different Treatments Received
TKI alone
|
24 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
|
|---|---|
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Number of Participants With Different Drug Therapies
Axitinib
|
1 Participants
|
|
Number of Participants With Different Drug Therapies
Pembrolizumab + Axitinib
|
46 Participants
|
|
Number of Participants With Different Drug Therapies
Nivolumab + Ipilimumab
|
21 Participants
|
|
Number of Participants With Different Drug Therapies
Sunitinib
|
11 Participants
|
|
Number of Participants With Different Drug Therapies
Nivolumab
|
8 Participants
|
|
Number of Participants With Different Drug Therapies
Cabozantinib
|
6 Participants
|
|
Number of Participants With Different Drug Therapies
Tivozanib
|
3 Participants
|
|
Number of Participants With Different Drug Therapies
Pembrolizumab
|
3 Participants
|
|
Number of Participants With Different Drug Therapies
Pazopanib
|
3 Participants
|
|
Number of Participants With Different Drug Therapies
Avelumab + Axitinib
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
|
|---|---|
|
Best Overall Response
CR
|
5.8 Percentage of participants
|
|
Best Overall Response
PR
|
35.6 Percentage of participants
|
|
Best Overall Response
SD
|
5.8 Percentage of participants
|
|
Best Overall Response
PD
|
1.9 Percentage of participants
|
|
Best Overall Response
Not Evaluable
|
5.8 Percentage of participants
|
|
Best Overall Response
Not Applicable
|
45.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=11 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.
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|---|---|
|
Duration of Response (DOR)
|
9.3 Months
Interval 2.1 to 19.8
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
|
|---|---|
|
Time to Progression (TTP)
|
9.7 Months
Interval 0.7 to 46.7
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=44 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.
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|---|---|
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Time to Next Therapy (TTNT)
|
8.3 Months
Interval 1.4 to 29.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=104 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.
|
|---|---|
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Number of Participants With at Least 1 Dose Modification or Drug Discontinuation
|
32 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=32 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.
|
|---|---|
|
Number of Participants Continuing Therapy After Dose Modification
|
23 Participants
|
SECONDARY outcome
Timeframe: 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.
Number of participants with discontinuation of one or two drugs were reported in this outcome measure.
Outcome measures
| Measure |
All Participants
n=32 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.
|
|---|---|
|
Number of Participants With Discontinuation of One or Two Drugs
|
9 Participants
|
SECONDARY outcome
Timeframe: 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.
Number of participants continuing therapy after temporary/permanent discontinuation of single drugs are reported in this outcome measure.
Outcome measures
| Measure |
All Participants
n=9 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.
|
|---|---|
|
Number of Participants Continuing Therapy After Temporary/Permanent Discontinuation of Single Drugs
|
1 Participants
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER