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).
- Conditions
- Carcinoma, Renal Cell
- Registration Number
- NCT05534789
- Lead Sponsor
- Pfizer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 106
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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 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 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 Outcome Measures
Name Time 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.
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.
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.
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.
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.
Trial Locations
- Locations (1)
Pfizer New York
🇺🇸New York, New York, United States