Metastatic Renal Cell Carcinoma
Conditions
Keywords
Vascular endothelial growth factor (VEGF), Sunitinib
Brief summary
This is a retrospective, longitudinal cohort study that assessed clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) who received sunitinib as first-line treatment.
Detailed description
Clear cell mRCC patients who initiated sunitinib as first-line treatment between 2010 and 2018 were identified from the IMDC database. Patients were classified as favorable, intermediate, or poor prognostic risk group according to IMDC criteria. Overall survival, time to treatment discontinuation, and physician-assessed tumor response were evaluated.
Interventions
DRUGSunitinib
patients who received sunitinib as first line therapy for mRCC
Sponsors
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
Analysis Group, Inc.
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with mRCC * Initiated treatment post mRCC diagnosis and received sunitinib as first-line therapy * Age 18 years or over at the time of mRCC diagnosis * Actively treated at an IMDC clinical center
Exclusion criteria
* Initiated first line sunitinib treatment before 2010 * Had non-clear cell mRCC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 60 months | Overall survival was defined as the time between index date and death due to any cause or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy. |
| Time to First-Line Sunitinib Treatment Discontinuation | 60 months | Time to treatment discontinuation was defined as the time between index date and either discontinuation of first-line sunitinib therapy due to any reason including disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy. |
| Number of Participants Who Discontinued First-Line Sunitinib Treatment | 60 months | In this outcome measure, participants who discontinued treatment due to any reason like disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability are reported. |
| Percentage of Participants With Objective Response (OR) | 60 months | Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters. |
| Percentage of Participants With Progressive Disease | 60 months | Progressive disease (PD) was defined as an increase in visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. |
| Percentage of Participants With Stable Disease | 60 months | Stable disease was defined as no change in size of visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), stable disease neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters. |
Countries
Canada
Participant flow
Recruitment details
International metastatic renal cell carcinoma database consortium (IMDC) real-world database was used to collect the data from the medical charts of adult participants with clear metastatic renal cell carcinoma (mRCC), who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018.
Participants by arm
| Arm | Count |
|---|---|
| IMDC Prognostic Risk Group: Favorable Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as favorable survival group (with no IMDC risk factor). | 318 |
| IMDC Prognostic Risk Group: Intermediate Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as intermediate survival group (with 1 or 2 IMDC risk factor). | 1,031 |
| IMDC Prognostic Risk Group: Poor Participants with clear mRCC, who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018 and were stratified IMDC prognostic risk group as poor survival group (with 3 or more than 3 IMDC risk factor). | 420 |
| Total | 1,769 |
Baseline characteristics
| Characteristic | IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor | Total |
|---|---|---|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 9.6 | 62.9 years STANDARD_DEVIATION 10.2 | 62.6 years STANDARD_DEVIATION 9.6 | 63.0 years STANDARD_DEVIATION 9.9 |
| Race/Ethnicity, Customized Non-white | 34 Participants | 119 Participants | 46 Participants | 199 Participants |
| Race/Ethnicity, Customized Not reported | 101 Participants | 407 Participants | 165 Participants | 673 Participants |
| Race/Ethnicity, Customized White | 183 Participants | 505 Participants | 209 Participants | 897 Participants |
| Sex: Female, Male Female | 84 Participants | 259 Participants | 117 Participants | 460 Participants |
| Sex: Female, Male Male | 234 Participants | 772 Participants | 303 Participants | 1309 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Who Discontinued First-Line Sunitinib Treatment
In this outcome measure, participants who discontinued treatment due to any reason like disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability are reported.
Time frame: 60 months
Population: Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IMDC Prognostic Risk Group: Favorable | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Death | 2 Participants |
| IMDC Prognostic Risk Group: Favorable | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Other reasons | 11 Participants |
| IMDC Prognostic Risk Group: Favorable | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Disease progression and toxicity | 1 Participants |
| IMDC Prognostic Risk Group: Favorable | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Toxicity | 52 Participants |
| IMDC Prognostic Risk Group: Favorable | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Disease progression | 91 Participants |
| IMDC Prognostic Risk Group: Intermediate | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Disease progression | 316 Participants |
| IMDC Prognostic Risk Group: Intermediate | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Toxicity | 141 Participants |
| IMDC Prognostic Risk Group: Intermediate | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Other reasons | 54 Participants |
| IMDC Prognostic Risk Group: Intermediate | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Death | 17 Participants |
| IMDC Prognostic Risk Group: Intermediate | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Disease progression and toxicity | 8 Participants |
| IMDC Prognostic Risk Group: Poor | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Disease progression and toxicity | 7 Participants |
| IMDC Prognostic Risk Group: Poor | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Death | 13 Participants |
| IMDC Prognostic Risk Group: Poor | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Disease progression | 122 Participants |
| IMDC Prognostic Risk Group: Poor | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Other reasons | 22 Participants |
| IMDC Prognostic Risk Group: Poor | Number of Participants Who Discontinued First-Line Sunitinib Treatment | Toxicity | 42 Participants |
Primary
Overall Survival
Overall survival was defined as the time between index date and death due to any cause or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy.
Time frame: 60 months
Population: Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | Overall Survival | 52.1 months |
| IMDC Prognostic Risk Group: Intermediate | Overall Survival | 31.5 months |
| IMDC Prognostic Risk Group: Poor | Overall Survival | 9.8 months |
Primary
Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters.
Time frame: 60 months
Population: Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | Percentage of Participants With Objective Response (OR) | 38.5 percentage of participants |
| IMDC Prognostic Risk Group: Intermediate | Percentage of Participants With Objective Response (OR) | 34.6 percentage of participants |
| IMDC Prognostic Risk Group: Poor | Percentage of Participants With Objective Response (OR) | 21.7 percentage of participants |
Primary
Percentage of Participants With Progressive Disease
Progressive disease (PD) was defined as an increase in visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time frame: 60 months
Population: Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | Percentage of Participants With Progressive Disease | 16.3 percentage of participants |
| IMDC Prognostic Risk Group: Intermediate | Percentage of Participants With Progressive Disease | 27.1 percentage of participants |
| IMDC Prognostic Risk Group: Poor | Percentage of Participants With Progressive Disease | 46.0 percentage of participants |
Primary
Percentage of Participants With Stable Disease
Stable disease was defined as no change in size of visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), stable disease neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters.
Time frame: 60 months
Population: Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | Percentage of Participants With Stable Disease | 45.1 percentage of participants |
| IMDC Prognostic Risk Group: Intermediate | Percentage of Participants With Stable Disease | 38.4 percentage of participants |
| IMDC Prognostic Risk Group: Poor | Percentage of Participants With Stable Disease | 32.3 percentage of participants |
Primary
Time to First-Line Sunitinib Treatment Discontinuation
Time to treatment discontinuation was defined as the time between index date and either discontinuation of first-line sunitinib therapy due to any reason including disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy.
Time frame: 60 months
Population: Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | Time to First-Line Sunitinib Treatment Discontinuation | 15.0 months |
| IMDC Prognostic Risk Group: Intermediate | Time to First-Line Sunitinib Treatment Discontinuation | 8.5 months |
| IMDC Prognostic Risk Group: Poor | Time to First-Line Sunitinib Treatment Discontinuation | 4.2 months |