Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Favorable IMDC risk group The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as favorable IMDC risk group for having 0 individual risk factor |
Drug: Sunitinib
patients who received sunitinib as first line therapy for mRCC
|
Intermediate IMDC risk group The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as intermediate IMDC risk group for having 1 or 2 individual risk factors |
Drug: Sunitinib
patients who received sunitinib as first line therapy for mRCC
|
Poor IMDC risk group The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as poor IMDC risk group for having 3 or more individual risk factors |
Drug: Sunitinib
patients who received sunitinib as first line therapy for mRCC
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Calgary | Calgary | Alberta | Canada | P2N4N2 |
Sponsors and Collaborators
- Pfizer
- International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
- Analysis Group
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- A6181229
Study Results
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. |
---|---|
Pre-assignment Detail |
Arm/Group Title | IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor |
---|---|---|---|
Arm/Group Description | 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). | 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). | 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). |
Period Title: Overall Study | |||
STARTED | 318 | 1031 | 420 |
COMPLETED | 318 | 1031 | 420 |
NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor | Total |
---|---|---|---|---|
Arm/Group Description | 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). | 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). | 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). | Total of all reporting groups |
Overall Participants | 318 | 1031 | 420 | 1769 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
63.8
(9.6)
|
62.9
(10.2)
|
62.6
(9.6)
|
63.0
(9.9)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
84
26.4%
|
259
25.1%
|
117
27.9%
|
460
26%
|
Male |
234
73.6%
|
772
74.9%
|
303
72.1%
|
1309
74%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
White |
183
57.5%
|
505
49%
|
209
49.8%
|
897
50.7%
|
Non-white |
34
10.7%
|
119
11.5%
|
46
11%
|
199
11.2%
|
Not reported |
101
31.8%
|
407
39.5%
|
165
39.3%
|
673
38%
|
Outcome Measures
Title | Overall Survival |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor |
---|---|---|---|
Arm/Group Description | 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). | 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). | 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). |
Measure Participants | 117 | 553 | 327 |
Median (95% Confidence Interval) [months] |
52.1
|
31.5
|
9.8
|
Title | Time to First-Line Sunitinib Treatment Discontinuation |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor |
---|---|---|---|
Arm/Group Description | 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). | 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). | 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). |
Measure Participants | 244 | 884 | 383 |
Median (95% Confidence Interval) [months] |
15.0
|
8.5
|
4.2
|
Title | Number of Participants Who Discontinued First-Line Sunitinib Treatment |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor |
---|---|---|---|
Arm/Group Description | 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). | 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). | 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). |
Measure Participants | 157 | 536 | 206 |
Disease progression |
91
28.6%
|
316
30.6%
|
122
29%
|
Toxicity |
52
16.4%
|
141
13.7%
|
42
10%
|
Other reasons |
11
3.5%
|
54
5.2%
|
22
5.2%
|
Death |
2
0.6%
|
17
1.6%
|
13
3.1%
|
Disease progression and toxicity |
1
0.3%
|
8
0.8%
|
7
1.7%
|
Title | Percentage of Participants With Objective Response (OR) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor |
---|---|---|---|
Arm/Group Description | 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). | 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). | 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). |
Measure Participants | 288 | 902 | 350 |
Number [percentage of participants] |
38.5
12.1%
|
34.6
3.4%
|
21.7
5.2%
|
Title | Percentage of Participants With Progressive Disease |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor |
---|---|---|---|
Arm/Group Description | 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). | 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). | 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). |
Measure Participants | 288 | 902 | 350 |
Number [percentage of participants] |
16.3
5.1%
|
27.1
2.6%
|
46.0
11%
|
Title | Percentage of Participants With Stable Disease |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor |
---|---|---|---|
Arm/Group Description | 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). | 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). | 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). |
Measure Participants | 288 | 902 | 350 |
Number [percentage of participants] |
45.1
14.2%
|
38.4
3.7%
|
32.3
7.7%
|
Adverse Events
Time Frame | Not applicable as safety data were not collected during the study | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | Safety data were not planned to be collected during the study. | |||||
Arm/Group Title | IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor | |||
Arm/Group Description | 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). | 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). | 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). | |||
All Cause Mortality |
||||||
IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Serious Adverse Events |
||||||
IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Other (Not Including Serious) Adverse Events |
||||||
IMDC Prognostic Risk Group: Favorable | IMDC Prognostic Risk Group: Intermediate | IMDC Prognostic Risk Group: Poor | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
- A6181229