Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04076787
Collaborator
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) (Other), Analysis Group (Other)
1,769
1
1
53843.9

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

Study Type:
Observational
Actual Enrollment :
1769 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Effect of Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitors (TKI) on Clinical Outcomes Among Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received First-Line Sunitinib in the International mRCC Database Consortium (IMDC) Based on Prognostic Risk Score
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Sep 2, 2018
Actual Study Completion Date :
Sep 2, 2018

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

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.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04076787
Other Study ID Numbers:
  • A6181229
First Posted:
Sep 3, 2019
Last Update Posted:
Feb 23, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Pfizer
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Primary Outcome
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
3. Primary Outcome
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%
4. Primary Outcome
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%
5. Primary Outcome
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%
6. Primary Outcome
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

[Not Specified]

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
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04076787
Other Study ID Numbers:
  • A6181229
First Posted:
Sep 3, 2019
Last Update Posted:
Feb 23, 2021
Last Verified:
Feb 1, 2021