Trial Outcomes & Findings for Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib (NCT NCT04076787)
NCT ID: NCT04076787
Last Updated: 2023-04-06
Results Overview
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.
COMPLETED
1769 participants
60 months
2023-04-06
Participant Flow
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.
Participant milestones
| Measure |
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).
|
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).
|
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
318
|
1031
|
420
|
|
Overall Study
COMPLETED
|
318
|
1031
|
420
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
Baseline characteristics by cohort
| Measure |
IMDC Prognostic Risk Group: Favorable
n=318 Participants
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).
|
IMDC Prognostic Risk Group: Intermediate
n=1031 Participants
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).
|
IMDC Prognostic Risk Group: Poor
n=420 Participants
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
n=1769 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
259 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
460 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
234 Participants
n=5 Participants
|
772 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
1309 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
183 Participants
n=5 Participants
|
505 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
897 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-white
|
34 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
199 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
101 Participants
n=5 Participants
|
407 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
673 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: 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.
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.
Outcome measures
| Measure |
IMDC Prognostic Risk Group: Favorable
n=117 Participants
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).
|
IMDC Prognostic Risk Group: Intermediate
n=553 Participants
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).
|
IMDC Prognostic Risk Group: Poor
n=327 Participants
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).
|
|---|---|---|---|
|
Overall Survival
|
52.1 months
Interval 43.4 to 61.2
|
31.5 months
Interval 28.9 to 33.9
|
9.8 months
Interval 8.3 to 11.4
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: 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.
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.
Outcome measures
| Measure |
IMDC Prognostic Risk Group: Favorable
n=244 Participants
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).
|
IMDC Prognostic Risk Group: Intermediate
n=884 Participants
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).
|
IMDC Prognostic Risk Group: Poor
n=383 Participants
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).
|
|---|---|---|---|
|
Time to First-Line Sunitinib Treatment Discontinuation
|
15.0 months
Interval 12.4 to 17.3
|
8.5 months
Interval 8.0 to 9.5
|
4.2 months
Interval 3.4 to 4.9
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: 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.
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.
Outcome measures
| Measure |
IMDC Prognostic Risk Group: Favorable
n=157 Participants
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).
|
IMDC Prognostic Risk Group: Intermediate
n=536 Participants
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).
|
IMDC Prognostic Risk Group: Poor
n=206 Participants
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).
|
|---|---|---|---|
|
Number of Participants Who Discontinued First-Line Sunitinib Treatment
Disease progression
|
91 Participants
|
316 Participants
|
122 Participants
|
|
Number of Participants Who Discontinued First-Line Sunitinib Treatment
Toxicity
|
52 Participants
|
141 Participants
|
42 Participants
|
|
Number of Participants Who Discontinued First-Line Sunitinib Treatment
Other reasons
|
11 Participants
|
54 Participants
|
22 Participants
|
|
Number of Participants Who Discontinued First-Line Sunitinib Treatment
Death
|
2 Participants
|
17 Participants
|
13 Participants
|
|
Number of Participants Who Discontinued First-Line Sunitinib Treatment
Disease progression and toxicity
|
1 Participants
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: 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.
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.
Outcome measures
| Measure |
IMDC Prognostic Risk Group: Favorable
n=288 Participants
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).
|
IMDC Prognostic Risk Group: Intermediate
n=902 Participants
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).
|
IMDC Prognostic Risk Group: Poor
n=350 Participants
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).
|
|---|---|---|---|
|
Percentage of Participants With Objective Response (OR)
|
38.5 percentage of participants
|
34.6 percentage of participants
|
21.7 percentage of participants
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: 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.
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.
Outcome measures
| Measure |
IMDC Prognostic Risk Group: Favorable
n=288 Participants
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).
|
IMDC Prognostic Risk Group: Intermediate
n=902 Participants
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).
|
IMDC Prognostic Risk Group: Poor
n=350 Participants
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).
|
|---|---|---|---|
|
Percentage of Participants With Progressive Disease
|
16.3 percentage of participants
|
27.1 percentage of participants
|
46.0 percentage of participants
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: 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.
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.
Outcome measures
| Measure |
IMDC Prognostic Risk Group: Favorable
n=288 Participants
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).
|
IMDC Prognostic Risk Group: Intermediate
n=902 Participants
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).
|
IMDC Prognostic Risk Group: Poor
n=350 Participants
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).
|
|---|---|---|---|
|
Percentage of Participants With Stable Disease
|
45.1 percentage of participants
|
38.4 percentage of participants
|
32.3 percentage of participants
|
Adverse Events
IMDC Prognostic Risk Group: Favorable
IMDC Prognostic Risk Group: Intermediate
IMDC Prognostic Risk Group: Poor
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