Trial Outcomes & Findings for A Retrospective Real World Analysis Of Sutent In Patients With Metastatic Renal Cell Carcinoma In Community And Academic Centers To Assess The Impact Of Dose Variation On Duration Of Response And Overall Survival (NCT NCT01917214)
NCT ID: NCT01917214
Last Updated: 2015-03-26
Results Overview
PFS was defined as the time from initiation of Sutent (sunitinib malate) to first documentation of tumor progression or to death due to any cause, whichever occurred first. Time to treatment failure was used as a surrogate for PFS as PFS could not be determined due to retrospective nature of this study.
COMPLETED
212 participants
From initiation of treatment up to 72 months
2015-03-26
Participant Flow
Participant milestones
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
Participants diagnosed with mRCC who received either systemic therapy (Sutent \[sunitinib malate\] 25 milligram \[mg\], 37.5 mg or 50 mg or other systemic drugs \[like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus\]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
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|---|---|
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Overall Study
STARTED
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212
|
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Overall Study
COMPLETED
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212
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Retrospective Real World Analysis Of Sutent In Patients With Metastatic Renal Cell Carcinoma In Community And Academic Centers To Assess The Impact Of Dose Variation On Duration Of Response And Overall Survival
Baseline characteristics by cohort
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=212 Participants
Participants diagnosed with mRCC who received either systemic therapy (Sutent \[sunitinib malate\] 25 milligram \[mg\], 37.5 mg or 50 mg or other systemic drugs \[like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus\]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
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|---|---|
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Age, Continuous
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60.73 years
n=5 Participants
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Sex: Female, Male
Female
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59 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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153 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From initiation of treatment up to 72 monthsPopulation: Time to treatment failure (given in outcome measure 4) was used as a surrogate for PFS due to the lack of consistent regular restaging scans in clinical practice.
PFS was defined as the time from initiation of Sutent (sunitinib malate) to first documentation of tumor progression or to death due to any cause, whichever occurred first. Time to treatment failure was used as a surrogate for PFS as PFS could not be determined due to retrospective nature of this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From initiation of treatment up to 72 monthsPopulation: Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy.
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) as per clinical and radiological documentation in clinical notes. CR was defined as complete resolution of all visible disease, whereas PR was defined as partial reduction in size of visible disease.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy
n=125 Participants
Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
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|---|---|
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Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy
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30.4 percentage of participants
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SECONDARY outcome
Timeframe: From diagnosis until death (up to 72 months)Population: Participants diagnosed with mRCC during time period between 1 January 2006 and 31 December 2011 and received Sutent or Best Supportive Care as a first-line therapy. Here, "N" (number of participants analyzed)=participants who were evaluable for this outcome measure. "n"=participants who were evaluable for this measure for each specified treatment.
Overall survival was the duration from diagnosis of disease to death. Overall survival was compared for those who had received best supportive care to those who received Sutent as first-line therapy.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy
n=153 Participants
Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
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|---|---|
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Overall Survival (OS)
Sutent (n=119)
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27.63 months
Interval 18.88 to 34.97
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Overall Survival (OS)
Best Supportive Care (n=34)
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7.90 months
Interval 2.86 to 31.48
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SECONDARY outcome
Timeframe: From initiation of treatment up to 72 monthsPopulation: Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Time to treatment failure was defined as the time from initiation of study treatment to the date of the first documentation of Progressive Disease (PD), symptomatic deterioration, death due to any cause, or discontinuation of treatment due to AE, refusal or other reason. PD was defined as an increase in visible disease.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy
n=102 Participants
Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
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|---|---|
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Time to Treatment Failure From Initiation of Sutent Therapy
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8.95 months
Interval 7.07 to 10.39
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SECONDARY outcome
Timeframe: From initiation of treatment up to 72 monthsPopulation: Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, "n" signifies those participants who were evaluable for this measure for specified Sutent treatment.
Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different Sutent doses were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease. Here "other" refers to Sutent 12.5 mg.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy
n=125 Participants
Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
|
|---|---|
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 50 mg, CR (n=100)
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4 participants
0
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 50 mg, PR (n=100)
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29 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 50 mg, SD (n=100)
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35 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 50 mg, PD (n=100)
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21 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 50 mg,Unknown (n=100)
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11 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 37.5 mg, CR (n=4)
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0 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 37.5 mg, PR (n=4)
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2 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 37.5 mg, SD (n=4)
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1 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 37.5 mg, PD (n=4)
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1 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 37.5 mg, Unknown (n=4)
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0 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 25 mg, CR (n=10)
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0 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 25 mg, PR (n=10)
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2 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 25 mg, SD (n=10)
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5 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 25 mg, PD (n=10)
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2 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Sutent 25 mg, Unknown (n=10)
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1 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Other, CR (n=1)
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0 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Other, PR (n=1)
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0 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Other, SD (n=1)
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0 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Other, PD (n=1)
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0 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Other, Unknown (n=1)
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1 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Unknown, CR (n=10)
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0 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Unknown, PR (n=10)
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1 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Unknown, SD (n=10)
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1 participants
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Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Unknown, PD (n=10)
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3 participants
|
|
Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Unknown, Unknown (n=10)
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5 participants
|
SECONDARY outcome
Timeframe: From initiation of treatment up to 72 monthsPopulation: Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, "n" signifies those participants who were evaluable for this measure for specified treatment duration.
Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different durations of treatment with Sutent were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy
n=125 Participants
Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
|
|---|---|
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Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Less than (<) 3 months, CR (n=30)
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0 participants
0
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Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
<3 months, PR (n=30)
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2 participants
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Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
<3 months, SD (n=30)
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6 participants
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Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
<3 months, PD (n=30)
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16 participants
|
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Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
<3 months, Unknown (n=30)
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6 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
3-6 months, CR (n=23)
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0 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
3-6 months, PR (n=23)
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4 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
3-6 months, SD (n=23)
|
11 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
3-6 months, PD (n=23)
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7 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
3-6 months, Unknown (n=23)
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1 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
6-12 months, CR (n=25)
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0 participants
|
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Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
6-12 months, PR (n=25)
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11 participants
|
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Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
6-12 months, SD (n=25)
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13 participants
|
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Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
6-12 months, PD (n=25)
|
1 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
6-12 months, Unknown (n=25)
|
0 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
12-24 months, CR (n=14)
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0 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
12-24 months, PR (n=14)
|
7 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
12-24 months, SD (n=14)
|
7 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
12-24 months, PD (n=14)
|
0 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
12-24 months, Unknown (n=14)
|
0 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Greater than (>) 24 months, CR (n=10)
|
2 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
>24 months, PR (n=10)
|
5 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
>24 months, SD (n=10)
|
2 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
>24 months, PD (n=10)
|
0 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
>24 months, Unknown (n=10)
|
1 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Unknown, CR (n=23)
|
2 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Unknown, PR (n=23)
|
5 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Unknown, SD (n=23)
|
3 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Unknown, PD (n=23)
|
3 participants
|
|
Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy
Unknown, Unknown (n=23)
|
10 participants
|
Adverse Events
Metastatic Renal Cell Carcinoma (mRCC) Cohort
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 Restriction Description: 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