Metastatic Renal Cell Carcinoma
Conditions
Brief summary
This is a retrospective, non-interventional study which looks at the cohort of Renal Cell Carcinoma patients in a real life clinical setting and analyses into factors why these patients have been surviving for as long as 3-5 years unlike Clinical study where the survival is around 2 years. The factors which will be analysed include patient characteristics, dosage and adverse event management and tries to correlate these factors with survival.
Detailed description
A single cohort of 200 patients who are diagnosed with metastatic renal cell carcinoma prior to 1st Jan 2012, and are seen by the medical oncologist at the centers involved with BIOGRID and its affiliated registries. Patients will be identified from the first date of their consultation with the medical oncologist and captured in the electronic database. Consent to use datasets has already been obtained from participating research institutes and hospitals IRB/Ethics Committees
Interventions
Sutent oral therapy
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 * Male or female * Metastatic renal cell cancer * First presentation with metastatic disease prior to 1st Jan 2012 since 2006, i.e. between 1st Jan 2006 to 31st Dec 2011
Exclusion criteria
* No referral to medical oncologist * No record available in electronic database
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) From Initiation of Sutent Therapy | From initiation of treatment up to 72 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy | From initiation of treatment up to 72 months | 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. |
| Overall Survival (OS) | From diagnosis until death (up to 72 months) | 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. |
| Time to Treatment Failure From Initiation of Sutent Therapy | From initiation of treatment up to 72 months | 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. |
| 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 | From initiation of treatment up to 72 months | 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. |
| 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 | From initiation of treatment up to 72 months | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 212 |
| Total | 212 |
Baseline characteristics
| Characteristic | Metastatic Renal Cell Carcinoma (mRCC) Cohort |
|---|---|
| Age, Continuous | 60.73 years |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Progression-Free Survival (PFS) From Initiation of Sutent Therapy
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.
Time frame: From initiation of treatment up to 72 months
Population: 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.
Secondary
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
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.
Time frame: From initiation of treatment up to 72 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 29 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 35 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 21 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 11 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 2 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 1 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 2 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 5 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 2 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 1 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 1 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 1 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 3 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 5 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 4 participants | 0 |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 1 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 1 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | — |
Secondary
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
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.
Time frame: From initiation of treatment up to 72 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | 0 |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 2 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 6 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 16 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 6 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 4 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 7 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 1 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 11 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 13 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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) | 0 participants | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | 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 | — |
Secondary
Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent 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.
Time frame: From initiation of treatment up to 72 months
Population: Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy | 30.4 percentage of participants |
Secondary
Overall Survival (OS)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | Overall Survival (OS) | Sutent (n=119) | 27.63 months |
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | Overall Survival (OS) | Best Supportive Care (n=34) | 7.90 months |
p-value: 0.0308Log Rank
Secondary
Time to Treatment Failure From Initiation of Sutent Therapy
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.
Time frame: From initiation of treatment up to 72 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy | Time to Treatment Failure From Initiation of Sutent Therapy | 8.95 months |