Metastatic Renal Cell Carcinoma ( mRCC)
Conditions
Keywords
Sunitinib -
Brief summary
To describe real-world demographic and clinical characteristics, treatment characteristics, and clinical outcomes among patients in Latin America who were treated with first-line sunitinib for metastatic renal cell carcinoma and switched from the 4/2 to 2/1 administration schedule
Detailed description
Understanding characteristics of patients who switched from a 4/2 to a 2/1 sunitinib schedule or initiated the 2/1 schedule in Brazil, and the resulting clinical outcomes in the real-world setting • Describing the occurrence of AEs on the 4/2 and 2/1 schedules
Interventions
DRUGSunitinib
Patients to receive Sunitinib as first line therapy for mRCC
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with metastatic RCC with clear cell histology a. The patient may have been initially diagnosed with Stage IV or initially diagnosed at an earlier stage and progressed to having disease at distant sites (i.e., metastatic disease) 2. Initiated first-line treatment for metastatic RCC with sunitinib on the 4/2 schedule (all countries) or initiated first-line treatment for metastatic RCC with sunitinib on the 2/1 schedule (Brazil only) 3. Switched to the 2/1 schedule (all countries) or initiated the 2/1 schedule (Brazil only) during the first treatment line between January 1, 2014, and June 30, 2018 a. The final dates defining this selection period will be dependent on country-specific ethics and reporting requirements
Exclusion criteria
1\. Evidence of other malignant neoplasms (except nonmelanoma skin cancer or carcinoma in situ) within 5 years before switching to the sunitinib 2/1 schedule (all countries) or initiation of the 2/1 schedule (Brazil only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographic Characteristic of Participants: Year of Birth | During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | — |
| Demographic Characteristic of Participants: Comorbidities | During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Data for participants with following comorbidities were observed and reported: cerebrovascular disease,chronic pulmonary disease,congestive heart failure,connective tissue disease,dementia,diabetes with end organ damage,diabetes without end organ damage,depression,hemiplegia or paraplegia, history of myocardial infarction,human immunodeficiency virus/ acquired immunodeficiency syndrome,hypertension,mild liver disease (i.e., chronic hepatitis or cirrhosis without portal hypertension),moderate to severe liver disease (i.e., cirrhosis and portal hypertension),use of warfarin,moderate to severe renal disease (i.e., creatinine \>3mg% \[265 mcmol/l\],dialysis,transplantation,uremic syndrome),ulcer disease,peripheral vascular disease,skin ulcers/cellulitis,horseshoe kidney,polycystic kidney disease,von hippel-lindau disease,chronic viral hepatitis, previous thyroid disorders. Categories with at least 1 non-zero data are reported below. One participant could have more than 1 comorbidities. |
| Demographic Characteristic of Participants: Primary Health Insurance Type | During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Participants with following insurance status were observed and reported: Private insurance only and public insurance. |
| Demographic Characteristic of Participants: Height | During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | — |
| Demographic Characteristic of Participants: Weight | During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | — |
| Demographic Characteristic of Participants: Body Mass Index | During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Body mass index (BMI) is calculated as the body mass in kilograms divided by the square of the body height in meters. |
| Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | In this outcome measure participants diagnosed with mRCC between 2012 to 2018 were reported. |
| Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) | During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | The American Joint Committee on Cancer (AJCC) stages were assigned. Stage I- defined as tumor of 7 cm across or smaller, while Stage II- defined as tumor larger than 7 cm across and did not spread to lymph nodes or distant organs, Stage III- defined as tumor was growing into a major vein (like the renal vein or the vena cava) or into tissue around the kidney, but it was not growing into the adrenal gland or beyond Gerota's fascia. There was no spread to lymph nodes or distant organs. Stage IV- defined as main tumor was growing beyond Gerota's fascia and may be growing into the adrenal gland on top of the kidney. It might or might not had spread to nearby lymph nodes. It had not spread to distant lymph nodes or other organs. |
| Clinical Characteristic of Participants: Risk Groups | During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Participants with Memorial Sloan Kettering Cancer Center(MSKCC)model and International Metastatic Renal Cell Carcinoma Database Consortium(IMDC)criteria risks groups are reported.MSKCC model assessed as low(0),intermediate(1-2) or high risk(=\>3)based on number of criteria present.Criteria=Karnofsky performance status(KPS)score \<80,lactate dehydrogenase\>1.5\*upper limit of normal,hemoglobin\<lower limit of normal, corrected serum calcium\>10 mg/dL,time from first diagnosis of RCC to start of systemic therapy of\<1 year.KPS score range:0=death to 100=no evidence of disease,higher score=higher ability to perform daily tasks.IMDC risk group stratifies participants in poor,intermediate(had 1 or 2 poor factors)and favorable(had no poor factors)risk groups based on number of adverse clinical,laboratory parameters.Poor factors included KPS score of\<80 at initiation of treatment,time from diagnosis to metastasis treatment of\<12 months,anemia,corrected calcium\>10 mg/dL,neutrophilia,thrombocythemia. |
| Clinical Characteristic of Participants: Sites of Distant Metastases | During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Number of participants with the sites of distant metastasis at initial metastatic diagnosis are reported in this outcome measure. Sites evaluated for distant metastasis were lymph nodes, bone, brain, liver, lung/pleura, adrenal gland, pancreas, others (peritoneum, surgical lodge, soft tissue, nephrectomy bed). One participant could have more than 1 sites of metastases. |
| Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | The ECOG performance status was used to assess the effect of disease progression on participant's daily activities. ECOG performance status Grade 0: fully active, able to carry on all pre-disease performance without restriction; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2: ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours, Grade 3: capable of only limited self-care, confined to bed or chair for more than 50% of waking hours, Grade 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair. |
| Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | Before diagnosis of mRCC, anytime during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | In this outcome measure participants with different treatment modalities including partial nephrectomy, radical nephrectomy, radiation therapy, neoadjuvant systemic therapy and adjuvant systemic therapy were reported. One participant could have more than 1 treatment modalities. |
| Duration Between Last Treatment Received and Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | From last treatment received to mRCC diagnosis, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | In this outcome measure the duration form last treatment received including: partial nephrectomy, radical nephrectomy, radiation therapy, neoadjuvant systemic therapy and adjuvant systemic therapy was reported. |
| Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | From date of metastatic diagnosis to end of data identification period, for a maximum of 5 years (data recorded during approximately 12 months of retrospective observation period) | Number of participants were classified and reported according to the number of treatment lines received including first-line, second-line and third-line or more after diagnosis of mRCC. |
| Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | Duration between initiating and termination date of each treatment line received after mRCC diagnosis, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | This outcome measure was analyzed by using Kaplan-Meier method. |
| Duration of Treatment With Sunitinib | Day 1 of sunitinib first line treatment to end date of sunitinib treatment, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | — |
| Duration Between Discontinuation of 4/2 Schedule and Initiation of 2/1 Schedule | End date of 4/2 sunitinib schedule and start date of 2/1 sunitinib schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | — |
| Participants With Reasons for Switching to 2/1 Treatment Schedule | Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Number of participants with their reasons for switching to 2/1 schedule treatment including adverse event, local or professional protocol, participant decision, performance status and other (renal function deterioration; medical decision, site of cytoreductive surgery), were reported. One participant could have multiple reasons to switch to 2/1 treatment schedule. |
| Duration of Sunitinib 2/1 Treatment Schedule After Switching From 4/2 Treatment Schedule | From index date to end date of 2/1 treatment schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | — |
| Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | From index date to end date of sunitinib 2/1 schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Participants who had a termination of sunitinib treatment for reasons other than regimen change or switch, disease progression, or death were reported as discontinued. Categories with at least 1 non-zero data are reported below. One participant could have more than 1 reason for discontinuation. |
| Number of Participants With At-least 1 Dose Change | Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | — |
| Number of Participants With Reason For Dose Change | Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Participants who had change in the dose of sunitinib during the data identification period were reported. Categories with at least 1 non-zero data are reported below. |
| Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Index date up to end of follow up, disease progression, death, whichever occurred first during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Best response includes complete response (CR): equal to disappearance of all target lesions; partial response (PR): greater than equal to (\>=) 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions; progressive disease (PD): \>=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of \>=1 new lesion; stable disease (SD): neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start; as well as response not assessed and unknown also reported. |
| Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Number of participants with different supportive care including anticoagulants, antibiotics, antidepressants, antidiarrheal, antiemetics, antifungals, antihistamines, antihypertensive medication, erythropoiesis stimulating agents (ESAs), granulocyte colony-stimulating factor (GSCF), hormone replacement, iron supplements, nutritional supplements, pain medications, platelet transfusion, red blood cell transfusion, steroids, topical skin care lotions/creams/moisturizers, other (pantoprazole) were reported. One participant could have more than 1 supportive care elements. |
| Adverse Events Observed During First-line Treatment With Sunitinib | Day 1 of sunitinib first line treatment to follow up, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | An adverse event (AE) was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). |
| Progression Free Survival (PFS) From Initial Metastatic Diagnosis | From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Progression free survival (PFS) was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death case report forms (CRFs). This outcome measure was analyzed by using Kaplan-Meier method. |
| Progression Free Survival (PFS) From Initiation of Sunitinib 4/2 Treatment Schedule | From date of initiation of sunitinib 4/2 schedule to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | PFS was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death CRFs. This outcome measure was analyzed by using Kaplan-Meier method. |
| Progression Free Survival (PFS) From Initiation of Sunitinib 2/1 Treatment Schedule | From index date to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | PFS was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death CRFs. This outcome measure was analyzed by using Kaplan-Meier method. |
| Overall Survival (OS) From Metastatic Diagnosis | From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | Overall survival (OS) was defined as the time from the start of treatment to the date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date participant alive. Kaplan-Meier method was used for OS analysis. This outcome measure was analyzed by using Kaplan-Meier method. |
| Overall Survival (OS) From Initiation of Sunitinib 4/2 Treatment Schedule | From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | OS was defined as the time from the start of treatment to the date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date participant alive. Kaplan-Meier method was used for OS analysis. This outcome measure was analyzed by using Kaplan-Meier method. |
| Overall Survival (OS) From Initiation of Sunitinib 2/1 Treatment Schedule | From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | OS was defined as the time from the start of treatment to the date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date participant alive. Kaplan-Meier method was used for OS analysis. This outcome measure was analyzed by using Kaplan-Meier method. |
| Time to Initiate Second Line Treatment | From mRCC diagnosis to start date of second line treatment and from end date of first line treatment to start date of second line treatment,data identification period of 5 years(data recorded during approx. 12 months of retrospective observation period) | — |
Countries
Argentina, Brazil, Colombia, Ecuador
Participant flow
Recruitment details
Participants who were diagnosed with metastatic renal cell carcinoma (mRCC), as per customized retrospective medical record review conducted in 7 countries (Argentina, Brazil, Colombia, Costa Rica, Ecuador, Mexico, and Peru) from January 2014 to June 2018 (+/- 6 months, maximum up to 5 years), and treated with Sunitinib, were included in this study and their data was observed retrospectively.
Pre-assignment details
The index date was the date of switching first-line treatment from 4/2 administration schedule (4 weeks sunitinib treatment followed by 2 weeks off treatment) to 2/1 administration schedule (2 weeks sunitinib treatment followed by 1 week off treatment) or initiating first-line treatment on the 2/1 schedule.
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months. | 42 |
| Sunitinib 2/1 Schedule Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months. | 15 |
| Total | 57 |
Baseline characteristics
| Characteristic | Sunitinib: Switched From 4/2 to 2/1 Schedule | Sunitinib 2/1 Schedule | Total |
|---|---|---|---|
| Age, Customized 18 to 39 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized 40 to 49 years | 6 Participants | 1 Participants | 7 Participants |
| Age, Customized 50 to 59 years | 15 Participants | 6 Participants | 21 Participants |
| Age, Customized 60 to 69 years | 15 Participants | 4 Participants | 19 Participants |
| Age, Customized >=70 years | 5 Participants | 0 Participants | 5 Participants |
| Age, Customized Unknown | 0 Participants | 3 Participants | 3 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 23 Participants | 3 Participants | 26 Participants |
| Sex: Female, Male Male | 19 Participants | 12 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 20 / 42 | 3 / 15 |
| other Total, other adverse events | 42 / 42 | 42 / 42 | 14 / 15 |
| serious Total, serious adverse events | 7 / 42 | 5 / 42 | 0 / 15 |
Outcome results
Primary
Adverse Events Observed During First-line Treatment With Sunitinib
An adverse event (AE) was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).
Time frame: Day 1 of sunitinib first line treatment to follow up, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in all of three arms including 4/2 schedule, 4/2 to 2/1 schedule and 2/1 schedule.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Adverse Events Observed During First-line Treatment With Sunitinib | Severe | 7 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Adverse Events Observed During First-line Treatment With Sunitinib | Moderate | 30 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Adverse Events Observed During First-line Treatment With Sunitinib | Mild | 42 Participants |
| Sunitinib 2/1 Schedule | Adverse Events Observed During First-line Treatment With Sunitinib | Severe | 5 Participants |
| Sunitinib 2/1 Schedule | Adverse Events Observed During First-line Treatment With Sunitinib | Mild | 42 Participants |
| Sunitinib 2/1 Schedule | Adverse Events Observed During First-line Treatment With Sunitinib | Moderate | 24 Participants |
| Sunitinib 2/1 Schedule | Adverse Events Observed During First-line Treatment With Sunitinib | Moderate | 11 Participants |
| Sunitinib 2/1 Schedule | Adverse Events Observed During First-line Treatment With Sunitinib | Mild | 14 Participants |
| Sunitinib 2/1 Schedule | Adverse Events Observed During First-line Treatment With Sunitinib | Severe | 0 Participants |
Primary
Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status
The ECOG performance status was used to assess the effect of disease progression on participant's daily activities. ECOG performance status Grade 0: fully active, able to carry on all pre-disease performance without restriction; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2: ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours, Grade 3: capable of only limited self-care, confined to bed or chair for more than 50% of waking hours, Grade 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair.
Time frame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 0 | 13 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 1 | 23 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 2 | 3 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 3 | 0 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 4 | 0 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Unknown | 3 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 4 | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 0 | 5 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 3 | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 1 | 7 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Unknown | 2 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 2 | 1 Participants |
Primary
Clinical Characteristic of Participants: Risk Groups
Participants with Memorial Sloan Kettering Cancer Center(MSKCC)model and International Metastatic Renal Cell Carcinoma Database Consortium(IMDC)criteria risks groups are reported.MSKCC model assessed as low(0),intermediate(1-2) or high risk(=\>3)based on number of criteria present.Criteria=Karnofsky performance status(KPS)score \<80,lactate dehydrogenase\>1.5\*upper limit of normal,hemoglobin\<lower limit of normal, corrected serum calcium\>10 mg/dL,time from first diagnosis of RCC to start of systemic therapy of\<1 year.KPS score range:0=death to 100=no evidence of disease,higher score=higher ability to perform daily tasks.IMDC risk group stratifies participants in poor,intermediate(had 1 or 2 poor factors)and favorable(had no poor factors)risk groups based on number of adverse clinical,laboratory parameters.Poor factors included KPS score of\<80 at initiation of treatment,time from diagnosis to metastasis treatment of\<12 months,anemia,corrected calcium\>10 mg/dL,neutrophilia,thrombocythemia.
Time frame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, number analyzed signifies the number of participants evaluable at specific category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | MSKCC: Intermediate risk | 12 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | MSKCC: Low risk | 25 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | MSKCC: Poor risk | 5 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | IMDC: Favorable risk | 4 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | IMDC: Intermediate risk | 11 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | IMDC: Poor risk | 2 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | IMDC: Intermediate risk | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | MSKCC: Intermediate risk | 7 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | IMDC: Favorable risk | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | MSKCC: Low risk | 6 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | IMDC: Poor risk | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Risk Groups | MSKCC: Poor risk | 2 Participants |
Primary
Clinical Characteristic of Participants: Sites of Distant Metastases
Number of participants with the sites of distant metastasis at initial metastatic diagnosis are reported in this outcome measure. Sites evaluated for distant metastasis were lymph nodes, bone, brain, liver, lung/pleura, adrenal gland, pancreas, others (peritoneum, surgical lodge, soft tissue, nephrectomy bed). One participant could have more than 1 sites of metastases.
Time frame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Liver | 8 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Pancreas | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Brain | 3 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Other: Peritoneum | 3 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Lung/pleura | 25 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Other: Surgical lodge | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Bone | 10 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Other: Soft tissue | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Adrenal gland | 5 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Other: Nephrectomy bed | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Lymph nodes | 13 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Other: Nephrectomy bed | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Lymph nodes | 3 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Bone | 2 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Brain | 1 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Liver | 1 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Lung/pleura | 8 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Adrenal gland | 2 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Pancreas | 2 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Other: Peritoneum | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Other: Surgical lodge | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Sites of Distant Metastases | Other: Soft tissue | 0 Participants |
Primary
Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC)
The American Joint Committee on Cancer (AJCC) stages were assigned. Stage I- defined as tumor of 7 cm across or smaller, while Stage II- defined as tumor larger than 7 cm across and did not spread to lymph nodes or distant organs, Stage III- defined as tumor was growing into a major vein (like the renal vein or the vena cava) or into tissue around the kidney, but it was not growing into the adrenal gland or beyond Gerota's fascia. There was no spread to lymph nodes or distant organs. Stage IV- defined as main tumor was growing beyond Gerota's fascia and may be growing into the adrenal gland on top of the kidney. It might or might not had spread to nearby lymph nodes. It had not spread to distant lymph nodes or other organs.
Time frame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) | Stage II | 6 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) | Stage IV | 17 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) | Stage III | 6 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) | Unknown | 12 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) | Stage I | 1 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) | Unknown | 3 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) | Stage I | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) | Stage II | 1 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) | Stage III | 1 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) | Stage IV | 10 Participants |
Primary
Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma
In this outcome measure participants diagnosed with mRCC between 2012 to 2018 were reported.
Time frame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2012 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2016 | 8 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2014 | 3 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2017 | 15 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2013 | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2018 | 4 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2015 | 9 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Unknown | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Unknown | 1 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2012 | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2013 | 1 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2014 | 0 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2015 | 1 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2016 | 5 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2017 | 4 Participants |
| Sunitinib 2/1 Schedule | Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma | Year: 2018 | 3 Participants |
Primary
Demographic Characteristic of Participants: Body Mass Index
Body mass index (BMI) is calculated as the body mass in kilograms divided by the square of the body height in meters.
Time frame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Body Mass Index | 28.2 Kilogram per square meter (kg/m^2) | Standard Deviation 5.7 |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Body Mass Index | 31.8 Kilogram per square meter (kg/m^2) | Standard Deviation 4.4 |
Primary
Demographic Characteristic of Participants: Comorbidities
Data for participants with following comorbidities were observed and reported: cerebrovascular disease,chronic pulmonary disease,congestive heart failure,connective tissue disease,dementia,diabetes with end organ damage,diabetes without end organ damage,depression,hemiplegia or paraplegia, history of myocardial infarction,human immunodeficiency virus/ acquired immunodeficiency syndrome,hypertension,mild liver disease (i.e., chronic hepatitis or cirrhosis without portal hypertension),moderate to severe liver disease (i.e., cirrhosis and portal hypertension),use of warfarin,moderate to severe renal disease (i.e., creatinine \>3mg% \[265 mcmol/l\],dialysis,transplantation,uremic syndrome),ulcer disease,peripheral vascular disease,skin ulcers/cellulitis,horseshoe kidney,polycystic kidney disease,von hippel-lindau disease,chronic viral hepatitis, previous thyroid disorders. Categories with at least 1 non-zero data are reported below. One participant could have more than 1 comorbidities.
Time frame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Cerebrovascular disease | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Congestive heart failure | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Diabetes with end organ damage | 3 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Diabetes without end organ damage | 7 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Depression | 3 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | History of myocardial infarction | 4 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Hypertension | 27 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Mild liver disease | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Moderate to severe renal disease | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Horseshoe kidney | 0 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Polycystic kidney disease | 0 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Previous thyroid disorders | 5 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Polycystic kidney disease | 1 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Cerebrovascular disease | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Hypertension | 10 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Congestive heart failure | 1 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Horseshoe kidney | 1 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Diabetes with end organ damage | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Mild liver disease | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Diabetes without end organ damage | 5 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Previous thyroid disorders | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Depression | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | Moderate to severe renal disease | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Comorbidities | History of myocardial infarction | 0 Participants |
Primary
Demographic Characteristic of Participants: Height
Time frame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Height | 164.4 Centimeter | Standard Deviation 10.4 |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Height | 168.9 Centimeter | Standard Deviation 6.6 |
Primary
Demographic Characteristic of Participants: Primary Health Insurance Type
Participants with following insurance status were observed and reported: Private insurance only and public insurance.
Time frame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Primary Health Insurance Type | Public health plan | 11 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Primary Health Insurance Type | Private health plan | 31 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Primary Health Insurance Type | Unknown | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Primary Health Insurance Type | Public health plan | 7 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Primary Health Insurance Type | Private health plan | 6 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Primary Health Insurance Type | Unknown | 2 Participants |
Primary
Demographic Characteristic of Participants: Weight
Time frame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Weight | 73.5 Kilograms | Standard Deviation 13.6 |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Weight | 90.5 Kilograms | Standard Deviation 12.4 |
Primary
Demographic Characteristic of Participants: Year of Birth
Time frame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1954 | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1947 | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1956 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1955 | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1957 | 4 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1948 | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1958 | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1943 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1959 | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1949 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1960 | 0 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1939 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1963 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1950 | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1965 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1944 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1966 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1951 | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1968 | 0 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1937 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1969 | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1952 | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1975 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1946 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1978 | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1953 | 5 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1983 | 0 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1942 | 1 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1983 | 1 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1937 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1939 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1942 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1943 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1944 | 2 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1946 | 1 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1947 | 1 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1948 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1949 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1950 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1951 | 1 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1952 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1953 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1954 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1956 | 2 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1957 | 1 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1958 | 2 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1959 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1960 | 1 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1963 | 2 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1965 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1966 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1968 | 1 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1969 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1975 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1978 | 0 Participants |
| Sunitinib 2/1 Schedule | Demographic Characteristic of Participants: Year of Birth | Year: 1955 | 0 Participants |
Primary
Duration Between Discontinuation of 4/2 Schedule and Initiation of 2/1 Schedule
Time frame: End date of 4/2 sunitinib schedule and start date of 2/1 sunitinib schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.Data for this outcome measure is reported for evaluable participants in arm 4/2 to 2/1 schedule only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Duration Between Discontinuation of 4/2 Schedule and Initiation of 2/1 Schedule | 0.6 Months | Standard Deviation 0.7 |
Primary
Duration Between Last Treatment Received and Metastatic Renal Cell Carcinoma (mRCC) Diagnosis
In this outcome measure the duration form last treatment received including: partial nephrectomy, radical nephrectomy, radiation therapy, neoadjuvant systemic therapy and adjuvant systemic therapy was reported.
Time frame: From last treatment received to mRCC diagnosis, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Duration Between Last Treatment Received and Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | 46.0 Months | Standard Deviation 50.3 |
| Sunitinib 2/1 Schedule | Duration Between Last Treatment Received and Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | 59.1 Months | Standard Deviation 94.3 |
Primary
Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
This outcome measure was analyzed by using Kaplan-Meier method.
Time frame: Duration between initiating and termination date of each treatment line received after mRCC diagnosis, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, number analyzed signifies the number of participants evaluable at specific category.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | First-line treatment | 12.3 Months |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | Second-line treatment | 6.5 Months |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | Third-line treatment | 6.6 Months |
| Sunitinib 2/1 Schedule | Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | First-line treatment | 37.5 Months |
| Sunitinib 2/1 Schedule | Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | Second-line treatment | NA Months |
| Sunitinib 2/1 Schedule | Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | Third-line treatment | NA Months |
Primary
Duration of Sunitinib 2/1 Treatment Schedule After Switching From 4/2 Treatment Schedule
Time frame: From index date to end date of 2/1 treatment schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. Data for this outcome measure is reported for evaluable participants in arms including 4/2 to 2/1 schedule only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Duration of Sunitinib 2/1 Treatment Schedule After Switching From 4/2 Treatment Schedule | 6.7 Months |
Primary
Duration of Treatment With Sunitinib
Time frame: Day 1 of sunitinib first line treatment to end date of sunitinib treatment, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in all of three arms including 4/2 schedule, 4/2 to 2/1 schedule and 2/1 schedule.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Duration of Treatment With Sunitinib | 4.6 Months | Standard Deviation 3.7 |
| Sunitinib 2/1 Schedule | Duration of Treatment With Sunitinib | 7.5 Months | Standard Deviation 5.5 |
| Sunitinib 2/1 Schedule | Duration of Treatment With Sunitinib | 13.6 Months | Standard Deviation 11.2 |
Primary
Number of Participants With At-least 1 Dose Change
Time frame: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in all of three arms including 4/2 schedule, 4/2 to 2/1 schedule and 2/1 schedule.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With At-least 1 Dose Change | 4 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With At-least 1 Dose Change | 3 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With At-least 1 Dose Change | 2 Participants |
Primary
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Number of participants with different supportive care including anticoagulants, antibiotics, antidepressants, antidiarrheal, antiemetics, antifungals, antihistamines, antihypertensive medication, erythropoiesis stimulating agents (ESAs), granulocyte colony-stimulating factor (GSCF), hormone replacement, iron supplements, nutritional supplements, pain medications, platelet transfusion, red blood cell transfusion, steroids, topical skin care lotions/creams/moisturizers, other (pantoprazole) were reported. One participant could have more than 1 supportive care elements.
Time frame: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in arms including 4/2 schedule only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Anticoagulants | 3 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Antibiotics | 4 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Antidepressants | 4 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Antidiarrheal | 26 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Antiemetics | 14 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Antifungals | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Antihistamines | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Antihypertensive medication | 24 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | ESAs | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | GSCF | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Hormone replacement | 5 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Iron supplements | 4 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Nutritional supplements | 4 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Pain medications | 21 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Platelet transfusion | 0 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Red blood cell transfusion | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Steroids | 3 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Topical skin care lotions/creams/moisturizers | 14 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment | Other: Pantoprazole | 1 Participants |
Primary
Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib
Best response includes complete response (CR): equal to disappearance of all target lesions; partial response (PR): greater than equal to (\>=) 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions; progressive disease (PD): \>=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of \>=1 new lesion; stable disease (SD): neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start; as well as response not assessed and unknown also reported.
Time frame: Index date up to end of follow up, disease progression, death, whichever occurred first during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Complete response | 4 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Partial response | 14 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Stable disease | 17 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Progressive disease | 5 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Response not assessed | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Unknown | 0 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Response not assessed | 0 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Complete response | 4 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Progressive disease | 3 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Partial response | 5 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Unknown | 1 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib | Stable disease | 2 Participants |
Primary
Number of Participants With Reason For Dose Change
Participants who had change in the dose of sunitinib during the data identification period were reported. Categories with at least 1 non-zero data are reported below.
Time frame: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. Data for this outcome measure is reported for evaluable participants in all of three arms including 4/2 schedule, 4/2 to 2/1 schedule and 2/1 schedule.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Reason For Dose Change | Adverse event | 4 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Reason For Dose Change | Adherence | 2 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reason For Dose Change | Adverse event | 3 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reason For Dose Change | Adherence | 0 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reason For Dose Change | Adverse event | 2 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reason For Dose Change | Adherence | 0 Participants |
Primary
Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation
Participants who had a termination of sunitinib treatment for reasons other than regimen change or switch, disease progression, or death were reported as discontinued. Categories with at least 1 non-zero data are reported below. One participant could have more than 1 reason for discontinuation.
Time frame: From index date to end date of sunitinib 2/1 schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Adverse event | 4 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Participant decision | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Progressive disease | 26 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Performance status | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Lost to follow-up | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Death | 3 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Unknown | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Other | 2 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Other | 3 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Adverse event | 0 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Lost to follow-up | 0 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Participant decision | 1 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Unknown | 1 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Progressive disease | 2 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Death | 2 Participants |
| Sunitinib 2/1 Schedule | Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation | Performance status | 0 Participants |
Primary
Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
Number of participants were classified and reported according to the number of treatment lines received including first-line, second-line and third-line or more after diagnosis of mRCC.
Time frame: From date of metastatic diagnosis to end of data identification period, for a maximum of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | First -line treatment | 15 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | Second-line treatment | 20 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | Three or more lines of treatment | 7 Participants |
| Sunitinib 2/1 Schedule | Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | First -line treatment | 14 Participants |
| Sunitinib 2/1 Schedule | Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | Second-line treatment | 0 Participants |
| Sunitinib 2/1 Schedule | Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) | Three or more lines of treatment | 1 Participants |
Primary
Overall Survival (OS) From Initiation of Sunitinib 2/1 Treatment Schedule
OS was defined as the time from the start of treatment to the date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date participant alive. Kaplan-Meier method was used for OS analysis. This outcome measure was analyzed by using Kaplan-Meier method.
Time frame: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Overall Survival (OS) From Initiation of Sunitinib 2/1 Treatment Schedule | 42.0 Months |
| Sunitinib 2/1 Schedule | Overall Survival (OS) From Initiation of Sunitinib 2/1 Treatment Schedule | NA Months |
Primary
Overall Survival (OS) From Initiation of Sunitinib 4/2 Treatment Schedule
OS was defined as the time from the start of treatment to the date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date participant alive. Kaplan-Meier method was used for OS analysis. This outcome measure was analyzed by using Kaplan-Meier method.
Time frame: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in arm including 4/2 to 2/1 schedule only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Overall Survival (OS) From Initiation of Sunitinib 4/2 Treatment Schedule | 46.1 Months |
Primary
Overall Survival (OS) From Metastatic Diagnosis
Overall survival (OS) was defined as the time from the start of treatment to the date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date participant alive. Kaplan-Meier method was used for OS analysis. This outcome measure was analyzed by using Kaplan-Meier method.
Time frame: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Overall Survival (OS) From Metastatic Diagnosis | 46.1 Months |
| Sunitinib 2/1 Schedule | Overall Survival (OS) From Metastatic Diagnosis | NA Months |
Primary
Participants With Reasons for Switching to 2/1 Treatment Schedule
Number of participants with their reasons for switching to 2/1 schedule treatment including adverse event, local or professional protocol, participant decision, performance status and other (renal function deterioration; medical decision, site of cytoreductive surgery), were reported. One participant could have multiple reasons to switch to 2/1 treatment schedule.
Time frame: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in arm including 4/2 schedule only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Participants With Reasons for Switching to 2/1 Treatment Schedule | Adverse event | 31 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Participants With Reasons for Switching to 2/1 Treatment Schedule | Local or professional protocol | 2 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Participants With Reasons for Switching to 2/1 Treatment Schedule | Participant decision | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Participants With Reasons for Switching to 2/1 Treatment Schedule | Performance status | 10 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Participants With Reasons for Switching to 2/1 Treatment Schedule | Other: Renal function deterioration | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Participants With Reasons for Switching to 2/1 Treatment Schedule | Other: Medical decision, site of cytoreductive surgery | 1 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Participants With Reasons for Switching to 2/1 Treatment Schedule | Unknown | 3 Participants |
Primary
Progression Free Survival (PFS) From Initial Metastatic Diagnosis
Progression free survival (PFS) was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death case report forms (CRFs). This outcome measure was analyzed by using Kaplan-Meier method.
Time frame: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Progression Free Survival (PFS) From Initial Metastatic Diagnosis | 19.1 Months |
| Sunitinib 2/1 Schedule | Progression Free Survival (PFS) From Initial Metastatic Diagnosis | NA Months |
Primary
Progression Free Survival (PFS) From Initiation of Sunitinib 2/1 Treatment Schedule
PFS was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death CRFs. This outcome measure was analyzed by using Kaplan-Meier method.
Time frame: From index date to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Progression Free Survival (PFS) From Initiation of Sunitinib 2/1 Treatment Schedule | 12 Months |
| Sunitinib 2/1 Schedule | Progression Free Survival (PFS) From Initiation of Sunitinib 2/1 Treatment Schedule | NA Months |
Primary
Progression Free Survival (PFS) From Initiation of Sunitinib 4/2 Treatment Schedule
PFS was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death CRFs. This outcome measure was analyzed by using Kaplan-Meier method.
Time frame: From date of initiation of sunitinib 4/2 schedule to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in arm including 4/2 schedule only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Progression Free Survival (PFS) From Initiation of Sunitinib 4/2 Treatment Schedule | 16.6 Months |
Primary
Time to Initiate Second Line Treatment
Time frame: From mRCC diagnosis to start date of second line treatment and from end date of first line treatment to start date of second line treatment,data identification period of 5 years(data recorded during approx. 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Time to Initiate Second Line Treatment | From mRCC diagnosis | 19.7 Months | Standard Deviation 16.4 |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Time to Initiate Second Line Treatment | From first-line discontinuation | 2.6 Months | Standard Deviation 2.9 |
| Sunitinib 2/1 Schedule | Time to Initiate Second Line Treatment | From mRCC diagnosis | 37.5 Months | — |
| Sunitinib 2/1 Schedule | Time to Initiate Second Line Treatment | From first-line discontinuation | 28.0 Months | — |
Primary
Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis
In this outcome measure participants with different treatment modalities including partial nephrectomy, radical nephrectomy, radiation therapy, neoadjuvant systemic therapy and adjuvant systemic therapy were reported. One participant could have more than 1 treatment modalities.
Time frame: Before diagnosis of mRCC, anytime during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | Radical nephrectomy | 28 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | Neoadjuvant systemic therapy | 0 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | Radiation therapy | 0 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | Adjuvant systemic therapy | 0 Participants |
| Sunitinib: Switched From 4/2 to 2/1 Schedule | Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | Partial nephrectomy | 1 Participants |
| Sunitinib 2/1 Schedule | Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | Adjuvant systemic therapy | 0 Participants |
| Sunitinib 2/1 Schedule | Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | Partial nephrectomy | 0 Participants |
| Sunitinib 2/1 Schedule | Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | Radical nephrectomy | 8 Participants |
| Sunitinib 2/1 Schedule | Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | Radiation therapy | 0 Participants |
| Sunitinib 2/1 Schedule | Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis | Neoadjuvant systemic therapy | 1 Participants |