A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With mRCC in Latin America (LA)

Study Overview
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Brief Summary
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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
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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

Official Title
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A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With Metastatic Renal Cell Carcinoma in Latin America

Conditions
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Metastatic Renal Cell Carcinoma ( mRCC)

Intervention / Treatment
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* Drug: Sunitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Metastatic RCC<br>Patients diagnosed with metastatic RCC with clear cell histology who switched from a 4/2 schedule to a 2/1 schedule of sunitinib in first-line metastatic treatment between January 1, 2014 and June 30, 2018 | Drug: Sunitinib<br>* Patients to receive Sunitinib as first line therapy for mRCC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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: Primary Health Insurance Type | Participants with following insurance status were observed and reported: Private insurance only and public insurance. | 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: 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 | Body mass index (BMI) is calculated as the body mass in kilograms divided by the square of the body height in meters. | 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) | 
| 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. | 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) | 
| 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. | 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) | 
| 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. | 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) | 
| 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. | 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) | 
| 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. | 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) | 
| 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. | Before diagnosis of mRCC, anytime during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | 
| 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. | From last treatment received to mRCC diagnosis, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | 
| 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. | 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) | 
| 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. | 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) | 
| 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 | 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. | Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | 
| 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 | 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. | 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) | 
| 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 | 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. | Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | 
| 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. | 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) | 
| 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. | Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period) | 
| 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). | 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) | 
| 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. | 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) 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. | 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) | 
| 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. | 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) | 
| 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. | 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) 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. | 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) 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. | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sunitinib -