Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Analgesics

Everolimus

Sirolimus

Sunitinib

Interferons

Sorafenib

Interleukin-2

Interferon-alpha

Temsirolimus

MTOR Inhibitors

Pfizer CT.gov Call Center

The clinical outcome of advanced / metastatic renal cell carcinoma has been changed since targeted therapy being widely applied. This study will retrospectively analyse the clinical outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance Research Database.

Targeted therapy agents have significantly changed the clinical outcome of advanced / metastatic renal cell carcinoma. However, the dosing pattern varied and might result in impact to duration of treatment. In Taiwan, National Health Insurance system has a coverage more than 90% of population and thus can serve as an appropriate database for further analysis on Taiwanese advanced renal cell carcinoma. This study will retrospectively analyse the clinical outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance Research Database.

Clinical Outcome Of Advanced Renal Cell Carcinoma In Taiwan

CLINICAL OUTCOME OF ADVANCED RENAL CELL CARCINOMA IN TAIWAN, A RETROSPECTIVE NHIA DATABASE ANALYSIS

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Treatment durations (in days) of Sunitinib and Pazopanib were calculated from the date of the first prescription to the last dose of Sunitinib and Pazopanib during the 11 year observation period.

The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from the time of start of treatment up to Month 3 were reported here.

The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 3 (after the start of treatment) to Month 6 were reported here.

The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 6 (after the start of treatment) to Month 9 were reported here.

The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 9 (after the start of treatment) to Month 12 were reported here.

The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from the time of start of treatment to Month 12 were reported here.

Direct medical costs include the cost of the Sunitinib or Pazopanib and all follow-up costs for other medication and health care interventions in ambulatory, inpatient, and nursing care. All specialist and general practitioner care, including emergency care, as well as rehabilitation and physiotherapy.

Overall survival of participants was defined as time (in days) between date of prescribing treatment (Sunitinib or Pazopanib) till date of death.

Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 1 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 1 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 1 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 1 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.

Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 3 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 3 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 3 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 3 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.

Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 6 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 6 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 6 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 6 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.

Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 12 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 12 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 12 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 12 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.

To calculate number of patient receiving antihypertensive prescriptions at baseline for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.

To calculate number of patient receiving antihypertensive prescriptions at Month 1 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.

To calculate number of patient receiving antihypertensive prescriptions from Month 1 to Month 3 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.

To calculate number of patient receiving antihypertensive prescriptions from Month 3 to Month 6 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.

To calculate number of patient receiving antihypertensive prescriptions from Month 6 to Month 12 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.

Pfizer

Due to the non-interventional nature of this study, adverse events (AEs) were not collected for this study.

Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.

Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.

Pazopanib

Total

Age, Continuous

Sex/Gender, Customized

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Low income

Medium income

High income

Income levels of the participants were divided into three categories, 1) Low income, which included all the participants with income less the 15,000 new Taiwan dollars per month, 2) Median income, which included all the participants with income 15,000-24,999 new Taiwan dollars per month, 3) High income, which included all the participants with income more than 25,000 new Taiwan dollars per month.

Participants by Different Income Levels

Hypertension

Diabetes mellitus

Dyslipidemia

Coronary artery disease

Chronic kidney disease

Liver cirrhosis

Co-morbid conditions included all diseases (hypertension, diabetes mellitus, dyslipidemia, coronary artery disease, chronic kidney disease, and liver cirrhosis) other than metastatic RCC, from which the participants were suffering during the observation period. A participant could have more than one co-morbid condition. Here, NHIRD in the comment field signifies to National Health Insurance Research Database.

Participants With Different Co-Morbid Conditions

Beta blockers

Calcium channel blockers

Diuretics

Angiotensin-converting enzyme inhibitors

Angiotensin receptor blocker

Insulin

Biguanides

Sulfonylurea

Glucosidase inhibitors

Thiazolidinediones

Dipeptidyl peptidase 4 inhibitors

Statins

Fibrates

Bile acid sequestrants and Nicotinic acid

Ezetimibe

Antiplatelets

Anticoagulants

Concomitant-medications were the medications that the study participants had taken along with Sunitinib or Pazopanib. Participants could have received more than one concomitant medication.

Participants Who Had Received Concomitant-Medications

Medical center

Other than medical center

Medical center was defined by Taiwan Food and Drug Administration as hospitals accredited with medical training, research, high-tech equipment, and ability to support other hospital nearby.

Participants Admitted/Visited to Hospital by Type of Hospitals

Capital area hospital

Non-capital area hospital

Geographical location of hospitals included capital area and non-capital area. Capital area hospitals includes the hospitals that were located at national capital and non-capital area hospitals includes the hospitals that were located outside of national capital.

Participants Admitted/Visited to the Hospital According to the Geographical Location of Hospitals

All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).

Prioritization of outcome measures as primary and secondary was based on the study team's discretion.

Pfizer ClinicalTrials.gov Call Center

Duration of Sunitinib and Pazopanib Treatment in Participants

Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 3

Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 3 to Month 6

Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 6 to Month 9

Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 9 to Month 12

Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 12

All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the Diagnosis Date to the First Dose of Sunitinib and Pazopanib

Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the First Dose of the Sunitinib and Pazopanib to the End of Observation Period

Overall Survival

Unchanged

Increased

Decreased

Switched

All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Spots Global Cancer Trial Database for Clinical Outcome Of Advanced Renal Cell Carcinoma In Taiwan

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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