Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (Pharmetrics)

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01381601

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom burden is limited in commercially insured adult patients. Additionally, limited information exists on economic burden of adverse events associated with treatments for advanced/metastatic renal cell carcinoma. An objective of the current study is to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic RCC in a US "real-world" setting. Another objective is to quantify the economic burden of severe adverse events with agents used in management of first line advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective cohort design. Analyses of health insurance claims data from a large commercially insured population will be employed in the current study. Study subjects will consist of all persons, aged ≥18 years, with evidence of advanced RCC between January 1, 2000 and December 31, 2009; these persons will be identified based in part on case-ascertainment algorithms. Analyses will be directed at estimating annual rates of incidence and prevalence of advanced/metastatic RCC, as well as symptom burden and costs of common severe adverse events associated with treatments used in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)

Study Design

Study Type:

Observational

Actual Enrollment :

1 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (Pharmetrics)

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Severe adverse event claims in subjects with metastatic RCC Presence or absence of common severe treatment related adverse events (based on existence of claims) in patients with metastatic RCC. Common severe adverse event defined as Grade 3 or higher with >=5% frequency of occurence as reported in product label.	Drug: Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib) Metastatic RCC patients on either sunitinib or sorafenib or bevacizumab or pazopanib (identified based on claims) will be evaluated for presence or absence of common severe adverse events. These common severe adverse events will be identified from agent's product labels. Other Names: VOTRIENT™ (pazopanib) SUTENT® (sunitinib malate) AVASTIN® (bevacizumab) NEXAVAR® (sorafenib)

Arm

Intervention/Treatment

Severe adverse event claims in subjects with metastatic RCC

Presence or absence of common severe treatment related adverse events (based on existence of claims) in patients with metastatic RCC. Common severe adverse event defined as Grade 3 or higher with >=5% frequency of occurence as reported in product label.

Drug: Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)

Metastatic RCC patients on either sunitinib or sorafenib or bevacizumab or pazopanib (identified based on claims) will be evaluated for presence or absence of common severe adverse events. These common severe adverse events will be identified from agent's product labels.

Other Names:

VOTRIENT™ (pazopanib)

SUTENT® (sunitinib malate)

AVASTIN® (bevacizumab)

NEXAVAR® (sorafenib)

Outcome Measures

Primary Outcome Measures

New and existing claims of metastatic renal cell carcinoma across multiple years [2000 - 2009 (up to 10 years)]
Identifying new and existing claims (based on claims based case-ascertainment algorithm) of metastatic renal cell carcinoma across multiple years
Cost associated with management of common severe adverse events related to 1st line treatments used in metastatic renal cell carcinoma [2000 - 2009 (up to 10 years)]
Quantifying economic burden associated with management of common severe adverse events (defined as grade 3 and above adverse events occurring >= 5% as per product label) related to agents used in 1st line metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib). Adverse events will be identified based on product labels.

Secondary Outcome Measures

Quantify symptom burden associated with metastatic renal cell carcinoma [2000 - 2009 (up to 10 years)]
Quantifying symptom burden based on identification of claims associated with the respective symptoms. Disease related symptoms will be identified based on published literature.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

two or more medical encounters with a diagnosis of kidney cancer (ICD-9-CM 189.0) or malignant neoplasm of the renal pelvis (189.1), and
two or more medical encounters with a diagnosis of distant secondary malignant neoplasm (ICD-9-CM 197.XX-199.0, excluding 198.0 [kidney metastasis]) on different days <120 days apart (the date of the earliest such encounter will be designated the "index date").

Exclusion Criteria:

evidence of receipt of chemotherapeutic agents indicated or used in the treatment of advanced TCC, or
evidence of cystoscopy, biopsy of the bladder, or radical cystectomy
evidence of any other primary cancer