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Proposal 1057

Title of the Proposed Research

Health-related utility and disutility value in metastatic renal cell carcinoma patient treated with pazopanib

Lead Researcher

Chang Wook Jeong

Affiliation

Department of Urology
Seoul National University Hospital
College of Medicine Seoul National University

Funding Source

Intramural Grant: SNUBH Research Fund grant no 02-2014-015 “Statistical research methods for Comparative Effectiveness Research in Academic Healthcare Centers” (PI: Soyeon Ahn)

Potential Conflicts of Interest

None

Data Sharing Agreement Date

15 March 2016

Lay Summary

In decision analysis addressing quality of life (QoL), health-related utility and disutility of a certain health state (for example, progression-free survival stage) are important information since they are the basis for deriving a quality-adjusted life year (QALY) which is a popular measure of health burden. For instance, it is naturally expected that QoLs of a certain health state under a standard care would be different to those under a new treatment. Thus, if we could properly extract utility and disutility information from diverse treatment groups, they can be integrated in comparative effectiveness researches such as quality-adjusted survival analysis and cost-effectiveness/utility analysis.

Recent first-line treatment for metastatic renal cell carcinoma (mRCC) is multiple tyrosine-kinase inhibitor (TKI) such as pazopanib. It is known that TKI has quite different profiles for adverse events in traditional chemotherapy, however, there is a paucity of data for utility and disutility value of the health states including adverse events in mRCC patients treated with TKI. The lack of such information has been a hindrance in conducting well-designed comparative effectiveness researches for clinical decision strategies for mRCC patient.

The objective of this study is to obtain the utility and disutility value of diverse health states in mRCC patient who were treated with pazopanib. Furthermore, a relationship between EORTC QLQ-C30 and EQ-5D will be explored in regard of health states including adverse events.

For this purpose, we would like to utilize a modeling approach with data from NCT00334282 trial (J Clin Oncol 2010;28:1061-8, Eur J Cancer 2013;49:1287-96). What we would like to request is individual patient-level data of EORTC QLQ-C30, EQ-5D, and EQ-5D VAS with at 6, 12, 18, 24, and 48th week and when what kind of adverse events were occurred in each patient. Available prognosis information (progression-free, progressive, death) up to the last follow-up period are also needed.

A three-health-state model (progression-free, progressive, death) will be used. Baseline utility values of each disease status will be determined. Disutility of adverse event (grade I, II and grade III, IV) will be examined by a linear regression model. QoL will be transformed using global health state QoL questionnaires (EORTC QLQ, ED-5D, and EQ-5D VAS).

We expect that the end results would be used for QoL-related study for mRCC patients. Furthermore, the derived index values would be used for quality-adjusted survival analysis for patients with mRCC treated in COMPARZ trial (NCT00720941). We have preliminary result which shows better benefit in pazopanib than sunitinib for mRCC patients.

Study Data Provided

Study GSK-VEG105192: A Randomised, Double-blind, Placebo controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients with Locally Advanced and/or Metastatic Renal Cell Carcinoma

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.