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Proposal 1157

Title of the Proposed Research

Quality-adjusted survival analysis for patients with metastatic renal cell carcinoma treated in a phase III trial of pazopanib versus sunitinib (COMPARZ trial)

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

COMPARZ (NCT00720941), phase III randomized controlled trials, demonstrated that pazopanib is non-inferior for progression-free survival and better for quality-of-life profiles compared with sunitinib in metastatic renal cell carcinoma (mRCC) patients (N Engl J Med 2013;369:722-31). However, some clinician has concern about shorter progression-free survival and overall survival in pazopanib group, even though they were statistically non-inferior. Thus we would like to comprehensively compare overall benefit of these two target agents using a novel quality-adjusted survival analysis.

Quality-Adjusted Survival Analysis using Proportion (QASAP), which is developed by the researchers, will be used as an analytical method. In brief, we will construct three-state model consisting of progression-free disease, progression, and death. Quality-adjusted survival proportion will be generated by multiplying rate of each disease state by its quality-of-life (QoL), and QoL will be calculated by multiplying various probabilities by its utility such as adverse events. The utility values of adverse events will be calculated by previously proposed study using NCT00334282 trial data (Reference name: Health-related utility and disutility value in metastatic renal cell carcinoma patient treated with pazopanib_Version 1.0). The final model will be visualized by the Quality-Adjusted Survival Curve (QASC), which is developed by the researchers.

We have preliminary result which shows better benefit in pazopanib than sunitinib for mRCC patients. Quality-Adjusted Life Month (QALM) of pazopanib group was 13.41 months and it is slightly better than sunibitinb group (13.14 months). However, this preliminary analysis was performed with many presumed data. It will be more sophisticated through the proposed study using real cohort data.

Study Data Provided

Study GSK-VEG108844: Study VEG108844, A study of Pazopanib versus Sunitinib in the Treatment of Subjects 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.