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

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

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

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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.

[{ "PostingID": 463, "Title": "GSK-VEG108844", "Description": "Medicine: pazopanib, Condition: Carcinoma, Renal Cell, Phase: 3, GSK Clinical Study ID: VEG108844, Sponsor: GSK." }]

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