Quality-adjusted time without symptoms or toxicity analysis of pazopanib versus sunitinib in patients with renal cell carcinoma.

Autor: Beaumont JL; Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois., Salsman JM; Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.; Comprehensive Cancer Center at Wake Forest Baptist, Winston-Salem, North Carolina., Diaz J; Novartis Pharma AG, Basel, Switzerland., Deen KC; GlaxoSmithKline, Collegeville, Pennsylvania., McCann L; GlaxoSmithKline, Collegeville, Pennsylvania., Powles T; Barts Cancer Institute, London, United Kingdom., Hackshaw MD; Novartis Pharma Services AG, Basel, Switzerland., Motzer RJ; Memorial Sloan Kettering Cancer Center, New York, New York., Cella D; Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.
Jazyk: angličtina
Zdroj: Cancer [Cancer] 2016 Apr 01; Vol. 122 (7), pp. 1108-15. Date of Electronic Publication: 2016 Jan 27.
DOI: 10.1002/cncr.29888
Abstrakt: Background: In a phase 3, randomized, open-label trial (Pazopanib versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma, COMPARZ; NCT00720941), pazopanib was found to be noninferior to sunitinib in terms of progression-free survival in patients with metastatic renal cell carcinoma with no prior therapy. Overall treatment differences were evaluated in a post hoc analysis with a quality-adjusted time without symptoms or toxicity (Q-TWiST) methodology.
Methods: Each patient's overall survival was partitioned into 3 mutually exclusive health states: time with grade 3 or 4 toxicity (TOX), time without symptoms of disease or grade 3/4 toxicity of treatment, and time after tumor progression or relapse (REL). The time spent in each state was weighted by a health-state utility associated with that state and summed to calculate the Q-TWiST. A threshold utility analysis was used, and utilities were applied across the range of 0 (similar to death) to 1 (perfect health).
Results: A total of 1110 patients were enrolled (557 on pazopanib and 553 on sunitinib). The mean TOX was 31 days (95% confidence interval, 13-48 days) longer for sunitinib versus pazopanib. In the threshold utility analysis, the difference in the Q-TWiST ranged from -11 days (utility for TOX, 1; utility for REL, 0) to 43 days (utility for TOX, 0; utility for REL, 1) in favor of pazopanib across most utility combinations. Differences were significant in less than half of the utility combinations examined, and this typically occurred when the utility for TOX was lower than the utility for REL.
Conclusions: Patients randomized to pazopanib had a slightly longer Q-TWiST in comparison with sunitinib patients, and this was primarily due to the reduced length of TOX.
Competing Interests: Information Summary: Jennifer L. Beaumont Received grants from GlaxoSmithKline for the conduct of the study and personal fees from GlaxoSmithKline, Gilead, and Ipsen outside the submitted work. John M. Salsman Reports other (support for manuscript writing) from GlaxoSmithKline during the conduct of the study. Jose Diaz Was employed by GlaxoSmithKline and Novartis, and owned stock in GlaxoSmithKline. Keith Deen Was employed by GlaxoSmithKline and owned stock in GlaxoSmithKline. Lauren McCann Was employed by GlaxoSmithKline and owned stock in GlaxoSmithKline. Thomas Powles Reports personal fees from Roche, Novartis and Pfizer outside the submitted work. Michelle D. Hackshaw Reports employment (former) by and stock ownership in GlaxoSmithKline. Robert J. Motzer Reports grants from GlaxoSmithKline during the conduct of the study; grants and personal fees from Novartis and Pfizer outside the submitted work. David Cella Reports personal fees from GlaxoSmithKline outside the submitted work.
(© 2016 American Cancer Society.)
Databáze: MEDLINE
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