Format

Send to

Choose Destination
Cancer. 2016 Apr 1;122(7):1108-15. doi: 10.1002/cncr.29888. Epub 2016 Jan 27.

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

Author information

1
Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
2
Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.
3
Comprehensive Cancer Center at Wake Forest Baptist, Winston-Salem, North Carolina.
4
Novartis Pharma AG, Basel, Switzerland.
5
GlaxoSmithKline, Collegeville, Pennsylvania.
6
Barts Cancer Institute, London, United Kingdom.
7
Novartis Pharma Services AG, Basel, Switzerland.
8
Memorial Sloan Kettering Cancer Center, New York, New York.
9
Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.

Abstract

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.

KEYWORDS:

angiogenesis inhibitors; drug toxicity; pazopanib; renal cell carcinomas; sunitinib

PMID:
27000445
PMCID:
PMC4996632
DOI:
10.1002/cncr.29888
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

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.

Supplemental Content

Full text links

Icon for Wiley Icon for PubMed Central
Loading ...
Support Center