Q-TWiST analysis to estimate overall benefit for patients with metastatic renal cell carcinoma treated in a phase III trial of sunitinib vs interferon-α Journal Article

   

Authors:	Patil, S.; Figlin, R. A.; Hutson, T. E.; Michaelson, M. D.; Negrier, S.; Kim, S. T.; Huang, X.; Motzer, R. J.
Article Title:	Q-TWiST analysis to estimate overall benefit for patients with metastatic renal cell carcinoma treated in a phase III trial of sunitinib vs interferon-α
Abstract:	Background: In a randomised phase III trial of treatment-naive patients with metastatic renal cell carcinoma, sunitinib showed significant improvement in progression-free survival (PFS) compared with interferon (IFN)-α. We assessed between-treatment differences in overall benefit using a quality-adjusted Time Without Symptoms of disease progression or Toxicity of treatment (TWiST; Gelber and Goldhirsch) analysis. Methods: In this analysis, in which only grade 3/4 treatment-related toxicities were included, overall survival was partitioned into three health states: toxicity (time with toxicity after randomisation and before progression), time without symptoms of disease progression or toxicity, and time from progression until death. Between-treatment differences in the mean duration of each state were calculated. A threshold utility analysis was used to assess quality-adjusted TWiST (Q-TWiST) outcomes. Results: Q-TWiST scores showed that quality-adjusted survival time was greater with sunitinib than with IFN-α, even though certain grade 3/4 toxicities occurred more frequently with sunitinib. For both treatments, the mean number of days with toxicity was small compared with PFS. This effect was more pronounced with sunitinib in which time spent without progression or toxicity was 151 days greater than with IFN-α. Conclusion: Patients randomised to sunitinib had longer clinical benefit, defined as Q-TWiST scores, than patients randomised to IFN-α. © 2012 Cancer Research UK. All rights reserved.
Keywords:	cancer survival; controlled study; major clinical study; overall survival; sunitinib; cancer growth; unspecified side effect; alpha interferon; cancer patient; outcome assessment; analysis; randomized controlled trial; phase 3 clinical trial; kidney metastasis; progression-free survival; metastatic renal cell carcinoma; twist; q-twist; quality-adjusted survival; quality adjusted time without symptom of disease progression or toxicity of treatment analysis
Journal Title:	British Journal of Cancer
Volume:	106
Issue:	10
ISSN:	0007-0920
Publisher:	Nature Publishing Group
Date Published:	2012-05-08
Start Page:	1587
End Page:	1590
Language:	English
DOI:	10.1038/bjc.2012.149
PROVIDER:	scopus
PMCID:	PMC3349250
PUBMED:	22568998
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-84860725464&partnerID=40&md5=5039dbb1406dffd700e1e9dc1c86d72b
Notes:	--- - "Export Date: 4 June 2012" - "CODEN: BJCAA" - "Source: Scopus"

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