Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-α in a phase III trial: Final results and geographical analysis

D. Cella*, M. D. Michaelson, A. G. Bushmakin, J. C. Cappelleri, C. Charbonneau, S. T. Kim, J. Z. Li, R. J. Motzer

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

44 Scopus citations

Abstract

Background: In a randomised phase III trial, sunitinib significantly improved efficacy over interferon-α (IFN-α) as first-line therapy for metastatic renal cell carcinoma (mRCC). We report the final health-related quality of life (HRQoL) results. Methods:Patients (n=750) received oral sunitinib 50 mg per day in 6-week cycles (4 weeks on, 2 weeks off treatment) or subcutaneous IFN-α 9 million units three times weekly. Health-related quality of life was assessed with nine end points: the Functional Assessment of Cancer Therapy-General and its four subscales, FACT-Kidney Symptom Index (FKSI-15) and its Disease-Related Symptoms subscale (FKSI-DRS), and EQ-5D questionnaire's EQ-5D Index and visual analogue scale. Data were analysed using mixed-effects model (MM), SUPPL.emented with pattern-mixture models (PMM), for the total sample and the US and European Union (EU) subgroups.results: Patients receiving sunitinib reported better scores in the primary end point, FKSI-DRS, across all patient populations (P<0.05), and in nine, five, and six end points in the total sample, in the US and EU groups respectively (P<0.05). There were no significant differences between the US and EU groups for all end points with the exception of the FKSI item I am bothered by side effects of treatment (P=0.02). In general, MM and PMM results were similar.Conclusion: Patients treated with sunitinib in this study had improved HRQoL, compared with patients treated with IFN-α. Treatment differences within the US cohort did not differ from those within the EU cohort.

Original languageEnglish (US)
Pages (from-to)658-664
Number of pages7
JournalBritish Journal of Cancer
Volume102
Issue number4
DOIs
StatePublished - Feb 2010

Keywords

  • Health-related quality of life
  • Metastatic renal cell carcinoma
  • Patient-reported outcomes
  • Receptor tyrosine kinase inhibitor
  • Sunitinib

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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