Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2010 Feb 16;102(4):658-64.
doi: 10.1038/sj.bjc.6605552. Epub 2010 Jan 26.

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

D Cella  1 , M D Michaelson, A G Bushmakin, J C Cappelleri, C Charbonneau, S T Kim, J Z Li, R J Motzer
Affiliations
Clinical Trial

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

D Cella et al. Br J Cancer. .

Abstract

Background: In a randomised phase III trial, sunitinib significantly improved efficacy over interferon-alpha (IFN-alpha) 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-alpha 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), supplemented 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-alpha. Treatment differences within the US cohort did not differ from those within the EU cohort.

Trial registration: ClinicalTrials.gov NCT00083889.

PubMed Disclaimer

Figures

Figure 1
Figure 1
(A–C) Comparison of results between MM and PMM analyses across all available post-baseline observations. MM, mixed-effects model difference between sunitinib and IFN-α; PMM, pattern-mixture model difference between sunitinib and IFN-α; FKSI-15, FACT–Kidney Symptom Index-15 item; FKSI-DRS, FKSI Disease-Related Symptoms subscale; FACT-G, Functional Assessment of Cancer Therapy–General; EQ-5D Index, EuroQoL health-utility index; EQ-VAS, EQ visual analogue scale.
See this image and copyright information in PMC

References

    1. Abrams TJ, Murray LJ, Pesenti E, Holway VW, Colombo T, Lee LB, Cherrington JM, Pryer NK (2003) Preclinical evaluation of the tyrosine kinase inhibitor SU11248 as a single agent and in combination with ‘standard of care’ therapeutic agents for the treatment of breast cancer. Mol Cancer Ther 2: 1011–1021 - PubMed
    1. Castellano D, García del Muro X, Pérez-Gracia JL, González-Larriba JL, Abrio MV, Ruiz MA, Pardo A, Guzmán C, Cerezo SD, Grande E (2009) Patient reported outcomes in a phase 3, randomized study of sunitinib versus interferon-α as first-line systemic therapy for patients with metastatic renal cell carcinoma in European population. Ann Oncol 20: 1803–1812 - PMC - PubMed
    1. Cella D, Li JZ, Cappelleri JC, Charbonneau C, Kim ST, Chen I, Motzer RJ (2008) Quality of life in patients with metastatic renal cell carcinoma treated with sunitinib or interferon alfa: results from a phase III randomized trial. J Clin Oncol 26: 3763–3769 - PubMed
    1. Cella D, Yount S, Brucker PS, Du H, Bukowski R, Vogelzang N, Bro WP (2007) Development and validation of a scale to measure disease-related symptoms of kidney cancer. Value Health 10: 285–293 - PubMed
    1. Cella D, Yount S, Du H, Dhanda R, Gondek K, Langefeld K, George J, Bro WP, Kelly C, Bukowski R (2006) Development and validation of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI). J Support Oncol 4: 191–199 - PubMed

Publication types

Associated data