This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Cella, D. Articles by Motzer, R. J. Search for Related Content PubMed Articles by Cella, D. Articles by Motzer, R. J. Social Bookmarking                            What's this?

Quality of Life in Patients With Metastatic Renal Cell Carcinoma Treated With Sunitinib or Interferon Alfa: Results From a Phase III Randomized Trial

David Cella, Jim Z. Li, Joseph C. Cappelleri, Andrew Bushmakin, Claudie Charbonneau, Sindy T. Kim, Isan Chen, Robert J. Motzer

From the Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, Evanston, IL; Pfizer Global Research and Development, San Diego, CA; Pfizer Global Research and Development, New London, CT; Pfizer Global Research and Development; and Memorial Sloan-Kettering Cancer Center, New York, NY

Corresponding author: David Cella, PhD, Center on Outcomes, Research and Education (CORE), Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, 1001 University Place, Evanston, IL 60201; e-mail: d-cella{at}northwestern.edu

Purpose In an international, randomized phase III trial, sunitinib demonstrated statistically significant efficacy over interferon alfa (IFN-) as first-line therapy in patients with metastatic renal cell carcinoma (mRCC) (progression-free survival time, 11 v 5 months, respectively; P < .001; objective response rate, 31% v 6%, respectively; P < .001). We report health-related quality-of-life (QOL) results from this trial.

Patients and Methods Seven hundred fifty mRCC patients were randomly assigned to sunitinib (6-week cycles: 50 mg orally once daily for 4 weeks, followed by 2 weeks off) or IFN- (9 million units subcutaneous injections, three times weekly). QOL measures included the Functional Assessment of Cancer Therapy–General (FACT-G), the FACT-Kidney Symptom Index–15 item (FKSI-15), and the EuroQoL-5D's utility score (EQ-5D Index) and its visual analog scale (EQ-VAS). The primary QOL end point was the FKSI Disease-Related Symptoms (FKSI-DRS) subscale. Higher scores indicated better outcomes (better QOL or fewer symptoms). Data were analyzed for the intent-to-treat population using mixed-effects models, supplemented with pattern-mixture models.

Results Patients receiving sunitinib reported higher FKSI-15 and FKSI-DRS scores at each cycle than those receiving IFN-, with a significant difference in the overall least squares means (3.27 and 1.98, respectively; P < .0001). Similarly, differences in least squares means for FACT-G (and all subscales), EQ-5D Index, and EQ-VAS were all significantly favorable for sunitinib (P < .01). Per pre-established thresholds, between-treatment differences in the mean scores were clinically meaningful after cycle 4 for FKSI-DRS and at all assessments for FKSI-15, FACT-G, and the FACT-G functional well-being subscale.

Conclusion Sunitinib provides superior QOL compared with IFN- in mRCC patients.

Supported by Pfizer Inc.

Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006, Atlanta, GA, and the 5th International Kidney Cancer Symposium, September 22-23, 2006, Chicago, IL.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available on www.JCO.org.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				D. Castellano, X. G. del Muro, J. L. Perez-Gracia, J. L. Gonzalez-Larriba, M. V. Abrio, M. A. Ruiz, A. Pardo, C. Guzman, S. D. Cerezo, and E. Grande Patient-reported outcomes in a phase III, randomized study of sunitinib versus interferon-{alpha} as first-line systemic therapy for patients with metastatic renal cell carcinoma in a European population Ann. Onc., November 1, 2009; 20(11): 1803 - 1812. [Abstract] [Full Text] [PDF]

				G. Di Lorenzo, R. Autorino, G. Bruni, G. Carteni, E. Ricevuto, M. Tudini, C. Ficorella, C. Romano, M. Aieta, A. Giordano, et al. Cardiovascular toxicity following sunitinib therapy in metastatic renal cell carcinoma: a multicenter analysis Ann. Onc., September 1, 2009; 20(9): 1535 - 1542. [Abstract] [Full Text] [PDF]

				R. J. Motzer, T. E. Hutson, P. Tomczak, M. D. Michaelson, R. M. Bukowski, S. Oudard, S. Negrier, C. Szczylik, R. Pili, G. A. Bjarnason, et al. Overall Survival and Updated Results for Sunitinib Compared With Interferon Alfa in Patients With Metastatic Renal Cell Carcinoma J. Clin. Oncol., August 1, 2009; 27(22): 3584 - 3590. [Abstract] [Full Text] [PDF]

				W. M. Stadler Effective Therapy for Metastatic Renal Cancer, Whither to Now J. Clin. Oncol., August 1, 2009; 27(22): 3573 - 3574. [Full Text] [PDF]

				B. I. Rini Metastatic Renal Cell Carcinoma: Many Treatment Options, One Patient J. Clin. Oncol., July 1, 2009; 27(19): 3225 - 3234. [Abstract] [Full Text] [PDF]

				D. Cella, J. C. Cappelleri, A. Bushmakin, C. Charbonneau, J. Z. Li, S. T. Kim, I. Chen, M. D. Michaelson, and R. J. Motzer Quality of Life Predicts Progression-Free Survival in Patients With Metastatic Renal Cell Carcinoma Treated With Sunitinib Versus Interferon Alfa J. Oncol. Pract, March 1, 2009; 5(2): 66 - 70. [Abstract] [Full Text] [PDF]