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Cella, D. et al.

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

Quality of life in patients with metastatic renal cell carcinoma treated with sunitinib or interferon alfa: results from a phase III randomized trial.

PURPOSE: In an international, randomized phase III trial, sunitinib demonstrated statistically significant efficacy over interferon alfa (IFN-alpha) 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-alpha (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-alpha, 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-alpha in mRCC patients.[1]

References

Quality of life in patients with metastatic renal cell carcinoma treated with sunitinib or interferon alfa: results from a phase III randomized trial. Cella, D., Li, J.Z., Cappelleri, J.C., Bushmakin, A., Charbonneau, C., Kim, S.T., Chen, I., Motzer, R.J. J. Clin. Oncol. (2008) [Pubmed]

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