Author(s)
David Cella, PhD, Professor and Director1, Jim Z. Li, MD, PhD, Associate Director2, Andrew G. Bushmakin, MS, Manager3, Joseph C. Cappelleri, PhD, MPH, MS, Director, Statistics4, Sindy T. Kim, BS, Clinical Research Scientist2, Isan Chen, MD, Director, Oncology Clinical Development, Pfizer Global research and Development2, Claudie Charbonneau, MSc, Director, Outcomes Research5, Robert J Motzer, MD, Attending Physician61Evanston Northwestern Healthcare, Evanston, IL, USA; 2 Pfizer Inc, San Diego, CA, USA; 3 Pfizer, Inc, Groton, CT, USA; 4 Pfizer Inc, Groton, CT, USA; 5 Pfizer Inc, New York, NY, USA; 6 Memorial Sloan Kettering Cancer Center, New York, NY, USA
OBJECTIVES: Sunitinib malate is an oral, tyrosine kinase inhibitor that targets VEGFRs, PDGFRs, KIT, RET and FLT3, with antitumour and antiangiogenic effects. Sunitinib demonstrated statistically superior efficacy and HRQOL over IFN-alfa as first-line mRCC therapy (P<0.001) in an international, randomised phase III trial [Motzer et al. NEJM 2007;356:115–24]. These analyses examine the association between geography and treatment effect on patient-reported outcomes (PROs). METHODS: Patients with mRCC (N=750) were randomised 1:1 to sunitinib 50 mg/day orally in 6-week cycles (4 weeks on, 2 weeks off) or IFN-alfa (9 MU SC TIW). HRQOL was assessed on days 1 and 28 of each cycle using the following instruments: 1) FACT-Kidney Symptom Index (FKSI) and its disease-related symptom subscale (FKSI-DRS); 2) Functional Assessment of Cancer Therapy-General (FACT-G) and its 4 subscales; and 3) population-preference-based health state utility score (EQ-5D Index) and patient self-rated overall health state (EQ-VAS) from the EQ-5D self-report questionnaire. Data were analysed using repeated-measures mixed-effects models for the EU+ (France, Germany, Italy, Poland, Russia, Spain, UK, plus Australia and Canada; n=400) and US (n=346) subsamples. RESULTS: Sunitinib provided a significant benefit compared with IFN-alfa in the overall post-baseline least-square means for in all 9 PRO endpoints (P<0.05), except EQ-5D in the US subsample (P=0.4105). Most of the 9 FKSI-DRS items also favoured sunitinib. These findings were consistent with the overall sample results. Larger between-treatment differences were generally observed in the EU+ subsample compared with the US subsample. CONCLUSION: In both Europe and the US, sunitinib offers consistent HRQOL and kidney cancer-related symptoms advantages compared with IFN-alfa in the first-line treatment of mRCC. These advantages were more pronounced in the EU+ sample and may reflect differences in treatment experience or underlying differences in HRQOL reporting.
Conference/Value in Health Info
2007-10, ISPOR Europe 2007, Dublin, Ireland
Value in Health, Vol. 10, No. 6 (November/December 2007)
Code
PCN72
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
Oncology
