PATIENT-REPORTED OUTCOMES IN ELDERLY VS. YOUNG PATIENTS WITH ADVANCED RENAL CELL CARCINOMA TREATED WITH SORAFENIB VS. PLACEBO
Author(s)
Sonalee Shah, PhD, Global Project Leader1, David Cella, PhD, Professor and Director2, Kathleen Gondek, PhD, Head1, Frank Cihon, MS, Statistician1, Sibyl Anderson, MD, Deputy Director11Bayer Healthcare Pharmaceuticals, West Haven, CT, USA; 2 Evanston Northwestern Healthcare, Evanston, IL, USA
Objective: Elderly patients are underrepresented in oncology trials and may be at higher risk of toxicity with less than optimal quality of life compared with younger patients. The Phase III TARGET clinical trial showed that sorafenib significantly prolonged progression-free survival (PFS) compared with placebo (P<0.000001) in patients with advanced renal cell carcinoma (RCC). This retrospective analysis of sorafenib in advanced RCC patients from the pivotal TARGET trial compared patient reported outcomes (PRO) in young and elderly patients. Methods: This subgroup analysis examined the PRO in elderly (>= 70 years of age) and young patients (<70 years of age) for sorafenib and placebo. PRO was assessed at baseline and day 1 of each cycle using Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Kidney Cancer Symptom Index (FKSI). Descriptive statistics compared the proportion of patients with a clinically meaningful change (4 point change) in total scores of FKSI and Physical Well Being (PWB) from baseline. Time to health status deterioration (4 point drop in total FKSI scores or PWB scores of FACT-G) was assessed using Cox-proportional Hazards model. Results: A greater proportion of patients in the sorafenib-treated group had improved or stable symptom response and physical functioning in later cycles of treatment, irrespective of age. Sorafenib delayed median time to health status deterioration (as measured by FKSI questionnaire) compared to placebo in elderly patients (121 days vs. 85 days) The median time to health status deterioration as measured by PWB domain of FACT-G was also longer for sorafenib compared to placebo among elderly patients (126 vs. 84 days). A similar trend was observed in younger patients. Conclusion: When compared with placebo, elderly patients with advanced RCC receiving sorafenib had PROs similar to those of young patients receiving the same treatment, with both groups maintaining their quality of life longer on sorafenib.
Conference/Value in Health Info
2008-05, ISPOR 2008, Toronto, Ontario, Canada
Value in Health, Vol. 11, No. 3 (May/June 2008)
Code
PCN82
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
Oncology