Abstract
BackgroundOur objective was to test a brief, symptom index for advanced renal cell carcinoma, a disease affecting over 38,000 Americans each year and often diagnosed in late stages.MethodsWe conducted secondary data analyses on patient-reported outcomes of 209 metastatic renal cell carcinoma patients participating in a Phase III clinical trial. Patient-reported outcomes, obtained from the FACT-Biological Response Modifier (FACT-BRM) scale, were available at baseline, 2, and 8 weeks. We analyzed data from eight FACT-BRM items previously identified by clinical experts to represent the most important symptoms of advanced renal cell carcinoma. Items comprising this index assess nausea, pain, appetite, perceived sickness, fatigue and weakness, with higher scores indicating fewer symptoms. We determined reliability and validity of the index and estimated a minimally important difference.ResultsThe index had excellent internal reliability at all three time points (alphas ≥ 0.83). Baseline scores were able to discriminate patients across Karnofsky performance status, number of metastatic sites, and risk group categories (ps < .01). Mean index scores declined over time likely indicative of the toxic nature of the administered treatments. Distribution- and anchor-based methods converged on a minimally important difference estimate of 2 to 3 points.ConclusionThe 8-item index of patient-reported symptoms of renal cell carcinoma appears to be a psychometrically sound measure. It is a brief, reliable, and valid measure that can easily be adapted for use in clinical trials and observational studies.
Highlights
Our objective was to test a brief, symptom index for advanced renal cell carcinoma, a disease affecting over 38,000 Americans each year and often diagnosed in late stages
A recent Phase II trial demonstrating the efficacy of second-line sunitinib – a multi-targeted, tyrosine kinase inhibitor – has led to the rapid approval of this drug for the treatment of metastatic Renal cell carcinoma (RCC) [7]
These experts were shown a pool of items from a previously validated tool used to assess health-related quality of life (HRQL) in patients treated with biological response modifiers – the Functional Assessment of Cancer Therapy – BRM (FACT-BRM) [8]
Summary
Our objective was to test a brief, symptom index for advanced renal cell carcinoma, a disease affecting over 38,000 Americans each year and often diagnosed in late stages. Renal cell carcinoma (RCC) is estimated to affect over 38,000 Americans annually and account for over 12,000 deaths [1] It is often diagnosed in advanced stages, with varied sites of metastases. Biological response modifiers such as interleukin-2 and interferon-alfa have proven effective at delaying tumor growth and disease progression These treatments can result in severe and sometimes dose-limiting toxicities such as fever, chills, nausea, vomiting, hypotension, and fatigue [3]. Less-toxic targeted therapies have shown antitumor activity in clinical trials of metastatic RCC. A recent Phase II trial demonstrating the efficacy of second-line sunitinib – a multi-targeted, tyrosine kinase inhibitor – has led to the rapid approval of this drug for the treatment of metastatic RCC [7]. Regardless of treatment type, the clinical picture of advanced RCC features an array of symptoms and complications
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