Patients with advanced renal cell carcinoma (RCC) treated with single-agent, oral sunitinib malate (Sutent) reported experiencing significantly lower severity of symptoms like bone pain and breathlessness, among others, than patients treated with interferon-alfa. This secondary analysis was published in a recent issue of the Journal of Clinical Oncology (26:3763-3769, 2008).
These data are from a large, randomized, pivotal phase III trial that previously demonstrated that sunitinib more than doubled progression-free survival vs interferon-alfa.
“Symptoms associated with a devastating and debilitating illness like kidney cancer, including lack of energy, weight loss, fever, and others, often have a significant effect on patients’ quality of life,” said Dr. David Cella, Davis Family Chair of outcomes research and executive director, Center on Outcomes, Research and Education, Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, and lead investigator on this analysis. “Therefore, patients’ perceptions of their symptoms are an important and meaningful measure of treatment impact.”
About the Study
In this study, 750 previously untreated patients with advanced RCC were randomized to receive either sunitinib (50 mg/d on a 4-weeks-on, 2-weeks-off schedule) or interferon-alfa (9 mU three times per week). Patients were asked to complete several validated questionnaires to measure their health-related quality of life, a secondary endpoint of the trial. Questionnaires were completed on days 1 and 28 of each 42-day treatment cycle and at the end of treatment or withdrawal from the study.
The Disease-Related Symptoms (DRS) subscale of the Functional Assessment of Cancer Therapy–Kidney Symptom Index (FKSI) was prespecified as the primary quality-of-life endpoint in the study and was intended to measure the impact of sunitinib on disease-related symptoms experienced by patients.
Results showed that for patients receiving sunitinib, scores on the FKSI-DRS were better at each cycle than for those in the interferon-alfa group, indicating patients reported experiencing lower severity of symptoms (lack of energy, weight loss, bone pain, fatigue, breathlessness, coughing, and fever) than patients treated with interferon-alfa. Patient-reported outcomes from other validated scales used to measure quality of life in this study also favored sunitinib vs interferon-alfa.