Baseline Quality of Life as a Prognostic Survival Tool in Patients Receiving Sumitinib for Metastatic Renal Cell Carcinoma
BACKGROUND: In a randomized phase III trial of sunitinib vs interferon-alfa (IFN-α) in metastatic renal cell carcinoma (mRCC), better baseline quality of life (QoL) was predictive of longer survival. Using this dataset, we have developed a novel prognostic tool that establishes a relationship between baseline QoL scores and median survival time.
METHODS:Baseline QoL was assessed using the FACT-Kidney Symptom Index-15 item (FKSI-15), its disease-related symptoms (FKSI-DRS) subscale, and the Functional Assessment of Cancer Therapy-General (FACT-G) scale. Weibull models estimated median progression-free survival (mPFS) and overall survival (mOS) as a function of baseline QoL.
RESULTS: Longer PFS and OS were associated with higher baseline FKSI-15, FKSI-DRS, and FACT-G scores (P<0.05), and baseline FKSI-15 score was the best predictor of survival. For example, for a baseline FKSI-15 score of 60, the predicted mPFS was 67.9 weeks, and predicted mOS was 240.6 weeks. The magnitude of benefit was greater with sunitinib vs IFN-α for a given baseline QoL score.
CONCLUSION: This novel tool indicates that baseline FKSI-15 scores were linked to mPFS and mOS in a clear and interpretable way. The results support evaluation of patient-reported QoL symptoms at baseline as a prognostic indicator of survival in clinical research and practice.
RESEARCHERS: Cella D, Bushmakin AG, Cappelleri JC, Charbonneau C, Michaelson MD, Motzer RJ., Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, US
Treatment-related Optimism Protects Quality of Life in a Phase II Clinical Trial for Metastatic Renal Cell Carcinoma
BACKGROUND: Patients on clinical trials often experience declining quality of life (QOL). Little is known about the psychosocial variables that buffer against decline.
PURPOSE: This study aims to examine correlations between psychosocial variables and QOL over the course of a clinical trial in patients with metastatic renal cell cancer.
METHODS: At baseline, 114 participants completed measures of treatment-related optimism, social support, and QOL (Functional Assessment of Cancer Therapy-General). QOL was also assessed 2, 4, and 8 weeks after the start of treatment with low-dose or intermediate-dose interferon.
RESULTS: QOL decreased significantly in the intermediate-dose group but not in the low-dose group (p < .01). The decline was less severe for patients who had high rather than low treatment optimism (p = .03). A higher level of social support was significantly associated with higher baseline QOL (p < .05) but a more rapid decline in QOL over time (p < .01).
CONCLUSION: Treatment optimism was favorably associated with QOL.
RESEARCHERS: Milbury K, Tannir NM, Cohen L., Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, USA. kmilbury@mdanderson.org
