In an analysis of SWOG clinical trials reported in JCO Oncology Practice, David Hui, MD, MS, MSc, and colleagues found that better baseline health-related quality of life was associated with better survival outcomes in patients with advanced cancer.
Study Details
The study involved a review of completed SWOG clinical trials to identify those involving patients with advanced cancer that incorporated Functional Assessment of Cancer Therapy (FACT) questionnaires at baseline and included progression-free and overall survival outcomes. The analysis included three trials, with a total of 1,295 patients (85% of total 1,527 enrolled patients) with both FACT–Trial Outcome Index (FACT-TOI) and survival outcome data available: S0027 (n = 111) and S9509 (n = 219) in advanced non–small cell lung cancer and S0421 (n = 965) in hormone-refractory prostate cancer. FACT-TOI scores were standardized to 0 to 100, with higher scores indicating better health-related quality of life.
The association between baseline FACT-TOI scores and survival underscores their potential as a stratification factor in clinical trials.— David Hui, MD, MS, MSc, and colleagues
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Key Findings
In univariate analysis of progression-free survival by FACT-TOI quartiles, a statistically significant gradient effect was observed in all three trials, with higher baseline FACT-TOI scores corresponding with better progression-free survival in S0027 (range of median progression-free survival from lowest to highest quartile = 2 to 7 months, P < .001), S9509 (median range = 2 to 5 months, P = .02), and S0421 (median range = 6 to 11 months, P < .001).
In multivariate analysis adjusted for age, sex, disease stage, performance status, race, body mass index, study treatment assignment, and study stratification factors, higher FACT-TOI was significantly associated with improved progression-free survival in S0027 (hazard ratio [HR] = 0.64, 95% confidence interval [CI] = 0.42–1.00, P = .048) but not in S9509 (HR = 0.77, 95% CI = 0.56–1.05, P = .10) or S0421 (HR = 0.86, 95% CI = 0.73–1.01, P = .07).
In univariate analysis of overall survival using FACT-TOI quartiles, a statistically significant gradient effect was observed in all three trials, with higher baseline FACT-TOI scores corresponding with better overall survival in S0027 (range of median overall survival from lowest to highest quartile = 3 to 14 months, P < .001), S9509 (median range = 5 to 12 months, P = .003), and S0421 (median range = 14 to 27 months, P < .001).
In multivariate analysis, higher FACT-TOI was significantly associated with improved overall survival in S0027 (HR = 0.51, 95% CI = 0.33–0.80, P = .004), S9509 (HR = 0.58, 95% CI = 0.42–0.81, P = .001), and S0421 (HR = 0.68, 95% CI = 0.57–0.81, P < .001).
The investigators concluded, “The association between baseline FACT-TOI scores and survival underscores their potential as a stratification factor in clinical trials.”
Dr. Hui, of the Department of Palliative, Rehabilitation & Integrative Medicine, The University of Texas MD Anderson Cancer Center, is the corresponding author for the JCO Oncology Practice article.
Disclosure: The study was supported by grants from the National Cancer Institute (NCI), NCI Division of Cancer Prevention, and The Hope Foundation for Cancer Research. For full disclosures of the study authors, visit ascopubs.org.
