In an analysis of four SWOG clinical trials of patients with advanced cancer reported in JCO Oncology Practice, Mo et al found that clinically significant fatigue at baseline was associated with poorer survival and increased risk of severe adverse events.
Study Details
The analysis included data from a total of 1,907 patients with complete quality-of-life survey data from four SWOG phase II or III trials, including two in advanced non–small cell lung cancer (S0027, n = 111; S9509, n = 206) and two in advanced hormone-refractory prostate cancer (S0421, n = 960; S9916, n = 630).
Clinically significant fatigue at baseline was defined as a rating of ≥ 2 on the Functional Assessment of Cancer Therapy fatigue question or EORTC Quality of Life Questionnaire-Core 30 fatigue symptom score ≥ 50%.
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Key Findings
Among the 1,907 patients, 994 (52%) had clinically significant fatigue at baseline.
In the two trials in prostate cancer, median overall survival rates for patients with vs without baseline fatigue were 16 vs 24 months in S0421 (adjusted hazard ratio [HR] = 1.32, 95% confidence interval [CI] = 1.13–1.55, P < .001) and 14 vs 19 months in S9916 (adjusted HR = 1.31, 95% CI = 1.02–1.67, P = .03). Rates of grade ≥ 3 adverse events were significantly greater among patients with baseline fatigue for constitutional adverse events in both studies (16.5% vs 9.4%, P = .002; 13.9% vs 6.3%, P = .002), neurologic events in both studies (11.7% vs 6.1%, P = .006; 9.0% vs 3.9%, P = .01), blood or bone marrow events (44.2% vs 37.4%, P = .04) in S0421, and gastrointestinal events (19.9% vs 9.7%, P < .001) and pain (12.0 vs 6.5, P = .02) in S9916.
In the two trials in lung cancer, median overall survival rates for patients with vs without baseline fatigue were 6 months vs 11 months in S0027 (adjusted HR = 1.53, 95% CI = 0.95–2.45, P = .08) and 7 vs 12 months in S9509 (adjusted HR = 1.44, 95% CI = 1.04–2.00, P = .03). No significantly increased risk of grade ≥ 3 adverse events was observed in any category among patients with baseline fatigue.
The investigators concluded, “Oncology trial participants with baseline clinically significant fatigue had poorer survival and experienced more adverse events than participants without clinically significant fatigue. This indicates fatigue as an important baseline prognostic factor in oncology treatment trials.”
Robert S. Krouse, MD, of the Department of Surgery, Hospital of the University of Pennsylvania, is the corresponding author for the JCO Oncology Practice article.
Disclosure: The study was supported by the National Cancer Institute and others. For full disclosures of the study authors, visit ascopubs.org.
