Higher baseline quality of life (QOL) independently predicted longer overall survival (OS) in patients with myelofibrosis (MF) who were enrolled in the COMFORT-I clinical trial, according to a recent study.
The authors of the study, led by Heidi Kosiorek, MS, of Mayo Clinic, analyzed data from the COMFORT-I trial, which compared treatment with ruxolitinib to placebo in patients with intermediate-2 or high-risk MF. The results of the analysis were reported in a letter to the editor published in the British Journal of Haematology.
The trial enrolled 309 patients for treatment with ruxolitinib (n = 155) or placebo (n = 154), with 111 (72%) patients receiving placebo eventually crossing over to receive ruxolitinib. Baseline global health status and quality of life (GHS/QOL) data were available for 296 patients and did not differ by treatment arm.
Four patient-reported outcome variables were considered for prediction of OS. The variables were GHS/QOL, total symptom score, functional subscales, and fatigue. The analysis of OS included both the intention-to-treat method and censoring placebo patients at crossover, the authors reported.
A higher GHS/QOL score at baseline (greater than median versus equal to or less than the median) was significantly associated with increased OS in an intention-to-treat analysis (hazard ratio [HR], 0.69; 95% CI, 0.49-0.96; P=.03) and when patients receiving placebo were censored at crossover (HR, 0.57; 95% CI, 0.37-0.88; P=.001). Baseline GHS/QOL also had a significant effect on OS in multivariable results (HR, 0.92; 95% CI, 0.85-0.99; P=.03 for a 10-point increase).
Total symptom scores and fatigue were significantly higher in patients with lower GHS/QOL scores (P<.001 and P<.001, respectively).
However, individual symptoms and total symptom score at baseline were not predictive for OS, “emphasizing the importance of QOL in addition to symptom assessment,” Ms. Kosiorek and colleagues reported.
The mean GHS/QOL differed significantly with performance status. The mean GHS/QOL was 59.6 in patients with a performance status of 0, while it was 51.7 in patients with a performance status of 1 and 43.8 in patients with a performance status of 2 or 3 (P<.001). The mean GHS/QOL was not significantly different between intermediate-2 (55.8) and high-risk patients (50.9; P=.07).
Overall, baseline QOL “provided prognostication above and beyond [performance status], standard disease risk scores, and patient-reported symptoms,” according to the authors.
QOL was only assessed at baseline due to the impact of ruxolitinib on patient-reported outcomes; however, Ms. Kosiorek and colleagues concluded that “QOL changes over time may be an important consideration when evaluating survival.”