EORTC QLQ-C30 Fatigue Research Articles

Prevalence, predictors, and prognostic impact of fatigue among Brazilian outpatients with advanced cancers

The purposes of this study are to evaluate the impact of cancer-related fatigue (CRF) on quality of life (QoL), and to identify its clinical predictors. In addition, the authors investigated the prognostic impact of CRF and its relationship with the inflammatory marker C-reactive protein. Data regarding patient characteristics, symptom scores, and QoL indices were collected at the initial evaluation. At the same time, blood samples were collected in order to evaluate some laboratorial markers. Patients were followed by telephone interviews every 15 days until death. CRF was defined as ≥66.67 points on EORTC QLQ-C30 fatigue subscale. The examined patients had a median age of 61 years (range, 21-86 years) and 50.7 % were male. Median Karnofsky performance score (KPS) was 75.5 (SD, 15.1). The prevalence of CRF was 25 % (55 out of 221). Overall, patients with CRF presented higher symptom burden and also worst QoL scores. The following variables were independently associated with CRF: nausea (OR 1.22, p = 0.009), dyspnea (OR 1.33, p = 0.002), KPS (OR 0.96, p = 0.009), body mass index (OR 0.93, p = 0.046), and C-reactive protein (OR 1.08, p = 0.004). The median overall survival (OS) was lower in CRF patients (p < 0.0001). Only KPS (HR = 0.96, p < 0.001) and C-reactive protein (HR = 1.07, p < 0.001) were independent prognostic factors for OS. Advanced cancer patients (ACP) with CRF had a higher burden of symptoms and impaired QoL. Our findings support the hypothesis that chronic inflammatory state (CIS) could play a role in the pathogenesis of fatigue in ACP. Moreover, CIS seems to have greater prognostic impact than the associated fatigue.

Effect of the Terminal Complement Inhibitor Eculizumab on Patient Reported Outcomes in Paroxysmal Nocturnal Hemoglobinuria (PNH): Phase III Triumph Study Results.

Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired hemolytic anemia in which complement-sensitive RBCs are destroyed leading to chronic intravascular hemolysis. PNH patients suffer from diverse and serious hemolysis-induced morbidities leading to a poor quality of life (QoL). Fatigue in PNH patients may be disabling and levels are similar to anemic cancer patients. Fatigue is multifactoral, related to both the underlying anemia and hemolysis. Patients suffer from reduced global health status, patient functioning, pain and dyspnea. Treatment with the terminal complement inhibitor eculizumab reduces intravascular hemolysis and improves anemia. The impact of eculizumab treatment on levels of fatigue and other patient reported outcomes was prospectively examined in a double-blind placebo controlled study (TRIUMPH) using two distinct instruments, the FACIT-Fatigue and the EORTC QLQ-C30. Improvements in QoL were quantified using standardized effect sizes (SES), a measure of the magnitude of the clinical benefit in various instruments. Eculizumab treatment, as compared to placebo, was associated with a very large and significant improvement in fatigue as measured by the FACIT-Fatigue scale (SES=1.13, P<0.001) as well as the EORTC QLQ-C30 fatigue subscale (SES=1.12, P<0.001). Similarly, the percentage of patients achieving a pre-specified minimally important difference (MID) was 53.7% versus 20.5% of eculizumab- and placebo-treated patients, respectively (P=0.003) using the FACIT-Fatigue; 67.7% versus 24.4%, respectively (P<0.001) with the EORTC QLQ-C30. Treatment independent univariate analyses showed that reduction in intravascular hemolysis (decreased LDH levels) and improvement in anemia (increased hemoglobin levels) were both significantly associated with an improvement in fatigue. Further, multivariate analyses indicated that reduction in hemolysis was more predictive than improvement in anemia of an improvement in fatigue. Eculizumab treatment was also associated with significant improvements with moderate to large SES in the following EORTC QLQ-C30 subscales: global health status (0.87, P<0.001); role functioning (0.93, P<0.001); social functioning (0.57, P=0.003); cognitive functioning (0.78, P=0.002); physical functioning (1.01, P<0.001); emotional functioning (0.51, P=0.008); pain (0.65, P=0.002); dyspnea (0.69, P<0.001); and appetite loss (0.50, P<0.001). These data demonstrate that resolution of intravascular hemolysis with eculizumab treatment results in large and clinically meaningful improvements in patient reported outcomes including fatigue, global health status, patient functioning, and disease-related symptoms in PNH.

The validity of EORTC QLQ-C30 fatigue scale in advanced cancer patients and cancer survivors.

Fatigue is a major complaint among advanced cancer patients. Several instruments are available for measuring fatigue. The EORTC QLQ-C30 is one of the most frequently used health-related quality of life (HRQOL) instruments, and it includes a three-item fatigue subscale. Limited knowledge exists about the validity, performance and sensitivity of EORTC QLQ-C30 fatigue scale as compared with a fatigue-specific instrument. The aim of the present study was to validate the EORTC QLQ-C30 fatigue scale (FA) against the Fatigue Questionnaire (FQ). The FQ is frequently used and was developed to measure fatigue in both cancer and noncancer populations. The FQ measures physical (PF, seven items) and mental fatigue (MF, four items). The study population included two different cohorts: A) patients with advanced metastatic cancer included in a prospective randomized study of palliative radiotherapy (n = 238); B) patients with leukaemia and malignant lymphoma curatively treated with stem-cell transplantation and high-dose chemotherapy (n = 128). The analysis demonstrated that the FA correlated higher with the PF scale (r = 0.67-0.75) as compared with the MF scale (r = 0.49-0.61). The item scale correlations between FA items and the PF scale were consistently higher than between FA items and the MF scale. A factor analysis including all the items within the FA and the FQ identified two factors. All FA items loaded on a PF factor (0.70-0.85). A floor/ ceiling effect, indicating a high number of respondents with lowest, respectively, highest scores was observed more frequently in the FA as compared with the FQ. The PF discriminated better between diagnostic groups with different levels of fatigue than the FA did. In conclusion, the EORTC QLQ-C30 fatigue scale is measuring physical fatigue. A floor/ ceiling effect seems to appear for the EORTC QLQ-C30 fatigue scale. The validity of the EORTC QLQ-C30 fatigue scale is to be questioned for use in palliative care patients. In studies with fatigue as a defined end point, a domain-specific instrument should, therefore, be added.