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. 2017:12:97-110.

Prognostic significance of baseline fatigue for overall survival: A patient-level meta-analysis of 43 oncology clinical trials with 3915 patients

Jeff A Sloan  1 , H Liu  2 , D V Satele  2 , S Puttabasavaiah  2 , J S Kaur  2 , J Hubbard  2 , A Dueck  3 , P J Stella  4 , Jasvinder A Singh  5
Affiliations

Prognostic significance of baseline fatigue for overall survival: A patient-level meta-analysis of 43 oncology clinical trials with 3915 patients

Jeff A Sloan et al. Trends Cancer Res. 2017.

Abstract

We have previously identified a single-item measure for baseline overall quality of life (QOL) as a strong prognostic factor for survival, and that fatigue was an important component of patient QOL. To explore whether patient-reported fatigue was supplemental or redundant to the prognostic information of overall QOL, we performed a patient-level pooled analysis of 43 North Central Cancer Treatment Group (NCCTG) and Mayo Clinic Cancer Center (MCCC) oncology clinical trials assessing the effect of baseline fatigue on overall survival (OS). 3,915 patients participating in 43 trials provided data at baseline for fatigue on a single-item 0-100 point scale. OS was tested for association with clinically deficient fatigue (CDF, score 0-50, n = 1,497) versus not clinically deficient fatigue (nCDF, score 51-100, n = 2,418). We explored whether fatigue contributed to overall survival in the presence of performance status and overall QOL. We used Cox proportional hazards models that adjusted for the effects of overall QOL, performance score, race, disease site, age and gender. Baseline fatigue was a strong predictor of OS for the entire patient cohort (CDF vs. nCDF: 31.5 months vs > 83.9 months, p < 0.0001). The effect sizes of fatigue on survival were more variable across different disease sites than was seen for overall QOL (GI, esophageal, head and neck, prostate, lung, breast and others). After controlling for covariates, including performance status and overall QOL, baseline fatigue remained a strong prognostic factor in multivariate models (CDF vs. nCDF: HR = 1.23, p = 0.02). Baseline fatigue is a strong and independent prognostic factor for OS over and above performance status (PS) and overall QOL in a wide variety of oncology patient populations. Single-item measures of overall QOL and fatigue can help to identify vulnerable subpopulations among cancer patients. We recommend these single-item measures for routine inclusion as a stratification factor or key covariate in the design and analysis of oncology treatment trials.

Keywords: Quality of life; cancer; fatigue; patient-reported outcomes; prediction; survival.

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Conflict of interest statement

CONFLICT OF INTEREST STATEMENT There are no financial conflicts related directly to this study. Dr. Singh has received research grants from Takeda and Savient and consultant fees from Savient, Takeda, Regeneron and Allergan. Dr. Singh is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 36 companies, a member of the American College of Rheumatology’s Guidelines Subcommittee of the Quality of Care Committee and a member of the Veterans Affairs Rheumatology Field Advisory Committee.

Figures

Figure 1:
Figure 1:
Pyramid graphic of PS, QOL, and fatigue.
Figure 2.
Figure 2.
Assessment scales used in the studies, Visual analog scale uniscale (2A) and Numeric rating scale (2B).
Figure 3.
Figure 3.
Boxplot of individual study fatigue scores.
Figure 4:
Figure 4:. Survival plot for OS comparing patients with clinically deficient baseline fatigue (≤ 50) and those without deficient baseline fatigue (> 50).
The figure shows ‘Years’ in the X-axis and ‘% Alive’ in the Y-axis.
Figure 5:
Figure 5:
Adjusted Kaplan-Meier survival curves.
See this image and copyright information in PMC

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