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Annals of Oncology Advance Access published online on December 15, 2005
Annals of Oncology, doi:10.1093/annonc/mdj072
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© 2005 European Society for Medical Oncology
Received August 8, 2005
Revised October 5, 2005
Accepted October 10, 2005

original article

Clinically meaningful changes in health-related quality of life in patients diagnosed with hepatobiliary carcinoma

J. L. Steel 1 *, D. T. Eton 2, D. Cella 2, M. C. Olek 1, and B. I. Carr 1

1 University of Pittsburgh School of Medicine, Starzl Transplantation Institute, Liver Cancer Center, Pittsburgh, PA, USA
2 Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, Chicago, IL, USA

* To whom correspondence should be addressed.
J. L. Steel, E-mail: steeljl{at}msx.upmc.edu


  Abstract

Background: To test the reliability, sensitivity to change in biomarkers associated with disease progression and response to treatment, and clinical meaningfulness of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) in patients with hepatobiliary carcinoma.

Patients and methods: One hundred and fifty-eight patients diagnosed with hepatobiliary carcinoma were prospectively studied. Health-related quality of life (HRQL) was assessed at baseline (prior to treatment), 3-month follow-up (n = 55) and 6-month follow-up (n = 27).

Results: The internal consistency of all the scales of the FACT-Hep were adequate at all time points (>0.75). The FACT-Hep was found to be sensitive to changes in clinical indicators (alkaline phosphate, alpha-fetoprotein, hemoglobin and survival) that reflect disease progression and response to treatment. Combined results from distribution-based and cross-sectional anchor-based analyses provide the following minimally important difference (MID) estimates: FACT-General (FACT-G) subscales = 2-3; FACT-G = 6-7; Hepatobiliary Cancer Subscale = 5-6; FACT-Hep = 8-9; Trial Outcome Index = 7-8; and FACT-Hepatobiliary Symptom Index = 2-3 points.

Conclusions: The FACT-Hep is a reliable instrument that is responsive to clinical indicators of disease progression and response to treatment. The MID estimates can aid interpretation of HRQL data and facilitate sample size calculation in clinical trials.

Keywords: clinical significance; Functional Assessment of Cancer Therapy-Hepatobiliary; health-related quality of life; hepatobiliary carcinoma; minimally important difference.
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