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


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.
Steel
J L
JL
University of Pittsburgh School of Medicine, Starzl Transplantation Institute, Liver Cancer Center, Pittsburgh, PA 15213, USA. steeljl@msx.upmc.edu
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Cella
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Carr
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D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000469:Alkaline Phosphatase / Q000097:blood; D001661:Biliary Tract Neoplasms / Q000097:blood* / Q000628:therapy; D014408:Biomarkers, Tumor / Q000097:blood*; D001918:Brachytherapy; D006528:Carcinoma, Hepatocellular / Q000097:blood* / Q000628:therapy; D016461:Chemoembolization, Therapeutic; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000097:blood* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D000509:alpha-Fetoproteins / Q000032:analysis
D014408:Biomarkers, Tumor; D000509:alpha-Fetoproteins; D000469:Alkaline Phosphatase