Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer

Evaluate reliability and validity of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire and
its derivative FACT Hepatobiliary Symptom Indexes (FHSI-18 and FHSI-8) in people with metastatic pancreatic cancer.

Self-reported questionnaire data from a randomized controlled Phase II study evaluating the efficacy and safety of conatumumab
(AMG 655), ganitumab (AMG 479) or placebo combined with gemcitabine were evaluated. The following were assessed: internal
consistency, using Cronbach’s α; discriminant validity, comparing baseline patient-reported outcomes (PRO) scores across Eastern
Cooperative Oncology Group (ECOG) performance status (PS) levels; and ability to detect change, comparing change from baseline
PRO score at each cycle across PS and tumour response groups.

The analysis included 96 patients. All scale scores demonstrated good internal consistency (Cronbach’s α > 0.7) and discriminant
validity. Baseline scores were significantly poorer among patients with PS = 1 versus patients with PS = 0 (e.g. difference
in FACT-Hep total score −17.27; p < 0.001). Ability to detect change was established for Cycles 2/3 versus baseline; PRO scores reduced in the PS-worsened
group versus the PS-stable group (e.g. difference in FACT-Hep total score −24.29; p < 0.001). All PRO scale scores showed significant decline for progressive disease versus stable disease (e.g. difference
in FACT-Hep total score −12.58; p = 0.004). Changes on the FHSI-18 and FHSI-8 scales were similar in magnitude whether ECOG improved or worsened.

FACT-Hep detects change and is a reliable and valid instrument for measuring health-related quality of life in patients with
metastatic pancreatic cancer.