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The Prognostic Significance of Patient-reported Outcomes in Pancreatic Cancer Cachexia
Department of Health Economics and Pricing, Johnson & Johnson Pharmaceutical Services, Raritan, New Jersey; the Center on Outcomes, Research and Education (CORE), Northwestern University, Evanston, Illinois; Centocor Research and Development, Inc., Horsham, Pennsylvania; Centocor Oncology, Leiden, the Netherlands; and Centocor Hematology and Oncology, Malvern, Pennsylvania
Data from a clinical study of 86 pancreatic cancer patients with involuntary, significant weight loss (cachexia) were used to explore the relationship between patient-reported outcomes (PROs) and survival. In all, 28 pancreatic cancer patients with cachexia were given gemcitabine (Gemzar) plus 3 mg/kg of infliximab (Remicade), 28 were given gemcitabine plus 5 mg/kg of infliximab, and 30 were given gemcitabine plus placebo in a double-blinded, phase II, multicenter trial. PRO endpoints included scores from the Functional Assessment of Chronic Illness Therapy.Fatigue (FACIT–F), Functional Assessment of Anorexia/ Cachexia Therapy (FAACT), Brief Pain Inventory (BPI), and the Short-Form 36 general health survey (SF-36). Population mean scores at baseline indicated fatigue problems (FACIT–F), nutritional health issues (FAACT), and mild-to-moderate pain (BPI "worst painh score"). Baseline normalized SF-36 values for physical functioning, vitality, and mental health indicated substantial impairment. Baseline fatigue and physical-functioning scores predicted survival as well as, or better than, baseline Karnofsky Performance Status or hemoglobin level. A cut-point in the FACIT–F score (median ≤ 30) strongly predicted mortality; patients with greater fatigue had a lower median overall survival than did those with less fatigue. These findings supported several features of an a priori clinical-benefit model. Patient-reported fatigue provided powerful prognostic information; tracking of this symptom may be useful for treatment planning and medical monitoring of advanced-stage pancreatic cancer patients with cachexia. These results must be confirmed by larger trials.
| J Support Oncol 2008;6:283–290 | full text |  179 kb |