title: The prognostic significance of patient-reported outcomes in pancreatic cancer cachexia.
abstract: 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 pain" 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 < or = 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.
authors: Department of Health Economics and Pricing, Johnson & Johnson Pharmaceutical Services, Raritan, New Jersey, USA. Drobins4@cntus.jnj.com
authors: Donald W
authors: DW
authors: Robinson
authors: Debra F
authors: DF
authors: Eisenberg
authors: David
authors: D
authors: Cella
authors: Ning
authors: N
authors: Zhao
authors: Carla
authors: C
authors: de Boer
authors: Mark
authors: M
authors: DeWitte
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D001066:Appetite; D002100:Cachexia / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005221:Fatigue / Q000209:etiology / Q000401:mortality; D005260:Female; D006801:Humans; D000069285:Infliximab; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010190:Pancreatic Neoplasms / Q000150:complications* / Q000401:mortality; D011379:Prognosis; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D015431:Weight Loss; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D000964:Antimetabolites, Antineoplastic; D014409:Tumor Necrosis Factor-alpha; D003841:Deoxycytidine; D000069285:Infliximab; D000093542:Gemcitabine