title: Quality-of-life (QoL) as a predictive biomarker in patients with advanced pancreatic cancer (APC) receiving chemotherapy: results from a prospective multicenter phase 2 trial.
abstract: OBJECTIVE
  Pancreatic cancer is rapidly fatal with median survival of only 6 months (mo). Quality-of-life (QoL) was analyzed prospectively in a phase 2 study of gemcitabine (G), capecitabine (C) and bevacizumab (B) in APC patients.
  
  
  METHODS
  A total of 50 patients with APC received B 15 mg/kg, C 1,300 mg/m(2) daily for 2 weeks and G 1,000 mg/m(2) weekly 2 times; cycles were repeated every 21 days.
  
  
  METHODS
  progression free survival (PFS), overall survival (OS) and assessment of QoL prior to each cycle using the European organization for research and treatment of cancer (EORTC) PAN-26 QoL questionnaire. An exact 95% confidence interval (CI) (Clopper-Pearson method) was used to assess rate of improved QoL (defined as >5% decrease in two consecutive scores compared with baseline).
  
  
  RESULTS
  Patient characteristics- Stage IIB/III/IV: 3/5/42; Sex: 28 M/22 F; Median age: 64 years. QoL in patients- improved: 56%, no improvement: 24%; unevaluable: 20%. Median PFS: 5.8 mo, OS: 9.8 mo. QoL improvement rate: 28/40=0.7 (95% CI: 0.53-0.83) in evaluable patients. Using QoL improvement rate, no significant difference was seen in patients with OS ≥6 mo compared to OS <6 mo. However QoL scores at 3 and 6 weeks from start of treatment correlated strongly with ≥6 mo survival (P value 0.0092 and 0.0081, respectively).
  
  
  CONCLUSIONS
  Baseline score and change in QoL scores of patients on G, C and B were not predictive of survival ≥6 mo. Post treatment scores at 3 and 6 weeks from start of therapy however, were predictive of survival ≥6 mo suggesting the potential predictive value of this tool for use in future studies.
authors.affiliation: 1 Department of Internal Medicine, State University of New York, Buffalo NY, USA ; 2 Department of Biostatistics, Roswell Park Cancer Institute, Buffalo NY, USA ; 3 Department of Biostatistics, State University of New York, Buffalo NY, USA ; 4 Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Centre, Houston TX, USA ; 5 Department of Medicine, Roswell Park Cancer Institute, Buffalo NY, USA.
authors.forename: Sidra
authors.initials: S
authors.lastname: Anwar
authors.affiliation: 1 Department of Internal Medicine, State University of New York, Buffalo NY, USA ; 2 Department of Biostatistics, Roswell Park Cancer Institute, Buffalo NY, USA ; 3 Department of Biostatistics, State University of New York, Buffalo NY, USA ; 4 Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Centre, Houston TX, USA ; 5 Department of Medicine, Roswell Park Cancer Institute, Buffalo NY, USA.
authors.forename: Wei
authors.initials: W
authors.lastname: Tan
authors.affiliation: 1 Department of Internal Medicine, State University of New York, Buffalo NY, USA ; 2 Department of Biostatistics, Roswell Park Cancer Institute, Buffalo NY, USA ; 3 Department of Biostatistics, State University of New York, Buffalo NY, USA ; 4 Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Centre, Houston TX, USA ; 5 Department of Medicine, Roswell Park Cancer Institute, Buffalo NY, USA.
authors.forename: Jinhee
authors.initials: J
authors.lastname: Yu
authors.affiliation: 1 Department of Internal Medicine, State University of New York, Buffalo NY, USA ; 2 Department of Biostatistics, Roswell Park Cancer Institute, Buffalo NY, USA ; 3 Department of Biostatistics, State University of New York, Buffalo NY, USA ; 4 Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Centre, Houston TX, USA ; 5 Department of Medicine, Roswell Park Cancer Institute, Buffalo NY, USA.
authors.forename: Alan
authors.initials: A
authors.lastname: Hutson
authors.affiliation: 1 Department of Internal Medicine, State University of New York, Buffalo NY, USA ; 2 Department of Biostatistics, Roswell Park Cancer Institute, Buffalo NY, USA ; 3 Department of Biostatistics, State University of New York, Buffalo NY, USA ; 4 Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Centre, Houston TX, USA ; 5 Department of Medicine, Roswell Park Cancer Institute, Buffalo NY, USA.
authors.forename: Milind
authors.initials: M
authors.lastname: Javle
authors.affiliation: 1 Department of Internal Medicine, State University of New York, Buffalo NY, USA ; 2 Department of Biostatistics, Roswell Park Cancer Institute, Buffalo NY, USA ; 3 Department of Biostatistics, State University of New York, Buffalo NY, USA ; 4 Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Centre, Houston TX, USA ; 5 Department of Medicine, Roswell Park Cancer Institute, Buffalo NY, USA.
authors.forename: Renuka
authors.initials: R
authors.lastname: Iyer
keywords: Quality of life (QoL); biomarkers; neoplasm, European organization for research and treatment of cancer (EORTC); outcomes; palliative care; pancreas; pancreatic cancer; supportive oncology