Significance of baseline and change in quality of life scores in predicting clinical outcomes in an international phase III trial of advanced pancreatic cancer: NCIC CTG PA.3

Pancreatology. 2016 Nov-Dec;16(6):1106-1112. doi: 10.1016/j.pan.2016.08.013. Epub 2016 Aug 30.

Abstract

Background: There is insufficient information regarding the prognostic significance of baseline and change in quality of life (QoL) scores on overall survival (OS) in advanced pancreatic cancer.

Methods: QoL was assessed prospectively using the EORTC QLQ-C30 as part of the PA.3 trial of gemcitabine + erlotinib (G + E) vs. gemcitabine + placebo (G + P). Relevant variables and QoL scores at baseline and change at 8 weeks were analyzed by Cox stepwise regression to determine predictors of OS.

Results: 222 of 285 patients (pts) treated with G + E and 220 of 284 pts treated with G + P completed baseline QoL assessments. In a multivariable Cox analysis combining all pts, better QoL physical functioning (PF) score independently predicted longer OS (HR 0.86; CI: 0.80-0.93), as did non-white race (HR 0.64; CI: 0.44-0.95), PS 0-1 (HR 0.65; CI: 0.50-0.85), locally advanced disease (HR 0.55; CI: 0.43-0.71) and G + E (HR 0.78; CI: 0.64-0.96). Improvement in physical function at week 8 also predicted for improved survival (HR 0.89; CI: 0.81-0.97 for 10 point increase in score, p = 0.02).

Conclusion: In addition to clinical variables, patient reported QoL scores at baseline and change from baseline to week 8 added incremental predictive information regarding survival for advanced pancreatic cancer patients.

Keywords: Pancreatic cancer; Patient-reported outcomes; Quality of life.

Publication types

  • Clinical Trial, Phase III

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibiotics, Antineoplastic / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Child
  • Child, Preschool
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Erlotinib Hydrochloride / administration & dosage
  • Female
  • Gemcitabine
  • Humans
  • Infant
  • Karnofsky Performance Status
  • Male
  • Middle Aged
  • Pancreatic Neoplasms / psychology*
  • Pancreatic Neoplasms / therapy*
  • Predictive Value of Tests
  • Quality of Life*
  • Racial Groups
  • Survival Analysis
  • Treatment Outcome*
  • Young Adult

Substances

  • Antibiotics, Antineoplastic
  • Deoxycytidine
  • Erlotinib Hydrochloride
  • Gemcitabine