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.
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).


CONCLUSIONS
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.
The Ottawa Hospital Cancer Center, Ottawa, ON, Canada. Electronic address: mvickers@toh.ca.
M M
MM
Vickers
NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, NSW, Australia.
C
C
Lee
NCIC Clinical Trials Group, Queen's University, Kingston, ON, Canada.
D
D
Tu
The Ottawa Hospital Cancer Center, Ottawa, ON, Canada.
P
P
Wheatley-Price
NCIC Clinical Trials Group, Queen's University, Kingston, ON, Canada.
W
W
Parulekar
Kingston Cancer Centre, Kingston, ON, Canada.
M D
MD
Brundage
BC Cancer Agency, Vancouver, BC, Canada.
M J
MJ
Moore
NCIC Clinical Trials Group, Queen's University, Kingston, ON, Canada.
H
H
Au
NCIC Clinical Trials Group, Queen's University, Kingston, ON, Canada.
C J
CJ
O'Callaghan
The Ottawa Hospital Cancer Center, Ottawa, ON, Canada.
D J
DJ
Jonker
Princess Margaret Cancer Centre and the University of Toronto, Toronto, ON, Canada.
J
J
Ringash
Prince of Wales Hospital, Randwick, NSW, Australia.
D
D
Goldstein
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007223:Infant; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000523:psychology* / Q000628:therapy*; D011237:Predictive Value of Tests; D011788:Quality of Life; D044469:Racial Groups; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult; D000093542:Gemcitabine
D000903:Antibiotics, Antineoplastic; D003841:Deoxycytidine; D000069347:Erlotinib Hydrochloride; D000093542:Gemcitabine
Pancreatic cancer; Patient-reported outcomes; Quality of life