title: Quality of life assessment in advanced pancreatic adenocarcinoma: results from a phase III randomized trial.
abstract: BACKGROUND
  A phase III trial suggested that a PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) regimen might improve the outcome compared to gemcitabine in advanced pancreatic adenocarcinoma. The analysis of treatment impact on quality of life (QOL) is reported.
  
  
  METHODS
  Patients completed the European Organization for Research and Treatment of Cancer QLQ-C30 and PAN-26 questionnaires at baseline and every second month of treatment until disease progression.
  
  
  RESULTS
  The largest differences between arms favored PEFG. Expressed as improvement > or =10 points from baseline (PEFG/gemcitabine), these were: emotional function (43/18%), fatigue (41/17%), QOL (55/29%), pain (64/41%), and flatulence (50/26%). Only change in sexual function favored gemcitabine (19/42%). Physical function, fatigue, appetite, and satisfaction with healthcare improved in 40-46% of partial responders compared with 0-12% of patients with stable disease.
  
  
  CONCLUSIONS
  Clinically relevant improvement in QOL from baseline was observed more often after PEFG than after gemcitabine, suggesting that the PEFG regimen did not impair QOL, Partial response was associated with improved QOL suggesting that effective treatment of pancreatic adenocarcinoma may have an important role in these patients.
authors.affiliation: Department of Oncology, S Raffaele Scientific Institute, Milan, Italy. reni.michele@hsr.it
authors.forename: Michele
authors.initials: M
authors.lastname: Reni
authors.forename: Elisa
authors.initials: E
authors.lastname: Bonetto
authors.forename: Stefano
authors.initials: S
authors.lastname: Cordio
authors.forename: Paolo
authors.initials: P
authors.lastname: Passoni
authors.forename: Carlo
authors.initials: C
authors.lastname: Milandri
authors.forename: Stefano
authors.initials: S
authors.lastname: Cereda
authors.forename: Anna
authors.initials: A
authors.lastname: Spreafico
authors.forename: Laura
authors.initials: L
authors.lastname: Galli
authors.forename: Roberto
authors.initials: R
authors.lastname: Bordonaro
authors.forename: Carlo
authors.initials: C
authors.lastname: Staudacher
authors.forename: Valerio
authors.initials: V
authors.lastname: Di Carlo
authors.forename: Colin D
authors.initials: CD
authors.lastname: Johnson
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D015251:Epirubicin / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D011788:Quality of Life; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D015251:Epirubicin; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine