title: Sequential FOLFIRI.3 + Gemcitabine Improves Health-Related Quality of Life Deterioration-Free Survival of Patients with Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial.
abstract: BACKGROUND
  A randomized multicenter phase II trial was conducted to assess the sequential treatment strategy using FOLFIRI.3 and gemcitabine alternately (Arm 2) compared to gemcitabine alone (Arm 1) in patients with metastatic non pre-treated pancreatic adenocarcinoma. The primary endpoint was the progression-free survival (PFS) rate at 6 months. It concludes that the sequential treatment strategy appears to be feasible and effective with a PFS rate of 43.5% in Arm 2 at 6 months (26.1% in Arm 1). This paper reports the results of the longitudinal analysis of the health-related quality of life (HRQoL) as a secondary endpoint of this study.
  
  
  METHODS
  HRQoL was evaluated using the EORTC QLQ-C30 at baseline and every two months until the end of the study or death. HRQoL deterioration-free survival (QFS) was defined as the time from randomization to a first significant deterioration as compared to the baseline score with no further significant improvement, or death. A propensity score was estimated comparing characteristics of partial and complete responders. Analyses were repeated with inverse probability weighting method using the propensity score. Multivariate Cox regression analyses were performed to identify independent factors influencing QFS.
  
  
  RESULTS
  98 patients were included between 2007 and 2011. Adjusting on the propensity score, patients of Arm 2 presented a longer QFS of Global Health Status (Hazard Ratio: 0.52 [0.31-0.85]), emotional functioning (0.35 [0.21-0.59]) and pain (0.50 [0.31-0.81]) than those of Arm 1.
  
  
  CONCLUSIONS
  Patients of Arm 2 presented a better HRQoL with a longer QFS than those of Arm 1. Moreover, the propensity score method allows to take into account the missing data depending on patients' characteristics.
  Eudract N° 2006-005703-34. (Name of the Trial: FIRGEM).
authors.affiliation: National Quality of Life in Oncology Platform, Besançon, France; Methodological and Quality of Life in Oncology Unit (EA 3181), University Hospital of Besançon, Besançon, France.
authors.forename: Amélie
authors.initials: A
authors.lastname: Anota
authors.affiliation: Methodological and Quality of Life in Oncology Unit (EA 3181), University Hospital of Besançon, Besançon, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Mouillet
authors.affiliation: Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, University of Paris Descartes, Paris, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Trouilloud
authors.affiliation: Department of Gastroenterology, University Hospital of Besançon, Besançon, France.
authors.forename: Anne-Claire
authors.initials: AC
authors.lastname: Dupont-Gossart
authors.affiliation: Hepato-Gastro-Enterology and Digestive Oncology Department, Hospital Jean Mermoz, Lyon, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Artru
authors.affiliation: Department of Gastroenterology and Digestive Oncology, University Hospital of Tours- Trousseau Hospital, Chambray-Les-Tours, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lecomte
authors.affiliation: Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, University of Paris Descartes, Paris, France.
authors.forename: Aziz
authors.initials: A
authors.lastname: Zaanan
authors.affiliation: Biostatistics and Quality of Life Unit, Centre Georges François Leclerc, Dijon, France.
authors.forename: Mélanie
authors.initials: M
authors.lastname: Gauthier
authors.affiliation: Department of Gastroenterology, University Hospital of Besançon, Besançon, France.
authors.forename: Francine
authors.initials: F
authors.lastname: Fein
authors.affiliation: Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, University of Paris Descartes, Paris, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Dubreuil
authors.affiliation: Methodological and Quality of Life in Oncology Unit (EA 3181), University Hospital of Besançon, Besançon, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Paget-Bailly
authors.affiliation: Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, University of Paris Descartes, Paris, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Taieb
authors.affiliation: National Quality of Life in Oncology Platform, Besançon, France; Methodological and Quality of Life in Oncology Unit (EA 3181), University Hospital of Besançon, Besançon, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006304:Health Status; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology / Q000556:secondary; D008137:Longitudinal Studies; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology / Q000556:secondary; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000523:psychology; D011788:Quality of Life / Q000523:psychology*; D012107:Research Design; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine