title: Baseline physical functioning status of metastatic colorectal cancer patients predicts the overall survival but not the activity of a front-line oxaliplatin-fluoropyrimidine doublet.
abstract: BACKGROUND
  No differences in response rate (RR), progression-free survival (PFS), overall survival (OS) and quality of life (QoL) were seen in patients randomly treated with biweekly oxaliplatin plus either fluorouracil/folinic acid or capecitabine.
  
  
  METHODS
  We investigated the independent effect of baseline clinical characteristics and physical functioning (PF) domain on RR, PFS, and OS in 310 patients who completed the EORTC QLQ-C30 questionnaire. Multivariate analyses stratified by treatment were performed. An exploratory analysis was done by grouping patients with a PF score superior or equal to the highest quartile (n = 111), included between the highest and the lowest quartiles (n = 99), or inferior to the lowest quartile (n = 100). The relationship between these three groups and the ECOG PS was then analysed.
  
  
  RESULTS
  At multivariate analysis, OS was negatively affected by the number of metastatic sites, the serum alkaline phosphatase, and the ECOG PS, while it was positively affected by the previous surgical resection of the primary tumour. Adding the baseline PF score, the number of disease sites (p < 0.0001), the serum alkaline phosphatase (p = 0.0057), and the PF (p = 0.0007) retained an independent significance, while the ECOG PS and the previous surgery were no longer significant. PF did not significantly affect PFS or RR. A good but not totally overlapping correlation was found between PF grouping and ECOG PS score.
  
  
  CONCLUSIONS
  Baseline self-reported PF independently predicted the OS of patients. Assessment of QoL should be incorporated in randomised trials evaluating the management of patients with MCRC.
authors.affiliation: Unit of Medical Oncology, Department of Gastrointestinal Tumour, National Tumour Institute, Naples, Italy. pasqualecomella@libero.it
authors.forename: Pasquale
authors.initials: P
authors.lastname: Comella
authors.forename: Rossana
authors.initials: R
authors.lastname: Casaretti
authors.forename: Raffaella
authors.initials: R
authors.lastname: Manzo
authors.forename: Claudia
authors.initials: C
authors.lastname: Sandomenico
authors.forename: Marina
authors.initials: M
authors.lastname: Licenziato
authors.forename: Antonio
authors.initials: A
authors.lastname: Avallone
authors.forename: Luca
authors.initials: L
authors.lastname: Franco
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011379:Prognosis; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D016896:Treatment Outcome