title: Prognostic factors predictive of response and survival to a modified FOLFOX regimen: importance of an increased neutrophil count.
abstract: OBJECTIVE
  The aim of this study was to identify prognostic indicators of survival and response in a homogeneous population of chemotherapy-naive patients treated with oxaliplatin as part of 3 successive trials.
  
  
  METHODS
  Patient data were derived from 3 successive phase II trials evaluating modifications of the FOLFOX4 (oxaliplatin/5-fluorouracil/leucovorin) regimen. Clinical and laboratory prognostic factors were identified from the literature. Multifactor analyses stratified by treatment cohort were performed to identify independent prognostic factors for progression-free survival (PFS), overall survival (OS), and response rate.
  
  
  RESULTS
  One hundred thirty-four patients were enrolled across all 3 studies. Reduced PFS (n = 128) was associated with patients with the following characteristics: no previous surgery (P = 0.003); previous adjuvant chemotherapy (P = 0.015); > 1 organ involvement (P = 0.001); baseline absolute neutrophil count (ANC) > or = upper limit of normal (P = 0.001); and time from diagnosis to metastases < 9 months (P = 0.043). Poor OS (n = 128) was associated with patients with the following characteristics: performance status > 1 (P < 0.001); > 1 organ involvement (P = 0.018); and baseline ANC > or = upper limit of normal (P < 0.001). Response rate was related to previous surgery (P = 0.017) and performance status (P = 0.02).
  
  
  CONCLUSIONS
  This analysis has identified the additional prognostic importance of an increased ANC for PFS and OS. Further consideration needs to be given to include markers of systemic inflammation such as ANC as well as relevant cytokine levels in a larger cohort of identically treated patients.
authors.affiliation: Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, Victoria, 8006, Australia. michael.michael@petermac.org
authors.forename: Michael
authors.initials: M
authors.lastname: Michael
authors.forename: David
authors.initials: D
authors.lastname: Goldstein
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Clarke
authors.forename: Alvin D
authors.initials: AD
authors.lastname: Milner
authors.forename: Phillip
authors.initials: P
authors.lastname: Beale
authors.forename: Michael
authors.initials: M
authors.lastname: Friedlander
authors.forename: Paul
authors.initials: P
authors.lastname: Mitchell
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D015179:Colorectal Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007770:L-Lactate Dehydrogenase / Q000097:blood; D002955:Leucovorin / Q000008:administration & dosage; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009504:Neutrophils; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D011379:Prognosis
chemical_list: D009944:Organoplatinum Compounds; D007770:L-Lactate Dehydrogenase; D002955:Leucovorin; D005472:Fluorouracil